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Behavioral Interventions to Increase Parent Adherence With Behavior Plans

Primary Purpose

Family Accommodation, Nonadherence, Behavior Problem

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
DEAL
Sponsored by
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Family Accommodation focused on measuring Family Accommodation, Nonadherence

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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%.

Sites / Locations

  • Kennedy Krieger InstituteRecruiting
  • Kennedy Krieger InstituteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Treatment as Usual

Treatment + DEAL

Arm Description

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

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.

Outcomes

Primary Outcome Measures

Accommodation to Adherence Change Score
Conditional probabilities derived from a contingency space analysis
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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
January 19, 2022
Last Updated
June 28, 2023
Sponsor
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Collaborators
Organization for Autism Research
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1. Study Identification

Unique Protocol Identification Number
NCT05238766
Brief Title
Behavioral Interventions to Increase Parent Adherence With Behavior Plans
Official Title
Contextual Behavioral Strategies to Help Parents Adhere to Behavior Plans for Children With Autism
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 21, 2022 (Actual)
Primary Completion Date
January 31, 2024 (Anticipated)
Study Completion Date
January 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Collaborators
Organization for Autism Research

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Family Accommodation, Nonadherence, Behavior Problem
Keywords
Family Accommodation, Nonadherence

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment as Usual
Arm Type
No Intervention
Arm Description
This arm does not receive any intervention. It will serve as a comparison for the experimental arm.
Arm Title
Treatment + DEAL
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
DEAL
Intervention Description
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 Outcome Measure Information:
Title
Accommodation to Adherence Change Score
Description
Conditional probabilities derived from a contingency space analysis
Time Frame
Change from Time 1 (Week 1) to Time 2 (Week 7)
Title
Experiential Avoidance
Description
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.
Time Frame
Change from Time 1 (Week 1) to Time 2 (Week 7)
Title
Cognitive Fusion
Description
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.
Time Frame
Change from Time 1 (Week 1) to Time 2 (Week 7)
Title
Parenting Stress
Description
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.
Time Frame
Change from Time 1 (Week 1) to Time 2 (Week 7)

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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%.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Craig W Strohmeier, Psy.D.
Phone
4439233871
Email
strohmeier@kennedykrieger.org
Facility Information:
Facility Name
Kennedy Krieger Institute
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21205
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patricia F Kurtz, Ph. D.
Phone
443-923-2894
Email
kurtz@kennedykrieger.org
Facility Name
Kennedy Krieger Institute
City
Columbia
State/Province
Maryland
ZIP/Postal Code
21046
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Craig W Strohmeier, Ph. D
Phone
443-923-3871
Email
strohmeier@kennedykrieger.org

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
There is not a plan at this time for individual participant data sharing outside of resultant published data. The analytic plan for this trial includes within and between participant analyses. These data may be available at some point in time by specific request.

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Behavioral Interventions to Increase Parent Adherence With Behavior Plans

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