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Completed

NCT Number: NCT05238766

Behavioral Interventions to Increase Parent Adherence With Behavior Plans

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.

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Key information

Conditions

Family Accommodation Behavior Problem Mental Disorders Nonadherence

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kennedy Krieger Institute, Baltimore, Maryland, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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%.

Treatment and study plan

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.

Primary outcomes

  1. Accommodation to Adherence Change Score

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

    Conditional probabilities derived from a contingency space analysis

  2. Experiential Avoidance

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

    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.

  3. Cognitive Fusion

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

    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.

  4. Parenting Stress

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

    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.

Sponsors and collaborators

Lead sponsor

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

Other

Collaborators

  • Organization for Autism Research

Registry information

Official study title

Contextual Behavioral Strategies to Help Parents Adhere to Behavior Plans for Children With Autism

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Feb 14, 2022
Registry last updated
Feb 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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