- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07630376
Evaluating a Workbook to Promote Autistic Wellbeing
Evaluating the Use of a Guided Self-help Workbook to Promote Wellbeing for Autistic Adults: A Mixed-methods Multiple Single-case Study
The goal of this clinical trial is to examine the feasibility and acceptability of a brief guided self-help wellbeing intervention for autistic adults accessing UK secondary mental health services. The study also aims to begin to evaluate whether use of the workbook is associated with any changes in wellbeing. The main questions it aims to answer are:
- Is it feasible to recruit and retain autistic adults to participate in the study?
- Do participants find the workbook acceptable and relevant?
- Are there measurable improvements in wellbeing following workbook use?
- What changes, if any, do participants recommend for future versions of the intervention?
Participants will:
- Take part in 4-6 sessions of 30-60 minutes using the guided self-help workbook with the support of a trained National Health Service support worker, assistant psychologist, or mental health professional
- Complete wellbeing questionnaires before, during, and after using the workbook
- Complete brief daily wellbeing ratings throughout the study
- Take part in a 1:1 semi-structured interview of up to an hour to discuss their experience of the workbook
Study Overview
Status
Intervention / Treatment
Detailed Description
Autism is a lifelong neurodevelopmental difference that affects how people communicate, experience the world, and relate to others. In the UK, more than 1% of people are estimated to be autistic, with rates of diagnosis rapidly increasing. Many autistic adults experience mental health challenges such as anxiety, depression, and suicidal thoughts. Some may experience 'autistic burnout', a state of deep exhaustion and loss of coping ability. These difficulties can result from long-term stress, 'masking' (hiding autistic traits to fit in), and lack of understanding or support.
In the UK National Health Service, post-diagnostic support for autistic adults is limited, often consisting only of information or signposting. While existing psychological therapies can help with anxiety and depression, they are not always designed with the needs of autistic people in mind. This highlights a clear need for preventative, accessible, and autism-specific wellbeing support, especially within the National Health Service, where demand is high and resources are limited.
This study aims to explore whether a new guided self-help wellbeing workbook designed specifically for autistic adults is feasible and acceptable, and to get an initial impression of its helpfulness in improving wellbeing. It focuses on helping people to understand autism and manage their energy levels using 'energy accounting' (Toudal & Attwood, 2024), and to plan for wellbeing using personalised strategies. The aim is to help autistic adults improve self-understanding, communicate their needs, and enhance wellbeing in everyday life.
The study will have three phases (baseline: a 1-2 week period prior to completing the workbook; intervention: a 4-6 week period during completion of the workbook; follow-up: a 3-4 week period following workbook completion). Participants will be asked to complete standardised questionnaires at the beginning and end of each phase. Brief daily wellbeing ratings will be collected throughout all three phases. Finally, an interview of up to an hour will be conducted with participants at the end of the follow-up phase.
There are six primary indicators which will be compared against pre-specified progression criteria. The primary outcomes are 1) ease of recruitment to the study; 2) participant retention in the intervention; 3) participant retention in the study; 4) intervention acceptability; 5) outcome measure completion; 6) whether there is a preliminary indicator of efficacy on the primary outcome measure (wellbeing). Progression criteria will be used to help decide whether the research should progress to more powered intervention studies in future.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Kirsten Mann
- Phone Number: +44 (0) 333 011 7101
- Email: k.mann2949@canterbury.ac.uk
Study Contact Backup
- Name: Fergal Jones
- Phone Number: +44 (0) 1227 927110
- Email: fergal.jones@canterbury.ac.uk
Study Locations
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-
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Maidstone, United Kingdom, ME16 9PH
- Kent and Medway Mental Health NHS Trust
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Contact:
- Dan Brown
- Phone Number: +44 (0) 1622 725000
- Email: dan.brown9@nhs.net
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- A pre-existing diagnosis of autism OR on a waiting list for autism assessment OR self-identified as autistic and scoring above cut-off on the autism quotient (AQ-50) screening questionnaire.
- Aged 18 years or over and able to give informed consent to participate.
- Under the care of a community-based mental health team in Kent and Medway Mental Health NHS Trust and not due for discharge during the study period.
- Have already completed assessment processes (including risk assessment) during intake by the clinical team and a management plan is in place.
- The named clinician assesses that the individual is in sufficiently stable condition to participate in the study, and is likely to remain engaged in the intervention.
- Proficiency in reading and writing English.
- If on medication for mental health, the dose is stable (minimum of 3 months) with no planned changes during the study.
Exclusion Criteria:
- Presence of a moderate to severe learning disability that would limit independent engagement with self-help materials.
- Engaged in another psychological therapy or psychologically-informed intervention, or due to begin another during the study.
- Current acute mental health crisis or elevated risk to self/others requiring intensive intervention (assessed via clinical team judgement).
- Insufficient capacity to engage with the study protocol or complete measures (as determined by the care team).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Guided self-help workbook for autistic adults
Within-subjects comparison
|
The workbook's components are: psycho-education and energy accounting (Toudal & Attwood, 2024) - including sensory awareness - and planning for wellbeing.
It will be delivered over four to six sessions of between 30-60 minutes each with a trained National Health Service support worker, assistant psychologist, or mental health professional.
Sessions would be conducted in-person, via telephone, or via video.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of participants recruited to the study
Time Frame: 6 months following start of recruitment
|
The number of participants recruited over 6 months will be compared against the following progression criterion to assess the feasibility of recruitment: Green: 8-10; Amber: 6-7; Red: <5
|
6 months following start of recruitment
|
|
Proportion of participants who complete the guided self-help intervention
Time Frame: Weeks 2-8
|
The proportion of participants who complete the guided self-help intervention will be compared against the following progression criterion to assess retention in the intervention: Green: ≥75%; Amber: ≥50%; Red: <50%
|
Weeks 2-8
|
|
Proportion of participants who remain in the study
Time Frame: Weeks 0-12
|
The proportion of study participants who remain in the study will be compared against the following progression criterion to assess retention in the study: Green: ≥75%; Amber: ≥50%; Red: <50%
|
Weeks 0-12
|
|
Guided self-help intervention acceptability
Time Frame: Weeks 11-12
|
Response to Likert type questions and thematic analysis of qualitative data will be compared against the following progression criterion to assess retention in the study: Green: the majority of participants report the intervention is acceptable as it is or with minor adjustments; Amber: there are inconsistent reports of acceptability or the intervention requires bigger adjustments; Red: the majority of participants report the intervention is unacceptable or requires adjustments which cannot be completed
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Weeks 11-12
|
|
Completion rate of outcome measures
Time Frame: Weeks 0-12
|
The rate of the outcome measures completion will be compared against the following progression criterion to assess the feasibility of outcome measurement: Green: ≥75%; Amber ≥50%; Red: <50%
|
Weeks 0-12
|
|
Proportion of participants showing reliable improvement on the ReQoL-20 from baseline (weeks 0-1) to post-intervention (weeks 7-8)
Time Frame: Baseline (weeks 0-1) and post-intervention (weeks 7-8)
|
The ReQoL-20 contains 20 items measuring quality of life, with higher scores indicating greater quality of life. The proportion of participants showing reliable improvement on the ReQoL-20 from baseline (weeks 0-1) to post-intervention (weeks 7-8) will be compared against the following progression criterion to provide a preliminary indicator of effectiveness: Green: ≥75%; Amber: ≥50%; Red: <50% |
Baseline (weeks 0-1) and post-intervention (weeks 7-8)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Proportion of participants showing reliable improvement on the ReQoL-20 from baseline (weeks 0-1) to follow-up (weeks 11-12)
Time Frame: Baseline (weeks 0-1) and follow-up (weeks 11-12)
|
The ReQoL-20 contains 20 items measuring quality of life, with higher scores indicating greater quality of life. The proportion of participants showing reliable improvement on the ReQoL-20 from baseline (weeks 0-1) to follow-up (weeks 11-12) will be compared against the following progression criterion to provide a preliminary indicator of effectiveness: Green: ≥75%; Amber: ≥50%; Red: <50% |
Baseline (weeks 0-1) and follow-up (weeks 11-12)
|
|
Proportion of participants showing reliable improvement on the DIALOG from baseline (weeks 0-1) to post-intervention (weeks 7-8)
Time Frame: Baseline (weeks 0-1) and post-intervention (weeks 7-8)
|
The DIALOG scale contains 11 items measuring quality of life and treatment satisfaction, with higher scores indicating greater satisfaction. The proportion of participants showing reliable improvement on the DIALOG from baseline (weeks 0-1) to post-intervention (weeks 7-8) will be compared against the following progression criterion to provide a preliminary indicator of effectiveness: Green: ≥75%; Amber: ≥50%; Red: <50% |
Baseline (weeks 0-1) and post-intervention (weeks 7-8)
|
|
Proportion of participants showing reliable improvement on the DIALOG from baseline (weeks 0-1) to follow-up (weeks 11-12)
Time Frame: Baseline (weeks 0-1) and follow-up (weeks 11 to 12)
|
The DIALOG scale contains 11 items measuring quality of life and treatment satisfaction, with higher scores indicating greater satisfaction. The proportion of participants showing reliable improvement on the DIALOG from baseline (weeks 0-1) to follow-up (weeks 11-12) will be compared against the following progression criterion to provide a preliminary indicator of effectiveness: Green: ≥75%; Amber: ≥50%; Red: <50% |
Baseline (weeks 0-1) and follow-up (weeks 11 to 12)
|
|
Change in average level of daily ratings from baseline (weeks 0-1) to post-intervention (weeks 7-8)
Time Frame: Baseline (weeks 0-1) to post-intervention (weeks 7-8)
|
Brief daily wellbeing ratings (e.g.
'rate your wellbeing on a scale of 0-10') will be collected throughout all phases (baseline, intervention, follow-up) to provide additional time-linked data to evaluate intervention efficacy
|
Baseline (weeks 0-1) to post-intervention (weeks 7-8)
|
|
Change in average level of daily ratings from baseline (weeks 0-1) to follow-up (weeks 11-12)
Time Frame: Baseline (weeks 0-1) to follow-up (weeks 11-12)
|
Brief daily wellbeing ratings (e.g.
'rate your wellbeing on a scale of 0-10') will be collected throughout all phases (baseline, intervention, follow-up) to provide additional time-linked data to evaluate intervention efficacy
|
Baseline (weeks 0-1) to follow-up (weeks 11-12)
|
|
Qualitative data from follow-up interviews with participants
Time Frame: Weeks 11-12
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An interview of up to an hour will be conducted with participants at the end of the follow-up phase to explore their experiences of using the workbook
|
Weeks 11-12
|
Collaborators and Investigators
Publications and helpful links
General Publications
- Toudal, M., & Attwood, T. (2024). Energy accounting: Stress management and mental health monitoring for autism and related conditions. Jessica Kingsley Publishers.
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
- DClinPsychol24KMann
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
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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