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Clinical Trials/NCT04298164
NCT04298164CompletedNot Applicable

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

University College Dublin2 sites in 1 country56 target enrollmentStarted: November 25, 2019Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
56
Locations
2
Primary Endpoint
Change in psychological flexibility

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (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.

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Arms & Interventions

Control group

Active Comparator

Group that receives treatment as usual

Intervention: Treatment as Usual (Behavioral)

Intervention group

Experimental

Group that receives the intervention

Intervention: START programme (Behavioral)

Outcomes

Primary Outcomes

Change in psychological flexibility

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)

Measured using the Comprehensive assessment of Acceptance and Commitment Therapy Processes (CompACT)

Secondary Outcomes

  • Parent relationship(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))
  • Parenting stress(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))
  • Mental wellbeing(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))

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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