NCT07024303Not yet recruitingEarly phase 1
Measurement of Treatment Effects
Measuring the Effects of Medication and Behavioral Treatments for Challenging Behavior
Source: ClinicalTrials.gov · Last updated 17 Jun 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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).
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Early phase 1
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- First submitted
- 8 Jun 2025
- Start date
- 15 Jun 2025
- Primary completion date
- 1 Jul 2027
- Lead sponsor
- Matthew J O'Brien, PhD, BCBA-D
- Diseases
- Autism
- NCT number
- NCT07024303
What you commit to
- Study type: Interventional · Early phase 1
- Planned participants: 20
- From 15 Jun 2025 to the primary completion date, 1 Jul 2027
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Criteria the registry did not label
- The adult subjects will be the caregiver/guardian of the minor subjects. The only inclusion criterion for the adult subjects is that they must be the caregiver/legal guardian of the minor subject and their home is primarily English speaking.
- The minor subjects will be individuals who were referred to Child and Adolescent Psychiatry at University of Iowa Healthcare for management of challenging behavior (e.g., physical aggression, self-injury, destruction, elopement, generalized refusal) and meet the following criteria:
- 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
- Live in a home where English is the primary language spoken.
- The caregiver is considering medication, behavioral therapy, or both to treat the child's challenging behavior.
- Subjects would be excluded if:
- Not diagnosed with autism spectrum disorder
- Do not have a moderate or severe/profound intellectual disability
- Do not display challenging behavior
- Live in a home where English is not the primary language spoken
- Caregivers are not considering medication, behavior therapy, or both to treat challenging behavior
Age in the registry: 2 years to 12 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.