Combining child social skills training with a parent early intervention program for inhibited preschool children

Accepted Manuscript Title: Combining child social skills training with a parent early intervention program for inhibited preschool children Authors: Elizabeth X. Lau, Ronald M. Rapee, Robert J. Coplan PII: DOI: Reference:

S0887-6185(17)30104-4 http://dx.doi.org/10.1016/j.janxdis.2017.08.007 ANXDIS 1967

To appear in:

Journal of Anxiety Disorders

Received date: Revised date: Accepted date:

13-3-2017 28-7-2017 27-8-2017

Please cite this article as: Lau, Elizabeth X., Rapee, Ronald M., & Coplan, Robert J., Combining child social skills training with a parent early intervention program for inhibited preschool children.Journal of Anxiety Disorders http://dx.doi.org/10.1016/j.janxdis.2017.08.007 This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.

Combining child social skills training with a parent early intervention program for inhibited preschool children

Elizabeth X. Lau, Ronald M. Rapee Centre for Emotional Health, Macquarie University, Sydney Robert J. Coplan Department of Psychology, Carleton University, Ottawa

Correspondence: Ron Rapee, Department of Psychology, Macquarie University, Sydney, NSW, Australia, 2109. [email protected] ANZCTR: ACTRN12610001019099

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Highlights 

Shy, inhibited children are at risk for later anxiety and depression

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Brief, early parent education for preschool children can reduce later anxiety and depression

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Combining parent education with social skills for children reduced child anxiety in this study

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Quasi-experimental comparison suggested that this combined intervention may show some slightly stronger effects than a parent-only intervention

Abstract Background: Previous studies have demonstrated the efficacy of early intervention for anxiety in preschoolers through parent-education. The current study evaluated a sixsession early intervention program for preschoolers at high risk of anxiety disorders in which a standard educational program for parents was supplemented by direct training of social skills to the children. Methods: Seventy-two children aged 3-5 years were selected based on high behavioural inhibition levels and concurrently having a parent with high emotional distress. Families were randomly assigned to either the intervention group, which consisted of six parent-education group sessions and six child social skills training sessions, or waitlist. After six months, families on waitlist were offered treatment consisting of parent-education only. Results: Relative to waitlist, children in the combined condition showed significantly fewer clinician-rated anxiety disorders and diagnostic severity and maternal (but not paternal) reported anxiety symptoms and life interference at six months. Mothers also reported less overprotection. These gains were maintained at 12-month follow-up. Parent only education following waitlist

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produced similar improvements among children. Quasi-experimental comparison between combined and parent-only interventions indicated greater reductions from combined intervention according to clinician reports, but no significant differences on maternal reports. Conclusions: Results suggest that this brief early intervention program for preschoolers with both parent and child components significantly reduces risk and disorder in vulnerable children. The inclusion of a child component might have the potential to increase effects over parent-only intervention. However, future support for this conclusion through long-term, randomised controlled trials is needed. Keywords: childhood; prevention; preschool; social skills; parenting

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Introduction Anxiety disorders are high frequency mental disorders that affect large numbers of adults (Remes, Brayne, van der Linde, & LaFortune, 2016; Slade et al., 2009) and youth (Ford, Goodman, & Meltzer, 2003; Merikangas et al., 2010). Anxiety is associated with moderate impact on functioning including reduced social interactions, increased family and personal distress, reduced academic and career functioning, and increased medical complications (Rapee, Schniering, & Hudson, 2009). Anxiety is also highly chronic, with disorders typically starting early in life and continuing to impact functioning for many years. These chronic impairments combined with their high prevalence, means that anxiety disorders provide very significant contributions to the burden of disease (Ezpeleta, Keeler, Alaatin, Costello, & Angold, 2001; Murray et al., 2012). Early intervention for anxiety is therefore an important social and economic objective. Evidence has pointed to a number of likely risk factors for the onset and chronicity of anxiety disorders. Some of the most well researched risks include an inhibited temperament; parent emotional distress; parenting style; and poor interpersonal processes (Broeren, Muris, Diamantopoulou, & Baker, 2013; Mian, Wainwright, Briggs-Gowan, & Carter, 2011; Spence & Rapee, 2016). An inhibited temperamental style has been the most widely studied risk and shown to be associated with elevated rates of later anxiety disorders, especially social anxiety (ChronisTuscano et al., 2009; Hudson, Dodd, Lyneham, & Bovopoulous, 2011; Rapee, 2014). Early childhood inhibition has been defined and assessed in a variety of ways, most common of which have been behavioural inhibition to the unfamiliar (N. A. Fox, Henderson, Marshall, Nichols, & Ghera, 2005; Kagan, Reznick, Clarke, Snidman, & Garcia-Coll, 1984) and social withdrawal or shyness (Coplan, Prakash, O'Neill, &

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Armer, 2004; Rubin, Coplan, & Bowker, 2009). Early social withdrawal has also been shown to predict later internalising distress, including both anxiety and depression (Ollendick, Greene, Weist, & Oswald, 1990; Rubin, 1993). Parental anxiety and negative affectivity more broadly also predict child and adolescent anxiety (Hudson et al., 2011; Rapee, 2014; Wichstrom, Belsky, & BergNeilsen, 2013). Several family studies demonstrate associations between offspring anxiety disorders and both parent anxiety and mood disorders (Vidair, Fichter, Kunkle, & Boccia, 2012). The relation between parent and child negative affectivity is likely to reflect both genetic and non-genetic factors. Non-genetically, parents of anxious children are likely to model avoidant styles of coping and may also support their child’s avoidant characteristics through overly protective parenting. Evidence supports the associations between overprotective parenting and anxiety disorders (McLeod, Wood, & Weisz, 2007; Yap, Pilkington, Ryan, & Jorm, 2014) and some longitudinal data also demonstrate prospective, bi-directional relationships (Edwards, Rapee, & Kennedy, 2010). Identification of factors that place children at risk for anxiety disorders provides promising targets for early intervention (LaFreniere & Capuano, 1997; Rapee, 2002). Consequently, some early intervention programs (Anticich, Barrett, Silverman, Lacherez, & Gillies, 2013; J. K. Fox et al., 2012; Hirshfeld-Becker et al., 2010; LaFreniere & Capuano, 1997; Rapee, Kennedy, Ingram, Edwards, & Sweeney, 2005) and clinical treatments (Cartwright-Hatton et al., 2011; Comer et al., 2012; Pincus, Eyberg, & Choate, 2005) have addressed the above risks. The most extensively evaluated so far is the Cool Little Kids program (Rapee, Lau, & Kennedy, 2010). This program provides brief (6 session), inexpensive (group), education to parents of highly inhibited preschool-aged children that teaches strategies to 1) counter the child’s natural

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avoidance style; 2) reduce parental overprotection; and 3) manage parent anxious expression. Empirical evaluation has shown reduced anxiety disorders, life impairment, and behavioural inhibition by early to middle childhood (Kennedy, Rapee, & Edwards, 2009; Rapee, Kennedy, Ingram, Edwards, & Sweeney, 2010). By mid-adolescence, girls in active intervention showed lower levels of anxiety and mood disorders (Rapee, 2013). These outcomes have been estimated to be highly cost-effective (Mihalopoulos, Vos, Rapee, Pirkis, & Carter, 2015). In addition to the risks for emotional disorders noted above, a related literature has addressed the role of peer relationships and social interactions in the development of anxiety. Shy preschool aged children are characterised by solitary play and social isolation (Coplan, Arbeau, & Armer, 2008) and, as they mature, anxious middle aged children experience peer neglect, rejection, and victimisation (Gazelle & Ladd, 2003). These relationship difficulties are likely underpinned by poor social processes demonstrated by shy children from preschool age, including minimal verbalisations, reduced social initiations, and poor social interchange (Coplan, Schneider, Matheson, & Graham, 2010; Karevold, Ystrøm, Coplan, Sanson, & Mathiesen, 2012). In a recent longitudinal study, over 700 children aged 4 years were followed for two years to determine risk for the development of anxiety disorders (Wichstrom et al., 2013). Peer victimisation at age 4 emerged as a significant predictor of later anxiety and social competence rated by preschool teachers was a significant protective factor. Based on this literature, training young children to increase social competence and create positive peer relationships should be a valuable additional target in the prevention of emotional disorders. An emerging literature has begun to develop programs that directly address the social difficulties of shy preschool children (Social Skills Facilitated Play)(Coplan et

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al., 2010). Fully powered randomised control trials are yet to be conducted, but pilot studies have shown promise, particularly in terms of improving social skills and social participation. In an early pilot, 22 highly inhibited preschool-aged children were allocated to either waitlist or social skills training (Coplan et al., 2010). Children in active intervention demonstrated greater increases in observed social competence and interaction and a decrease in social wariness at preschool relative to controls. A more recent trial among Chinese preschool children showed that those taught social skills, relative to waitlist, were observed to express more pro-social behaviours, better social communication, and stronger peer interactions (Li et al., 2016). Unfortunately, the impact on shyness and anxiety were not reported. Given the range of risk factors for anxiety, it is likely that stronger efficacy from early intervention could be achieved by simultaneously addressing a larger number of risk factors. The efficacy of parent-focused programs that address parent behaviours and child avoidance and the promising results from child-focused interventions that aim to increase children’s social skills, suggests that combining these methods might create a more efficacious intervention. One small trial has tested this model (Chronis-Tuscano et al., 2015). Forty preschool-aged children were randomly assigned to either waitlist or the Turtle Program comprising eight, 90-minute sessions conducted concurrently with the parents and children. Parents were taught methods to increase in vivo exposure for their child and methods to improve general parenting and consistency. Children were taught social interaction skills following the Social Skills Facilitated Play program (Coplan et al., 2010). Immediately following intervention, children in the Turtle program showed significantly lower levels of anxiety symptoms and parent-reported inhibition, although the difference in anxiety disorders did not reach significance.

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The aim of the current study was to conduct an initial evaluation of the efficacy of a program for the prevention of emotional disorders that comprised a combined focus on the risk factors addressed by Cool Little Kids with the addition risk (social competence) targeted by Social Skills Facilitated Play. We were also able to include a quasi-experimental comparison between the new, combined intervention and the standard Cool Little Kids program.

Method Participants The participants in this study were 72 children (38 boys, 34 girls) aged 36-65 months (Mage = 52.1). The children were attending local childcare centres and preschools in Sydney, Australia. Target criteria to be included in the study were (1) age within 36-66 months at the time of recruitment; (2) a minimum of 30 (1.15 SD above the norm) on the child’s score of social approach on the Short Temperament Scale for Children (see below) as rated by one parent; (3) a minimum of 30 on at least one parent’s self-reported scores on the Depression Anxiety Stress Scales; (4) no known diagnosis of any severe developmental disorders; and (5) parents who were able to complete questionnaires in English. Children were randomly assigned to the combined intervention (Comb; n=39) or 6-month waitlist control (WL; n=33). The two groups did not differ significantly on age (MComb = 52.4 mos., SD=7.4; MWL= 51.6 mos., SD=7.3), t (70) = -.44, p= .658, or gender (Comb = 51.3% girls, WL = 42.4% girls), χ2(1, N=72)=.56, p= .453. The flow of participants is shown in Figure 1. Measures

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Behavioural Inhibition. One parent (usually the mother) completed the Short Temperament Scale for Children (STSC) (Prior, Smart, Sanson, & Oberklaid, 2000), designed for children aged 3 to 8 years. The approach subscale, assessing approach/withdrawal from unfamiliar people and situations, was used as a construct related to behavioural inhibition (Prior et al., 2000). Internal consistency in the current sample was α=.79. Both parents also completed the Behavioral Inhibition Questionnaire (BIQ) (Bishop, Spence, & McDonald, 2003), assessing the three main domains of behavioral inhibition (social, situational, physical caution). In the present sample internal consistency was α=.89 for mothers and α=.92 for fathers. Child anxiety symptoms. Both parents completed the Preschool Anxiety ScaleRevised (PAS-R) (Edwards, Rapee, Kennedy, & Spence, 2010), a 28-item parent report of anxiety symptoms in preschool-aged children (α=.88 for mothers, α=.91 for fathers). Child anxiety diagnosis. At least one parent (most commonly the mother) was interviewed about their child’s current anxiety using the Anxiety Disorders Interview Schedule for Children and Parents IV- Parent Version (ADIS-IV-P)(Silverman & Albano, 1996). As part of the interview, interviewers assigned a clinician severity rating (CSR) that indicated the degree of distress, impairment and interference associated with each disorder. A clinical diagnosis was determined when the CSR associated with a given set of symptoms was rated at 4 (moderate) or above. Interviews were completed by graduate students in clinical psychology who were trained to criterion. Interviewers were blind to group allocation. The ADIS-IV-P has shown good to excellent test-retest reliability (Silverman, Saavedra, & Pina, 2001) and has shown good reliability in preschool-aged children with kappas ranging from .77 to .86 (Kennedy et al., 2009; Rapee et al., 2005; Roth, Dadds, McAloon, Guastella, & Weems, 2004). In the current

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study, 20% of the ADIS interviews were coded for inter-rater reliability, with kappas ranging from .72-.82. At pre-treatment, children met criteria for primary anxiety diagnoses of social anxiety disorder (n= 49), generalized anxiety disorder (n=15), separation anxiety disorder (n=6) and specific phobia (n=2). Despite not being part of the inclusion criteria, 100% of the children had at least one anxiety disorder at pre-treatment. As an indication of overall distress, given the significant comorbidity in the sample, total CSR was calculated by summing CSR for each disorder. Child anxiety life interference. Both parents completed the Child Anxiety Life Interference Scale—Preschool Version (CALIS-PV) (Kennedy, 2007), a 24-item scale designed to assess the impact of anxiety on the child’s life, on family life and on the parent's personal life (α=.92 for mothers, α=.94 for fathers). Parent negative affectivity. At screening, one parent (96% mothers) completed the trait, short form of the Depression Anxiety Stress Scales (DASS) (Lovibond & Lovibond, 1995) as a measure of negative affectivity (α=.86). Intervention Program Parent-and-child Intervention Group protocol (Combined): Families randomly allocated to the intervention group were invited to participate in a program comprising 6 parent-education sessions and 6 social skills training sessions for the child. The program was conducted in small groups (5-7 families), with 90 minute sessions for child and parent, held concurrently in adjacent rooms. Sessions were scheduled over 10 weeks, with breaks (first 4 sessions held once a week, followed by a 1-week break between sessions 4-5 and a 3-week between sessions 5-6) to allow parents time to practice skills.

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Parent component: The “Cool Little Kids” program is an early intervention program aimed at addressing some of the core risk factors for anxiety (Rapee, Lau, et al., 2010). All sessions were conducted by the first author, a clinical psychologist with experience treating anxious children. Components of the intervention included psychoeducation, parental management strategies (e.g., praising, reducing overprotection), using in-vivo exposure for their child, and anxiety management skills for the parent (e.g., cognitive restructuring). Each family was provided with a workbook and given practice tasks to be completed during the week. Child component: The child component was a modified version of the Social Skills Facilitated Play program developed by Coplan et al. (2010). Groups were mixedgender and were co-led by two leaders who were either graduate students in clinical psychology or final-year psychology students. Groups were held in a play room within the university, containing age-appropriate toys and games. All sessions were videoed. Skills taught in the program included initiating play, communicating to keep friends, expressing feelings, and relaxation. The principal investigator reviewed recordings and met session leaders weekly to provide feedback and suggestions for improvement and ensure adherence to protocols. Procedure Parents who responded to the advertisement were sent the screening questionnaires (STSC and DASS) to be completed online. Families that met the inclusion criteria were further screened via a phone call where they were asked to report any known severe developmental delay. Eligible families were then invited for the ADIS-IV-P interview and questionnaires for parents were disseminated. A coin toss by a research assistant who was blind to baseline assessment details, was used to allocate families to the two conditions. Upon completion of the pre-treatment assessment, the

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Combined group embarked on the program. Six months after the pre-treatment assessment, all families were invited to complete the 6-month follow-up ADIS-IV-P assessment (interviewers blind to treatment condition) and questionnaires. At this point, families in the waitlist group were offered the parent-education program (Cool Little Kids). The same assessment procedure was applied 12-months after the pre-assessment. Results Within the combined intervention, the majority of sessions (five or six) were attended by 92.3% of children, 87.2% of mothers, 17.9% of fathers and 12.8% of both parents. Clinician-based assessments were collected on all children at baseline, 71 children (98.6%) at 6-months, and 63 children (87.5%) at 12-months. Baseline questionnaires were returned by: Combined - 100% mothers, 94.9% fathers; Waitlist 93.9% mothers, 90.9% fathers. Six-month questionnaires were returned by: Combined 94.9% mothers, 84.6% fathers; Waitlist - 72.7% mothers, 60.6% fathers. Twelve-month questionnaires were returned by: Combined - 92.3% mothers, 82.1% fathers; Waitlist 66.7% mothers, 54.5% fathers. Data were analysed based on all participants who entered the trial (intent to treat). Missing data were estimated with multiple imputation based on 10 imputations and analysis of continuous data utilised mixed model analyses of variance. Given the low return of data by fathers, especially in Waitlist, together with the very low participation of fathers in the intervention, only maternal reports will be formally reported here. It should be noted that, although the patterns of means among fathers’ reports were similar to those of mothers (see Table 1), when imputed paternal reports were analysed using mixed models, none of the group by time interactions were statistically significant (all p’s > .05). Efficacy of the Combined Intervention vs. Waitlist at 6-months

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Remission of anxiety. At 6-months 34.2% of the children in the Combined condition were free of all anxiety diagnoses, compared with none in Waitlist, χ2 (1, n=70) = 13.44, p < .001. Clinician reports. Mixed model analyses comparing the groups on the total number of anxiety diagnoses indicated a significant main effect reduction over time t(70)=11.26, p< .001, and a significant group by time interaction t(70)=6.72, p< .001, reflecting a significantly greater reduction for those in the Combined group. Similarly, for total clinician severity ratings (CSR), there was a significant main effect of time t(70)=15.61, p<.001, and a significant group by time interaction t(70)=9.92, p<.001, reflecting a significantly greater reduction in the intervention group. Means are displayed in Table 1.

Maternal reports. Mixed model analysis on mothers’ reports of anxiety symptoms (PAS-R) reflected a significant main effect reduction over time, t(70)=5.98, p<.001, which was qualified by a significant group by time interaction t(70)=3.57, p< .001. Similarly, there was a significant reduction over time on the CALIS-PV t(70)=5.51, p< .001, as well as a significant group by time interaction, t(70)=2.89, p=.004.

Mothers’ reports of the child’s behavioral inhibition (BIQ),

demonstrated a significant main effect reduction over time t(70)=6.47, p<.001, however, the group by time interaction failed to meet conventional levels of significance, t(70)=1.83, p=.070. Finally, in their reports of overprotection (OPQ), mothers reported a significant reduction over time, t(70)=5.39, p<.001, and a significant group by time interaction, t(70)=2.38, p=.020. Combined Intervention at 12-Month Follow-Up

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At the 6-month time point, the waitlist group was offered the Cool Little Kids, parent-only intervention and the two groups could therefore no longer be statistically compared. At the 12-month follow-up, 67.6 % of children from the Combined intervention were free of anxiety diagnoses. All gains made at the 6-month follow-up were maintained or increased at 12-months (See Table 1). Pairwise t-tests based on imputed data demonstrated significant continued reductions from 6-months to 12months on: maternal reports of anxiety symptoms (PAS-R), life interference (CALISPV), and inhibition (BIQ), (all t’s > 2.1; p’s<.05). Non-significant changes (maintenance) were demonstrated on total clinician severity rating, total number of anxiety diagnoses, and maternal reports of overprotection. Quasi-Experimental Comparison of the Two Active Treatments Since families on waitlist were offered the parent-only intervention (Cool Little Kids) after 6-months, it was possible to compare these outcomes with those of the parent-and-child (Combined) group. It must be noted that the time point of comparison between the treatments was different. In other words, changes from baseline to 6months for children in the combined condition were compared with changes from 6months to 12-months for children on waitlist whose parents were offered parent only intervention. As for the previous analyses, missing data were imputed based on 10 iterations and analyses were based on mixed models. At 12 months, 30.6% of children in the waitlist/parent-only condition were free of all anxiety disorders. Relevant descriptive statistics are displayed in Table 2 (minor variations in the data from the previous analyses are due to random differences in imputations). There was a significant reduction over time t(70)=8.60, p<.001, on the number of anxiety disorders diagnoses qualified by a significant group by time interaction t(70)=2.65, p=.008. As can be seen in Table 2, children in the combined

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parent and child condition showed a greater reduction in the number of anxiety disorders than children in the parent only condition. Clinician severity ratings similarly showed a significant reduction over time t(70)=11.95, p<.001, and a significant group by time interaction t(70)=3.38, p=.001. Again, total severity reduced more for children in the combined condition relative to those in parent only. In contrast to clinician measures, maternal reports all indicated significant reductions over time, but no significant group by time interactions. This was true for: anxiety symptoms (PAS-R), time main effect t(70)=5.86, p<.001, group by time interaction t(70)= 0.84, p=.408; life interference (CALIS-PV), time main effect t(70)=5.74, p<.001, group by time interaction t(70)= 0.94, p=.348; behavioural inhibition (BIQ), time main effect t(70)=6.48, p<.001, group by time interaction t(70)= 1.09, p=.283; and maternal overprotection (POQ), time main effect t(70)=5.90, p<.001, group by time interaction t(70)= 0.84, p=.404. Discussion The current study evaluated a novel early intervention in which six, group sessions of parent education were combined with six, group sessions of training in social skills for inhibited preschool-aged children. The overall efficacy of the program was clearly demonstrated relative to a waitlist comparison condition, six months after initial assessment. Thirty-four percent of children in the intervention were fully remitted from anxiety disorders compared with none on waitlist. Relative to waitlist, children in the combined intervention demonstrated significantly greater reductions in number of anxiety disorders, total clinician-rated severity of anxiety, and maternal reports of the child’s anxiety symptoms and life interference. There were no significant differences between conditions in paternal reports. However, these were characterised by poor response rates and mean scores showed a similar pattern to the maternal reports.

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Consistent with previous data (Chronis-Tuscano et al., 2015), the results demonstrate the feasibility and efficacy of early intervention for very young children at high risk for emotional disorders that includes components for both the parents and the child in the intervention. Previous early intervention for high-risk, preschool-aged children has demonstrated efficacy when intervention was provided only to the parents (Kennedy et al., 2009; Rapee, Kennedy, et al., 2010). This is clearly an easier and less resourceintensive form of delivery than the current combined program. Therefore, the current program that requires intervention for both the parent and child would only be of value if it demonstrates significantly greater efficacy and prevention value than a program delivered only to parents. The current research design was unable to fully address this question, but it did allow a quasi-experimental exploration. A comparison of outcomes at the completion of the combined (parent and child) intervention with a parent-only intervention six months later, provided mixed results. Both interventions demonstrated marked reductions in anxiety and life interference over time. Maternal reports failed to demonstrate any significant differences between interventions. However, according to clinician reports, the combined program did appear to show greater efficacy in reduction of anxiety disorders and the total severity of anxiety disorders. Naturally, strong conclusions cannot be drawn from these results due to the non-experimental nature of the comparison. The two assessment points differed in the age and maturity of the children, as well as the number of prior assessments and the motivation of the parents. It is interesting to note the slightly greater number of parents who dropped out from the 12 month assessments in the delayed parent-only condition relative to the immediate combined condition, possibly due to reduced motivation following a 6month wait. Regression to the mean is very likely to impact results when high-risk

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children are selected (Rapee et al., 2005), and would also have had different impacts at these two assessment points. Therefore, the interesting possibilities raised by the current trial will require a more direct, experimental, and long-term comparison in future. Two measures in the study are worth additional consideration. First, maternal reports indicated some reduction in the temperamental trait of behavioural inhibition (although the difference between conditions did not reach traditional levels of significance). Previous research using parent-only interventions has shown mixed results in this regard. For example, in an early trial, despite significant reduction in anxiety symptoms and disorders, no significant impact was demonstrated on behavioural inhibition over the effects of time (Rapee et al., 2005). In contrast, a later trial that recruited a markedly higher-risk sample, did show a significant effect of the intervention on inhibition assessed by both maternal report and laboratory observation (Kennedy et al., 2009). The current study utilised a high-risk sample, whereby participation required a high score on symptoms of negative affectivity. However, this is not quite as high in risk as was the case in Kennedy et al. (1999), where children were included if their parents met diagnostic criteria for an anxiety disorder. Children in the Kennedy study also had a higher minimum score (35) on the inhibition screener than those in the current study (30). Although we can’t be certain why the impact of the intervention on inhibition differed between studies, there seems to have been slightly less reduction over time in inhibition in the study by Kennedy et al., relative to the other two studies. One suggestion, therefore, is that behavioural inhibition may be more fluid in the mid ranges and less malleable at the upper ends. This would mean that selecting children who are less extreme on inhibition might increase vulnerability to regression to the mean effects, which in turn would mask any impact of the intervention.

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If this is true, then it appears that early intervention programs can have small but significant effects on inhibition if the sample has sufficiently high risk to minimise natural fluctuations in inhibition. It should be noted that selection of such high risk children means that most already meet diagnostic criteria for an anxiety disorder, so this work is best described as early intervention. Nonetheless, the implications are profound. Early childhood inhibition is one of the most consistently demonstrated risk factors for later emotional disorders (Clauss & Blackford, 2012; Degnan, Almas, & Fox, 2010; N. A. Fox et al., 2005; Rapee et al., 2009). Therefore the ability to reduce this core risk is critical to the value of such programs to prevent the development of later disorder. This study is also the first to demonstrate an effect of intervention on maternal overprotection. Parental overprotection is another risk factor for anxiety disorders that has received moderate empirical support (McLeod et al., 2007; Yap et al., 2014). Reducing parental overprotection is one of the key aims of the Cool Little Kids program. As with inhibition, the ability to reduce this risk factor is critical to the efficacy of such programs to prevent later anxiety. Therefore, it is surprising that more attention has not been paid previously to the impact of these programs on overprotection or on parenting more broadly. Naturally, the use of maternal reports in the current study creates a number of obvious limitations and future research will need to replicate these effects with corroborating reports and observations. The current study is constrained by several limitations. Perhaps most critically, there was no assessment of changes in the children’s social competence or interactions. Previous programs including the SSFP showed observable improvements in social skills and social interaction after the intervention (Coplan et al., 2010; Li et al., 2016). The lack of such measures in the current trial mean that we are unable to say whether these skills improved in treated children, nor whether reductions in anxiety were mediated by

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increased social interactions. Further limitations include that the sample did not represent the broad population and was relatively small, the data were based largely on self-report, and there was a very limited follow-up. As a demonstration of prevention, the latter is the most critical limitation. As noted earlier, the current study was designed as an initial test of a combined early intervention and it was therefore compared to waitlist in the short term. Given the promising results, the next step will be to compare combined intervention against a parent-only intervention and to follow the children over a number of years. To the extent that inhibition is reduced and social competence is improved, continued and possibly increased prevention of anxiety and depression would be predicted (Rapee, 2013). Finally, it should be noted that this intervention was conducted within a specialty anxiety research centre by expert staff and these results may not easily generalise to delivery in the general community. Indeed some research has shown difficulties engaging parents in the general community in prevention programs for inhibited young children (Bayer et al., in press; Mian, Eisenhower, & Carter, 2015) and the efficacy of these programs might be undermined in this way. Anxiety and mood disorders represent the most common mental disorders with an especially high societal impact (Murray et al., 2012). Refining affordable, practical, and efficacious early intervention is an essential step in reducing the burden of disease from these disorders. The current results extend previous research pointing to the value of parent-focused early intervention for inhibited young children by highlighting that potentially stronger effects might be gained by incorporating social skills training for the children themselves. We await future research to more clearly demonstrate whether this is the case.

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Figure 1. Flow diagram of participants

Children screened and met eligibility (N=72)

Baseline assessment and randomisation

Dropped out (N=1)

Dropped out (N=2)

Parent and Child Intervention (Combined) (N=39)

Waitlist-control (WL) (N= 33)

6 month assessment (n= 38)

6 month assessment (Commence parent only intervention) (n= 33)

Quasi-experimental comparison 12 month assessment (n= 36)

Dropped out (N= 0)

Dropped out (N= 7)

12 month assessment (Post parent only intervention) (n= 26)

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Table 1: Means and standard deviations comparing parent and child (combined) intervention against waitlist Measure

Parent-and-child Intervention

Waitlist

PreIntervention Mean (SD)

6-month follow-up Mean (SD)

Pre-6 mth effect size (d)

12-month follow-up Mean (SD)

PreIntervention Mean (SD)

6-month follow-up Mean (SD)

Pre-6 mth effect size (d)

N Dx

3.80 (1.44)

1.26 (1.44)

1.76

0.87 (1.56)

3.55 (1.44)

3.24 (1.44)

0.22

CSR

19.95 (5.18)

8.94 (5.25)

2.11

7.90 (4.62)

17.39 (5.17)

16.67 (5.17)

0.14

PAS-R (mother)

63.15 (16.11)

44.74 (16.74)

1.12

36.63 (16.05)

63.70 (16.60)

63.28 (20.85)

0.02

PAS-R (father)

51.76 (20.48)

46.38 (20.36)

0.26

35.60 (15.61)

57.26 (20.57)

59.59 (32.28)

-0.09

CALIS-PV (mother) CALIS-PV (father) BIQ (mother)

52.59 (12.68)

41.06 (13.11)

0.89

36.71 (11.30)

51.94 (13.38)

50.18 (14.25)

0.13

45.90 (15.61)

43.36 (16.55)

0.16

34.68 (8.93)

49.36 (15.22)

50.01 (19.93)

-0.04

161.26 (25.85)

130.96 (27.04)

1.15

122.14 (27.17)

163.69 (26.14)

147.13 (34.58)

0.54

BIQ (father)

150.25 (29.04)

132.02 (29.73)

0.62

118.79 (26.73)

150.89 (31.14)

146.86 (35.62)

0.12

POQ (mother)

52.72 (15.55)

41.18 (15.30)

0.75

39.66 (11.93)

52.38 (16.72)

48.27 (15.80)

0.25

POQ (father)

47.35 (20.23)

42.80 (19.73)

0.23

40.80 (9.93)

54.54 (18.90)

49.10 (22.35)

0.26

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Note: N Dx = Total number of anxiety disorders; CSR= total Clinician Severity Rating for anxiety diagnoses; PAS-R= Preschool Anxiety ScaleRevised; CALIS-PV= Child Anxiety Life Interference Scale- Preschool Version; BIQ= Behavioral Inhibition Questionnaire; POQ = Parent Overprotection Questionnaire Table 2: Means and standard deviations from the quasi-experimental comparison between parent and child (combined) intervention against parent only intervention Measure

Parent-and-child Intervention

Parent only Intervention

Pre-Intervention 6-month Mean (SD) follow-up Mean (SD)

Pre-6 mth effect Pre-Intervention 6-month size (d) Mean (SD)a follow-up Mean (SD)

Pre-6 mth effect size (d)

N Dx

3.80 (1.37)

1.26 (1.37)

1.85

3.24 (1.38)

1.91 (1.61)

0.89

CSR

19.95 (5.43)

8.97 (5.49)

2.01

16.67 (5.45)

10.49 (5.97)

1.08

PAS-R (mother)

63.15 (16.30)

44.33 (16.55)

1.15

63.02 (20.51)

49.46 (26.25)

0.58

CALIS-PV (mother) BIQ (mother)

52.59 (11.99)

40.76 (12.24)

0.98

50.17 (14.07)

41.73 (17.98)

0.52

161.26 (25.79)

130.92 (26.60)

1.16

148.26 (32.80)

127.29 (43.03)

0.55

POQ (mother)

52.66 (13.68)

40.74 (13.30)

0.88

48.17 (16.31)

39.14 (16.49)

0.55

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Note: N Dx = Total number of anxiety disorders; CSR= total Clinician Severity Rating for anxiety diagnoses; PAS-R= Preschool Anxiety ScaleRevised; CALIS-PV= Child Anxiety Life Interference Scale- Preschool Version; BIQ= Behavioral Inhibition Questionnaire; POQ = Parent Overprotection Questionnaire Note: a – Pre-intervention for the parent only condition refers to post-waitlist assessment point.

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