Contextual Emotion-Regulation Therapy for Childhood Depression: Description and Pilot Testing of a New Intervention

Contextual Emotion-Regulation Therapy for Childhood Depression: Description and Pilot Testing of a New Intervention MARIA KOVACS, PH.D., JOEL SHERRILL, PH.D., CHARLES J. GEORGE, M.S., MYRNA POLLOCK, M.S.W., RAMESHWARI V. TUMULURU, M.D., AND VINCENT HO, M.D.

ABSTRACT Objective: To pilot test the acceptability and efficacy of contextual emotion-regulation therapy (CERT), a new, developmentally appropriate intervention for childhood depression, which focuses on the self-regulation of dysphoria. Method: Two samples of convenience (n = 29, n = 2) served to verify some CERT constructs; it was then operationalized in a treatment manual. To pilot test CERT, 20 children (ages 7Y12; 35% girls) with DSM dysthymic disorder (mean duration 24.4 months) entered an open, 30-session, 10-month, 4-phase trial, with 6- and 12-month follow-up. Assessments included independent clinical evaluations and self-rated questionnaires. Results: Fifteen children completed therapy, four were administratively terminated, and one dropped out. Completers did not clinically differ from the rest, but they were more likely to have better educated and less depressed mothers and intact families. At the end of treatment, 53% of the completers had full and 13% partial remission of dysthymia (remission from superimposed major depression was 80%). By 6- and 12-month follow-up, 79% and 92% had full remission of dysthymia (p G .0001). Self-reported depressive and anxiety symptoms significantly declined by the end of treatment (p G .001) and remained so throughout follow-up. Conclusions: CERTenables clinicians to Bmatch[ the intervention to children_s emotion regulatory needs and symptoms and was readily accepted by families. The promising results suggest the need for a randomized trial. J. Am. Acad. Child Adolesc. Psychiatry, 2006;45(8):892Y903. Key Words: childhood depression, dysthymia, emotion regulation, treatment.

The nonsomatic treatment of depressive disorders in juveniles continues to be a mental health priority Accepted March 14, 2006. Drs. Kovacs and Tumuluru are with the Department of Psychiatry, University of Pittsburgh School of Medicine and Western Psychiatric Institute and Clinic, Pittsburgh; Dr. Sherrill is with the National Institute of Mental Health, Bethesda, MD; Mr. George and Ms. Pollock are with the University of Pittsburgh Medical Center; Dr. Ho is with CYKE, Inc., Atlanta. This article is based on work that was completed while Dr. Sherrill was at the University of Pittsburgh. Views expressed within this article represent those of the authors and are not intended to represent the position of National Insitute of Mental Health (NIMH), National Institutes of Health (NIH), or the Department of Health and Human Services (DHHS). This study was supported by NIMH grant 5R21 MH55244; preparation of the manuscript was supported by NIMH Program Project grant 5P01 MH56193. The authors thank Melina Orsini-Young, M.S.W., for her participation in the study and an anonymous reviewer for helpful suggestions. Correspondence and requests for the treatment manual, parents_ manual, and unpublished assessment tools to Dr. Maria Kovacs, WPIC, 3811 O_Hara Street, Pittsburgh, PA 15213; e-mail: [email protected]. 0890-8567/06/4508-0892Ó2006 by the American Academy of Child and Adolescent Psychiatry. DOI: 10.1097/01.chi.0000222878.74162.5a

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(Compton et al., 2004; Curry, 2001; Kendall and Choudhury, 2003; Michael and Crowley, 2002). However, research in this area has focused typically on adolescents 12 years of age and older and short-term interventions for episodes of major depressive disorder (MDD; e.g., Curry, 2001). Although in terms of sheer numbers, children 12 years old and younger with chronic depression represent a minority of the population of depressed juveniles, there are several reasons why they should be targeted for intervention research. In clinically referred children, dysthymic disorder (DD), one form of chronic depression, lasts almost 4 years on average, and about 18% of youngsters with MDD have episodes longer than 1.5 years (Kovacs et al., 1997). Such extended periods of depression are likely to have deleterious functional and developmental consequences across the elementary school years, a period during which various basic skills must be acquired. In addition, protracted dysphoric mood at a young age

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NEW TREATMENT FOR CHILDHOOD DEPRESSION

may interfere with the structural and functional maturation of cortical and subcortical brain circuits, a normative process that continues into adolescence (Casey et al., 2000; Durston et al., 2001). Finally, among youngsters, DD typically predates subsequent MDD (Kovacs et al., 1994) and thus represents one of the earlier manifestations of vulnerability to major mood disorders. One likely reason for the lack of psychological intervention trials with clinically depressed children is that available treatments generally are not developmentally appropriate or sensitive (see Weisz et al., 1992), a concern specifically noted with regard to the cognitivebehavioral therapies (Hammen et al., 1999; Kendall and Choudhury, 2003). The emphasis on short-term interventions for MDD probably reflects various constraints imposed by health care insurers as well as a range of practical and clinical issues (e.g., Weisz et al., 1997). Thus, the relative scarcity of treatment trials with chronically depressed children is likely to mirror a combination of factors along with the belief that brief intervention may be inappropriate for dysthymia. Consequently, there is scant empirical information about whether and how long-term depression in childhood can be ameliorated. In the present article, we describe a new intervention, developed specifically for school-age depressed children, and report on its application to treat chronic depression. The goals of this open pilot testing trial were to assess the intervention_s acceptability (willingness to remain in treatment) and efficacy (diagnostic and symptom severity outcomes). CONTEXTUAL EMOTION-REGULATION THERAPY (CERT) FOR DEPRESSION

CERT, which focuses on the self-regulation of distress and dysphoria, was inspired by a combination of clinical observations, the literature on stress and coping, and a developmental approach to emotion regulation. It is a goal-directed and problem-focused intervention, with a strong didactic emphasis. The intervention_s explanatory paradigm and its application to chronic depression have been operationalized in a working treatment manual, which also addresses practical issues (e.g., basic therapeutic stance, effective use of language with children), provides Bhow to[ guidance (e.g., introducing the explanatory framework, selecting target symptoms and intervention techniques, reframing mood-related incidents in terms of emotion regulation), notes special

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problems (e.g., acute suicidality), and includes a module on coping skills training. Framework and Rationale

The relationships between stress and coping and between stress and depression, which have been extensively documented, serve as a general framework for the treatment. Within this framework, CERT posits that problems in the adaptive self-regulation of distress and dysphoria compromise a child_s ability to cope and facilitate the emergence of clinical depression. The specific assumptions of CERT are that dysfunctional selfregulation of distress and dysphoria, a key characteristic of depressed children, developmentally precedes the onset of depressive disorder; stress, along with contextual variables, interact with preexisting regulatory difficulties to enable progression of dysphoric emotion to dysphoric mood and then to a depressive disorder; ongoing affective distress (dysphoria, irritability, anhedonia) maintains the depressive syndrome and therefore its reduction must be a salient treatment target; and dysfunctional regulatory responses to distress and dysphoria can be identified and remediated. The CERT explanatory paradigm is presented to families as the following themes: (1) the child_s Bmood problems[ are likely to have come about gradually, along with earlier signs of sensitivity to even small, everyday distress elicitors (i.e., has had difficulties in the adaptive down-regulation of distress), (2) the depressive episode has been preceded by one or more stressors or difficulties (distress elicitors), representing either a major negative event or an accumulation of minor hassles, (3) given that this child has been historically sensitive to distress elicitors, as well as specific contextual issues, he or she has been unable to modulate or down-regulate the dysphoric emotion, leading to protracted negative mood, which has adverse effects on the parentYchild and other relationships, and (4) protracted negative mood and its social repercussions negatively affect other areas of functioning, contributing to a spiral of symptoms, which culminate in clinical depression. Examples are used to reframe the child_s emotion regulatory difficulties and depressive symptoms in the context of stress and coping, which helps families to anchor key CERT concepts in their daily lives. The treatment goals are identified as helping the child to recover from his or her current depressive disorder (symptom reduction) and become more skilled at

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regulating dysphoric emotions and in responding to distress-eliciting situations (Bcoping skills training[ with an emphasis on adaptive emotion regulatory responses). Development of Emotion Regulatory (ER) Responses

A major conceptual basis of CERT is that starting in infancy and continuing thereafter, ER responses in general and those evoked by distress and dysphoria in particular unfold as part of a complex normative developmental process within a social context (e.g., Kopp, 1989; Thompson, 1994). How this process takes place, what its key components are, and how salient features are best defined or measured have been topics of lively debates during the past 15 years or so. Kopp_s 1989 article on the regulation of distress and negative emotions in infancy has served as an important stimulus for research on this construct. A monograph entirely dedicated to the development of emotion regulation (Fox, 1994), a special issue of the journal Child Development 10 years later (March/April 2004), as well as various books on this topic (e.g., Bradley, 2000; Garber and Dodge, 1991) reveal both the multifaceted nature of ER and the variety of approaches used to study it. There is general consensus that distress or dysphoria can elicit a variety of regulatory responses that can serve to diminish or alleviate it, that multiple interactive processes are involved (or called upon) in any given ER response, and that the nature of the response or its component elements vary as a function of developmental stage. There also is considerable agreement that the ability to refocus attention away from the source of distress or dysphoria, or the associated feelings, represents a primary ER response, starting in early childhood, and that refocusing of attention can be achieved through a variety of actions and behaviors. Although ER responses are typically initiated by caregivers for distressed infants and toddlers, children become increasingly able to self-regulate such negative emotions. For example, during infancy, dysphoria and distress are modulated mostly through input from caregivers who achieve that goal by various actions (e.g., gentle touching, coddling, rocking, attempts to distract the infant, feeding). With the emergence of basic skills (e.g., ambulation, motor coordination, language, attention focusing), toddlers and young children gradually master a repertoire of responses that they can initiate and deploy to modulate or terminate their own feelings of sadness or distress. Thus, a distressed young child can alleviate that emotion by self-soothing, turning to play activity, leaving

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the scene, finding some distracter, or trying to engage caregivers_ help for distress relief. The increasing sophistication of language, cognitive, and interpersonal skills gradually enables children and adolescents to master a variety of additional ER responses, which can involve their own thought processes (cognitions), more strategic discourse and interaction with caregivers or peers, or manipulation of features of their environment. In general, the family context and the social Bregulators[ therein play key roles in the unfolding and use of distress-specific ER responses during childhood, whereas peers as Bsocial regulators[ become important in adolescence. Overall, the developmental literature reveals several important features of the normative unfolding of distress/ dysphoria self-regulation. First, the vast majority of ER responses to distress, which human beings display, are products of learning, having been molded and shaped by social context in general, and the family context in particular. Second, a wide variety of behaviors and actions can serve as ER responses, which typically (but not invariably) become increasingly sophisticated with age. Correspondingly, caregiver-initiated ER responding is gradually replaced by self-initiated responding. Third, as a normal part of development, children_s ER repertoires become larger, come to include mostly functional but also some dysfunctional responses, and are characterized by ER response deployment, which is both flexible and context sensitive. Fourth, there are considerable individual differences in ER responses to distress and dysphoria, which are likely to represent a combination of innate physiology, history of ER response acquisition and deployment, and personal resources. Finally, ER responses can occur at various points along an emotion experience and can be defined in various ways. CERT and the Regulation of Dysphoria

In CERT, emotion regulation is defined as responses, which may serve to interrupt, lessen, diminish and terminate, or maintain, accentuate, and prolong the emotion. Adaptive or functional ER responses to dysphoria serve to down-regulate it and therefore enable the child to feel better, whereas maladaptive or dysfunctional responses exacerbate or prolong the negative mood (and thereby engender other problems). Thus, one of the goals of CERT is to identify the specific ways in which a given child has historically responded to dysphoria or distress elicitors in various contexts and the types of ER responses that have been useful.

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NEW TREATMENT FOR CHILDHOOD DEPRESSION

Within the framework of CERT, ER responses to dysphoria are grouped into four interconnected domains: biological, behavioral, cognitive, and social/interpersonal. This concept is presented to families as Bsources of emotion regulation[ or Btypes of control processes[ that can help a child to feel better. The Bbiological[ domain of ER is defined as the physiological infrastructure underlying emotions and ER, or the Bphysical processes[ in one_s body, which also involves a child_s innate sensitivity and possibly high reactivity to emotion elicitors. The Bbehavioral[ regulatory domain is presented to families as Bways of acting or what you do[ to manage or control dysphoria, including responses such as walking away from a distressing situation, turning to play activity, doing physical exercise, playing music, doing chores, and working on a project. The Bcognitive[ regulatory domain is described to children as Bwhat goes on in your head[ that can help to feel better, including conjuring up some image to counter the dysphoric emotion, helpful Bselftalk,[ focusing attention on neutral or positive topics, and changing how you think about what makes you sad, such as minimizing its significance. The Bsocial/interpersonal[ ER domain, which entails enlisting other people as the means to down-regulate one_s own dysphoria, is presented as Bhow other people can affect you or help you to feel better.[ This domain includes both the types of interactions whereby others can help modulate a given child_s distress, such as the child getting a hug or being physically comforted, talking to a parent or teacher about the dysphoria, and engaging a peer in play or some project, and effective ways of recruiting social regulators such as the use of explicit language. Consistent with the importance of context in the experience and regulation of emotions (e.g., Thompson, 1994), the treatment also considers environmental manipulation and the use of external resources as (behavioral) regulatory responses. Salient Features of CERT

The developmental ER perspective of CERT had several implications for its implementation. First, because ER is Bboth an individually based and a relational phenomenon[ (Grolnick et al., 1996) and the use of social agents to regulate distress is a major ER domain (Hofer, 1994), at least one caregiver had to actively participate in the child_s treatment. Second, because developmental perspectives highlight individual differences, no assumptions were made about one ER domain or set of regulatory responses being more important than

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another. On the contrary, the individually tailored approach of CERT accommodates the fact that a given ER response (e.g., provision of physical comfort) may help one child to regain emotional homeostasis, but have the opposite effect on another child and that there are age-related differences in regulatory competencies (e.g., a 7-year-old_s ER repertoire is less likely than that of a 11-year-old to contain adaptive cognitive responses). Third, because ER responding is shaped across development through learning and practice, didactics and rehearsal are key components of CERT. Another salient feature of CERT is the emphasis on the Bcontext[ of symptoms and ER responses. The Bcontextual mapping[ of a symptom or problem scenario (i.e., constructing a detailed account of a distress-eliciting incident) enables the therapist to select a point of intervention (for that given complaint), which may be the ER response, some nonmood depressive symptom, or environmental features. Throughout treatment, the ongoing goals are to identify the given child_s habitual adaptive and maladaptive responses to persistent dysphoria and daily events that exacerbate it (the latter being typically exemplified by problem scenarios brought into sessions); pinpoint to families ER responding that upregulates (rather than modulates) or has no effect on the emotion or mood; reinforce or teach age-appropriate, adaptive, dysphoria-specific regulatory responses; and reframe the child_s difficulties using a general ER and coping perspective. If the existing repertoire of adaptive ER responses to dysphoria is inadequate, then the child_s inclination toward one versus another ER domain is used to remediate deficits. For example, a child who is social by nature would be taught adaptive ways of recruiting Bsocial regulators[ as one way to feel better when he or she feels sad. Alternatively, with a child who has a clear preference for thinking (but may not be socially inclined), various cognitive ER responses would be explored. To facilitate adaptive ER response deployment, any number of strategies can be used including social modeling, differential reinforcement, paired-associate learning, and depending on the child_s age and skills, didactics focusing on cognitive processes (i.e., alternative explanations, visual imagery). If the child_s history reveals past deployment of adaptive regulatory responses to dysphoria, then the goal is to reinforce them and ensure a facilitative context. For example, if a child had been able to self-regulate distress/dysphoria in the past by engaging in physical

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activity, but recent environmental changes have constrained him or her, the therapist and the family together identify alternative venues to enable deployment of that ER response. To ensure active parental participation in CERT, the parent is asked to serve as an Bassistant coach[ and is provided with six Brules of coaching[ (e.g., Bcoaches are made, not born,[ Beven a coach can have a bad day[). The rules of coaching are included in a parent_s manual that summarizes basic CERT concepts. As an assistant coach, the parent not only helps the child but also tries on a new role and new ways of interacting, which were envisioned to have positive effects both on the child_s ER skills and the parentYchild relationship. In managing depressive symptoms other than mood, the therapist can select from a broad array of focused, problem solvingYoriented, behavioral, interpersonal, and cognitive techniques that have been widely described in the literature as practical and useful. These techniques include teaching Bsleep hygiene[ as one way to counter sleep disturbance, keeping a log to identify temporal features of symptoms such as fatigue, assigning pleasant social activities to counter withdrawal, teaching visual imagery to counter negative thoughts about the self or others, or designing behavioral experiments to explore new ways of responding. During Bcoping skills training,[ the final phase of CERT, age-appropriate didactic aids are employed to reinforce what has been learned about ER. For example, the therapist and the family together view film segments depicting dysphoric emotions and the protagonists_ ER responses (e.g., precued sections from The Lion King, Babe). A list of a priori defined questions and probes posed by the therapist help children review appropriate emotion-naming, recognize putative causes, and identify ER responses that were adaptive (helped the protagonist to feel better) and those that were not (made the protagonist feel more distressed or dysphoric). ParentY child pairs also are helped to catalog dysphoria-eliciting contexts that have been historically troublesome for the child, and how to prepare for them by the child_s ongoing adaptive use of ER responses. The importance of contexts and strategies that help to initiate or maintain positive emotions also are discussed. In short, the emphasis is on practicing adaptive regulatory responses to dysphoria to be able to prevent such an emotion from Bgetting out of hand.[ In addition, by reviewing the general coping framework within which problems can be

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understood, it is reiterated that under some conditions involving dysphoric emotion, solving the given problem may be the most practical and useful approach.

PRETRIAL VERIFICATION OF SELECTED CONSTRUCTS

Two samples of convenience served to explore aspects of the explanatory framework and ER responses, namely 19 psychiatrically referred (PR) children with various clinical diagnoses of depression (ages 7Y12 years; 63% male; 58% living in single-parent homes), and 10 normal controls (NC) with no history of psychiatric illness or treatment (ages 7Y12 years; 50% male; 40% living in single-parent homes). Members of the Treatment Development Team, using a combination of a semistructured questionnaire and an open-ended interview, individually interviewed the children about Bcauses[ of and ways to alleviate dysphoria in youngsters their age and about means of expressing such emotions to an adult. Both groups cited aversive peer behavior (being teased, called names) as a salient cause of dysphoria (42% and 60%, respectively), but only the PR children cited highly painful experiences (e.g., someone having died [11 of 19], being left or put in foster care [5 of 19]). Some social/interpersonal response was most commonly cited as a way to modulate dysphoria, including talking to someone (63% and 40%, respectively). The PR children also generated ER responses such as Bdoing something fun[ (6 of 19) and someone buying you something nice (3 of 19). Regarding methods to express dysphoric feelings, rated from Beasy[ to Bdifficult,[ 70% of the NC children opined that Btalking about it[ is somewhere in the middle range, but only 37% of the PR children said so, and another 37% stated that it was Bdifficult.[ By rank order, both groups noted that talking about one_s emotion was the hardest, and drawing pictures of faces to show your emotion was relatively easy, but for the PR children, selecting an emotion-expression face from a chart of faces was the easiest way to identify their emotion to an adult. According to both groups, keeping a written notebook can help children track their daily emotions and moods (63% of the PR group; 80% of the NC), but only a minority stated that this would be easy (42% of PR; 20% of NC), citing various barriers (e.g., Bhe_ll forget the paper[).

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NEW TREATMENT FOR CHILDHOOD DEPRESSION

In addition, during brief therapy with two psychiatrically referred children (a 9-year-old boy and an 11-year-old girl, both with 2-year histories of depressed mood and associated problems), we piloted enrolling the parent as an Bassistant coach[ or Bcotherapist[ and techniques such as the young patients keeping mood and activity logs, and involving parentYchild pairs in behavioral experiments. Parents were found to be most receptive to intervention strategies that were developed in collaboration with them as Bco-therapists.[ The children were able (with reminders) to complete mood logs that served to pinpoint diurnal variations (which, interestingly were found to differ from initial parental perceptions), and activity logs that helped to identify behaviors that diminished dysphoria as well as parentYchild interactions that exacerbated it. In summary, the informal survey suggested that children recognize the relationship between dysphoria and stressful events. Many of the ER responses they generated map onto those in CERT, with one exception (traditional Bcognitive[ responses, e.g., thinking about the distress differently), were rare. However, this finding is age appropriate (M.K., unpublished manuscript). The results also suggested the advisability of using visual aids to facilitate discourse about dysphoric emotion. All of these sources of information were used to produce a working treatment manual, subsequent to which we initiated the clinical trial.

CLINICAL TRIAL METHOD Subjects Children had to meet the following study entry criteria: ages between 7 and 12 years; no evidence of major systemic medical disorder, mental retardation, or psychosis; presence of chronic depressive disorder; not receiving pharmacotherapy; and willingness of at least one parent to actively participate in the treatment. Recruitment efforts (at our child psychiatric outpatient referral units, various other child mental health clinics, and via community advertisement) resulted in 101 initial phone screens; 36 children then had a full evaluation; 20 met criteria and entered the treatment protocol. Treatment was provided free of charge. Families signed informed consents, and children provided assents. The sample of 20 was 35% female, had a mean age at entry of 10.4 years (SD = 2.2 years), 90% were white, and 10% were African American or biracial; 90% lived in two-parent households and 80% lived in intact families of origin. For 65% of the sample, educational attainment of the head of household was a college degree (or higher). Of the children, 50% had a history of outpatient mental health treatment; none had a history of psychotropic medication use or inpatient hospitalization. Chronic depression was defined as the diagnosis of DD according to either DSM-IV or DSM-III, in part because the validity of DSM-IV DD criteria for youth has not yet been documented. Three cases with clear Bdysthymia-like[ presentation (two were somewhat short of the 1-year duration at intake and one with chronic illness but one symptom short) were formally diagnosed as depressive disorder not otherwise specified, but were considered for practical purposes as having DD. At study entry, 16 subjects met criteria for both DSM-IV and DSM-III DD and 4 met only DSM-III criteria. Duration of the index episode was 24.4 months (SD = 11.9). Six children had a superimposed MDD at intake (two others had previous MDD episodes) and 70% had nonaffective (anxiety and oppositional defiant) comorbid disorders (Table 1).

TABLE 1 Clinical Characteristics of the Sample at Four Time Points Treatment Completers

All Subjects at Intake (N = 20)

Intake (n = 15)

Tx End (n = 15)

6-Mo FU (n = 14)

12-Mo FU (n = 13)

20 (100) 6 (30) 8 (40) 9 (45)

15 (100) 5 (33) 7 (47) 6 (40)

7 (47) 1 (7) 5 (33) 6 (40)

3 (21) 0 3 (21) 2 (14)

1 (8) 0 1 (8) 2 (15)

16.3 (10.1) 15.0 (6.7)

16.6 (10.7) 15.3 (6.7)

4.3 (6.8) 4.7 (5.9)

5.0 (7.6) 4.5 (5.4)

5.3 (7.2) 5.3 (5.6)

11.8 (6.5) 10.7 (5.0)

9.9 (5.6) 9.5 (4.5)

7.0 (3.9) 7.7 (3.2)

3.8 (3.4) 4.2 (3.3)

6.0 (3.2) 6.5 (5.4)

Variables Diagnosis present (no., %) DD MDD Anxiety disorder ODD Children_s self-rated symptoms (mean, SD) Depression (CDI) Anxiety (RCMAS) Mothers_ clinician-rated symptoms (mean, SD) Depression (HRS-D) Anxiety (HRS-A)

Note: Results of statistical analyses are in the text. Tx = treatment; FU = follow-up; DD = dysthymic disorder; MDD = major depressive disorder; ODD = oppositional defiant disorder; CDI = Children_s Depression Inventory; RCMAS = Revised Children_s Manifest Anxiety Scale; HRS-D = Hamilton Rating Scale for Depression; HRS-A = Hamilton Rating Scale for Anxiety.

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Assessment and Diagnostic Procedures Psychiatric diagnoses at intake, end of treatment, and 6- and 12-month follow-up were derived via the Schedule for Affective Disorders and Schizophrenia for School-Age Children (K-SADS; Kaufman et al., 1997), which was administered by trained, independent clinicians to the parent about the child and then separately to the child about him- or herself. The results were reviewed by at least one other experienced clinician to ensure consensus diagnoses. At the end of treatment and follow-up evaluations, remission of a given disorder was defined operationally (Kovacs et al., 1984) as being free of clinically significant and impairing symptoms (i.e., no more than one symptom and few, if any, subclinical symptoms of the particular disorder remaining), and maintenance of this essentially asymptomatic state continuously for a minimum of 2 months. For behavior disorders, the minimum time frame for remission was at least 3 months. Partial remission was defined as no longer meeting full diagnostic criteria for the specific disorder but the persistence of a subsyndromal clinical picture. During treatment, independent evaluators conducted monthly symptom assessments of the child via the Follow-up Depression and Anxiety Scales for Youths (FDS-Y, and FAS-Y, respectively). These clinician-rated scales were derived from the Interview Schedule for Children and Adolescents (Sherrill and Kovacs, 2000) and entail standard probes regarding symptom frequency and intensity. Based on separate interviews with the child and with the parent about the child, the clinician provides an overall rating for each symptom ranging from 0 = none to 3 = severe (pervasive/constant, impairing/ disrupts functioning). The FDS-Y (26 items) has a potential score range of 0 to 78; the FAS-Y (11 items) has a potential score range of 0 to 33. Clinical evaluators were aware that the children were participating in a treatment protocol. Children completed the Children_s Depression Inventory (CDI; Kovacs, 2003) and the Revised Children_s Manifest Anxiety Scale (RCMAS; Reynolds and Richmond, 1985) about themselves at preset time points. Parents (typically mothers) completed the Beck Depression Inventory (Beck et al., 1988) about themselves and other questionnaires and were evaluated by independent clinicians via the Hamilton Rating Scales for Depression (HRS-D; Hamilton, 1967a) and Anxiety (HRS-A; Hamilton, 1967b) at start of treatment, its end, and at follow-up. Per the protocol, clinically depressed parents were referred for treatment, which was available gratis by prior arrangement.

Treatment Protocol As an intervention for chronic depression, we designed a 30-session, multiphase, 10-month protocol as follows: phase IVmonth 1: intense treatment, one to two sessions per week (up to eight sessions); phase IIVmonths 2Y 4: regular treatment, one session per week (up to 13 sessions); phase IIIVmonths 5 Y 6: tapered treatment, one session every 2 weeks (up to five sessions); phase IVVmonths 7Y10: maintenance treatment, one session/month (up to four sessions). The first three phases were limited to 26 sessions owing to past research (with adults) that suggested that by session 26, the vast majority of patients show some improvement (Howard et al., 1986). The maintenance phase (phase IV) was spaced across 4 months to provide time for the consolidation of newly learned skills. The protocol required evidence of symptomatic improvement at the 5- and 7-month points (defined via specific CDI cutoff scores for boys and girls) to advance a child to the respective phase. At 6 and 12 months after end of

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treatment, follow-up evaluations included independent (but not blind) K-SADS interviews, and parent- and child-rated questionnaires. Participating were three therapists, whose psychotherapeutic experiences ranged from 5 to 7 years (their highest academic degrees were Ph.D., M.D., and M.S.W.). The treatment room included visual aids that were age appropriate for children (e.g., wall poster depicting the regulatory domains as rooms of a house with pertinent ER Btools[ noted in each ER room) and a poster that listed the Brules of coaching.[ Each session involved the parentYchild pair. Sessions were tape recorded and reviewed in weekly meetings by the Treatment Development Team to ensure adherence to the basic explanatory framework, identify protocol features that needed to be clarified, and discuss any modifications that may be warranted. Intersession telephone contacts were allowed if needed to verify or confirm some element of treatment.

RESULTS Characteristics of Completers Versus Noncompleters

Of the 20 cases, 15 completed the protocol. Four were administratively terminated owing to too many missed sessions (defined a priori as three out of four consecutively scheduled sessions, without extenuating circumstances) and one dropped out (noncompleters were provided with clinical referrals as needed). Completers averaged 30.6 (SD = 6.5) sessions across a mean interval of 12.2 months (SD = 2.6); noncompleters averaged 6.2 (SD = 4.7) sessions. Children who completed the protocol and those who did not were demographically similar, with two exceptions: completers were more likely to be living in intact families of origin (p = .03) and have better-educated parents (p G .01). The two groups did not differ with regard to past treatment, diagnostic composition, and illness duration at intake, rates of comorbid psychiatric diagnoses, or severity of self-rated depressive and anxiety symptoms. However, mothers of noncompleters versus completers had higher levels of depression at study entry, both by self-rating (mean Beck Depression Inventory score: 17.2, SD = 5.6 versus 7.7, SD = 6.4, respectively, p = .02) and clinical evaluation (mean HRS-D score: 17.6, SD = 6.0 versus 9.9, SD = 4.5, respectively p = .03). In the set of completers, three mothers and two fathers were in treatment (for a variety of problems) when their children entered the protocol (two of these mothers and one of these fathers continued their treatment during CERT). Subsequent to the start of the protocol, two other mothers and two other fathers entered separate treatment for themselves; of these, three were self-initiated and one was via referral by the CERT study coordinator.

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NEW TREATMENT FOR CHILDHOOD DEPRESSION

Changes in Children_s Diagnostic Status

At end of treatment, eight of the 15 completers (53.3%) had full remission of the chronic depression and two (13.3%) were in partial remission (by K-SADS). Five of these 10 patients also had had superimposed MDD, which was in full remission in four (80%). From among the seven patients with initial comorbid anxiety disorder, three were in full remission, but another patient developed an anxiety disorder postintake and was in episode at end of treatment (Table 1). All six patients with oppositional defiant disorder continued to meet full diagnostic criteria. Remission of dysthymia continued across the follow-up, with 79% of the available completers remitted by the 6-month follow-up and 92% by the 12-month follow-up. For comorbid anxiety disorders, the cumulative rates of remission were 79% by the 6- and 92% by the 12-month follow-up (Table 1). Mantel-Haenszel x2 analyses of the distribution of cases meeting full diagnostic criteria at intake, end of treatment, and 6- and 12-month follow-up confirmed statistically significant decreases in the rates of DD (x2 = 27.85, p G .0001), MDD (x2 = 10.26, p = .001), Bany depressive disorder[ (x2 = 27.85, p G .0001), and Bany anxiety disorder[ (x2 = 5.46, p = .02). Changes in Children_s Symptom Severity

Using the 20-patient intent-to-treat sample (and carrying forward the last scores of noncompleters), we found that self-rated depressive symptoms (CDI) declined from being in the clinical range at entry (mean = 16.3, SD = 10.1) to normal levels (mean = 5.2, SD = 6.7) by end of treatment (paired t test = 4.81, p G .001). There was a parallel, statistically significant pretreatment (mean = 15.0, SD = 6.7) to posttreatment (mean = 6.7, SD = 7.8) decrease in levels of anxious symptoms (paired t test = 5.48, p G .001) as quantified by the RCMAS. The findings were similar for the 15 completers (Table 1): there were highly significant pre/post changes in their levels of depression (CDI scores, paired t test = 4.45, p G .001) and anxiety (RCMAS scores, paired t test = 6.97, p G .001). Treatment gains were maintained across time, as suggested by comparing end-of-treatment scores to those at the 6- and 12-month follow-up for the CDI (t = j0.34, and t = j0.14, respectively, both not significant) and the RCMAS (t = 0.58 and t = j0.64, respectively, both not significant).

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As an alternative approach, we used longitudinal modeling procedures (restricted maximum likelihood models) on completers_ CDI and RCMAS scores at four time points: intake, end of treatment, and 6- and 12-month follow-up (Table 1). Similar to the results from paired t tests, the results were highly significant both for the model of depressive symptoms (F3,38 = 7.41 p G .001) and the model of anxiety symptoms (F3,38 = 11.57 p G .001). We also examined clinician-rated symptom severity patterns across the course of therapy at key treatment transition points (1, 4, and 7 months and treatment end). Overall, repeated-measures analyses of variance suggested significant changes across time in children_s clinician-rated depression (FDS-Y ratings; F3,12 = 6.81, p = .006) and anxiety (FAS-Y ratings; F3,12 = 7.49, p = .004). Profile contrasts, comparing evaluations at each given time point with those at the next time point, revealed that levels of depressive and anxiety symptoms dropped significantly from the 1-month to the 4-month assessments (F1,14 = 13.07, p = .003 for FDS-Y; F1,14 = 10.64, p = .006 for FAS-Y) and evidenced more gradual and statistically insignificant declines from 4 to 7 months, and from 7 months to the end of treatment (F1,14 = 3.88 and 0.04 for FDS-Y; and 0.92 and 0.05 for FAS-Y; all p > 0.05). Thus, the most dramatic decrements in symptoms occurred during the first 4 months of the treatment. Using clinically rated depressive symptoms, Figure 1 illustrates the changes during treatment relative to pretreatment levels. To generate the figure, the intake K-SADS (current ratings) was used to estimate symptom severity at entry by summing across 22 items that had counterparts in the FDS-Y. In turn, the relevant FDS-Y items were rescaled onto a 3-point scale.

Changes in Maternal Symptoms

We used longitudinal statistical procedures (restricted maximum likelihood models) to examine data from the clinical evaluations of mothers of completers (HRS-D and HRS-A scores; Table 1) at intake, end of treatment, and 6- and 12-month follow-up. According to the results, levels of maternal depression (HRS-D scores) and anxiety (HRS-A scores) significantly diminished across time (F3,31 = 4.71, p = .008, and F3,32 = 3.90 p = .018, respectively). However, because four mothers had been receiving their own treatment separately from the CERT protocol, we reran the analyses using only the remaining

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KOVACS ET AL.

DISCUSSION

Fig. 1 Clinician-rated severity of children_s depressive symptoms during treatment. Error bars represent the 95% upper confidence interval of the mean.

11 mothers. In this subgroup, changes in levels of maternal symptoms from intake and through the follow-up were not significant (HRS-D: F3,24 = 1.99, p = .143; and HRSA: F3,25 = 2.24, p = .109).

Parental Treatment and Changes in Children_s Symptom Severity

Can parents_ own treatment account for the significant symptomatic improvement of the children? To examine this issue, we reanalyzed children_s depressive and anxiety symptom scores, using only cases whose mothers were not receiving psychiatric treatment during the CERT study. The improvement in symptoms of depression and anxiety in this subgroup of young patients remained statistically significant across the four time points (restricted maximum likelihood model on 11 subjects CDI: F3,28 = 6.73, p = .002; and RMAS: F3,27 = 11.13, p G .001). Significant symptom improvement also was observed for the subset of cases who did not have either parent in treatment during the CERT protocol (n = 8; CDI: F3,20 = 4.88, p = .011; and RMAS: F3,19 = 4.20, p = .019).

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CERT is a new intervention for childhood depression that provides therapists and families with an explanatory framework that is conceptually meaningful, clinically sensible, and developmentally appropriate. It builds on emotion self-regulation and focuses on selfregulatory responses to distress and dysphoria, which unfold across development, are important for adaptive functioning, and appear to be dysfunctional in individuals with depressive disorders across the life span. It highlights the importance of parental involvement in treatment and offers one way to facilitate it. Because it incorporates commonly used intervention techniques and is manual based, CERT can be taught to therapists. The generally positive overall results of this pilot study underscore the feasibility of our approach and suggest the need for a larger, randomized trial of the efficacy of CERT. The importance of adaptive self-regulation of dysphoria and distress, which is the ultimate target of CERT, is supported by extensive developmental research addressing the years of childhood (Fox, 1994; Kopp, 1989) and ER skills remain critical across the life span (Gross, 1998). There is evidence that clinically depressed youngsters have fewer and less effective ER skills for managing negative emotions than do their nonaffected peers (Garber et al., 1995). Because dysregulated affect is a salient feature of depressive disorders, all empirically supported treatments of depression have components that target aspects of emotion regulation. However, cognitive-behavioral interventions and interpersonal psychotherapy, which have been specifically used with depressed youngsters (e.g., Brent et al., 1997; Mufson et al., 1999; Stark et al., 1987) represent Bdownward extensions[ of treatments that were originally designed for adults. Furthermore, none of them emphasizes ER as the key organizing principle in its delivery or case formulation, defines ER from a developmental perspective, takes into account the diverse ways in which dysphoria can be regulated, or strategically engages the parent as an emotion regulatory agent and treatment ally. In contrast, by viewing dysregulated mood as the key feature of depressive disorders and highlighting that ER responses are developmentally acquired, CERT guides clinicians to focus on a child_s history of ER response acquisition and deployment. By acknowledging the diversity of responses that serve to down-regulate dysphoria and individual (including age-associated) differences in

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NEW TREATMENT FOR CHILDHOOD DEPRESSION

that regard, CERT makes it possible to match the delivery of the treatment to a given child_s needs and competencies. By organizing ER responses into meaningful domains, CERT provides one useful way to characterize ER repertoires for distress management. Although partly for practical reasons, CERT_s presentation of ER, ER domains and responses, and contextual factors that affect them is somewhat simplified, its emphasis is supported by recent research directions on mood disorders (Davidson et al., 2002). Furthermore, some of the initial premises that guided CERT have been extended into a more comprehensive model of vulnerability to juvenile-onset depression (M.K., unpublished manuscript). In the extended model, the Bbiological[ regulatory domain is redefined as the neurophysiological underpinning of ER, with an emphasis on relevant brain cortical and subcortical circuits. A fourth (Bsomaticsensory[) regulatory domain has been defined to accommodate ER responses that rely on physical-sensory modalities to self-regulate dysphoria. The extended model acknowledges more fully the relations of ER responding and brain Bemotion circuits[ and that individual differences in brain circuitry may contribute to why some children find it more difficult than others to downregulate dysphoria, and why a given ER response may Bwork[ for some children but not for others. Given that the field of psychotherapy for depressed children has been generally bereft of developmentally based interventions (Weisz et al., 1992), it is hoped that CERT represents only one of several new initiatives to design treatments for that age group. Results of this open trial provide initial evidence of the feasibility and apparent clinical efficacy of CERT for chronic depression in childhood. The finding that 75% of the enrolled families completed this lengthy protocol suggests its acceptability. It is notable that the retention rate across our 10-month intervention was comparable to that reported for the 12-week, open, pilot trial of Interpersonal Psychotherapy for Adolescents (79%; 11 of 14 patients; Mufson et al., 1994). Parental involvement is a well-established component of evidence-based interventions for children with disruptive behavior disorders (see Chorpita et al., 2005) and increasingly so for those with anxiety disorders (e.g., Ginsburg et al., 2004). In contrast, the involvement of parents in manual-based treatment trials for depressed youths has entailed either adjunctive group sessions (e.g., Clarke et al., 1999) or systemic family therapy

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(e.g., Brent et al., 1997). Thus, our study is among the first to enlist parents in each session of an intervention, with a clearly defined role that is focused on the depressed child_s ER needs. Several preliminary findings are worthy of note. First, at the end of treatment, the rate of remission of superimposed MDD (80%) was high, suggesting the usefulness of CERT for nonchronic depression. Second, the finding that the rate of remission of DD was 53% at end of treatment and that it took an additional 6 to 12 months for another 40% of cases to achieve full remission underscore the recalcitrant nature of chronic depression. This finding also may partly mirror the fact that our patients already had illness durations somewhat longer than 2 years, on average, at study entry. Survival analyses of time to recovery from depression generally suggest that the probability of recovery in any given time interval is typically higher earlier in the illness and becomes less likely as time goes by (e.g., Kovacs et al., 1994); in other words, at the start, we had a sample with a low likelihood of recovery. Notably, even our lengthy protocol did not accommodate the needs of about 20% of the youths, whose treatments were somewhat extended during the tapering or maintenance phases. Third, although comorbid disorders were not targeted by CERT, the somewhat higher rate of recovery from anxiety disorders by the end of treatment (two of seven) compared to that from oppositional defiant disorders (zero of six) is worthy of note. This may possibly suggest that the ER responses and problem-solving approaches considered in CERT may have some relevance to conditions that have dysregulated mood, such as persistent anxiety, as a salient feature. This conclusion must be viewed with caution owing to the small overall sample size and the number of those with comorbid disorders. Underscoring the importance of monitoring parental psychopathology among clinically referred depressed youngsters (Ferro et al., 2000; Hammen et al., 1999), depression was a notable feature of noncompleter mothers, in spite of the availability of free treatment for parents (separate from the CERT study). Other characteristics of noncompleter mothers (e.g., lower level of education, more likely to be a single parent) echo findings from various treatment studies (e.g., Curry, 2005) that socioeconomic resources of families affect children_s treatment responses. Ways in which CERT can be modified to accommodate parents with suboptimal resources certainly warrants attention.

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KOVACS ET AL.

In most research trials, decisions about length of treatment, which is typically brief, appear to be guided by considerations other than clinical need (Kovacs and Sherrill, 2001). This presents a challenge when patients suffer from a chronic disorder and when an intervention seeks to apply a developmentally based paradigm because both imply the need for time. However, it can be argued that the lengthy protocol we piloted is likely to be above and beyond the resources of most clinical settings. Therefore, it is noteworthy that the most dramatic reduction in depressive symptoms in our sample occurred during the first 4 months of CERT, suggesting that 4 months could be a Bcompromise duration[ for treating chronic depression. However, this finding also could signify that treatment gains from less frequent sessions (months 5Y10) require more time. In any case, CERT is sufficiently flexible to accommodate various protocol lengths. In addition, along with the explanatory framework, the coping skills module of CERT can be Buncoupled,[ and with minor modifications, used in prevention trials. Limitations

By its very nature, an open pilot clinical trial such as ours is limited by the small sample size, which constrains its generalizability, and the unfeasibility of blind clinical evaluations, which may introduce rater bias. We sought to counter one other source of limitation in trials of this sort, namely, a single therapist who designed the treatment, by having three therapists, not including the originator of the intervention (M.K.). Furthermore, owing to the absence of a comparison treatment, we cannot unequivocally state that CERT was the agent responsible for our patients_ improvement and remission. Finally, there were no Hispanic families in our sample. Thus, future studies need to examine the usefulness of CERT with children who had had culturally diverse ER histories. Clinical Implications

The chronicity of childhood DD, the prevalence of comorbid diagnoses, and the likelihood of parental emotional distress present treatment challenges. However, the preliminary indications are that CERT, with its individually tailored approach and focus on ER, is well accepted by families and may help children to recover, although it does require commitment from the family and the clinician. Clinicians may wish to consider

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at least a 4-month treatment period as advisable for children with chronic depression. Disclosure: The Children_s Depression Inventory (CDI) is published by Multi-Health Systems, Inc., for which Dr. Kovacs receives royalties. The other authors have no financial relationships to disclose. REFERENCES Beck AT, Steer RA, Garbin MG (1988), Psychometric properties of the Beck Depression Inventory: twenty-five years of evaluation. Clin Psychol Rev 8:77Y100 Bradley SJ (2000), Affect Regulation and the Development of Psychopathology. New York: The Guilford Press Brent DA, Holder D, Kolko D et al. (1997), A clinical psychotherapy trial for adolescent depression comparing cognitive, family, and supportive therapy. Arch Gen Psychiatry 54:877Y885 Casey BJ, Giedd JN, Thomas KM (2000), Structural and functional brain development and its relation to cognitive development. Biol Psychol 54: 241Y257 Chorpita BF, Daleiden EL, Weisz JR (2005), Identifying and selecting the common elements of evidence based interventions: a distillation and matching model. Ment Health Serv Res 7:5Y20 Clarke GN, Rohde P, Lewinsohn PM, Hops H, Seeley JR (1999), Cognitive-behavioral treatment of adolescent depression: efficacy of acute group treatment and booster sessions. J Am Acad Child Adolesc Psychiatry 38:272Y279 Compton SN, March JS, Brent D, Albano AMV, Weersing R, Curry J (2004), Cognitive-behavioral psychotherapy for anxiety and depressive disorders in children and adolescents: an evidence-based medicine review. J Am Acad Child Adolesc Psychiatry 43:930Y959 Curry JF (2001), Specific psychotherapies for childhood and adolescent depression. Biol Psychiatry 49:1091Y1100 Curry JF (2005), Predictors and moderators of acute treatment outcome in TADS. Presented at the Joint Annual Meeting of the American Academy of Child and Adolescent Psychiatry, Toronto, October 18Y23, 2005 Davidson RJ, Pizzagalli D, Nitschke JB, PutnamK (2002), Depression: perspectives from affective neuroscience. Annu Rev Psychol 53: 545 Y574 Durston S, Pol HEH, Casey BJ, Giedd JN, Buitelaar JK, van Engeland H (2001), Anatomical MRI of the developing human brain: what have we learned? J Am Acad Child Adolesc Psychiatry 40:1012Y1020 Ferro T, Verdeli H, Pierre F, Weissman MM (2000), Screening for depression in mothers bringing their offspring for evaluation or treatment of depression. Am J Psychiatry 157:375 Y379 Fox NA ed. (1994), The development of emotion regulation: biological and behavioral considerations. Monogr Soc Res Child Dev 59(2Y3 Serial No. 240) Garber J, Braafladt N, Weiss B (1995), Affect regulation in depressed and nondepressed children and young adolescents. Dev Psychopathol 7: 93 Y115 Garber J, Dodge KA, eds (1991), The Development of Emotion Regulation and Dysregulation. New York: Cambridge University Press Ginsburg GS, Siqueland L, Masia-Warner C, Hedtke KA (2004), Anxiety disorders in children: family matters. Cogn Behav Pract 11:28Y43 Grolnick WS, Bridges LJ, Connell JP (1996), Emotion regulation in twoyear-olds: strategies and emotional expression in four contexts. Child Dev 67:928 Y941 Gross JJ (1998), The emerging field of emotion regulation: an integrative review. Rev Gen Psychol 2:271Y299 Hamilton M (1967a), Development of a rating scale for primary depressive illness. Br J Soc Clin Psychol 6:278Y296 Hamilton M (1967b), Diagnosis and rating of anxiety. Br J Psychiatry 3: 76 Y79 Hammen C, Rudolph K, Weisz J, Rao U, Burge D (1999), The context of depression in clinic-referred youth: neglected areas in treatment. J Am Acad Child Adolesc Psychiatry 38:64 Y71

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NEW TREATMENT FOR CHILDHOOD DEPRESSION Hofer MA (1994), Hidden regulators in attachment, separation, and loss. Monogr Soc Res Child Dev 59:192Y207 Howard KI, Kopta SM, Krause MS, Orlinsky DE (1986), The dose-effect relationship in psychotherapy. Am Psychol 41:159 Y164 Kaufman J, Birmaher B, Brent D et al. (1997), Schedule for affective disorders and schizophrenia for school-age childrenVpresent and lifetime version (K-SADS-PL): initial reliability and validity data. J Am Acad Child Adolesc Psychiatry 36:980Y988 Kendall PC, Choudhury MS (2003), Children and adolescents in cognitivebehavioral therapy: some past efforts and current advances, and the challenges in our future. Cogn Ther Res 27:89Y104 Kopp CB (1989), Regulation of distress and negative emotions: a developmental view. Dev Psychol 25:343Y354 Kovacs M (2003), Children_s Depression Inventory (CDI): Technical Manual Update. North Tonawanda, NY: Multi-Health Systems Kovacs M, Akiskal HS, Gatsonis C, Parrone PL (1994), Childhood-onset dysthymic disorder: Clinical features and prospective naturalistic outcome. Arch Gen Psychiatry 51:365Y374 Kovacs M, Feinberg TL, Crouse-Novak MA, Paulauskas SL, Finkelstein R (1984), Depressive disorders in childhood: I. A longitudinal prospective study of characteristics and recovery. Arch Gen Psychiatry 41:229Y237 Kovacs M, Obrosky DS, Gatsonis C, Richards C (1997), First-episode major depressive and dysthymic disorder in childhood: clinical and sociodemographic factors in recovery. J Am Acad Child Adolesc Psychiatry 36:777Y784 Kovacs M, Sherrill JT (2001), The psychotherapeutic management of major depressive and dysthymic disorders in childhood and adolescence: issues and prospects. In: The Depressed Child and Adolescent:

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Scaling Up Promising Interventions: Feasibility of Screening Adolescents for Suicide Risk in BReal-World[ High School Settings Denise Hallfors, PhD, Paul H. Brodish, MSPH, Shereen Khatapoush, PhD, Victoria Sanchez, DrPH, Hyunsan Cho, PhD, Allan Steckler, PhD Objectives: We evaluated the feasibility of a population-based approach to preventing adolescent suicide. Methods: A total of 1323 students in 10 high schools completed the Suicide Risk Screen. Screening results, student follow-up, staff feedback, and school responses were assessed. Results: Overall, 29% of the participants were rated as at risk of suicide. As a result of this overwhelming percentage, school staffs chose to discontinue the screening after 2 semesters. In further analyses, about half of the students identified were deemed at high risk on the basis of high levels of depression, suicidal ideation, or suicidal behavior. Priority rankings evidenced good construct validity on correlates such as drug use, hopelessness, and perceived family support. Conclusions: A simpler, more specific screening instrument than the Suicide Risk Screen would identify approximately 11% of urban high school youths for assessment, offering high school officials an important opportunity to identify young people at the greatest levels of need and to target scarce health resources. Our experiences from this study show that lack of feasibility testing greatly contributes to the gap between science and practice. American Journal of Public Health 2006; 96(2):282Y287.

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