Evaluating the Effectiveness of an Acceptance and Commitment Therapy-based Group Intervention for Parents of Children With a Diagnosis of Autism Spectrum Disorder
Primary Purpose
Autism Spectrum Disorder
Status
Completed
Phase
Not Applicable
Locations
Ireland
Study Type
Interventional
Intervention
START programme
Treatment as Usual
Sponsored by
About this trial
This is an interventional treatment trial for Autism Spectrum Disorder
Eligibility Criteria
Inclusion Criteria:
- Participants must be adults over the age of 18 with the capacity to provide informed consent who are willing to take part in all aspects of the study
- They must have at least 1 child with a diagnosed autism spectrum disorder who is linked in with one of the psychology service sites involved in the study.
- They must not have completed the START programme before, or be concurrently attending another group based parental intervention.
Exclusion Criteria:
- Individuals who are under the age of 18, or who unable or unwilling to provide informed consent for all aspects of the study will be not included.
- Individuals who are receiving other current group based parental interventions will not be included.
- Couples may not attend the programme together, as outlined by the Psychologists who developed the programme.
Sites / Locations
- HSE Donegal
- HSE Longford/Westmeath
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Intervention group
Control group
Arm Description
Group that receives the intervention
Group that receives treatment as usual
Outcomes
Primary Outcome Measures
Change in psychological flexibility
Measured using the Comprehensive assessment of Acceptance and Commitment Therapy Processes (CompACT)
Secondary Outcome Measures
Parenting stress
Measured using The Autism Parenting Stress Index
Mental wellbeing
Measured using The Warwick-Edinburgh Mental Wellbeing Scales (WEMWBS)
Parent relationship
Parent Problem Checklist (PPC)
Full Information
NCT ID
NCT04298164
First Posted
February 24, 2020
Last Updated
April 30, 2021
Sponsor
University College Dublin
1. Study Identification
Unique Protocol Identification Number
NCT04298164
Brief Title
Evaluating the Effectiveness of an Acceptance and Commitment Therapy-based Group Intervention for Parents of Children With a Diagnosis of Autism Spectrum Disorder
Official Title
Evaluating the Effectiveness of an Acceptance and Commitment Therapy-based Group Intervention for Parents of Children With a Diagnosis of Autism Spectrum Disorder Attending a Psychological Service
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
November 25, 2019 (Actual)
Primary Completion Date
March 30, 2021 (Actual)
Study Completion Date
March 30, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University College Dublin
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study is being conducted to look at whether a group programme designed for parents of children with a diagnosis of Autism is effective. The programme is called The START Programme ©- as it aims to provide a Supportive and Therapeutic environment to help parents gain Acceptance and reach Resolution so that they can Take action to live more consistently with their values. The programme was developed by two psychologists in Longford/Westmeath, Ireland, Dr. Michelle Howard and Kara McDermott in 2013, because they identified a lack of therapeutic support for such parents. The programme draws on research and theory from a branch of therapy called Acceptance and Commitment Therapy, as well as some other psychological techniques. Individuals who agree to participate in the research will be assigned at random to the intervention or to a treatment as usual control condition. They will be asked to fill out 4 questionnaires, on 3 different occasions, with a 7 week gap between the first time and second time, and a 3 month gap between the second and third time.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism Spectrum Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
Participants will generate a Unique Identifier Code which will be used to identify their data across each time point, but will mask their allocation until all of the data is entered and analysed.
Allocation
Randomized
Enrollment
56 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention group
Arm Type
Experimental
Arm Description
Group that receives the intervention
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
Group that receives treatment as usual
Intervention Type
Behavioral
Intervention Name(s)
START programme
Intervention Description
Acceptance and Commitment Therapy based programme for parents of children with Autism
Intervention Type
Behavioral
Intervention Name(s)
Treatment as Usual
Intervention Description
Treatment as usual in outpatient within outpatient psychology services
Primary Outcome Measure Information:
Title
Change in psychological flexibility
Description
Measured using the Comprehensive assessment of Acceptance and Commitment Therapy Processes (CompACT)
Time Frame
Measured before first session of programme (Week 1), at the final session of the programme (Week 7), and at 3 month follow up (12 Weeks after Week 7)
Secondary Outcome Measure Information:
Title
Parenting stress
Description
Measured using The Autism Parenting Stress Index
Time Frame
Measured before first session of programme (Week 1), at the final session of the programme (Week 7), and at 3 month follow up (12 Weeks after Week 7)
Title
Mental wellbeing
Description
Measured using The Warwick-Edinburgh Mental Wellbeing Scales (WEMWBS)
Time Frame
Measured before first session of programme (Week 1), at the final session of the programme (Week 7), and at 3 month follow up (12 Weeks after Week 7)
Title
Parent relationship
Description
Parent Problem Checklist (PPC)
Time Frame
Measured before first session of programme (Week 1), at the final session of the programme (Week 7), and at 3 month follow up (12 Weeks after Week 7)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Participants must be adults over the age of 18 with the capacity to provide informed consent who are willing to take part in all aspects of the study
They must have at least 1 child with a diagnosed autism spectrum disorder who is linked in with one of the psychology service sites involved in the study.
They must not have completed the START programme before, or be concurrently attending another group based parental intervention.
Exclusion Criteria:
Individuals who are under the age of 18, or who unable or unwilling to provide informed consent for all aspects of the study will be not included.
Individuals who are receiving other current group based parental interventions will not be included.
Couples may not attend the programme together, as outlined by the Psychologists who developed the programme.
Facility Information:
Facility Name
HSE Donegal
City
Donegal
Country
Ireland
Facility Name
HSE Longford/Westmeath
City
Longford
Country
Ireland
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Evaluating the Effectiveness of an Acceptance and Commitment Therapy-based Group Intervention for Parents of Children With a Diagnosis of Autism Spectrum Disorder
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