Evaluating a Workbook to Promote Autistic Wellbeing

NCT07630376 | Not Yet Recruiting

• 1 other identifier: DClinPsychol24KMann
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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. The main questions it aims to answer are:

• 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

Conditions

Autism; Wellbeing

Outcome Measures

Primary Outcomes (6)

• 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

• 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)

Secondary Outcomes (6)

• Proportion of participants showing reliable improvement on the ReQoL-20 from baseline (weeks 0-1) to follow-up (weeks 11-12)

  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)

  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)

  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)

  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)

  Baseline (weeks 0-1) to follow-up (weeks 11-12)

Study Arms (1)

Guided self-help workbook for autistic adults

EXPERIMENTAL

Within-subjects comparison

Behavioral: Guided self-help workbook for autistic adults

Interventions

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.

Guided self-help workbook for autistic adults

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Canterbury Christ Church University: lead

Study Sites (1)

Kent and Medway Mental Health NHS Trust

Maidstone, ME16 9PH, United Kingdom

Location

Related Publications (1)

• Toudal, M., & Attwood, T. (2024). Energy accounting: Stress management and mental health monitoring for autism and related conditions. Jessica Kingsley Publishers.

  BACKGROUND

MeSH Terms

Conditions

Autistic Disorder

Condition Hierarchy (Ancestors)

Autism Spectrum Disorder; Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Central Study Contacts

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 1, 2026
• First Posted: June 5, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: June 5, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)