About this trial
The overall objective is to evaluate and compare the efficacy of two common treatments for CB in children and adolescents with autism using multiple outcome measures. Our central hypothesis is that both behavioral treatment and medication will produce reductions in CB, but behavioral treatments, including behavior treatment + medication, will produce a greater reduction in CB when measured using direct observation within the contexts most associated with challenging behavior. We have four aims: Aim 1: Evaluate the concordance between indirect and direct measures of challenging behavior. We hypothesize that behavior change (% change) will be discordant between indirect and direct measurement data, regardless of treatment type, with direct measurement resulting in significantly greater change at each measurement timepoint. Aim 2: Compare the efficacy of psychotropic medication, behavior therapy, and combination therapy (medication+behavior therapy) on CB using indirect measures (ABC-I, BPI, CGI, MOSES) and direct observation (antecedent analysis). We hypothesize that all treatment modalities will reduce CB on both outcome measures at each standard timepoint, but behavioral therapy and combination therapy will produce a significantly greater reduction on direct observation of CB in the contexts most associated with challenging behavior. Aim 3: Compare the social validity of psychotropic medication, behavior therapy, and combination therapy using the Treatment Acceptability Rating Form-Revised (Reimers et al., 1992). Aim 4: Compare the social validity of measurement methods (indirect vs. direct).
Eligibility criteria
Qualifiers
Between the ages of 2 years, 0 months and 12 years, 0 months
Diagnosed with autism spectrum disorder
Diagnosed with intellectual disability at the moderate, severe, or profound range (called "profound autism").
Display challenging behavior, including one or more of the following: physical aggression, self-injury, destruction, elopement, generalized refusal
Disqualifiers
None
Trial design
Treatments tested in this trial
- Psychotropic medication (at discretion of psychiatrist)
- Behavioral therapy
Treatment groups
Locations
Sponsors and collaborators
Matthew J O'Brien, PhD, BCBA-D
Lead sponsor
University of Iowa
Sponsor institution