Development and content validity of the Therapy Behavior Scale

Infant Behavior & Development 35 (2012) 452–465

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Infant Behavior and Development

Development and content validity of the Therapy Behavior Scale夽 Mary Rahlin a,∗ , Constance McCloy b , Roberta Henderson a , Toby Long c , Wendy Rheault d a b c d

Department of Physical Therapy, Rosalind Franklin University of Medicine and Science, United States Center for Aging and Community, University of Indianapolis, United States School of Continuing Studies, Georgetown University, United States College of Health Professions, Rosalind Franklin University of Medicine and Science, United States

a r t i c l e

i n f o

Article history: Received 13 March 2011 Received in revised form 4 December 2011 Accepted 2 March 2012 Keywords: Infant Toddler Behavior Therapy Assessment Scale

a b s t r a c t The purpose of this study was to develop an assessment instrument that would allow clinicians to (1) evaluate behaviors of infants and toddlers during therapeutic intervention based on their own observations; (2) be applicable in a home-based or an outpatient therapeutic setting; and (3) be appropriate for use with infants and toddlers from birth to three years of age regardless of their developmental level or level of disability. Six pediatric therapists participated in the development and content evaluation of the instrument, Therapy Behavior Scale (TBS) with its subsequent revision into the TBS Version 1.0. Three raters pilot tested the scale with seven infants and toddlers. The results supported the content validity of the TBS Version 1.0 and led to the development of the TBS Version 1.1. Further research is needed to validate the newest version of the scale and to establish its intra-rater and interrater reliability. © 2012 Elsevier Inc. All rights reserved.

1. Introduction 1.1. Need for assessment of therapy-related behavior Assessing behavior of infants and toddlers during physical, occupational and developmental therapies1 is important to address the needs of the whole child when providing early intervention services. According to the Research Priorities for Early Intervention and Early Childhood Special Education developed by the Research Committee of the Council for Exceptional Children (About DEC, n.d.), Division of Early Childhood (DEC) (The Division for Early Childhood, 2006, p. 3), “there is a need to evaluate factors that moderate various outcomes and to determine the extent to which services, supports, and family involvement lead to enhanced capacity and other important outcomes for children and families.” Assessing therapy-related behavior and investigating the relationship between behavior and therapy outcomes may be helpful for early interventionists and other professionals working with children from birth to three years of age. Findings of such research may assist in

夽 This study was completed to fulfill a Juried Project requirement for the Doctor of Health Science degree at the University of Indianapolis, for the first author. ∗ Corresponding author at: Department of Physical Therapy, Rosalind Franklin University of Medicine and Science, 3333 Green Bay Road, North Chicago, IL 60064, United States. Tel.: +1 847 578 8766; fax: +1 847 578 8816. E-mail address: [email protected] (M. Rahlin). 1 In the State of Illinois, developmental therapists are Early Intervention specialists who hold a bachelors degree or higher in Special Education, Early Childhood Special Education, Early Childhood Education, Developmental Psychology or Social Work. Developmental Therapy or Special Instruction focuses on creating supportive environment for the child’s development of functional skills in a variety of areas, such as activities of daily living, communication, social and adaptive skills (Illinois Department of Human Services, Community Health and Prevention, Bureau of Early Intervention, 2009). 0163-6383/$ – see front matter © 2012 Elsevier Inc. All rights reserved. doi:10.1016/j.infbeh.2012.03.001

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improving early intervention service delivery by strengthening the link between assessment and intervention, as suggested by DEC (2006). As we have observed in our clinical practice, the behavior of infants and toddlers during therapy sessions may affect the duration of the session, the immediate success of intervention, active participation of the child and family within the session, and the level of parental and child stress. Children demonstrate a variety of behaviors. They may cry, avoid certain tasks, demonstrate low tolerance to therapeutic handling, exhibit excessive activity level, or be passive and unmotivated to move. Their ability to calm themselves without adult intervention or with minimal input from a caregiver may impact the outcome of the therapy session. Clinicians should take these behaviors into consideration when structuring therapy sessions, selecting intervention strategies, progressing intervention, and determining short-term prognosis for each child. Many behaviors infants and toddlers display during therapy sessions are not related to their level of development or level of disability. For example, while a child with a moderate developmental delay may exhibit temper tantrums in response to a new activity introduced by the therapist and refuse to participate in therapy sessions throughout infancy and toddlerhood, another child of the same age who has a significant developmental disability may participate eagerly in all activities and stay interested and engaged until the end of the session. One way of assessing behavior is to focus on a single behavioral characteristic children demonstrate during therapy sessions, such as crying. According to Brazelton (1992), there are many reasons for infant and toddler crying. These include pain, discomfort, hunger, fatigue, or boredom. In addition, crying may indicate overstimulation, or may be a limit-testing or an attention-seeking behavior. Crying may also be a part of the disorganized behavior associated with a developmental spurt (Brazelton, 1992). Rahlin, Cech, Rheault, and Stoecker (2007) found that music mediated crying in an infant with Erb’s palsy during therapy. Rahlin and Stefani (2009) subsequently conducted a larger, multiple single subject study with infants and toddlers, ages birth to three years. The results indicated that the participants had variable responses to music. Similar to the situations described by Brazelton (1992), that study revealed that there appeared to be multiple reasons for crying during therapy, and that other behavioral characteristics of the participants besides irritability might have played an important role in shaping their responses to music (Rahlin & Stefani, 2009). These observations support the hypothesis that using an instrument that assesses multiple therapy-related behaviors may be more appropriate and helpful than the tools that assess single behaviors. Furthermore, because infant or toddler behavior results from the interaction among the child, his or her temperament, and the environment in which he or she functions (Scarborough, Hebbeler, Spiker, & Simeonsson, 2007), it appears appropriate to use an instrument to evaluate behaviors the child demonstrates in a therapy situation and to assess possible effects of these behaviors on physical, occupational and developmental therapy outcomes. Such an instrument could assist therapists to: (1) evaluate behavioral responses exhibited by infants and toddlers to gross motor, fine motor, play, and behavior management interventions; (2) identify possible reasons for crying or uncooperative behavior; (3) determine the prognosis for the immediate success of intervention; (4) modify intervention taking into consideration the child’s behavioral responses; (5) assess changes in how infants and toddlers with developmental disorders and disabilities approach and work through difficult tasks; and (6) document the effects of variables such as the therapy setting, specific therapeutic environment, and the time of the day when the sessions are scheduled on a variety of behaviors infants and toddlers exhibit during therapy. Pediatric physical, occupational and developmental therapists (PTs, OTs and DTs) can use this information to individualize intervention to meet the unique needs of infants and toddlers based on objective behavioral data. In addition, this information may help therapists to provide valuable suggestions to the parents on how to interact with their children to promote positive participation in activities and routines, including home exercise program activities, while taking into consideration their behavioral responses documented during therapy sessions. 1.2. Existing instruments assessing different aspects of infant and toddler behavior We conducted a comprehensive review of existing pediatric standardized assessment instruments that evaluate various aspects of infant and toddler behavior, including temperament and social competence (ACF, OPRE, 2012; Carey, 2000; Hogan, Scott, & Bauer, 1992; Houck, 1999; Putnam, Gartstein, & Rothbart, 2006; Saylor, Boyce, & Price, 2003); problem and adaptive behaviors (Cerebral Palsy Glossary, 2005–2011; Limperopoulos, Majnemer, Steinbach, & Shevell, 2006; McCain, Kelley, & Fishbein, 1999; Mouton-Simien, McCain, & Kelley, 1997; Shevell, Majnemer, Platt, Webster, & Birnbaum, 2005; Sparrow, Balla, & Cicchetti, 1984); playfulness (Bundy, 1997; Bundy, Nelson, Metzger, & Bingaman, 2001; Okimoto, Bundy, & Hanzlik, 2000; Reid, 2004), and social-emotional and behavioral competencies (Bayley, 2005; Brazelton & Nugent, 1995; Brigance, 1991; Carter, Briggs-Gowan, Jones, & Little, 2003; Greenspan, 2004; Haley, Coster, Ludlow, Haltiwarger, & Andrellas, 1998; Johnson-Martin, Attermeier, & Hacker, 2004; Miller & Roid, 1994; Newborg, 2005; Rahlin, Rheault, & Cech, 2003). Appendix A provides detailed information on the psychometric properties of these instruments. Appendix B summarizes the results of the analysis of these tools for meeting the criteria we considered important for the future instrument, Therapy Behavior Scale (TBS), we were planning to develop. These criteria included whether (1) physical, occupational and developmental therapists (PTs, OTs and DTs) can use these tools to document infant and toddler behavior based on their own observations; (2) these instruments are applicable in a home-based or an outpatient therapeutic setting; (3) they evaluate therapy-related behaviors in infants and toddlers, including irritability, self-calming ability, level of physical activity,

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Table 1 Expert Group members – credentials and experience information. Discipline

Education

Other credentials

DTa

Bachelor of Science in Early Childhood Education

DTb

Master of Science in Early Childhood Education Doctor of Occupational Therapy

Type 04 Teacher Certification with Special Education Approval; Credentialed Early Intervention Specialist (Illinois) Credentialed Early Intervention Specialist (Illinois) Credentialed Early Intervention Specialist (Illinois)

OTb

OT PT

PTb

Master of Science in Occupational Therapy Master of Physical Therapy

Bachelor of Science in Physical Therapy

Credentialed Early Intervention Specialist (Illinois) Board Certified Specialist in Pediatric Physical Therapy; Credentialed Early Intervention Specialist (Illinois) Credentialed Early Intervention Specialist (Illinois); >20 years overall pediatric experience

Years of experience working with children, ages birth to three years 5

14 5

8 7

8

Clinical setting(s)

Early intervention

Educational and early intervention Research, early intervention, outpatient clinic Outpatient clinic and early intervention Hospital (outpatient department and NICU)

Outpatient clinic and early intervention

Note: DT = developmental therapist; OT = occupational therapist; PT = physical therapist. a Joined the Expert Group after the TBS items construction was completed. b Research assistant.

willingness to engage in therapeutic tasks, responses to therapeutic handling, etc.; and (4) they are appropriate for use with infants and toddlers regardless of their developmental level or level of disability. We found that although some of these instruments contain items that may be helpful to pediatric therapists in their assessment of infant and toddler behavior during therapy, they are not appropriate for use for this purpose in their entirety. In addition, the reviewed assessment tools do not meet the criteria stated above. They often rely on parental report (criterion 1) and many of them are norm-referenced (criterion 4) and unrelated to a therapy situation, or lack the capacity to evaluate the child’s responses to handling by a therapist (criterion 3). 1.3. Study purpose The purpose of this study was to develop and determine content validity of an assessment tool, the Therapy Behavior Scale (TBS) that would: (1) allow PTs, OTs and DTs to evaluate infant and toddler behavior based on the therapists’ own observations; (2) be applicable in a home-based or an outpatient therapeutic setting; (3) evaluate therapy-related behaviors in infants and toddlers; and (4) be appropriate for use with infants and toddlers from birth to three years of age, regardless of their developmental level or level of disability. The TBS was developed for use with physiologically stable infants and toddlers, regardless of their level of development or disability, who were receiving home-based or out-patient physical, occupational and/or developmental therapy. For the purpose of this investigation, we defined the term “physiologically stable infants and toddlers” as those who had vital signs within the average range, might require oxygen supplementation or other medical means to maintain physiological stability, but were not in physiological distress. 2. Method 2.1. Expert Group and research assistants Six pediatric therapists agreed to participate in the Expert Group for this project to help with construction, validation and pilot testing of the TBS. They included one DT, two PTs, and two OTs with extensive experience working with infants and toddlers from birth to three years of age. Three members of the Expert Group (a PT, an OT, and a DT) served as the Research Assistants (RAs) in this study. Table 1 provides the information related to the experts’ credentials and experience. 2.2. Procedure This study was approved by Institutional Review Boards at Rosalind Franklin University of Medicine and Science, North Chicago, IL, and University of Indianapolis, Indianapolis, IN. Fig. 1 summarizes the TBS development and validation process, including the preliminary phase, TBS construction, evaluation of its content validity, modification of the scale into the TBS Version 1.0 and its pilot testing.

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THERAPY BEHAVIOR SCALE Preliminary Phase

Construction of the TBS

Ten behaviors important for a successful outcome of a therapy session listed by 5 experts

Behavioral Themes Table compiled

Successful Therapy Session Behavior List developed

11 TBS items scored on a 4-point Likertlike ordinal scale constructed

Validation of the TBS

The TBS content evaluated by 6 experts

Scale revised into the TBS Version 1.0 Suitable items from existing instruments used as references when developing operational definitions of qualifying behaviors for each point of the TBS items

The TBS Version 1.0 content evaluated by 6 experts

The TBS Version 1.0 pilot testing performed by 3 RAs on 7 infants and toddlers

Revisions of the record form and 2 items suggested for development of the TBS Version 1.1 Fig. 1. Depicts the diagram of the Therapy Behavior Scale (TBS) development and validation process. RAs = research assistants.

2.2.1. Preliminary phase We asked each of the initial five members of the Expert Group to generate a list of ten behavioral characteristics of infants and toddlers younger than three years of age that they considered to be most important for a successful outcome of a therapy session. “A successful therapy session” was defined as a session during which the child’s behavior supported or led the progression of the session, and the child actively participated in and cooperated with therapeutic activities most of the time or the entire time. We compared the lists received from each of the experts with our own list and identified eleven behavioral themes, which we used to develop a Successful Therapy Session Behavior List (see Fig. 1 and Table 2). We developed the definitions of these behaviors (Table 2) based on the descriptors suggested by the experts.

Table 2 Successful therapy session behavior list. No

Behavior

Description

1 2

Alert, rested and fed Good tolerance to handling, low irritability

3

Interest in toys and environment

4

Ability to communicate wants/needs

5

Ability to self-calm or calm by distraction or redirection

6 7

Willingness to engage in play Ability to respond socially to therapist

8

Ability to cooperate with limits set by therapist

9

Appropriate level of physical activity

The child tolerates full session without needing feeding, frequent breaks or sleep. The child remains happy, maintains positive facial expression and body language when handled by the therapist. May become irritable at the end of the session due to fatigue. The child fixes gaze on toys and other objects in environment, attempts to move or moves toward and explores toys and other objects. The child expresses wants and needs through crying, gestures, sounds, or verbal communication The child is able to self-calm by placing fingers, pacifier or toy in the mouth or is easily calmed by therapist or caregiver who holds, distracts the child with a toy or redirects the child to another activity. The child accepts and participates in a play activity suggested/demonstrated by therapist. The child responds to therapist by making eye contact, moving toward/touching therapist, responding positively to praise, etc. The child follows rules and accepts limits set for an activity by therapist without expressing frustration. The child demonstrates physical activity level appropriate for the task (as compared to being passive or overactive). The child is able to focus on a task without being easily distracted by normal environmental sounds or occurrences. The child is able to handle changes in schedule, activity, toy, location, without a “meltdown”.

10

Appropriate level of attention

11

Ability to cooperate with change

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Table 3 Number of “yes” answers to the TBS content evaluation form questions. No

Question

1

Do the TBS items reflect behaviors that infants and toddlers usually demonstrate during therapy sessions conducted in a home-based or out-patient setting as related to your clinical experience? Do the TBS items cover the entire range of behaviors you consider important for a successful therapy session? Do the scoring criteria for each of the TBS items adequately sample the range of that specific behavior? Can each of the TBS items be used for infants and toddlers ages birth to three years regardless of their developmental level or level of disability?

2 3 4

Number of “yes” answersa Original TBS

TBS Version 1.0

6/6

6/6

6/6

6/6

53/66

66/66

54/66

64/66

a For each of the questions 1 and 2, there were a total of 6 possible “yes” or “no” answers (based on the number of experts). For each of the questions 3 and 4, there were 66 possible “yes” or “no” answers (based on six experts answering these questions for each of 11 TBS items).

2.2.2. Construction of the TBS We used the Successful Therapy Session Behavior List (Table 2) for the construction of the TBS items scored on a fourpoint ordinal scale.2 When developing the operational definitions of qualifying behaviors for each point of the scale, we used suitable items from several existing instruments as references if they seemed to fit the Successful Therapy Session Behavior List (Table 2 and Fig. 1). These instruments included the Infant–Toddler Social and Emotional Assessment (ITSEA) (Carter et al., 2003), the Test of Playfulness (ToP) (Bundy et al., 2001; Okimoto et al., 2000), and the Toddler and Infant Motor Evaluation (TIME) (Miller & Roid, 1994) Social-Emotional Abilities Subtest. The order of the TBS items followed the level of importance of each of the behaviors for a successful therapy session identified via a survey of pediatric physical therapists based on their experience working with children, ages birth to three years (Christakos et al., 2008). 2.2.3. Validation of the TBS Content validity of an instrument is its capability to sample all the behaviors that comprise the domain which this instrument measures (Portney & Watkins, 2008b). An assessment tool possesses content validity if its parts represent the entire universe of its content, and if the relative importance of its parts is established. The Expert Group evaluated the TBS content domain to determine its content validity as described by Portney and Watkins (2008b), and suggested appropriate changes (see Fig. 1 for the summary of the TBS validation process and Table 3 for the Content Evaluation Form questions). This evaluation of the TBS determined whether it met the scale criteria 3 and 4 stated in the study purpose (Section 1.3). We modified the TBS items and record form based on the experts’ feedback. The outcome of this process was the development of the TBS Record Form, Version 1.0, and the Expert Group evaluated the content of this new version. The 11 scale items were: 1 – Physiological Needs; 2 – Willingness to Engage in Play; 3 – Self-Calming and Calming Ability; 4 – Interest in Toys and Environment; 5 – Ability to Cope with Change; 6 – Attention Level; 7 – Ability to Respond Socially to Therapist; 8 – Tolerance to Physical Handling; 9 – Level of Physical Activity; 10 – Ability to Communicate Wants and Needs; and 11 – Ability to Cooperate with Limits Set by Therapist. 2.2.4. Pilot testing of the TBS Version 1.0 2.2.4.1. Participants. The TBS Version 1.0 pilot testing participants were seven infants and toddlers who had completed a previous research study, which involved videotaping physical therapy sessions. The investigators recruited children for that study from a private, home-based, pediatric physical therapy practice. We asked the participants’ parents to re-consent for further use of the video recordings made for the previous research. We created a research registry that contained the numbers assigned to the participants and the following information collected during the previous study: the child’s date of birth, age at the time the recording was made, gender, and medical diagnosis. The study participants were five infants and two toddlers, four boys and three girls, whose chronological age was between 6 and 18.5 months. All participants were receiving early intervention therapy services at the time the videos were made. Three of them (two boys and one girl) were born prematurely. The participants’ diagnoses included birth weight below 1000 grams, developmental delay, 4p deletion syndrome, Grade III intraventricular hemorrhage, hypertonicity, Poland syndrome, seizure disorder, and torticollis. Their gross motor skill level was that of a beginning walker or below, and their therapy goals varied based on the abilities they displayed at the time when the videos were made. 2.2.4.2. Pilot testing procedure. The goals of the pilot testing were to provide additional information regarding the content validity of the TBS and to assess the ease of its use in a home-based or an out-patient clinical setting. Three RAs

2

Examples of the original TBS items are available from the first author upon request.

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Table 4 TBS Version 1.0 Pilot testing feedback form questions and number of “yes” answers to statements 2–3 and question 4. No

Statement/question

Number of “yes answersa

1

After watching the entire recording of this therapy session a. I could easily recall the child’s behavior in order to complete the TBS Record Form b. I had some difficulty recalling some of the child’s behaviors in order to complete the TBS Record Form c. I had insufficient recollection of the child’s behavior in order to complete the TBS Record Form Based on my experience with scoring this child’s therapy-related behavior, the TBS will be easy to administer at the end of a physical, occupational or developmental therapy session in a home-based or an out-patient therapy setting. When filling out the TBS Record Form, I was able to account for all important therapy-related behaviors this child demonstrated during this therapy session. Did the scoring criteria for each of the TBS items adequately sample the range of that specific behavior for this child? It took me minutes to complete the TBS Record Form for this child.

N/A

2

3 4 5

3/3

3/3 211/231 N/A

a

For each of the statements 2 and 3, there were a total of 3 possible “yes” or “no” answers (based on the number of experts). For question 4, there were 231 possible “yes” or “no” answers (based on three RAs answering these questions for each of 11 TBS items for 7 participants).

performed the pilot testing of the TBS on the previously made video recordings of therapy sessions (see Section 2.2.4.1). We labeled each of the DVDs used for this study with the participant’s research registry number and age. The RAs used this number to identify each of the study participants when filling out the TBS Record Form, Version 1.0. They watched the DVDs of the physical therapy sessions in a quiet, private area. Each of them scored the DVDs independently from the other RAs and they did not communicate with one another during the entire pilot testing process. They filled out the TBS Record Form, Version 1.0 after watching the entire recording of the therapy session, without taking notes, as intended for the clinical use of this instrument. The RAs also completed the TBS Pilot Testing Feedback Form for each child (see Table 4).

2.3. Data analysis According to Portney and Watkins (2008b, p. 101), establishing content validity “is essentially a subjective process”, for which there are no available statistical procedures. An expert panel usually reviews the test in order to decide whether its questions adequately sample the stated content domain. For this study, we compared the feedback received from the Expert Group members and from the RAs to determine whether the content validity of the TBS and TBS Version 1.0 was supported. We compiled several lists of changes to be made to the scale as suggested by the experts and used tables to display the results of the content evaluation and pilot testing of the TBS Version 1.0.

3. Results 3.1. The TBS content evaluation The six members of the TBS Expert Group (two DTs, two OTs and two PTs) evaluated the TBS content and provided written comments regarding its specific items on the TBS Content Evaluation Form. We contacted each of the experts, discussed their comments with them over the phone or in person, and subsequently made decisions regarding the scale revisions. All six experts agreed that the TBS items reflected behaviors that infants and toddlers usually demonstrate during therapy sessions conducted in a home-based or an out-patient setting, and that the TBS items covered the entire range of behaviors the experts considered important for a successful therapy session (see questions 1 and 2 data for the original TBS in Table 3). While answering questions 3 and 4 on the TBS Content Evaluation Form, four of six experts stated their concerns regarding the scoring criteria for several TBS items and regarding some of the items’ use for infants and toddlers, ages birth to three years, regardless of their developmental level or level of disability (see Table 3). As the result, all but four TBS items (Physiological Needs, Self-Calming and Calming Ability, Interest in Toys and Environment and Ability to Respond Socially to Therapist) were modified from their original version based on the experts’ feedback, which led to the development of the TBS Version 1.0. The expert group evaluated the TBS Version 1.0 content and showed 100% agreement in answering “Yes” to the first three questions on the TBS Content Evaluation form (Table 3). Two experts commented on one item each (Interest in Toys and Environment, and Ability to Cope with Change, respectively) after answering “No” to question 4 (Table 3). After discussing the wording of these items with the experts, we made a decision to leave them unchanged until the pilot testing of the TBS Record Form Version 1.0 was completed.

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3.2. Pilot testing of the TBS Version 1.0 3.2.1. Pilot testing feedback form data The RAs reported that it took them 3–8 min (5 min on average) to complete the TBS Version 1.0 Record Form (see statement 5 in Table 4). All RAs were able to easily recall most behaviors in order to complete the TBS Version 1.0 Record Form after watching the entire recording of each of the therapy sessions (see statement 1 in Table 4). Table 4 shows the number of “Yes” answers to statements 2–3 and question 4 listed on the TBS Version 1.0 Pilot Testing Feedback Form. All three RAs agreed with statements 2 and 3. As for question 4, it was answered “yes” 91% of the time. Based on the RAs’ comments and a subsequent discussion, we decided to modify two items and the record form layout as described below. 3.3. Scale and record form revisions to create the TBS Version 1.1 Based on the results of pilot testing of the TBS Version 1.0, its two items that required revisions included Ability to Cope with Change (Item 5) and Tolerance to Physical Handling (Item 8).3 For Item 5, we included “indifference” as a behavioral characteristic for the score of 3 in the next TBS version (Appendix C). For Item 8, we decided to change the wording for the score of 3 to reflect more intermittent handling than had been described originally. These modifications were made to better differentiate behaviors of infants and toddlers when assessed on these two TBS items (Appendix C). The pilot testing results showed that the PT RA had difficulty scoring multiple TBS items, because she had not noticed the directions for score assignment printed at the top of the first page of the record form. This led to a systematic error as she consistently scored the participants’ behavior higher than the other two raters.4 To avoid this problem in the future, the record form layout was changed to include the scoring directions on each page, printed in a different color to enhance its visibility. The implemented changes led to the development of the next version of this instrument, the TBS Version 1.1 (Appendix C). 4. Discussion 4.1. Analysis of results Although numerous standardized assessments of infant and toddler behavior and development are available to clinicians, none of them is designed to evaluate therapy-related infant and toddler behavior in out-patient or home-based settings regardless of disability or developmental level. In this study, we developed and evaluated an assessment instrument (Therapy Behavior Scale) that met these needs and could be used by PTs, OTs and DTs within these therapy settings. The entire process entailed: (1) the development and content evaluation of the TBS; (2) subsequent revisions that led to the development of the TBS Version 1.0; (3) the initial content validation of the TBS Version 1.0 through evaluation by an expert panel; and (4) pilot testing by three raters on video recordings of PT sessions conducted with seven infants and toddlers (see Fig. 1). The evaluation of the TBS Version 1.0 by six experts supported its content validity which was evident from the high level of agreement among the experts when answering questions on the TBS Content Evaluation Form (Table 3). The results of pilot testing revealed a high level of agreement among three RAs when filling out the TBS Version 1.0 Pilot Testing Feedback Form (Table 4). Therefore, the TBS Version 1.0 met the definition of an instrument possessing content validity as defined by Portney and Watkins (2008b), because it was found to sample all the behaviors that comprised the domain which it had been designed to measure, and its parts were found to represent the entire universe of its content. However, the pilot testing results also pointed to the need to modify two of the TBS Version 1.0 items, which led to the development of the TBS Version 1.1 (Appendix C). 4.2. Limitations and suggestions for future research This research had several limitations: small sample size, the use of video recordings, and the fact that the RAs scored the participants’ behavior only during physical therapy sessions. The main purposes of this study were to develop the TBS and to examine its content validity. The pilot testing was one of the methods we used in order to evaluate the content validity of the TBS Version 1.0. The specific goal of pilot testing was to determine the clarity of the test record form and the ease of its administration with several children. Therefore, having seven participants in the study sample was adequate for the purposes of this research. Using the video recordings of therapy sessions instead of filling out the TBS Record Form after “live” interactions with patients during pilot testing simplified the recruitment of the study participants (see Pilot Testing section of this paper) and allowed the RAs to score their behavior at different times. This was more feasible for them than having to observe the

3

Items 5 and 8 of the TBS Version 1.0 can be obtained from the first author upon request. The complete data related to the results of scoring the video recordings on the TBS Version 1.0 during pilot testing of the scale by three RAs can be obtained from the first author upon request. 4

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same therapy session together. However, the process of scoring the child’s behavior during a therapy session conducted by someone else may be different from scoring the therapist’s own session with that child. In “live” situations, the therapists would directly interact with children through physical handling, verbal and non-verbal communication, and by using behavior management techniques as needed, which may change the therapists’ perception of behavior children exhibit during therapy sessions. Although the TBS is intended for use with infants and toddlers undergoing physical, occupational or developmental therapy, only physical therapy sessions’ recordings were used for pilot testing. This also limits the scope of content validity of the TBS Version 1.0 established by this study, because the results may not be applicable to occupational or developmental therapy situations. Therefore, further research is needed to validate the TBS Version 1.1 for use by PTs, OTs and DTs after they complete their “live” therapy sessions with infants and toddlers. Besides establishing the content validity of this instrument, we also need to examine its intra-rater and interrater reliability. The best plan would be to conduct a large, multicenter, validity and reliability study with the TBS Version 1.1, where therapists representing all three disciplines score the participants’ behavior after both “live” and recorded DT, OT and PT sessions. This would help to validate the TBS use in the clinic and for research purposes, as well as produce a large amount of data that could be analyzed for the development of the cut-off scores for interpretation of the test results. Other future studies with the TBS Version 1.1 may include using Rasch analysis to convert its ordinal scale into an interval scale to enhance its measurement properties (Linacre, 2006; Portney & Watkins, 2008a). Additional research could focus on investigating the effects of therapeutic interventions aimed at improving motor and/or play skills on therapy-related behaviors, or examine a possible relationship between therapy outcomes and patients’ behavior during therapy sessions. If the PTs, OTs and DTs involved in the child’s care conduct the TBS testing and share the results with the entire interdisciplinary team, they may be able to use these data to modify the therapy set-up, environment, timing and structure, and their style of interaction with the child during therapy sessions. The effects of these changes on the intervention outcomes will need to be investigated. Finally, we propose that the TBS may be used in outcomes research that compares different types of therapeutic intervention that address the same functional goal but elicit different patient behaviors. The results of such investigations may allow therapists to select the interventions that would produce the best functional and behavioral outcomes for their patients, which would address the needs of the whole child. 5. Conclusions In this study, we developed the TBS Version 1.0 and examined its content validity. The results showed that PTs, OTs and DTs can use this tool to evaluate infant and toddler behavior based on their own observations; it is applicable in a home-based or an outpatient therapeutic setting; it evaluates therapy-related behaviors in infants and toddlers; and it is appropriate for use with infants and toddlers regardless of their developmental level or level of disability. The results supported the content validity of the TBS Version 1.0 but also pointed to the need for minor changes that led to the development of the TBS Version 1.1. Further research is needed to validate this new instrument for clinical use and for research purposes, and to establish its intra-rater and interrater reliability. Acknowledgments The first author would like to thank Jennifer Suda for her thoughtful comments that helped generate the idea for this research. The authors wish to express their gratitude to the study participants, their parents, and the members of the Expert Group, including Amy Bye, Kate Davis, Liza O’Neal, Renita Overstreet, Margarita Redmond, and Bernadette Sarmiento, for their contribution to this research.

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Appendix A. Psychometric properties of reviewed standardized assessment instruments. Instrument

Internal consistency (Chronbach’s alpha)

Interrater reliability

Test–retest reliability (Pearson r)

Validity

The Carey Temperament Scales (CTS) (ACF, OPRE, 2012) The Early Childhood Behavior Questionnaire (ECBQ) (Putnam et al., 2006) The Adaptive Social Behavior Inventory (ASBI) (Houck, 1999; Hogan et al., 1992) The Toddler Behavior Screening Inventory (TBSI) (Mouton-Simien et al., 1997; McCain et al., 1999) The Vineland Adaptive Behavior Scale (VABS) (Shevell et al., 2005) The Test of Playfulness (ToP) (Bundy et al., 2001)

0.43–0.86

None reported

0.64–0.94

None reported

0.57–0.90

0.36–0.57 p < 0.01

None reported

Longitudinal stability coefficients: 0.33–0.78

0.72–0.85

None reported

None reported

Correlational stability coefficients: 0.28–0.51

0.84–0.90

None reported

0.68–0.89

Concurrent validity with Child Behavior Checklist: r = 0.48–0.79

0.76–0.99

0.62–0.78

0.76–0.93

None reported

None reported

The Infant–Toddler Social and Emotional Assessment (ITSEA) (Carter et al., 2003) The Bayley-III (Bayley, 2005)

0.45–0.90

Percentage of individual item ratings fitting the Rasch measurement model: 96% ICC: 0.43–0.79

Concurrent validity established with intelligence and achievement tests and the VABS communication subdomain Construct validity established using the Rasch model. Concurrent validity with Children’s Playfulness Scale: Pearson r = 0.46

0.69–0.90

0.77–0.96

None reported

0.67–0.86

The Neonatal Behavioral Assessment Scale (Brazelton & Nugent, 1995)

None reported

None reported

Low to moderate correlations

The Pediatric Evaluation of Disability Inventory (PEDI) (Haley et al., 1998)

0.95–0.99

ICC: 0.84–1.00

None reported

The Brigance Diagnostic Inventory of Early Development, Revised Edition (BIED-R) (ACF, OPRE, 2012) The Carolina Curriculum for Infants and Toddlers with Special Needs (CCITSN) (ACF, OPRE, 2012; Johnson-Martin et al., 2004)

0.94–0.99

None reported

0.77–0.99

None reported

Percent agreement: 97%

None reported

Validity indices calculated for the ITSEA Problem and Competence domains and for Evaluator Ratings Concurrent validity with Peabody Developmental Motor Scales 2 (PDMS-2) (Total Motor): r = 0.55 Predictive validity enhanced by application of repeated measures and concurrent assessment of caregiving environment. Content validity established with an expert panel. Construct validity: developmental trend established. Discriminant validity (correctly classified children as disabled or non-disabled): 47–100%. Content validity established based on a review of literature and on comparison with the original BDIED.

Content validity established with an expert panel. Field-tested in 22 intervention programs in North Carolina and 10 other sites in the United States.

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Appendix B. Analysis of existing instruments assessing infant and toddler behavior for meeting the TBS criteria. Assessment instrument

Area of assessment

TBS relevant aspects helpful to OTs, PTs and DTs

Meeting the TBS criteria?

Reasons for not meeting the TBS criteria

The Carey Temperament Scales (CTS)

Temperament

Assess activity level, adaptability, mood, attention span and persistence, and distractibility (helpful to OTs, PTs and DTs)

No

The Early Childhood Behavior Questionnaire (ECBQ)

Temperament

Contain Activity Level, Attentional Focusing, Frustration, Impulsivity, Inhibitory Control, Motor Activation, Soothability scales

No

The Adaptive Social Behavior Inventory (ASBI)

Social competence

Items evaluating social interactions with adults may be helpful in assessment of infant and toddler behavior during therapy sessions

No

The Toddler Behavior Screening Inventory (TBSI)

Developmentally appropriate toddler behaviors

Identifies toddlers who exhibit frequent, developmentally relevant, behavior management problems

No

The Vineland Adaptive Behavior Scale (VABS)

Adaptive behavior

Assesses communication, daily living skills, socialization and motor skills; is applicable across a variety of settings

No

The Test of Playfulness (ToP)

Playfulness

No

The Infant–Toddler Social and Emotional Assessment (ITSEA)

Social-emotional and behavioral competencies and problems

The Bayley-III (Social-Emotional Subtest)

Social-Emotional Milestones

The Neonatal Behavioral Assessment Scale

Newborn infant behavior and reflexes

Observational instrument; produces a score unrelated to the child’s level of development or disability; may be an appropriate for out-patient and home-based therapeutic settings Some of the items from various scale domains (Activity/Impulsivity, Attention, Compliance and a few others) assess behaviors relevant to OTs, PTs and DTs Identifies problems with development of social-emotional competencies; helps pediatric clinicians working with infants and toddlers to establish goals for early intervention Provides information regarding infants’ general interaction patterns

Parent-report questionnaires; evaluate “everyday” behaviors; do not assess the child’s tolerance to therapeutic handling; not suitable for use by OTs, PTs and DTs in out-patient or home-based therapeutic settings Parent-report instrument; covers a narrow age range (from 18 to 36 months); not suitable for OT, PT and DT assessment of therapy-related behaviors in infants and toddlers Is only applicable to 36-month-old toddlers who were born prematurely; pediatric therapists cannot use this instrument in its entirety Norm-referenced, parent-report instrument; not applicable with infants; does not contain items that PTs, OTs and DTs can use to assess therapy-related behavior unrelated to patients’ developmental level Norm-referenced instrument; does not assess the child’s responses to therapeutic handling or other behaviors specific to an out-patient or a home-based therapeutic setting Provides incomplete information (lacks the capacity to evaluate such infant and toddler behaviors as irritability, self-calming ability, and responses to therapeutic handling).

The Pediatric Evaluation of Disability Inventory (PEDI) The Brigance Diagnostic Inventory of Early Development, Revised Edition (BIED-R) The Carolina Curriculum for Infants and Toddlers with Special Needs (CCITSN)

Functional abilities

Eleven developmental domains

Level of development

Social Function subscale contains communication and social interaction tasks Includes assessment of social-emotional skills and adaptive behavior; can be administered by caregiver observation in different settings Contains communication and social adaptation subscales

No

No

No

No

No

No

Parent-report measure; generally unrelated to a therapy situation; cannot be used with infants younger than 12 months of age; not suitable for assessment of therapy-related behaviors in infants and toddlers Norm-referenced developmental measure; not designed to assess specific therapy-related behaviors

Cannot be used with infants older than 2 months chronological age or 48 weeks post-conceptional age (if born prematurely); not designed to assess specific therapy-related behaviors Norm-referenced measure; not designed to assess specific therapy-related behaviors Curriculum-linked assessment; not designed to assess specific therapy-related behaviors

Curriculum-based assessment; not designed to assess specific therapy-related behaviors an out-patient or a home-based therapeutic setting

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Appendix C. The Therapy Behavior Scale (TBS) record form, Version 1.1. Please complete this form after the therapy session is over. Please read all the descriptors listed for each TBS item and select and circle the score corresponding to the behavior(s) exhibited by this child during this session. If the child’s behavior does not fit the description of a higher score in its entirety, a score lower by one point should be assigned.

1 Has to be fed and/or requires a nap or falls asleep during therapy, which takes up significant amount of session time (at least 20–30 min).

1 Ignores or does not respond to therapist’s and/or parent’s attempts to engage him/her in play.

1 Displays intense, inconsolable crying, OR Has temper tantrums until exhausted, without an apparent reason, AND Is not able to calm by being held, talked to, distracted or redirected by caregiver.

1 Passive, indifferent to toys and environment.

1 Is unable to handle changes in schedule, activity, toy, or location without a “meltdown”. Cries and screams or has temper tantrums in response, AND Is difficult to calm. AND/OR May perseverate on one activity and become very upset when interrupted.

1. Physiological Needs 2 3 Needs or requests a snack to Stays alert throughout the session. reorganize or for comfort several May require a short break or may times during the session, fatigue by the end of the session. AND/OR May become hungry during therapy, eat quickly (10 min or <) Acts sleepy and tired during the session but looks/acts fine once it and return to therapy after that. is over. 2. Willingness to Engage in Play 2 3 Accepts and participates in play Expresses interest in play activities suggested by therapist and/or activities suggested by therapist parent during session but does not and/or parent during session engage in play, greater than 50% of the time, OR OR May engage in a play activity Selects a play activity from choices briefly (for 5 min or less at a time), provided by therapist or parent but remains shy, reluctant, or and engages in play. unwilling to participate 50% of the time or greater. 3. Self-Calming and Calming Ability 2 3 Is fussy or whiny throughout Is able to self-calm by placing session when not tired, fingers, a pacifier or a toy in the AND/OR mouth or by spontaneously engaging in play, Has difficulty calming down if becomes upset, unless held, talked OR to, distracted or redirected by Is easily calmed by therapist or caregiver, caregiver who briefly holds, distracts the child with a toy or OR redirects the child to another Requires calming from caregiver frequently during session. Does not activity several times during respond to therapist’s attempts to session. calm him/her down. 4. Interest in Toys and Environment 2 3 Looks at toys and other objects. Curious about new toys and other Quickly loses interest. May objects. Persists in exploring a toy increase UE and LE movement but or an object visually or by listening does not attempt to explore toys or to the sound the toy makes, other objects in the environment. OR Attempts to obtain or explore a toy or an object by reaching and/or via active movement or movement transition but loses interest or cries and does not persist if unable. 5. Ability to Cope with Change 2 3 Has difficulty handling changes in Is able to handle changes in schedule, activity, toy, or location schedule, activity, toy, or location without a “meltdown”. May refuse without a “meltdown”, to do as asked when a change is OR involved. May require several Is indifferent to change. warnings and significant rewards Occasionally may cry or may need to switch. to be redirected in order to cooperate. May occasionally need verbal cues to transition.

4 Alert, rested and fed. Tolerates the entire session without needing sleep, breaks or feeding.

4 Initiates play with therapist and/or parent during session, AND/OR Responds to therapist’s and/or parent’s cues in a way that supports the progression of play activity.

4 Stays calm throughout session; no external help needed to remain in a good mood.

4 Obtains a toy or an object and actively explores it, OR Persists in trying to overcome difficulties or obstacles in order to obtain and/or explore a toy or another object. May cry if not successful but keeps trying.

4 Easily and consistently cooperates with and adjusts to changes in schedule, activity, toy, or location.

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Please complete this form after the therapy session is over. Please read all the descriptors listed for each TBS item and select and circle the score corresponding to the behavior(s) exhibited by this child during this session. If the child’s behavior does not fit the description of a higher score in its entirety, a score lower by one point should be assigned. 1 Is very distractible and disorganized. Is unable to focus on a meaningful task even for a few seconds in absence of environmental distracters.

1 Avoids making eye contact with therapist, AND/OR Displays intense crying in therapist’s presence even when held by parent, and therapist is located on the opposite side of the room, OR Ignores therapist as if he/she is not in the room.

6. Attention Level 2 3 Needs constant redirection, Is able to focus on a meaningful reminders or rewards to stay on a task for at least 5 min without meaningful, age-appropriate task. being easily distracted by normal AND/OR environmental sounds or occurrences. Focuses well when Requires structure and a visually/auditorily quiet engaging in a new activity. May environment to focus. need a reminder or praise to continue. 7. Ability to Respond Socially to Therapist 2 3 Frequently makes eye contact, may Consistently makes eye contact, look at therapist when called by smiles back at therapist, responds name and smile back at therapist when called by name. May call or talk to him/her from across the therapist by name, initiate room or when held by parent, but conversation (if applicable), show a avoids being in close proximity to toy to therapist and move toward therapist, or reach for therapist, AND AND/OR Remains calm and content at least Cries often when in close proximity to therapist, 70% of the time when in close OR proximity to therapist. Clings to parent and may cry in close proximity to therapist.

4 Is able to focus on a meaningful task for the duration of activity without rewards or reminders. Carefully watches the demonstration of a new activity or is very attentive to verbal directions (if applicable). Easily participates in all activities over 75% of the session time. 4 Moves toward and reaches for therapist, initiates social touch to attract therapist’s attention. May talk to therapist or share a toy. Looks for and responds positively to praise. May clap for self when succeeds with a task and may look at therapist inviting him/her to do the same, AND Remains calm and content the entire time when in close proximity to therapist.

8. Tolerance to Physical Handling 2 3 4 Remains calm and maintains Remains calm, happy, pleasant and Remains calm when provided with minimal tactile cues, but starts positive facial expression and body engaging, maintains positive facial crying when repositioned, picked language most of the time when expression and body language up, or physically redirected by handled by therapist when handled by therapist therapist, intermittently, longer than 5 min, throughout the session. May several consecutive times, or request preferred handling OR continuously for at least activities during therapy. Remains calm during handling for up to 5 min, then gradually 10–15 min. Becomes irritable and becomes irritable, may cry intermittently after that or AND/OR cry in the last 5–10 min of the session due to handling-related Needs frequent breaks from handling to reorganize. fatigue or discomfort. 9. Level of Physical Activity (if you choose the score of 1 or 2, please denote passive or overactive by circling the score AND description in appropriate box) 3 4 1 2 Passive: Appears to have no May move between positions but energy to move, remains more static than active Normal level of physical activity. OR most of the time. If able to walk, Normal level of physical activity. Initiates physical activities prefers playing in sitting or lying Remains calm and content Moves willingly and appropriately appropriate for his/her age. Shows without moving around. down. in his/her environment. Plays in a pleasure when moving without Moves between toys very quickly, Overactive: Moves constantly variety of positions. Engages in being overly active. May try to and without an apparent faster than other children of both, quiet and active play. engage adults and/or other meaningful purpose. Is unable his/her age. Is unable to sit still children in a physical activity. to sit still and/or displays while playing. May frequently excessive body movements move, turn, or run away, come back when sitting. May be very and then engage in a new activity. impulsive and/or disregard safety. 10. Ability to Communicate Wants and Needs 2 3 4 1 Clearly and appropriately Crying or tantrums is the Attempts to express wants and Uses crying or tantrums as the only method of communicating predominant method of needs appropriately through expresses wants and needs wants and needs. communicating wants and needs, crying, gestures, body language, through crying, gestures, facial but the child sometimes attempts sounds or verbal communication expressions, body language, to use gestures, body language, AND sounds or verbal communication sounds or verbal communication throughout session, is successful at least 50–70% of the with limited success. time, AND AND Crying is not the predominant method of communication. Crying is not the predominant method of communication. 1 Has temper tantrums, hits, bites or kicks therapist in response to attempted therapeutic handling, AND/OR Cries and screams throughout session when handling is attempted.

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Please complete this form after the therapy session is over. Please read all the descriptors listed for each TBS item and select and circle the score corresponding to the behavior(s) exhibited by this child during this session. If the child’s behavior does not fit the description of a higher score in its entirety, a score lower by one point should be assigned. 1 Constantly demonstrates avoidance behaviors, refuses to cooperate with rules, follow directions appropriate for age or level of cognition, or accept limits set by therapist for a therapeutic activity. May disregard safety, AND/OR Constantly gets frustrated, cries or has temper tantrums when does not get his/her way or when asked to cooperate with a therapeutic activity set up by the therapist.

11. Ability to Cooperate with Limits Set by Therapist 2 3 Is difficult to engage in activity Tries to do as asked most of the requiring following directions time. Frequently cooperates with appropriate for age or level of rules, follows directions cognition, appropriate for age or level of cognition, and accepts limits set for AND/OR an activity by therapist, Frequently demonstrates avoidance behaviors, gets AND/OR frustrated or cries when asked to May occasionally get frustrated cooperate with a therapeutic and briefly cry when asked to activity set up by therapist. cooperate with a therapeutic activity set up by therapist.

4 Consistently cooperates with rules, follows directions appropriate for age or level of cognition, and accepts limits set for an activity by therapist, OR Consistently cooperates with therapeutic activities set up by therapist.

TOTAL SCORE:

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