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Measurement of Treatment Effects

NCT07024303 · Status: NOT_YET_RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2025-06-17

No results posted yet for this study

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).

Conditions

Interventions

DRUG

Psychotropic medication (at discretion of psychiatrist)

The timing and dose of medication will be determined by the prescribing provider. Most medications are delivered daily and some medications may be delivered more than once per day. Providers are expected to adhere to professional guidelines for prescribing.

BEHAVIORAL

Behavioral therapy

Functional communication training (FCT) will be delivered for 1 hour every week in-vivo or via telehealth. This timing and dosage has been shown effective in previous research. However, caregivers will be encouraged to practice the treatment procedures as often as possible on their own. Treatment will be delivered by a therapist and/or caregiver for those receiving in-vivo therapy and caregivers will deliver treatment with coaching from a therapist when using telehealth.

Sponsors & Collaborators

  • Matthew J O'Brien, PhD, BCBA-D

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-15
Primary Completion
2027-07-01
Completion
2027-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07024303 on ClinicalTrials.gov