About this trial
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:
1. Is it feasible to recruit and retain autistic adults to participate in the study? 2. Do participants find the workbook acceptable and relevant? 3. Are there measurable improvements in wellbeing following workbook use? 4. 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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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 design
Single group
Treatments tested in this trial
Guided self-help workbook for autistic adults
BehavioralThe 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.
Treatment groups
Trial outcomes
Primary outcomes
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
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%
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%
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
Secondary outcomes
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%
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%
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%
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
Sponsors and contacts
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