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Co-design and feasibility trial of well-being groups for autistic 11-16 year olds

Feasibility trial of autism social identity groups for psychological well-being in autistic adolescents

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN18332093
Enrollment
70
Registered
2025-12-11
Start date
2026-01-05
Completion date
Unknown
Last updated
2026-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Autism Mental and Behavioural Disorders

Interventions

A feasibility design has been selected because this will be the first trial of its kind, testing a new co-designed intervention in autistic young people. The study will assess the feasibility and acc
educational settings
autism research databases
social media (e.g., TikTok
Facebook parent groups
Instagram
X). We aim to recruit 70 participants (with a maximum sample size of 84) to be recruited and randomised to a-island and usual practice. A sample size of 70, with 80% follow-up rates, is deemed suffic
social media
charities

Sponsors

University College London
Lead Sponsor

Eligibility

Sex/Gender
All
Age
11 Years to 16 Years

Inclusion criteria

Inclusion criteria: 1. Young people aged 11-16 years 2. A professional diagnosis of Autism Spectrum Disorder (ASD) 3. Residing in England or Wales 4. Willing and able to attend group sessions during the available dates and times

Exclusion criteria

Exclusion criteria: 1. Participants who report that they have received 3 or more sessions of autism post-diagnostic support or psychoeducation from a health professional over the past 12 months will be excluded from the study 2. Risk of harm to self (suicidal intent and persistent serious self-harm) that would mean that a group well-being intervention is not appropriate. In terms of risk to self, the RCADS-25 will be administered to all potential participants. If the participant endorses (i.e. selects “sometimes, “often” or “always”) for items 18 (I think about death) and item 25 (I worry that something bad will happen to me), then follow-up will be conducted by the research assistant and qualified clinician where necessary, following the risk standardised operating procedure (SOP). Where clinic assessment or research follow-up is indicative that there is current suicidal intent, and/or self-harm which is serious and persistent, this will be communicated to the relevant health care professional (e.g., GP) and the participant will be excluded from the study. 3. Current mental health intervention such that this level of intervention is not clinically appropriate. During the expression of interest, potential participants will be asked if they are currently accessing mental health support. In such cases, permission to contact their mental health clinician will be sought to ensure that attending a group will not interfere with other ongoing interventions, and to ensure that the a-island groups would be a clinically appropriate intervention at the current time. If clinical discussion indicates that the well-being intervention is not clinically appropriate, the participant will be excluded from the study. 4. Risk of harm to others such that group participation would not be appropriate. This will be assessed by asking a series of questions about the individual’s school exclusion and forensic history (following the Risk SOP). If clinical or research follow-up identifies past behaviour towards others which has been directly related to an exclusion from a group environment or conviction/warning from the criminal justice system, the participant will be excluded from the study. In cases where the participant indicates that their GP or another relevant authority is not aware of this history, this will be communicated to the GP. 5. English, non-English & Welsh literacy levels such that the intervention materials are inaccessible without reasonable adjustments and a supporting person is not available. This will be established by information provided during the eligibility assessment when it is difficult to gain consent to participate in the research because of difficulties reading and thus comprehending the study information sheet. We will strive to include all potential participants in the study if supporters are available to help an individual access the treatment where written/spoken English, non-English & Welsh presents a barrier.

Design outcomes

Secondary

MeasureTime frame
The 10-, 16- and 24- week completion rates and outcome measure variances of: 1. Identification with the autistic community measured using the Autism Social Identification Measure 2. Quality of life measured using EQ-5D-Y-5L 3. Mental health measured using the Revised Children's Anxiety and Depression Scale (RCADS) (self and parent report) 4. Social anxiety and fear of negative evaluation measured using the Social Anxiety Scale for Adolescents 5. Self-esteem measured using the Rosenberg Self-Esteem Scale (RSES) 6. Loneliness measured using the UCLA Loneliness Scale 7. Resource use measured using the Adapted Client Service Receipt Inventory (CSRI) (completed by parents) 8. Carer impact measured using the Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS) and the Autism Parenting Stress Index (APSI)

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026