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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02255786
Other study ID # 2014P001563
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 2014
Est. completion date December 2016

Study information

Verified date August 2019
Source Massachusetts General Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 16
Est. completion date December 2016
Est. primary completion date December 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
United States Lurie Center | Massachusetts General Hospital Lexington Massachusetts

Sponsors (2)

Lead Sponsor Collaborator
Massachusetts General Hospital Organization for Autism Research

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. From Basline to Month 2 (post-intervention) and from Month 2 to Month 3 (maintenance)
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