Back to results"ACT" for Parents of Children With Autism Spectrum Disorder
Primary Purpose
Stress
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Acceptance and Commitment Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Stress focused on measuring Group Therapy, Parents, Autism, Quality of Life
Eligibility Criteria
Inclusion Criteria:
- A parent with a child (under the age of 15) with a diagnosis of Pervasive Developmental Disorder-NOS, Asperger's Disorder or Autistic Disorder
- Child with ASD diagnosed by a mental health or medical professional
- Must be comfortable speaking and reading and understanding English
Exclusion Criteria:
- Inability to attend sessions in person on the specified date/time/location of the intervention sessions
- unwillingness to be audio-taped should randomization into the experimental (ACT) group occur.
Sites / Locations
- Lurie Center | Massachusetts General Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
ACT Parent Group
Treatment as Usual
Arm Description
Participants will complete a total of five Acceptance and Commitment Therapy - Parent Group Sessions First four are held weekly, last session held one month from 4th session.
Treatment as usual-Control
Outcomes
Primary Outcome Measures
Change in Acceptance and Action Questionnaire-II Score
The Acceptance and Action Questionnaire (AAQ-II, Bond et al., 2011) is a 10-item Likert scale that measures experiential acceptance (i.e., tendency to accept, rather than avoid, uncomfortable internal experiences) in adult samples.
Secondary Outcome Measures
Full Information
NCT ID
NCT02255786
First Posted
September 15, 2014
Last Updated
August 12, 2019
Sponsor
Massachusetts General Hospital
Collaborators
Organization for Autism Research
1. Study Identification
Unique Protocol Identification Number
NCT02255786
Brief Title
"ACT" for Parents of Children With Autism Spectrum Disorder
Official Title
Taking ACTion: Acceptance and Commitment Therapy for Parents of Children With Autism Spectrum Disorder
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
October 2014 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
Collaborators
Organization for Autism Research
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The investigators will develop and pilot test an intervention called "ACT for Parents" which aims to decrease stress and improve quality of life in parents of children < 15 years who have a diagnosis of autism spectrum disorder. A small randomized trial testing phase will be conducted to gather initial data on the treatment feasibility and acceptability, detect treatment effects between groups (ACT for Parents versus Treatment as Usual), and to refine the treatment design for a future clinical trial.
Detailed Description
Acceptance and Commitment Therapy (ACT) is an intervention that fosters acceptance of uncomfortable thoughts and emotions as a coping strategy, and encourages engagement in valued behavior in the presence of these emotions. ACT has been successfully applied to parents with similar mental health presentations. Using a randomized controlled study design, investigators seek to gather initial data on the treatment feasibility and acceptability, detect treatment effects in a cohort of parents who have a child (under the age of 15) with autism spectrum disorder.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress
Keywords
Group Therapy, Parents, Autism, Quality of Life
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
16 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
ACT Parent Group
Arm Type
Experimental
Arm Description
Participants will complete a total of five Acceptance and Commitment Therapy - Parent Group Sessions First four are held weekly, last session held one month from 4th session.
Arm Title
Treatment as Usual
Arm Type
No Intervention
Arm Description
Treatment as usual-Control
Intervention Type
Behavioral
Intervention Name(s)
Acceptance and Commitment Therapy
Other Intervention Name(s)
ACT
Intervention Description
Acceptance and Commitment Therapy (ACT) is an intervention that fosters acceptance of uncomfortable thoughts and emotions as a coping strategy, and encourages engagement in valued behavior in the presence of these emotions. ACT has been successfully applied to parents of children with a variety of mental health presentations.
Primary Outcome Measure Information:
Title
Change in Acceptance and Action Questionnaire-II Score
Description
The Acceptance and Action Questionnaire (AAQ-II, Bond et al., 2011) is a 10-item Likert scale that measures experiential acceptance (i.e., tendency to accept, rather than avoid, uncomfortable internal experiences) in adult samples.
Time Frame
From Basline to Month 2 (post-intervention) and from Month 2 to Month 3 (maintenance)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
A parent with a child (under the age of 15) with a diagnosis of Pervasive Developmental Disorder-NOS, Asperger's Disorder or Autistic Disorder
Child with ASD diagnosed by a mental health or medical professional
Must be comfortable speaking and reading and understanding English
Exclusion Criteria:
Inability to attend sessions in person on the specified date/time/location of the intervention sessions
unwillingness to be audio-taped should randomization into the experimental (ACT) group occur.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lisa A. Nowinski, PhD
Organizational Affiliation
Massachusetts General Hospital - Lurie Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kirstin Brown Birtwell, PhD
Organizational Affiliation
Massachusetts General Hospital - Lurie Center
Official's Role
Study Director
Facility Information:
Facility Name
Lurie Center | Massachusetts General Hospital
City
Lexington
State/Province
Massachusetts
ZIP/Postal Code
02421
Country
United States
12. IPD Sharing Statement
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"ACT" for Parents of Children With Autism Spectrum Disorder
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