AutismNCT07630376
Evaluating a Workbook to Promote Autistic Wellbeing
A study testing Guided self-help workbook for autistic adults in people with Autism and Wellbeing, run by Canterbury Christ Church University at 1 site in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Guided self-help workbook for autistic adults
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Sep 2026to Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
Kent and Medway Mental Health NHS Trust
Maidstone, ME16 9PH
Dan Brown, +44 (0) 1622 725000, dan.brown9@nhs.net
About this study
Official title: 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?
Read more
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
Read the 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.
- Being tested
- Guided self-help workbook for autistic adults
- Medical subject headings
- Autistic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Guided self-help workbook for autistic adultsBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Guided self-help workbook for autistic adults | Experimental | Within-subjects comparison Receives: Behavioral: Guided self-help workbook for autistic adults |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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%
Measured: 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%
Measured: 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
Measured: 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%
Measured: Weeks 0-12
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%
Measured: Baseline (weeks 0-1) and post-intervention (weeks 7-8)
Secondary outcomes (6)
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%
Measured: 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%
Measured: 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%
Measured: 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
Measured: 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
Measured: 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
Measured: Weeks 11-12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2026
- Study start1 Sep 2026
- Primary completionMar 2027 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AutismStudies 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Canterbury Christ Church University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07630376
- Sponsor's protocol ID
- DClinPsychol24KMann
- Status last verified
- Sep 2026
- First submitted
- 1 Jun 2026
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
Toudal, M., & Attwood, T. (2024). Energy accounting: Stress management and mental health monitoring for autism and related conditions. Jessica Kingsley Publishers.
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Use of a Guided Self-help Workbook to Promote Wellbeing for Autistic Adults: A Mixed-methods Multiple Single-case Study
- ClinicalTrials.gov ID
- NCT07630376
- Acronym / sponsor ID
- DClinPsychol24KMann
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Canterbury Christ Church UniversityUniversity, hospital or other
- Study start
- 1 Sep 2026 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 5 Jun 2026 (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.
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
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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Guided self-help workbook for autistic adults | Experimental | Behavioral: Guided self-help workbook for autistic adultsWithin-subjects comparison |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (4 listed)
- 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).
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 |
|---|---|---|
| Guided self-help workbook for autistic adultsThe 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. | Behavioural | Guided self-help workbook for autistic adults |
Primary outcome
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
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%
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%
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
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%
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%
6 secondary outcomes
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)
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)
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)
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)
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)
Qualitative data from follow-up interviews with participants
Time frame: Weeks 11-12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2026.
- BackgroundToudal, M., & Attwood, T. (2024). Energy accounting: Stress management and mental health monitoring for autism and related conditions. Jessica Kingsley Publishers.
- Individual participant dataSharing planned: No. 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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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Guided self-help workbook for autistic adults in people with Autism and Wellbeing, run by Canterbury Christ Church University at 1 site in United Kingdom.
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 7 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kirsten Mann (+44 (0) 333 011 7101, k.mann2949@canterbury.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants recruited to the study (time frame: 6 months following start of recruitment). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07630376, which also lists 1 linked publication.
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 11 Sep 2026.