NCT02255786

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 15, 2014

Completed
16 days until next milestone

Study Start

First participant enrolled

October 1, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 3, 2014

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

August 13, 2019

Status Verified

August 1, 2019

Enrollment Period

2.2 years

First QC Date

September 15, 2014

Last Update Submit

August 12, 2019

Conditions

Keywords

Group TherapyParentsAutismQuality of Life

Outcome Measures

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.

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

Study Arms (2)

ACT Parent Group

EXPERIMENTAL

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

Treatment as Usual

NO INTERVENTION

Treatment as usual-Control

Interventions

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
ACT Parent Group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lurie Center | Massachusetts General Hospital

Lexington, Massachusetts, 02421, United States

Location

MeSH Terms

Conditions

Autistic Disorder

Interventions

Acceptance and Commitment Therapy

Condition Hierarchy (Ancestors)

Autism Spectrum DisorderChild Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Cognitive Behavioral TherapyBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Lisa A. Nowinski, PhD

    Massachusetts General Hospital - Lurie Center

    PRINCIPAL INVESTIGATOR
  • Kirstin Brown Birtwell, PhD

    Massachusetts General Hospital - Lurie Center

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Neuropsychology Training

Study Record Dates

First Submitted

September 15, 2014

First Posted

October 3, 2014

Study Start

October 1, 2014

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

August 13, 2019

Record last verified: 2019-08

Locations