RESEARCH OBJECTIVE(S)

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1 Bearss, K., Johnson, C., Smith, T., Lecavalier, L., Swiezy, N., Aman, M.,... & Scahill, L. (2015). Effect of parent training vs parent education on behavioral problems in children with autism spectrum disorder: A randomized clinical trial. Journal of the American Medical Association, 313, CLINICAL BOTTOM LINE Parent Training Autism spectrum disorder (ASD) is increasing in prevalence, with service providers and funding agencies struggling to meet the demand for evidence-based interventions. Emerging interventions are focusing on using the parent to facilitate interventions by building on the importance of the parent child relationship for young children in their natural environment, the home. The current randomized controlled study compares parent training (11 to 13 therapist instruction sessions for parents, one home visit, parent child coaching sessions, and telephone conversations) with parent education (12 information sessions for parents regarding young children with ASD and one home visit) to determine the effects on problem behaviors among 180 children with ASD. Both programs were found to be effective for reducing behavioral problems, but the parent training program was statistically more effective, although clinical significance is unknown. Implications for Occupational Therapy Decreasing a child s disruptive and noncompliant behavior problems supports the child s increased participation in daily activities in the home, school, and other settings. Occupational therapists can use evidence from this study to integrate parents participation into current intervention practices, building on parent-mediated and education models. In addition, they may inform parents on how best to implement strategies (e.g., visual schedules for routine events, planned ignoring of inappropriate behavior, positive reinforcement for appropriate behavior) to reduce behavioral problems. Evidence supports parent training as well as parent education as effective strategies for reducing behavior problems, which allows therapists to design treatment programs tailored to each family. Future research will better define any clinically significant differences between parent education and parent training methods. RESEARCH OBJECTIVE(S) Evaluate whether parent training is superior to parent education for reducing behavioral problems, such as tantrums, noncompliance, aggression, and self-injury, among children with ASD DESIGN TYPE AND LEVEL OF EVIDENCE Level I: Randomized controlled trial 1

2 PARTICIPANT SELECTION How were participants recruited and selected to participate? In total, 267 children were screened for inclusion with unreported methods. Inclusion criteria: ASD diagnosis based on clinical assessment by an experienced team at each site, according to the Autism Diagnostic Observation Schedule and Autism Diagnostic Interview Revised Moderate or greater behavioral problems (pretreatment score of 15 or greater on parent-rated Aberrant Behavior Checklist Irritability) Moderate or higher (greater or equal to 4) rating on Clinical Global Impression Severity, rated by independent evaluator Age 3 7 years Exclusion criteria: Children with receptive language less than 18 months on the Mullen Receptive Language scale, not enrolled in a school program, or living in a household without an English-speaking caregiver were excluded. Other exclusion criteria were a DSM IV TR diagnosis of Rett disorder or childhood disintegrative disorder, presence of a known serious medical condition in the child that would interfere with participation, or current psychiatric disorder requiring alternative treatment. Children whose parents participated in a structured parent training program in the past 2 years were also excluded (p. 1525) PARTICIPANT CHARACTERISTICS N= 180 #/ % Male: Parent training: 79/(88.8%) Parent education: 79/(86.8%) #/ % Female: Parent training: 10/(11.2%) Parent education: 12/(13.2%) Ethnicity: Hispanic: 26 (14.4%) Non-Hispanic: 154 (85.6%) Disease/disability diagnosis: ASD Moderate or greater behavioral problems INTERVENTION AND CONTROL GROUPS (Add groups if necessary) Group 1: Parent training group 2

3 Brief description of the intervention How many participants in the group? Where did the intervention take place? Who delivered? How often? For how long? Parent training: The first session taught parents to identify the function of a behavior by analyzing its antecedents (events occurring before the behavior) and consequences (events following the behavior). Subsequent sessions presented strategies for preventing disruptive behavior (eg, visual schedules for routine events), positive reinforcement for appropriate behavior, planned ignoring of inappropriate behavior, and techniques to promote compliance. In the last few sessions, the therapist instructed parents on teaching new skills (eg, communication or daily living skills) and how to maintain improvements over time (p. 1526). A total of 89 participants entered the study, with the following attrition: Seven exited the study before Week 24, 3 discontinued intervention but completed Week 24 assessments, and 7 were lost to follow-up between Weeks 24 and 28. Overall, 72 of the 89 participants returned for evaluation at Week 48 and were included in analysis of long-term results. Core sessions took place at Emory University, Indiana University, Ohio State University, University of Pittsburgh, University of Rochester, and Yale University. Home visits occurred in the participants home. The location for parent child coaching sessions was not specified. Therapists with at least master s level education delivered individual training to parents and sometimes coached the parent child dyad simultaneously. Therapists participated in weekly supervision at each site and monthly teleconferences across sites to ensure intervention integrity. 11 core sessions of 60 to 90 minutes duration, up to two optional sessions, one home visit, and up to six parent child coaching sessions over 16 weeks. Parent training also included one home visit and two telephone booster sessions between weeks 16 and 24 (p. 1526). 24 weeks Group 2: Parent education group Brief description of the intervention Parent education: During 12 core educational sessions and one home visit, participants received information regarding young children with ASD (essentials of evaluation, developmental changes, educational planning, advocacy, and current treatment options) but did not receive information about behavior management. 3

4 How many participants in the group? Where did the intervention take place? Who delivered? How often? For how long? A total of 91 participants entered the study, with the following attrition: Six exited the study before Week 24, 2 discontinued the intervention because of negative response but completed Week 24 assessments, 47 with negative response exited the study at Week 24, 13 with positive response crossed over to the parent training protocol (no long-term outcomes reported), and 6 with positive response were lost to follow-up. Overall, 17 of the 91 participants returned for evaluation at Week 48 and were included in analysis of long-term outcomes. Core sessions took place at Emory University, Indiana University, Ohio State University, University of Pittsburgh, University of Rochester, and Yale University. Home visits occurred in the participants home. Therapists with at least master s level education delivered education to parents. Within 24 weeks, as family schedules allowed 24 weeks INTERVENTION BIASES (Check yes or no, and include a brief explanation) Contamination: YES NR Explanation: Parents from the two intervention groups could have exchanged information at any or all of the sites. Co-intervention: Timing of intervention: YES NR Site of intervention: Explanation: Some participants participated in high-intensity school programs (at least 15 hr per week of 1:1 or 1:2 specialized instruction for ASD), but the researchers stratified by intensity to negate any effects. Four children (3 in the parent education group, 1 in the parent training group) switched from high- to low-intensity school programs during the intervention, and 6 children (3 from each group) switched from low- to highintensity school programs during the intervention. Thirty-six of 180 children were taking psychotropic medication at baseline. Ten of those 36 reported a dose change during the intervention, and 5 children started a new medication during the intervention. There were no differences in medication use between groups. Explanation: Although they are not specifically reported, maturation effects could have occurred over the 24-week study period. 4

5 YES NO Explanation: Use of different therapists to provide intervention: Explanation: Twenty-three therapists at six sites across the United States provided the interventions, but treatment fidelity was high (M = 96.7%, SD = 8.3%, for parent training; M = 97.2%, SD = 6.4%, for parent education). MEASURES AND OUTCOMES (Report only on measures relevant to occupational therapy practice) Measure 1: Name/type of Aberrant Behavior Checklist Irritability subscale (ABC I) measure used: What outcome is Three-point ordinal scale with 15 parent-rated items measuring irritability measured? Is the measure reliable (as reported in the article)? Is the measure valid (as reported in the article)? When is the measure used? Measure 2: Name/type of measure used: What outcome is measured? Is the measure reliable as reported in the article? Is the measure valid as reported in the article? When is the measure used? Measure 3: Name/type of measure used: (including tantrums, aggression, and self-injurious behaviors) YES NR YES NR To determine eligibility (baseline), every 4 weeks through the 24-week intervention, after treatment at 36 weeks and 48 weeks Home Situations Questionnaire Autism Spectrum Disorder (HSQ ASD) This 24-item, parent-rated questionnaire measures noncompliant behavior among children with ASD YES NR YES NR Baseline, every 4 weeks through the 24-week intervention, after treatment at 36 weeks and 48 weeks Clinical Global Impression Improvement scale (CGI I) 5

6 What outcome is measured? Is the measure reliable as reported in the article? Is the measure valid as reported in the article? When is the measure used? Seven-point ordinal scale, completed by a blinded independent evaluator, measures overall improvement from baseline. A positive response was considered a score of much improved or very much improved; all other responses were considered negative. YES NR YES NR Baseline, every 4 weeks through the 24-week intervention, after treatment at 36 weeks and 48 weeks MEASUREMENT BIASES (Check yes or no, and include a brief explanation) Were the evaluators blind to treatment status? NO Was there recall or memory bias? Explanation: Independent evaluators, who assessed the CGI I, were blinded to treatment conditions. Parents were not blind to treatment status, and parent report was used for the HSQ ASD and ABC I. Explanation: Because the parent-report measures (HSQ ASD and ABC I) were assessed every 4 weeks in this study, recall bias is a possibility. Other measurement biases: (List and explain) RESULTS List key findings based on study objectives: 6

7 At the end of 24 weeks, the parent training group showed a greater reduction than the parent education group on the ABC I and HSQ ASD scales (effect sizes =.62 and.45, respectively; p <.001 for both). Neither outcome met the predetermined clinically important difference, but the parent training group moved to a classification of mild on the ABC I after intervention, whereas the parent education group remained in the moderate range. More participants in the parent training group were rated as much improved or very much improved on the CGI I after intervention than parent education participants (p <.001). All parent training participants who participated in the follow-up study showed improvement on the ABC I and HSQ ASD at Week 48, compared with Week 24. Participants who showed a negative response to parent training at 24 weeks showed lower ABC I and HSQ ASD scores compared with baseline but higher scores compared with Week 24. Follow-up participants who showed a positive response to parent education maintained the improvement at Week 48. Seventy-nine percent of participants who showed a positive response on the CGI I after parent training maintained the response at Week 48. Thirty-two percent of participants who showed a negative response on the CGI I after parent training were rated much improved or very much improved on the CGI I at Week 48. Seventy percent of participants who showed a positive response in the parent education group showed a positive response on the CGI I at Week 48. Was this study adequately powered (large enough to show a difference)? (Check yes or no, and include a brief explanation) Explanation: Were the analysis methods appropriate? (Check yes or no, and include a brief explanation) Explanation: Were statistics appropriately reported (in written or table format)? (Check yes or no, and include a brief explanation) Explanation: Was the percent/number of subjects/participants who dropped out of the study reported? (Check yes or no, and include a brief explanation) Explanation: What are the overall study limitations? 7

8 This study relied on parent report for two primary outcome measures and part of the secondary outcome measure. The authors suggested that low attrition rates in both groups indicate that both parent groups were engaged in the study, and bias resulting from knowledge of treatment group is therefore unlikely. Additionally, the research team was unable to control for cointerventions, which could have affected outcomes in both groups. There was no indication of how participants were recruited to determine what other variable might have played a role in the outcome (socioeconomic status, location, education of parents, etc.). The parent education group had a sample size of 17 participants complete Week 48 assessments, compared with 72 participants in the parent training group. The sample size difference could have led to bias in long-term outcome analysis. CONCLUSIONS State the authors conclusions related to the research objectives. Parent training was more effective than parent education for decreasing problem behaviors in children with ASD after a 24-week intervention. The clinical significance of this difference is unclear and requires further research. This work is based on the evidence-based literature review completed by Sarah Hope, OTS, and Karla Ausderau, PhD, OTR/L, faculty advisor, University of Wisconsin Madison. adapted from Critical Review Form Quantitative Studies. Copyright 1998 by M. Law, D. Stewart, N. Pollack, L. Letts, J. Bosch, and M. Westmorland, McMaster University. Used with permission. For personal or educational use only. All other uses require permission from AOTA. Contact: 8