Measurement of Treatment Effects

NCT ID: NCT07024303

Last Updated: 2025-06-17

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-15
• Study Completion Date: 2027-12-31

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.

Conditions

Challenging Behavior; Autism Spectrum Disorder

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Psychotropic Medication

Classes of psychotropic medications used as treatment for challenging behavior include antipsychotics (e.g., aripiprazole, quetiapine), stimulants (e.g., methylphenidate), alpha 2 agonists (e.g., clonidine), and mood-stabilizing anticonvulsants (e.g., valproate). However, other classes of psychotropics may be used to indirectly address challenging behavior (e.g., anxiolytics, antidepressants). Two medications (aripiprazole and risperidone) are FDA approved to treatment irritability for individuals with autism and challenging behavior. Psychotropic medications range in timing and dosage and their effects may be immediate (e.g., stimulants) or take as long as 6 weeks for full therapeutic effects (e.g., risperidone).

Group Type: EXPERIMENTAL

Psychotropic medication (at discretion of psychiatrist)

Intervention Type: DRUG

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.

Behavior Therapy

In this study, FCT treatment will be provided weekly for approximately 60 min in duration. To facilitate communication during FCT, a word/picture card or microswitch (with recorded voice output) will be paired with any pre-existing child requests. Appropriate requests will be reinforced by the caregiver or therapist, and the occurrence of challenging behavior will be ignored (placed on extinction) or result in the caregiver/therapist providing guided compliance. An individualized FCT treatment plan will be developed based on the results of the functional analysis. For example, if the functional analysis identifies challenging behavior that functioned to escape task demands, then the FCT treatment plan will focus on teaching the child to request breaks appropriately after complying with instructions to complete a task. A typical task demand will be initiated by placing a small amount of developmentally appropriate "work" in front of the child and asking him or her to complete the task

Group Type: EXPERIMENTAL

Behavioral therapy

Intervention Type: BEHAVIORAL

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.

Combined Treatment (Medication+Behavior Therapy)

Participants in this arm will receive both medication and behavior therapy using the same manipulations as the Psychotropic Medication and Behavior Therapy Arms.

Group Type: EXPERIMENTAL

Psychotropic medication (at discretion of psychiatrist)

Intervention Type: DRUG

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 therapy

Intervention Type: BEHAVIORAL

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.

No Treatment

Participants who chose none of the treatment arms may participate in the assessments.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DRUG

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

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

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Matthew J O'Brien, PhD, BCBA-D

OTHER

Sponsor Role: lead

Responsible Party

Matthew J O'Brien, PhD, BCBA-D

Clinical Associate Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Central Contacts

Matthew O'Brien, PHD

Role: CONTACT

matthew-j-obrien@uiowa.edu

(309)373-3394

Other Identifiers

202411526

Identifier Type: -

Identifier Source: org_study_id