Behavioral Interventions to Increase Parent Adherence With Behavior Plans

NCT ID: NCT05238766

Last Updated: 2025-02-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-21

Study Completion Date

2024-11-04

Brief Summary

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Many children with autism demonstrate severe problem behavior (SPB) in the form of self-injury, aggression, and disruptive behavior. Conducting a functional analysis and implementing derived treatments can produce effective behavior plans. Nonetheless, skills training and an effective plan may not be sufficient to produce parent adherence. This applied research proposal describes an approach to target the negative maintaining contingencies supporting parent reinforcement of problem behavior (accommodation) and nonadherence. The intervention, borrowed from Acceptance and Commitment Therapy and Behavioral Activation strategies, is matched specifically to the hypothesized function of the problematic caregiver responses (negative reinforcement). Parents who participate in the proposed investigation will be assigned to either the Defuse Experience Accept Live intervention (DEAL) protocol group or treatment as usual. Five 45-min DEAL sessions will 1) introduce caregivers to behavior change strategies that maximize contact with positive-maintaining contingencies related to adherence, while undermining the contingencies that maintain accommodation, and 2) provide caregivers with new treatment-related committed actions that are sensitive to positive changes in parent-child interactions. Within and between participant analyses will be conducted to determine the effectiveness of the DEAL protocol.

Detailed Description

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Conditions

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Family Accommodation Nonadherence Behavior Problem

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment as Usual

This arm does not receive any intervention. It will serve as a comparison for the experimental arm.

Group Type NO_INTERVENTION

No interventions assigned to this group

Treatment + DEAL

Parents in the Treatment plus Defuse Experience Accept Live (T+DEAL) arm will attend five 45-min DEAL sessions with a therapist. Across the five sessions, the therapist will 1) introduce caregivers to behavior change strategies that maximize contact with positive-maintaining contingencies related to adherence, while undermining the contingencies that maintain accommodation, and 2) provide caregivers with new treatment-related committed actions that are sensitive to positive changes in parent-child interactions.

Group Type EXPERIMENTAL

DEAL

Intervention Type BEHAVIORAL

The DEAL protocol is an Acceptance and Commitment Therapy and Behavioral Activation informed clinical protocol to undermine accommodation and help parents adhere with behavioral treatment plan components.

Interventions

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DEAL

The DEAL protocol is an Acceptance and Commitment Therapy and Behavioral Activation informed clinical protocol to undermine accommodation and help parents adhere with behavioral treatment plan components.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Child under the age of 18 years,
* Child is diagnosed with ASD, as confirmed by the Gilliam Autism Rating Scale-3,
* Child problem behavior is socially-maintained as identified via functional analysis,
* Parent is English-speaking, and
* Parent attendance of at least 80% of appointments at entry into the study.

Exclusion Criteria

* Child is older than 18 years of age,
* Child does not have ASD,
* Child's problem behavior is not socially-maintained,
* Parent does not speak English, and
* Parent attendance at time of study entry is less than 80%.
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Organization for Autism Research

OTHER

Sponsor Role collaborator

Hugo W. Moser Research Institute at Kennedy Krieger, Inc.

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Kennedy Krieger Institute

Baltimore, Maryland, United States

Site Status

Kennedy Krieger Institute

Columbia, Maryland, United States

Site Status

Countries

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United States

Other Identifiers

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IRB00292589

Identifier Type: -

Identifier Source: org_study_id

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