StressNCT02255786
"ACT" for Parents of Children With Autism Spectrum Disorder
A study testing Acceptance and Commitment Therapy in people with Stress, run by Massachusetts General Hospital at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Stress
- What is being tested?
- Acceptance and Commitment Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2014to Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Lurie Center | Massachusetts General Hospital
Lexington, Massachusetts, 02421
About this study
Official title: Taking ACTion: Acceptance and Commitment Therapy for Parents of Children With Autism Spectrum Disorder
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.
- Conditions
- Stress
- Being tested
- Acceptance and Commitment Therapy
- Keywords
- Group Therapy, Parents, Autism, Quality of Life
- Medical subject headings
- Autistic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acceptance and Commitment TherapyBehavioural
Also called ACT
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Acceptance and Commitment Therapy |
| Treatment as Usual | No intervention | Treatment as usual-Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From Basline to Month 2 (post-intervention) and from Month 2 to Month 3 (maintenance)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2014 (estimated)
- Study startOct 2014
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StressStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Organization for Autism Research
- Responsible party
- Principal investigator, Lisa A. Nowinski, PhD, Massachusetts General Hospital
- Investigators
- Lisa A. Nowinski, PhD, Principal investigator, Massachusetts General Hospital - Lurie CenterKirstin Brown Birtwell, PhD, Study director, Massachusetts General Hospital - Lurie Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02255786
- Sponsor's protocol ID
- 2014P001563
- Status last verified
- Aug 2019
- First submitted
- 15 Sep 2014
- Last updated
- 13 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Taking ACTion: Acceptance and Commitment Therapy for Parents of Children With Autism Spectrum Disorder
- ClinicalTrials.gov ID
- NCT02255786
- Acronym / sponsor ID
- 2014P001563
- Conditions
- Stress
- Keywords
- Group Therapy, Parents, Autism, Quality of Life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Organization for Autism Research
- Study start
- Oct 2014
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 3 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ACT Parent Group | Experimental | Behavioral: Acceptance and Commitment TherapyParticipants 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. |
| Treatment as Usual | No intervention | –Treatment as usual-Control |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acceptance and Commitment TherapyAlso: ACTAcceptance 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. | Behavioural | ACT Parent Group |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lisa A. Nowinski, PhD principal investigator
Massachusetts General Hospital - Lurie Center
Kirstin Brown Birtwell, PhD study director
Massachusetts General Hospital - Lurie Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acceptance and Commitment Therapy in people with Stress, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2019.