Table 1

Trial registration information

Primary registry ID numberISRCTN10513626
Date of registration 5 October 2023
Funder National Institute for Health Research—Research for Social Care and Autistica (NIHR204276)
Sponsor University of Bath (UniBath)
Contact for all enquiries atag@bath.ac.uk
Protocol version number V1.4
Public title Autism Transition to Adulthood Group
Scientific title Peer-group intervention to promote successful transition to adulthood for
autistic people: A feasibility randomised controlled trial (RCT) of the Autism Transition to Adulthood Group (ATAG)
Countries of recruitment England and Wales
Interventions

  1. Understanding You, Discovering You (UYDY) groups

  2. Care as usual (CAU)

Inclusion criteria

  • Age between 16 and 25 years.

  • A clinical diagnosis of autism spectrum disorder (ASD)

Exclusion criteria

  • Risk of suicide

  • Risk of harm to others

  • Have attended autism psychoeducation or post-diagnostic support with a professional over the past 12 months

  • English, non-English and Welsh literacy levels such that the intervention materials are inaccessible without reasonable adjustments and a supporting person is not available

Trial design Feasibility randomised controlled trial with two arms, UYDY and CAU
Date of first enrolment December 2023
Sample size 70
Recruitment status Recruiting
Objectives Outcome measures
Assess the rates of recruitment and retention to inform the design of a full-scale RCT

  1. Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS)

  2. Autism social identification measure

  3. Health related quality of life (EQ-5D-5L)

  4. Interpersonal Support Evaluation List—short

  5. UCLA loneliness scale - short

  6. Use of services questionnaire based on the Client Service Receipt Inventory

  7. Carer measures: WEMWBS and Adult Social Care Outcomes (ASCOT-carer)

Assess the acceptability of randomisation and outcome measurement procedures to participants
Characterise CAU
Assess the acceptability of the A-TAG intervention and CAU
Calculate outcome measure variances for use in a power calculation for a full trial
Ethics review Ethical approval for the study granted by the Health Research Authority and Wales REC 5 (Reference: 23/WA/0113)
Study duration

  • Funding start date: 01 September 2023

  • Anticipated duration: 22 months (total; subject to change)

  • Anticipated end date: 30 June 2025 (subject to change)

IDP sharing statement Participants 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.