Trialling an optimised social groups intervention in services to enhance social connectedness and mental health in young people

ISRCTN	ISRCTN12505807
DOI	https://doi.org/10.1186/ISRCTN12505807
ClinicalTrials.gov (NCT)	Nil known
Clinical Trials Information System (CTIS)	Nil known
Integrated Research Application System (IRAS)	309287
Protocol serial number	IRAS 309287, CPMS 51865
Sponsor	University of Sussex
Funder	Applied Research Collaboration - Kent, Surrey & Sussex

Submission date: 08/04/2022
Registration date: 11/04/2022
Last edited: 16/08/2023

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:
We are testing an intervention called 'Groups 4 Health'. The intervention was designed by a team in Australia to support people to identify and develop connections with new people or social groups. Past research has found that the intervention can help people with their feelings of loneliness, their connections with other people, and their well-being. To understand if the intervention might be helpful for young people in the United Kingdom, it first needs to go through a small pilot research study.

This project will help us to learn:
1) What the experience of the intervention is like for young people currently experiencing mental health difficulties
2) What the intervention is like to deliver for members of staff delivering the intervention
3) Do our plans for this research study work?
4) This information will help us to learn whether we can run a larger study to test whether the intervention is helpful.

Who can participate?
This study is suitable for young people (aged 16-25 years) who are currently experiencing difficulties with their mental health and well-being.

What does the study involve?
Participants will meet with a researcher at three time points (baseline, 10 week and 14 week post-randomisation). Participants will also be randomised to receive the intervention alongside their usual treatment, or receive their usual treatment only. Participants randomised to receive the intervention, will receive the intervention by a trained practitioner from the community, health and/or youth mental health service they access.

What are the possible benefits and risks of participating?
This study will involve answering questions about mental health and social wellbeing. Some people in similar research studies have told us they find it interesting or helpful to answer such questions. However, some people can find it difficult or distressing. Some of the questions asked are of a potentially sensitive nature. For example, a small number of questions ask about low mood and suicidal thoughts.

We hope that those receiving the Groups 4 Health intervention will find it helpful. However, this cannot be guaranteed. By taking part in this study, participants will help us to learn about how helpful the intervention might be, and whether we should try and test this in a bigger project. Participants will also be helping us to learn how we can optimise the intervention.

Where is the study run from?
The University of Sussex

When is the study starting and how long is it expected to run for?
From April 2022 to September 2023

Who is funding the study?
The Applied Research Collaboration in Kent, Surrey and Sussex

Who is the main contact?
Claire Vella
c.vella@sussex.ac.uk

Contact information

Dr Clio Berry
Principal investigator

BSMS Teaching Building
University of Sussex
Brighton
East Sussex
BN1 9PX
Brighton
BN1 9PX
United Kingdom

ORCID ID	0000-0003-1164-9836
Phone	+44 (0)1273 641229
Email	c.berry@bsms.ac.uk

Miss Claire Vella
Public

Pevensey 1 Building
University of Sussex
Falmer
Brighton
BN1 9QH
United Kingdom

Phone	+44 (0)7920 086770
Email	c.vella@sussex.ac.uk

Miss Claire Vella
Scientific

Pevensey 1 Building
University of Sussex
Falmer
Brighton
BN1 9QH
United Kingdom

Phone	+44 (0)7920 086770
Email	c.vella@sussex.ac.uk

Study information

Primary study design	Interventional
Study design	Multicenter interventional blinded feasibility randomized controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Trialling an Optimised social Groups intervention in services to Enhance social connecTedness and mental Health in vulnERable young people (TOGETHER): a feasibility study
Study acronym	TOGETHER
Study objectives	1. Is it feasible to conduct a randomised controlled trial for the Groups 4 Health (G4H) intervention when delivered to young service-users accessing community, health and/or youth mental health services? 2. Is the G4H intervention feasible to deliver to young service-users involved in community, health and/or youth mental health services? 3. Is the G4H intervention safe and acceptable according to both the young service-users receiving the intervention, and the practitioners delivering the intervention? 4. What changes are indicated to improve the safety, acceptability, accessibility and feasibility of the intervention?
Ethics approval(s)	Approved 30/03/2022, Berkshire Research Ethics Committee (Temple Quay House, BS1 6PN; +44 (0)207 104 8178; berkshire.rec@hra.nhs.uk), ref: 22/SC/0040
Health condition(s) or problem(s) studied	Social connectedness and mental health in vulnerable young people
Intervention	5 session adapted Groups 4 Health (G4H) intervention, delivered by trained practitioners within an ~8 week time frame. Participants are randomised, stratified by site, to receive the intervention alongside treatment as usual, or receive treatment as usual only. Randomisation will be completed by a co-investigator statistician, who will not be involved in the research and intervention delivery, nor data analysis, using the Sealed Envelope online service. One of the trial study coordinators will be unblind during the trial. All other study team members will be blind to the randomisation procedure and allocation sequence.
Intervention type	Behavioural
Primary outcome measure(s)	Feasibility will be measured using the following: 1. Number of potential service-user participants referred each month throughout the recruitment period 2. Number of intervention providers from services involved in the trial aspect of the study who consent to take part each month throughout the recruitment period 3. Number and proportion of referred potential service-user participants who consent to take part in the study each month throughout the recruitment period 4. Number and proportion of referred potential service-user participants found to be eligible each month throughout the recruitment period 5. Number and proportion of consenting eligible participants who are retained in the study post-randomisation at 10 weeks and 14 weeks 6. Number and proportion of survey measures completed by each participant at baseline, 10 weeks, and 14 weeks 7. Number and proportion of consenting eligible service-user participants who take part in all five G4H sessions throughout the 8 week intervention period 8. Number and proportion of intervention adherence components completed for each session and across the whole G4H intervention throughout the 8 week intervention period 9. Number and nature of adverse events experienced by study participants each month throughout the 8 week intervention period 10. Number and proportion of breaks in blinding each month throughout the 14 week study period
Key secondary outcome measure(s)	There are no secondary outcome measures
Completion date	30/09/2023

Eligibility

Participant type(s)	Patient
Age group	Other
Lower age limit	16 Years
Upper age limit	25 Years
Sex	Not Specified
Target sample size at registration	30
Key inclusion criteria	1. Aged 16 – 25 years old 2. Accessing a community, health and/or youth mental health service involved in the study 3. Experiencing current mental health difficulties (operationalised by a rating of ≤60 on the Global Assessment Scale (GAS)) 4. Able to read, write and speak in English, or are non-English speaking but have access to an interpreter, to the degree they can give informed consent and are able to fully understand and participate in both the assessment questions and intervention content
Key exclusion criteria	1. At immediate and serious risk to self or others (assessed at the point of referral/eligibility review) 2. Currently participating, or be confirmed to participate in another interventional research study in which they are receiving an intervention that targets social isolation or utilises psychological therapy 3. Expected to be discharged, or be known to be unable to seek support from the referring service, in the 16 weeks following a referral to the trial being made (14 week research involvement + 2 weeks allowing for any missed/rearranged meetings)
Date of first enrolment	18/04/2022
Date of final enrolment	30/06/2023

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Sussex Partnership NHS Foundation Trust

Trust Hq
Swandean
Arundel Road
Worthing
BN13 3EP
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
IPD sharing plan	The datasets generated during and/or analysed during the current study are/will be available upon request from Claire Vella (c.vella@sussex.ac.uk). The type of data available will be anonymised quantitative and qualitative data, regarding intervention and research process feasibility, and trial outcome data. Participant consent was provided for data sharing for the purposes of research. There are no known other ethical nor legal restrictions. Data will become available from October 2023 for an indefinite period.

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Protocol article		15/08/2023	16/08/2023	Yes	No
HRA research summary			28/06/2023	No	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

16/08/2023: Publication reference added.
30/03/2023: The following changes were made to the trial record:
1. The recruitment end date was changed from 31/03/2023 to 30/06/2023.
2. The overall end date was changed from 30/06/2023 to 30/09/2023.
3. The plain English summary was updated to reflect these changes.
13/01/2023: The following changes have been made:
1. The recruitment end date has been changed from 31/01/2023 to 31/03/2023.
2. The overall trial end date has been changed from 31/05/2023 to 30/06/2023 and the plain English summary updated accordingly.
01/09/2022: The overall trial end date has been changed from 30/09/2022 to 31/05/2023 and the plain English summary has been updated accordingly.
08/04/2022: Trial’s existence confirmed by the HRA.