Behavioral Interventions to Increase Parent Adherence With Behavior Plans

Sponsor
Hugo W. Moser Research Institute at Kennedy Krieger, Inc. (Other)
Overall Status
Recruiting
CT.gov ID
NCT05238766
Collaborator
Organization for Autism Research (Other)
50
2
2
19.4
25
1.3

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: DEAL
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Contextual Behavioral Strategies to Help Parents Adhere to Behavior Plans for Children With Autism
Actual Study Start Date :
Jun 21, 2022
Anticipated Primary Completion Date :
Jan 31, 2024
Anticipated Study Completion Date :
Jan 31, 2024

Arms and Interventions

Arm Intervention/Treatment
No Intervention: Treatment as Usual

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

Experimental: 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.

Behavioral: 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.

Outcome Measures

Primary Outcome Measures

  1. Accommodation to Adherence Change Score [Change from Time 1 (Week 1) to Time 2 (Week 7)]

    Conditional probabilities derived from a contingency space analysis

  2. Experiential Avoidance [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 [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 [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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%.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Kennedy Krieger Institute Baltimore Maryland United States 21205
2 Kennedy Krieger Institute Columbia Maryland United States 21046

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Craig Strohmeier, Assistant Professor, Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
ClinicalTrials.gov Identifier:
NCT05238766
Other Study ID Numbers:
  • IRB00292589
First Posted:
Feb 14, 2022
Last Update Posted:
Jun 27, 2022
Last Verified:
Jun 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Craig Strohmeier, Assistant Professor, Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 27, 2022