Clinical trial NCT07024303: Measurement of Treatment Effects
Official title: Measuring the Effects of Medication and Behavioral Treatments for Challenging Behavior
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: EARLY_PHASE1
Conditions: Challenging Behavior
Autism Spectrum Disorder
Keywords: psychotropic medication
behavioral therapy
behavioral measurement
Lead sponsor: University of Iowa
Sponsor class: OTHER
First posted: 2025-06-17
Enrollment: 20
Sex: ALL
Minimum age (years): 2
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a non-randomized (preference) parallel group design
Primary purpose: TREATMENT

Brief summary: 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).

Detailed description: Our overall objective of this study 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 behavioral treatment, medication, and combination treatment (medication+behavior therapy) will produce reductions in CB, but behavioral treatment and combination treatment will produce a greater reduction in CB when measured using direct observation within the contexts most associated with challenging behavior.

To address this objective, we plan to recruit up to 20 individuals under 13 years of age who are diagnosed with autism and exhibit challenging behavior to participate in this study. Subjects will be recruited from clinics where patients receive consultation on medication for challenging behavior. Subjects will be given the options of initiating/continuing medication, initiating behavior therapy, both medication and behavior therapy, or neither medication nor behavior therapy. The behavioral treatment provided as part of the research study will be functional communication training or FCT. FCT is a scientifically validated behavior therapy that involves teaching the child to use communication (in various forms) instead of challenging behavior to get what they want. It will be delivered at a timing (1 time per week) and dosage (60 minutes per visit) that is common for individuals with challenging behavior. Subjects will participate in a baseline behavioral assessment (baseline), as well as monthly behavioral assessments. Each behavioral assessment will include indirect (rating scales) and direct (antecedent analysis) measures of challenging behavior, as well as measures of social validity (treatment acceptability rating scales). Subjects will be followed for 6 months and comparisons of behavior change across measures will be used to determine treatment effectiveness and concordance between measures.

Eligibility criteria: 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:

1. Between the ages of 2 years, 0 months and 12 years, 0 months
2. Diagnosed with autism spectrum disorder
3. Diagnosed with intellectual disability at the moderate, severe, or profound range (called "profound autism").
4. Display challenging behavior, including one or more of the following: physical aggression, self-injury, destruction, elopement, generalized refusal
5. Live in a home where English is the primary language spoken.
6. The caregiver is considering medication, behavioral therapy, or both to treat the child's challenging behavior.

Subjects would be excluded if:

1. Not diagnosed with autism spectrum disorder
2. Do not have a moderate or severe/profound intellectual disability
3. Do not display challenging behavior
4. Live in a home where English is not the primary language spoken
5. Caregivers are not considering medication, behavior therapy, or both to treat challenging behavior

Primary outcomes:
measure: Aberrant Behavior Checklist, Irritability Subscale
timeFrame: At enrollment and monthly for 12 months.
measure: Behavior Problems Inventory
timeFrame: At enrollment and monthly for 12 months.
measure: Clinical Global Impressions Scale
timeFrame: At enrollment and every month for 12 months.
measure: Home Situations Questionnaire
timeFrame: At enrollment and monthly for 12 months.
measure: Monitoring of Side Effects Scale
timeFrame: At enrollment and monthly for 12 months.
measure: Treatment Acceptability Rating Form - Revised
timeFrame: Monthly for 12 months.
Secondary outcomes:
Other outcomes:
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