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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04298164
Other study ID # START1
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 25, 2019
Est. completion date March 30, 2021

Study information

Verified date April 2021
Source University College Dublin
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 56
Est. completion date March 30, 2021
Est. primary completion date March 30, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
START programme
Acceptance and Commitment Therapy based programme for parents of children with Autism
Treatment as Usual
Treatment as usual in outpatient within outpatient psychology services

Locations

Country Name City State
Ireland HSE Donegal Donegal
Ireland HSE Longford/Westmeath Longford

Sponsors (1)

Lead Sponsor Collaborator
University College Dublin

Country where clinical trial is conducted

Ireland, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Parenting stress Measured using The Autism Parenting Stress Index 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 Mental wellbeing Measured using The Warwick-Edinburgh Mental Wellbeing Scales (WEMWBS) 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 Parent relationship Parent Problem Checklist (PPC) 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)
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