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"ACT" for Parents of Children With Autism Spectrum Disorder

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02255786
Recruitment Status : Completed
First Posted : October 3, 2014
Last Update Posted : August 13, 2019
Sponsor:
Collaborator:
Organization for Autism Research
Information provided by (Responsible Party):
Lisa A. Nowinski, PhD, Massachusetts General Hospital

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.

Condition or disease Intervention/treatment Phase
Stress Behavioral: Acceptance and Commitment Therapy Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Taking ACTion: Acceptance and Commitment Therapy for Parents of Children With Autism Spectrum Disorder
Study Start Date : October 2014
Actual Primary Completion Date : December 2016
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: ACT Parent Group
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.
Behavioral: Acceptance and Commitment Therapy
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.
Other Name: ACT

No Intervention: Treatment as Usual
Treatment as usual-Control



Primary Outcome Measures :
  1. Change in Acceptance and Action Questionnaire-II Score [ Time Frame: From Basline to Month 2 (post-intervention) and from Month 2 to Month 3 (maintenance) ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02255786


Locations
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United States, Massachusetts
Lurie Center | Massachusetts General Hospital
Lexington, Massachusetts, United States, 02421
Sponsors and Collaborators
Massachusetts General Hospital
Organization for Autism Research
Investigators
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Principal Investigator: Lisa A. Nowinski, PhD Massachusetts General Hospital - Lurie Center
Study Director: Kirstin Brown Birtwell, PhD Massachusetts General Hospital - Lurie Center
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Responsible Party: Lisa A. Nowinski, PhD, Director, Neuropsychology Training, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT02255786    
Other Study ID Numbers: 2014P001563
First Posted: October 3, 2014    Key Record Dates
Last Update Posted: August 13, 2019
Last Verified: August 2019
Keywords provided by Lisa A. Nowinski, PhD, Massachusetts General Hospital:
Group Therapy
Parents
Autism
Quality of Life
Additional relevant MeSH terms:
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Autism Spectrum Disorder
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders