Social Validity and the Children with Hyperactivity and Autism Research Treatment Study

Background:  Inattention and hyperactivity are often observed in children with Autism Spectrum Disorders (ASD). Traditional medications for ADHD have been shown to be less effective for children with ASDs.  Side effects also appear to be more problematic. Behavior intervention (BI) is an effective and established treatment for problem behavior. Few investigations have studied BI in group designs. In some cases BI alone is not enough and clinicians are recommending a combination of treatments. Recently, Strattera was indicated as an alternative treatment for ADHD symptoms. Therefore, we proposed a large multisite trial to include both parent training and Strattera, in order to determine Strattera’s clinical value in combination with a BI. Parents of study participants were surveyed to determine whether they viewed the study intervention as worthwhile and “socially valid.”  

Objectives:  To examine the social validity of a multimodal plan of treatment for decreasing symptoms of inattention, hyperactivity, and noncompliance, in children with ASD, who participated in a randomized clinical trial.

Methods:  Parent Treatment Preference Surveys were completed by 72 parents of children ages 5-13 years, with ASD, and ADHD symptoms, prior to study enrollment. Participants were randomly assigned to one of four treatment groups: (1) Strattera alone, (2) Strattera with parent training, (3) Placebo alone, and (4) Placebo with parent training. Ten weekly visits included parent training sessions. An optional 24-week extension study with parent training sessions (monthly) was also conducted. Parent Satisfaction Questionnaires were completed at study endpoint to determine whether the study intervention was socially valid.

Results:   Prior to enrollment 86.9% of parents gave BI an acceptability rating for treatment of ADHD symptoms and 79.6% of parents gave Strattera an acceptability rating for treatment of ADHD symptoms (p<.02).  Additionally, 61% of parents were concerned about considering a “medical solution” for their child’s problem behavior, while 97% of parents felt that their child’s behavior would improve if assigned to behavior intervention. Post-study, 92% of parents reported that they would recommend the study to other parents with children having similar conditions, and 86% of parents said that they would participate again if they could do it all again. Some, 12% of parents said they might do it again, but with some reservation. Of those who received BI, 79% of parents reported that they felt more confident in managing future problem behaviors in their children. To date, we have enrolled approximately half of our study sample, and of these, 35% have shown improvement. Overall, in regards to study participation parent satisfaction was high. (A more detailed description of the results will be added at the item level in regard to parent satisfaction on the final poster).

Conclusions:  The intervention introduced in this study appears to be socially valid, as a large majority of parents report that they would participate in this study again and an even larger proportion would recommend this study to parents with children having similar conditions. Parents of study participants were also highly satisfied with the results.