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DEAL Intervention for Behavioral Problems in Autism
N/A
Recruiting
Research Sponsored by Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from time 1 (week 1) to time 2 (week 7)
Awards & highlights
Study Summary
This trial will test a new intervention, DEAL, to help parents of children with autism who demonstrate severe problem behavior. The intervention is based on Acceptance and Commitment Therapy and Behavioral Activation strategies.
Who is the study for?
This trial is for English-speaking parents of children under 18 with autism, who often show severe problem behaviors. The child's behavior must be socially-maintained as confirmed by analysis, and the parent should have attended at least 80% of prior appointments.Check my eligibility
What is being tested?
The DEAL intervention is being tested to see if it helps parents stick to behavior plans for their autistic children. It uses strategies from Acceptance and Commitment Therapy and Behavioral Activation tailored to each family's needs.See study design
What are the potential side effects?
There may not be traditional 'side effects' like in drug trials, but participating in DEAL could bring up emotional discomfort or stress as parents learn new strategies to manage their child’s disruptive behaviors.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ change from time 1 (week 1) to time 2 (week 7)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from time 1 (week 1) to time 2 (week 7)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Accommodation to Adherence Change Score
Cognitive Fusion
Experiential Avoidance
+1 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Treatment + DEALExperimental Treatment1 Intervention
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.
Group II: Treatment as UsualActive Control1 Intervention
This arm does not receive any intervention. It will serve as a comparison for the experimental arm.
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Who is running the clinical trial?
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.Lead Sponsor
88 Previous Clinical Trials
24,888 Total Patients Enrolled
Organization for Autism ResearchOTHER
6 Previous Clinical Trials
101 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- The parent cannot speak English.The child's problematic behavior is a way for them to get attention or something they want from others.The child is not diagnosed with autism spectrum disorder (ASD).The child's problematic behavior is not caused by the desire to get attention or gain something from others.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment + DEAL
- Group 2: Treatment as Usual
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many participants are being administered this experimental treatment?
"Affirmative. Clinicaltrials.gov states that this study, which was published on June 21st 2022 and has since had no updates, is actively enrolling participants. Consequently, 50 individuals from two separate locations are being sought out for participation."
Answered by AI
Has this clinical trial opened its enrollment to new participants?
"Indeed, clinicaltrials.gov reveals that this trial is still in the recruitment phase. The study was initially posted on June 21st 2022 and has been revised since then; 50 participants are needed at two distinct sites."
Answered by AI
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