Behavioral Interventions to Increase Parent Adherence With Behavior Plans

NCT05238766 | Completed

• 1 other identifier: IRB00292589
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Family Accommodation; Nonadherence; Behavior Problem

Keywords

Family Accommodation; Nonadherence

Outcome Measures

Primary Outcomes (4)

• Accommodation to Adherence Change Score

  Conditional probabilities derived from a contingency space analysis

  Change from Time 1 (Week 1) to Time 2 (Week 7)

• Experiential Avoidance

  The Acceptance and Action Questionnaire 2nd Edition (AAQ-II) assesses experiential avoidance (EA). The AAQ-II is a 7 item self-report instrument with a range of 7-49. Higher scores are indicative of higher levels of experiential avoidance.

  Change from Time 1 (Week 1) to Time 2 (Week 7)

• Cognitive Fusion

  The Cognitive Fusion Questionnaire (CFQ) assesses cognitive fusion, or rigidly following self-generated rules. The CFQ is a 7 item self-report instrument with a range of 7-49. Higher scores are indicative of a higher level of cognitive fusion.

  Change from Time 1 (Week 1) to Time 2 (Week 7)

• Parenting Stress

  The Parenting Stress Index - Short Form (PSI-SF) is a 36 item self-report instrument that measures parenting stress on a 5-point Likert scale. The Parental Distress subscale contains items that resemble statements that a parent might make about their own parenting skills. Self-statements oftentimes may function as rules, which we conceptualize as a more specific measure of parent cognitive fusion. Therefore, we consider high scores on this subscale to be reflective of parent-based cognitive fusion.

  Change from Time 1 (Week 1) to Time 2 (Week 7)

Study Arms (2)

Treatment as Usual

NO INTERVENTION

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

Treatment + DEAL

EXPERIMENTAL

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.

Behavioral: DEAL

Interventions

DEAL 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.

Treatment + DEAL

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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%.

Sponsors & Collaborators

• Hugo W. Moser Research Institute at Kennedy Krieger, Inc.: lead
• Organization for Autism Research: collaborator

Study Sites (2)

Kennedy Krieger Institute

Baltimore, Maryland, 21205, United States

Location

Kennedy Krieger Institute

Columbia, Maryland, 21046, United States

Location

MeSH Terms

Conditions

Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 19, 2022
• First Posted: February 14, 2022
• Study Start: June 21, 2022
• Primary Completion: November 4, 2024
• Study Completion: November 4, 2024
• Last Updated: February 28, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)