Autism Spectrum DisorderNCT04298164
Evaluating the Effectiveness of an Acceptance and Commitment Therapy-based Group Intervention for Parents of Children With a Diagnosis of Autism Spectrum Disorder
A study testing START programme and Treatment as Usual in people with Autism Spectrum Disorder, run by University College Dublin at 2 sites in Ireland.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- START programme and Treatment as Usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 2 sitesIreland
- Study dates
- 25 Nov 2019to 30 Mar 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
About this study
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
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
- Being tested
- START programme, Treatment as Usual
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
START programmeBehavioural
Acceptance and Commitment Therapy based programme for parents of children with Autism
Treatment as UsualBehavioural
Treatment as usual in outpatient within outpatient psychology services
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Group that receives the intervention Receives: Behavioral: START programme |
| Control group | Active comparator | Group that receives treatment as usual Receives: Behavioral: Treatment as Usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in psychological flexibility
Measured using the Comprehensive assessment of Acceptance and Commitment Therapy Processes (CompACT)
Measured: 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 using The Autism Parenting Stress Index
Measured: 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 using The Warwick-Edinburgh Mental Wellbeing Scales (WEMWBS)
Measured: 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
Parent Problem Checklist (PPC)
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2020
- Study start25 Nov 2019
- Primary completion30 Mar 2021
- Study completion30 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- University College Dublin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04298164
- Sponsor's protocol ID
- START1
- Status last verified
- Apr 2021
- First submitted
- 24 Feb 2020
- Last updated
- 3 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04298164
- Acronym / sponsor ID
- START1
- Conditions
- Autism Spectrum Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- University College DublinUniversity, hospital or other
- Study start
- 25 Nov 2019 (actual)
- Primary completion
- 30 Mar 2021 (actual)
- Study completion
- 30 Mar 2021 (actual)
- First posted
- 6 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: START programmeGroup that receives the intervention |
| Control group | Active comparator | Behavioral: Treatment as UsualGroup that receives treatment as usual |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| START programmeAcceptance and Commitment Therapy based programme for parents of children with Autism | Behavioural | Intervention group |
| Treatment as UsualTreatment as usual in outpatient within outpatient psychology services | Behavioural | Control group |
Primary outcome
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)
3 secondary outcomes
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)
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)
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing START programme and Treatment as Usual in people with Autism Spectrum Disorder, run by University College Dublin at 2 sites in Ireland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2021.