ISRCTN ISRCTN10513626
DOI https://doi.org/10.1186/ISRCTN10513626
IRAS number 321840
Secondary identifying numbers CPMS 55812, NIHR204276, IRAS 321840
Submission date
04/10/2023
Registration date
05/10/2023
Last edited
24/06/2025
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Background and study aims
Our project will improve understanding of how social care professionals can enhance the life chances of autistic people without intellectual disability. We will conduct a feasibility study to learn if it is realistic and possible to conduct a research project testing a new intervention. This group intervention will support autistic people in a successful transition to adulthood.

Over the next 10 years, in the UK ~175,000 autistic people will engage in transition to adulthood. This is a challenging time, as they face the demands of adult life while support decreases.

This research aims to understand how possible it is to find 70 people who agree to take part, and if they are willing to continue taking part in the study. It will tell us if it is possible to do a bigger study to see if the intervention is effective.

Who can participate?
We will recruit 70 autistic people aged 16-25 years old to take part in the study.

What does the study involve?
Participants will be randomly allocated to receive usual care, or the new group intervention. Thirty-five people will receive the new intervention.

The intervention is being developed by young autistic adults and autism professionals. It involves six online group sessions, facilitated by an autistic young adult and two social care professionals. It will cover different topics including understanding the autism label, identifying your needs and understanding your rights, and where to get help. Carers, nominated by each participant, will also be offered online resources to learn about these topics.

Participants will complete questionnaires measuring well-being, interpersonal support, autism social identity, loneliness, and quality of life before the intervention starts, and after 3- and 12- months. We will also invite participants to be interviewed to find out their views on the intervention and taking part in the study.

Autistic people are involved in the research project. The intervention and research has been designed in collaboration with a group of autistic people.

What are the possible benefits and risks of participating?
Participants may find that taking part improves their well-being, but there is no guarantee of this. They may also benefit from the extra contact that comes with being part of the study. Even if there is no direct benefit from taking part in this study, participants will help to improve future support for autistic young people.

In terms of risks, participants may find it tiring to complete the questionnaires. We will try to ensure participants are comfortable and can take one or more breaks as needed. Participants might find that some of the topics covered are distressing, for example talking about challenges. We will help participants to get further support if needed.

Where is the study run from?
University of Bath (UK)

When is the study starting and how long is it expected to run for?
January 2023 to June 2025

Who is funding the study?
National Institute for Health and Care Research (NIHR) (UK).

Who is the main contact?
Kate Cooper, k.r.cooper@ucl.ac.uk

Study website

Contact information

Dr Kate Cooper
Scientific, Principal Investigator

Department of Clinical, Educational and Health Psychology
UCL
1-19 Torrington Place
London
WC1E 6BT
United Kingdom

ORCiD logoORCID ID 0000-0002-8216-5567
Email k.r.cooper@ucl.ac.uk
Ms Annabel Burnley
Public, Scientific

University of Bath
Bath
BA2 7AY
United Kingdom

Email ab3535@bath.ac.uk
Prof Will Mandy
Scientific, Principal Investigator

UCL
1-19 Torrington Place
London
WC1E 6BT
United Kingdom

Phone +44 20 7679 1897
Email w.mandy@ucl.ac.uk

Study information

Study designInterventional randomized controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Internet/virtual
Study typeQuality of life
Participant information sheet Not available in web format, please use the contact details to request a patient information sheet
Scientific titlePeer-group intervention to promote successful transition to adulthood for autistic people: A feasibility RCT of Autism Transition to Adulthood Groups (ATAG)
Study acronymATAG
Study objectivesThis research is a feasibility study to learn if it is realistic and possible to conduct a research project testing a new intervention. This group intervention will support autistic people in a successful transition to adulthood. It will tell us if it is possible to do a bigger study to see if the intervention is effective.
Ethics approval(s)

Approved 15/05/2023, HRA and Health and Care Research Wales (HCRW) (Castlebridge 4 15-19 Cowbridge Road East, Cardiff, CF11 9AB, United Kingdom; +44 (0)2920 230457; approvals@hra.nhs.uk), ref: 23/WA/0113

Health condition(s) or problem(s) studiedAutism spectrum conditions
InterventionParticipants will be randomised across two interventions: (1) Autism Transition to Adulthood Group (ATAG), or (2) Care as usual (CAU).

The ATAG intervention involves six online peer-group sessions in groups of 8-10 autistic young people with social care and autistic facilitators.

The CAU intervention involves receiving the standard care for autistic young people in each participant’s region.

The randomisation sequence will be generated by Sealed Envelope TM. Randomisation will be stratified by age (16-17 or 18-25). Participants will be randomised to one of two treatment groups on a 1:1 ratio, that is either ATAG (intervention arm) or CAU (control arm).
Intervention typeBehavioural
Primary outcome measureParticipant impact will be measured using the Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS) at baseline, 8, 16 and 24 weeks
Secondary outcome measures1. Affiliation with the autistic community will be measured through the Autism Social Identification Scale at 8, 16 and 24 weeks
2. Quality of life will be measured using the EQ-5D-5L at 8, 16 and 24 weeks
3. Interpersonal support will be measured using the Interpersonal Support Evaluation List – Short Scale at baseline, 8, 16 and 24 weeks
4. Loneliness will be measured using the UCLA Loneliness Scale at baseline, 8, 16 and 24 weeks
5. Resource Use will be measured using the Adapted Client Service Receipt Inventory at baseline, 8, 16 and 24 weeks
6. Carer Impact will be measured using the Social-care-related quality of life (ASCOT-CARER) and Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS) at baseline, 8, 16 and 24 weeks
Overall study start date01/01/2023
Completion date30/06/2025

Eligibility

Participant type(s)Service user
Age groupAdult
Lower age limit16 Years
Upper age limit25 Years
SexBoth
Target number of participantsPlanned Sample Size: 70; UK Sample Size: 70
Total final enrolment70
Key inclusion criteria1. Age between 16 - 25 years
2. A clinical diagnosis of Autism Spectrum Disorder (ASD)
Key exclusion criteriaCurrent exclusion criteria as of 10/06/2024:
1. Risk of suicide
2. Risk of harm to others
3. Have attended autism psychoeducation or post-diagnostic support from a professional over the past 12 months
4. English, non-English & Welsh literacy levels such that the intervention materials are inaccessible without reasonable adjustments and a supporting person is not available

Previous exclusion criteria:
1. Risk of suicide
2. Risk of harm to others
3. Have attended >6 sessions of autism psychoeducation or post-diagnostic support over the past 6 months
4. English, non-English & Welsh literacy levels such that the intervention materials are inaccessible without reasonable adjustments and a supporting person is not available
Date of first enrolment01/07/2023
Date of final enrolment10/06/2024

Locations

Countries of recruitment

  • United Kingdom

Study participating centres

University of Bath
Claverton Down
Bath
BA2 7AY
United Kingdom
Tavistock and Portman NHS Foundation Trust
The Tavistock Centre
120 Belsize Lane
London
NW3 5BA
United Kingdom

Sponsor information

University of Bath
University/education

Claverton Down
Bath
BA2 7AY
England
United Kingdom

Phone +44 (0) 1225 383167
Email pro-vc-research@bath.ac.uk
Website http://www.bath.ac.uk/
ROR logo "ROR" https://ror.org/002h8g185

Funders

Funder type

Government

NIHR Central Commissioning Facility (CCF)

No information available

Results and Publications

Intention to publish date30/06/2026
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryAvailable on request
Publication and dissemination planPlanned publication in a high-impact peer-reviewed journal
IPD sharing planParticipants are asked whether they consent to their anonymised data being shared with other researchers who have received appropriate ethical approval for their research. This will be made available to other eligible researchers on request.

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Protocol article 19/11/2024 02/12/2024 Yes No

Editorial Notes

24/06/2025: Total final enrolment added.
02/12/2024: Publication reference added.
18/09/2024: The participant level data sharing statement was added.
28/06/2024: The following changes were made:
1. Ethics approval information added.
2. Study website added.
3. The recruitment end date was changed from 31/07/2024 to 10/06/2024.
10/06/2024: The following changes were made to the study record:
1. Contact details updated.
2. The overall study start date was changed from 01/06/2023 to 01/01/2023.
3. The overall study end date was changed from 31/03/2025 to 30/06/2025.
4. The exclusion criteria were updated.
04/10/2023: Trial's existence confirmed by the National Institute for Health and Care Research (NIHR) (UK).