Stress Clinical Trial
Official title:
Taking ACTion: Acceptance and Commitment Therapy for Parents of Children With Autism Spectrum Disorder
| 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 |
| Verified date | August 2019 |
| Source | Massachusetts General Hospital |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| 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. |
| Country | Name | City | State |
|---|---|---|---|
| United States | Lurie Center | Massachusetts General Hospital | Lexington | Massachusetts |
| Lead Sponsor | Collaborator |
|---|---|
| Massachusetts General Hospital | Organization for Autism Research |
United States,
| 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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