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

April 30, 2021 updated by: University College Dublin

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

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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
56

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Ireland
      • Donegal, Ireland
        • HSE Donegal
      • Longford, Ireland
        • HSE Longford/Westmeath

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Intervention group
Group that receives the intervention
Behavioral: START programme
Acceptance and Commitment Therapy based programme for parents of children with Autism
ACTIVE_COMPARATOR: Control group
Group that receives treatment as usual
Behavioral: Treatment as Usual
Treatment as usual in outpatient within outpatient psychology services

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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)
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 Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Parenting stress
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 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)
Mental wellbeing
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 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)
Parent relationship
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)
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University College Dublin

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 25, 2019

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 30, 2021

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 30, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 24, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 4, 2020

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 6, 2020

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 3, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 30, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • START1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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