Evaluating the Effectiveness of an Acceptance and Commitment Therapy-based Group Intervention for Parents of Children With a Diagnosis of Autism Spectrum Disorder

NCT04298164 | Completed

• 1 other identifier: START1
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 2

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.

Conditions

Autism Spectrum Disorder

Outcome Measures

Primary Outcomes (1)

• Change in psychological flexibility

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

  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 Outcomes (3)

• 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)

• 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)

Study Arms (2)

Intervention group

EXPERIMENTAL

Group that receives the intervention

Behavioral: START programme

Control group

ACTIVE COMPARATOR

Group that receives treatment as usual

Behavioral: Treatment as Usual

Interventions

START programme BEHAVIORAL

Acceptance and Commitment Therapy based programme for parents of children with Autism

Intervention group

Treatment as Usual BEHAVIORAL

Treatment as usual in outpatient within outpatient psychology services

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University College Dublin: lead

Study Sites (2)

HSE Donegal

Donegal, Ireland

Location

HSE Longford/Westmeath

Longford, Ireland

Location

MeSH Terms

Conditions

Autism Spectrum Disorder

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2020
• First Posted: March 6, 2020
• Study Start: November 25, 2019
• Primary Completion: March 30, 2021
• Study Completion: March 30, 2021
• Last Updated: May 3, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

IE (2)