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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:
Participants will:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Guided self-help workbook for autistic adults | Experimental | Within-subjects comparison |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Guided self-help workbook for autistic adults | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants recruited to the study | 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 | 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 | 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 | 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 | Weeks 11-12 |
| Completion rate of outcome measures | 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 |
| 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) | 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% |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kirsten Mann | Contact | +44 (0) 333 011 7101 | k.mann2949@canterbury.ac.uk | |
| Fergal Jones | Contact | +44 (0) 1227 927110 | fergal.jones@canterbury.ac.uk |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kent and Medway Mental Health NHS Trust | Maidstone | ME16 9PH | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Toudal, M., & Attwood, T. (2024). Energy accounting: Stress management and mental health monitoring for autism and related conditions. Jessica Kingsley Publishers. |
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Individual participant data will not be shared because the study involves extensive data collection from a small number of participants, which may increase the risk of participant identification.
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| ID | Term |
|---|---|
| D001321 | Autistic Disorder |
| ID | Term |
|---|---|
| D000067877 | Autism Spectrum Disorder |
| D002659 | Child Development Disorders, Pervasive |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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Multiple single-case design (SCED): each participant acts as their own comparison, with wellbeing measures repeated before, during, and after using the workbook, and daily wellbeing ratings completed throughout each phase.
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| Proportion of participants showing reliable improvement on the ReQoL-20 from baseline (weeks 0-1) to 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) |
| 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) | 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) | 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) | 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) | 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 | 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 |