Children were assessed every 4 weeks through the 24-week trial and after treatment at weeks 36 and 48. The first primary outcome measure was the parent-rated ABC-I.17 (link) The second primary outcome measure was the per-item mean score on the parent-rated Home Situations Questionnaire–Autism Spectrum Disorder (HSQ-ASD).20 (link) A secondary outcome was the Improvement item of the clinician-rated CGI (CGI-I). By convention, we present results on the other ABC subscales, but these subscales were not hypothesized to show changes with parent training.
The ABC17 (link) is a 58-item, parent-rated measure that includes 5 subscales: Irritability (includes tantrums, aggression, and self-injurious behaviors, 15 items); Social Withdrawal (includes 16 items); Stereotypy (7 items); Hyperactivity (includes hyperactivity and noncompliance, 16 items); and Inappropriate Speech (repetitive vocalizations, 4 items).17 (link),21 (link) Each item is rated 0 to 3 with higher scores indicating greater severity. On the ABC-I subscale (range, 0–45), a 25% reduction from baseline is commonly used to indicate clinically meaningful improvement.14 (link),22 (link)The HSQ-ASD is a 24-item parent-rated measure of noncompliant behavior in children with ASD.20 (link) The scale yields per-item mean scores of 0 to 9 (higher scores indicating greater noncompliance) for the total score and on each of two 12-item subscales (Demand-specific, Socially Inflexible) (Michael Aman, PhD, and Monali Chowdhury, PhD, Ohio State University, written communication, November 10, 2014). Based on data from a prior study, a 25% decrease reflects meaningful improvement.14 (link)The CGI-I23 is a 7-point scale designed to measure overall improvement from baseline. This measure has been used in several clinical trials in ASD.22 (link),24 (link) Scores range from 1 (very much improved) through 4 (unchanged) to 7 (very much worse). Scores of much improved or very much improved were used to define positive response; all other scores indicated negative response. The independent evaluator, who was blind to treatment assignment, rated the CGI-I monthly during the randomized trial and after treatment at weeks 36 and 48. At baseline, the independent evaluators asked parents to identify the child’s 2 most pressing problems. From this discussion, the independent evaluator documented a brief narrative describing the frequency (eg, tantrums per day), duration, and intensity (actual appearance of the behavior) of episodes and effect of the behavior on the family. The baseline narrative was reviewed and revised in subsequent visits and used in combination with all other available information to score the CGI-I.
The protocol included 2 additional secondary outcomes. The Vineland II is a multidimensional measure requiring a detailed analytic approach; the results will be presented in a separate report. The Standardized Observational Analogue Procedure (SOAP) is a brief, semistructured laboratory observation of parent-child interactions. Since development of the protocol, questions have been raised about the ecological validity of the SOAP and whether it is representative of a child’s behavior.25 (link) The SOAP will be presented in a separate report.
The ABC17 (link) is a 58-item, parent-rated measure that includes 5 subscales: Irritability (includes tantrums, aggression, and self-injurious behaviors, 15 items); Social Withdrawal (includes 16 items); Stereotypy (7 items); Hyperactivity (includes hyperactivity and noncompliance, 16 items); and Inappropriate Speech (repetitive vocalizations, 4 items).17 (link),21 (link) Each item is rated 0 to 3 with higher scores indicating greater severity. On the ABC-I subscale (range, 0–45), a 25% reduction from baseline is commonly used to indicate clinically meaningful improvement.14 (link),22 (link)The HSQ-ASD is a 24-item parent-rated measure of noncompliant behavior in children with ASD.20 (link) The scale yields per-item mean scores of 0 to 9 (higher scores indicating greater noncompliance) for the total score and on each of two 12-item subscales (Demand-specific, Socially Inflexible) (Michael Aman, PhD, and Monali Chowdhury, PhD, Ohio State University, written communication, November 10, 2014). Based on data from a prior study, a 25% decrease reflects meaningful improvement.14 (link)The CGI-I23 is a 7-point scale designed to measure overall improvement from baseline. This measure has been used in several clinical trials in ASD.22 (link),24 (link) Scores range from 1 (very much improved) through 4 (unchanged) to 7 (very much worse). Scores of much improved or very much improved were used to define positive response; all other scores indicated negative response. The independent evaluator, who was blind to treatment assignment, rated the CGI-I monthly during the randomized trial and after treatment at weeks 36 and 48. At baseline, the independent evaluators asked parents to identify the child’s 2 most pressing problems. From this discussion, the independent evaluator documented a brief narrative describing the frequency (eg, tantrums per day), duration, and intensity (actual appearance of the behavior) of episodes and effect of the behavior on the family. The baseline narrative was reviewed and revised in subsequent visits and used in combination with all other available information to score the CGI-I.
The protocol included 2 additional secondary outcomes. The Vineland II is a multidimensional measure requiring a detailed analytic approach; the results will be presented in a separate report. The Standardized Observational Analogue Procedure (SOAP) is a brief, semistructured laboratory observation of parent-child interactions. Since development of the protocol, questions have been raised about the ecological validity of the SOAP and whether it is representative of a child’s behavior.25 (link) The SOAP will be presented in a separate report.
