- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07498049
CFT Guided Self-help Intervention: Parents of Autistic Children (CFT-GSH-PAC)
Testing a Compassion-focused Guided Self-help Intervention for Parents of Autistic Children - Single Case Series Design
This research will aim to test how practical, achievable and effective a brief, guided, self-help compassion focused intervention is for parents of autistic children aged 6-17 years old.
The demands of parenting can be rewarding but also challenging, and it is known that parents of autistic children experience additional pressures. As a result of this, parents of autistic children may be more likely to experience increased stress, anxiety, low mood and lower quality of life, compared to those parenting children who are not autistic.
There has been only a small amount of research so far regarding whether interventions that focus on building compassion, would be beneficial to parents of autistic children. The purpose of this study is to test whether a short, self-guided compassion-focused intervention is practical, achievable and effective for parents of autistic children. The intervention is based on Compassion Focused Therapy (CFT) and involves reading workbook material and listening to audio tracks. There will also be some questionnaires to complete and 30-minute weekly support calls with the lead researcher.
This intervention was adapted previously, from an intervention for parents in general, to be more suitable and focused on the needs of parents of autistic children. This study will be the first time the adapted intervention has been used by parents.
The intervention will be tested by 6-8 parents and will be about 13 weeks long. We will collect some demographic data at the start of the study, and there will be the opportunity to complete an evaluation questionnaire.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The primary aim of this project is to test the feasibility and effectiveness of a pilot, guided self-help intervention for PAC as adapted by Kemp et al (2024) from the original Compassionate Mind Training for Parents of Autistic Children (CMT-PAC) (Kirby, Hoang and Ramos 2023). The intervention will be tested and evaluated through completion of psychometric questionnaires, support telephone calls and change interviews.
Research Questions:
- Is a brief, guided, self-help compassion-focused intervention for PAC feasible?
- What is the impact of a brief, guided, self-help compassion-focused intervention for PAC on parental self-compassion, compassion to others, parental stress and perceived child behaviour?
It is anticipated that this could be utilised as an accessible intervention within charities, online or as a waiting list intervention. This would be subject to testing in this and future studies to demonstrate efficacy of this pilot intervention.
This will be a multi-centre study recruiting from University Hospitals of Derby and Burton NHS Trust and Lincolnshire Partnership NHS Trust. These sites will not provide the intervention and will be participant identification sites.
There will be no randomisation within the study.
The study will involve completion of outcome measures questionnaires before, during and after the intervention. Pre-intervention outcome measures will be completed over 3 weeks prior to intervention starting. The intervention is guided self-help where participants access a workbook and associated tasks that has been adapted for this population (Kemp et al., 2024) and this content will be provided to them on a weekly basis. This intervention will be supported by weekly video calls with the lead researcher to support with any barriers and questions from the participant and for the researcher to gather information related to completion of the weekly content and tasks. During this call, outcome measures will be completed. Participants will complete 4 weeks of post-intervention outcome measures. An evaluation form will be completed on the final week of contact. A change interview will also be arranged on this week with an independent researcher, likely a trainee or qualified clinical psychologist, to support likelihood of accurate feedback being given.
The total duration of the study is anticipated to be approximately 12 months. Participant enrolment will be open for approximately the first 6 months of the study. Following completion of enrolment and all participant follow-up, the remaining study period will include data cleaning, analysis, and preparation of study reports and publications. The study will close following completion of all study activities. The final submission is planned for September 2027.
Each participant will be involved in the study for approximately 13 weeks, which includes pre-intervention and post-intervention assessments. The intervention period is planned to last 6 weeks; however, where required, the intervention may be extended for an individual participant for up to a maximum of 12 weeks in total. In such cases, the overall participant involvement will not exceed 19 weeks. The research team anticipate that possible requirements for extension to the intervention period may include but are not limited to where participants have not been able to engage with intervention material due to expected or unexpected life or work commitments, ill health of themselves or their child, or holiday commitments.
Participants will be recruited through University Hospitals of Derby and Burton NHS Foundation Trust Children's Clinical Psychology Team and Lincolnshire Partnership NHS Foundation Trust Boston Community Child and Adolescent Mental Health (CAMHS) Team. Professionals in these teams will identify potential participants who meet the studies inclusion criteria and share the study recruitment flyer with them. Potential participants will be parents of children who may be accessing these services. Potential participants will be invited to contact the research team if they are interested in taking part in the study. Recruitment through NHS professionals constitutes purposive sampling, as clinicians will identify and approach parents who meet the study's inclusion criteria. NHS professionals will provide the study advert, and it will be for the potential participants to contact the research team should they be interested in participating.
For parents interested in participating in the study, they will be provided with the study recruitment poster/flyer by the clinical team and encouraged to contact the researcher via email as an expression of interest. They may see the study poster advertised by the clinical team or may have the study mentioned to them by staff working within the teams. The researcher will send the parent a Participant Information Sheet (PIS) and plain English summary.
The total participants time is intended to be 13 weeks including pre and post intervention commitments. The compassion-focused intervention itself is intended to be 6 weeks of this commitment. Participants will complete baseline outcome measures at three time points: at screening appointment or when consent form is signed, if this is not at the screening appointment, 1 week after initial outcome measures are completed and 2 weeks after initial outcome measures are completed. It is anticipated that the third baseline outcome measures will be completed immediately preceding the details for Week 1 of the compassion-focused intervention being sent to the participant.
The intervention will involve parents of autistic children working through an adapted compassion-focused workbook (Kemp et al, 2024), as a 6-week intervention where it is advised that parents read one chapter per-week and practice the associated exercises at least once per day. The workbook was adapted collaboratively using focus groups with stakeholders. It is estimated that these exercises should take 10-15 minutes daily. Participants will have access to audio tracks and written scripts of the exercises. Participants can use the audio tracks as often as they wish.
Participants will be sent one section of the workbook at a time, each week via email. They will also receive planned, weekly support calls (30 minutes approximately) via video call from the lead researcher. The calls will serve as a prompt to engage with the workbook material, to complete weekly outcome measures and an opportunity for any questions or problem-solving regarding the workbook content and exercises. The calls will be structured using a proforma to allow for analysis. Participants will be made aware that the data from the support calls will be analysed. Due to the nature of parenting an autistic child, some parents may need slightly longer to complete tasks and therefore it has been agreed that the intervention phase can be extended to up to 12 weeks long when needed but no longer. If study involvement was extended to the maximum length, it would lead to a maximum participant duration of 19 weeks. In situations where parents have needed additional time, contextual information around this will be gathered during support calls to ensure that researchers are aware of any contextual factors that may impact results.
Post-intervention, participants will participate in a weekly video call to complete outcome measures for three-weeks post-intervention. At one-month post-intervention, participants will complete a final set of measures and a brief evaluation questionnaire via video call. On the day of the final set of measures and brief evaluation questionnaire, the participant will also complete a change interview with an independent researcher.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Molly Beardsmore
- Phone Number: +44 0115 84 67523
- Email: molly.beardsmore@nottingham.ac.uk
Study Contact Backup
- Name: Mark Hudson, DClinPsy
- Phone Number: +44 0115 84 67523
- Email: mark.hudson@nottingham.ac.uk
Study Locations
-
-
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Nottingham, United Kingdom, NG8 1BB
- University of Nottingham
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Contact:
- Molly Beardsmore
- Phone Number: 0115 84 67523
- Email: molly.beardsmore@nottingham.ac.uk
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Principal Investigator:
- Mark Hudson, DClinPsy
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Participants must be a parent who lives with their autistic child. The parent must be aged 18 years and above and their child must be aged between 6 and 17 years old. The parent participant must have good use of the English language to provide informed consent, access the workbook material, listen to the audio tracks, engage verbally in the support telephone calls and change interviews and complete outcome measures. The child must have a formal diagnosis of autism spectrum disorder as confirmed following assessment by a doctor or practitioner psychologist. Participants must be technology-literate and have access to technology to access video calls for screening and check-in calls as needed.
Exclusion Criteria:
- Those who are currently receiving psychological or mental health input from professionals, those experiencing thoughts related to self-harm and/or suicide and those who are dependent on alcohol or drugs, those with a learning disability or other cognitive impairment will be excluded from this research.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Device Feasibility
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Guided Self-Help Compassion-Focused Intervention
Participants allocated to this arm will receive a guided self-help intervention based on principles of Compassion-Focused Therapy (CFT).
The programme consists of structured self-help materials designed to help participants develop compassion toward themselves and others and to reduce self-criticism and distress.
Participants will work through the materials independently over the course of the intervention period and will receive brief guidance and support from a facilitator.
|
The intervention is a 6-week guided self-help compassion focused therapy (CFT) intervention for parents of autistic children.
There will also be pre and post-intervention testing which will take the total duration time to 13 weeks.
The intervention will involve parents of autistic children working through an adapted compassion-focused workbook (Kemp et al, 2024), as a 6-week intervention where it is advised that parents read one chapter per-week and practice the associated exercises at least once per day.
The workbook was adapted collaboratively using focus groups with stakeholders.
It is estimated that these exercises should take 10-15 minutes daily.
Participants will have access to audio tracks and written scripts of the exercises.
Participants can use the audio tracks as often as they wish.
Participants will be sent one section of the workbook at a time, each week via email.
They will also receive planned, weekly support calls (30 minutes approximately).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Parental Stress Scale
Time Frame: Weekly from enrolment to the final week of post-intervention testing at week 13 which is the final week of the follow-up period.
|
The Parental Stress Scale will be administered at all weeks of the study.
This will be administered electronically during weekly support calls.
This is a validated self-report measure of stress associated with the parenting role.
|
Weekly from enrolment to the final week of post-intervention testing at week 13 which is the final week of the follow-up period.
|
|
State Self-Compassion Stress Scale
Time Frame: Weekly from enrolment to the final week of post-intervention testing at week 13 which is the final week of the follow-up period.
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The State Self-Compassion Stress Scale will be administered at all weeks of the study.
This will be administered electronically during weekly support calls.
This measure looks at momentary levels of self-compassion in response to their current experiences.
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Weekly from enrolment to the final week of post-intervention testing at week 13 which is the final week of the follow-up period.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Compassion Engagement and Action Scales
Time Frame: Completed at three time points during the study - at enrolment, at week 9 which is the first post-intervention week and at week 13 which is the final week of participant contact with the study.
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The Compassion Engagement and Action Scales will be administered at three points during the study.
This will be administered electronically during weekly support calls.
This measure looks at participants' engagement with and enactment of compassion.
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Completed at three time points during the study - at enrolment, at week 9 which is the first post-intervention week and at week 13 which is the final week of participant contact with the study.
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Mark Hudson, DClinPsy, University of Nottingham
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 26013
- 365576 (Other Identifier: NHS IRAS)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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