Trialling an optimised social groups intervention in services to enhance social connectedness and mental health in vulnerable young people (TOGETHER): Study protocol for a feasibility randomised controlled trial

PLoS One. 2023 Aug 15;18(8):e0288676. doi: 10.1371/journal.pone.0288676. eCollection 2023.

Abstract

Background: Calls have been made to rethink the mental health support currently available for young people. This study aims to help re-focus and reduce the inaccessibility of mental health services by offering an adapted version of a theoretically-driven, evidence-based, guided psychosocial intervention known as 'Groups 4 Health' (G4H). To date, the G4H intervention has mainly been trialled in Australia, with promising positive effects on social connection, mental health and well-being. The present study examines the feasibility of running a randomised controlled trial when delivering the G4H intervention for young people in the UK.

Methods: The TOGETHER study is a feasibility randomised controlled trial of an adapted version of the G4H intervention. Participants are aged 16-25, currently experiencing mental health difficulties and recruited from mental health services. The target sample size is 30, with 15 in each trial arm. Participants are randomly allocated to either G4H plus treatment as usual, or treatment as usual alone. The primary outcomes of interest are the feasibility of recruitment, randomisation, data collection and retention to the study at 10 and 14 week follow up, as well as the acceptability, and accessibility of the study protocol and G4H intervention.

Discussion: The results of this study will indicate if further optimisation is required to improve the feasibility, acceptability and accessibility of the intervention and study protocol procedures as perceived by end users and practitioners. This offers a significant opportunity to support the local and national demand for accessible, innovative, and effective psychosocial youth mental health support.

Trial registration: ISRCTN registry (ISRCTN12505807). Registration date: 11/04/2022.

Publication types

  • Clinical Trial Protocol
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adolescent
  • Feasibility Studies
  • Humans
  • Mental Health*
  • Psychosocial Support Systems
  • Randomized Controlled Trials as Topic
  • Social Group*
  • Social Work

Associated data

  • ISRCTN/ISRCTN12505807

Grants and funding

This research was funded by the National Institute for Health and Care Research (NIHR) Applied Research Collaboration Kent, Surrey, Sussex. CV was awarded the funding as a part of an NIHR ARC KSS PhD Scholarship. The views expressed are those of the authors and not necessarily those of the NHS, the NIHR or the Department of Health and Social Care. The funders did not and will not have a role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.