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CompletedNCT02255786Updated Aug 13, 2019

"ACT" for Parents of Children With Autism Spectrum Disorder

An interventional study of Acceptance and Commitment Therapy in Stress, sponsored by Massachusetts General Hospital. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2019-08-13.

Sponsored by Massachusetts General Hospital · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
16
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Stress

Keywords

  • Group Therapy
  • Parents
  • Autism
  • Quality of Life
03

In context

Autism Spectrum Disorder

1,727 studies on the registry are indexed under Autism Spectrum Disorder; 504 are open to participants now.

This study's planned enrollment of 16 is below the median of 52 across 1,371 interventional studies indexed under Autism Spectrum Disorder.

Browse Autism Spectrum Disorder studies →

Lead sponsor

Massachusetts General Hospital is the lead sponsor of 2,537 studies on the registry; 447 are open to participants now.

Of its 214 completed or terminated interventional studies of FDA-regulated products, 161 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
16 participants (estimated)

Study arms

  • 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

  • No intervention
    Treatment as Usual

    Treatment as usual-Control

Interventions

  • BehavioralAcceptance 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.

    Also known as: ACT

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: From Basline to Month 2 (post-intervention) and from Month 2 to Month 3 (maintenance)

07

Study locations

1 site
  • Lurie Center | Massachusetts General Hospital
    Lexington, Massachusetts 02421, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 13, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02255786
Lead sponsor
Massachusetts General Hospital
Collaborators
Organization for Autism Research
Responsible party
Lisa A. Nowinski, PhD (Director, Neuropsychology Training, Massachusetts General Hospital) — Principal investigator
First posted
Oct 3, 2014
Start date
Oct 2014
Primary completion
Dec 2016
Completion
Dec 2016
Last update
Aug 13, 2019

Study contacts

Lisa A. Nowinski, PhD
principal investigator · Massachusetts General Hospital - Lurie Center
Kirstin Brown Birtwell, PhD
study director · Massachusetts General Hospital - Lurie Center

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.

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