Behavioral Interventions to Increase Parent Adherence With Behavior Plans

Behavior Problem Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05238766
• Other study ID #: IRB00292589
• Status: Recruiting
• Phase: N/A
• Start date: June 21, 2022
• Est. completion date: October 31, 2024

Study information

• Verified date: April 2024
• Source: Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
• Contact: Craig W Strohmeier, Psy.D.
• Phone: 4439233871
• Email: strohmeier[@]kennedykrieger.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: October 31, 2024
• Est. primary completion date: October 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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%.

Related Conditions & MeSH terms

• Behavior Problem
• Nonadherence
• Problem Behavior

Intervention

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.

Locations

Country	Name	City	State
United States	Kennedy Krieger Institute	Baltimore	Maryland
United States	Kennedy Krieger Institute	Columbia	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.	Organization for Autism Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Accommodation to Adherence Change Score	Conditional probabilities derived from a contingency space analysis	Change from Time 1 (Week 1) to Time 2 (Week 7)
Primary	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)
Primary	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)
Primary	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)