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
調査の概要
詳細な説明
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.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Kirsten Mann
- 電話番号：+44 (0) 333 011 7101
- メール：k.mann2949@canterbury.ac.uk
研究連絡先のバックアップ
- 名前：Fergal Jones
- 電話番号：+44 (0) 1227 927110
- メール：fergal.jones@canterbury.ac.uk
研究場所
-
-
-
Maidstone、イギリス、ME16 9PH
- 募集
- Kent and Medway Mental Health NHS Trust
-
コンタクト：
- Dan Brown
- 電話番号：+44 (0) 1622 725000
- メール：dan.brown9@nhs.net
-
-
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
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).
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：支持療法
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Number of participants recruited to the study
時間枠：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
時間枠：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
時間枠：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
時間枠：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
|
Weeks 11-12
|
|
Completion rate of outcome measures
時間枠：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)
時間枠：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)
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Proportion of participants showing reliable improvement on the ReQoL-20 from baseline (weeks 0-1) to follow-up (weeks 11-12)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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
時間枠：Weeks 11-12
|
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
|
協力者と研究者
出版物と役立つリンク
一般刊行物
- Toudal, M., & Attwood, T. (2024). Energy accounting: Stress management and mental health monitoring for autism and related conditions. Jessica Kingsley Publishers.
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- DClinPsychol24KMann
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。