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Evaluating a Workbook to Promote Autistic Wellbeing

9 września 2026 zaktualizowane przez: Canterbury Christ Church University

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:

  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

Przegląd badań

Status

Rekrutacyjny

Warunki

Interwencja / Leczenie

Szczegółowy opis

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.

Typ studiów

Interwencyjne

Zapisy (Szacowany)

10

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Kopia zapasowa kontaktu do badania

Lokalizacje studiów

  • Zjednoczone Królestwo
      • Maidstone, Zjednoczone Królestwo, ME16 9PH
        • Rekrutacyjny
        • Kent and Medway Mental Health NHS Trust
        • Kontakt:

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dorosły
  • Starszy dorosły

Akceptuje zdrowych ochotników

Nie

Opis

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).

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie podtrzymujące
  • Przydział: Nie dotyczy
  • Model interwencyjny: Zadanie dla jednej grupy
  • Maskowanie: Brak (otwarta etykieta)

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: Guided self-help workbook for autistic adults
Within-subjects comparison
Behawioralne: Guided self-help workbook for autistic adults
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.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Number of participants recruited to the study
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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)

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Proportion of participants showing reliable improvement on the ReQoL-20 from baseline (weeks 0-1) to follow-up (weeks 11-12)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Canterbury Christ Church University

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Publikacje ogólne

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

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

1 września 2026

Zakończenie podstawowe (Szacowany)

1 marca 2027

Ukończenie studiów (Szacowany)

1 kwietnia 2027

Daty rejestracji na studia

Pierwszy przesłany

1 czerwca 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

1 czerwca 2026

Pierwszy wysłany (Rzeczywisty)

5 czerwca 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

11 września 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

9 września 2026

Ostatnia weryfikacja

1 września 2026

Więcej informacji

Terminy związane z tym badaniem

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • DClinPsychol24KMann

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIE

Opis planu IPD

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.

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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