Clinical trial NCT06656663: INcreasing Adolescent Social and Community SupporT - Pilot
Official title: INcreasing Adolescent Social and Community SupporT - Pilot
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Loneliness
Keywords: Social Prescribing
Loneliness
School
Pupils
Link Worker
Lead sponsor: University College, London
Sponsor class: OTHER
Collaborators: name: University of Manchester
First posted: 2024-10-24
Enrollment: 78
Sex: ALL
Minimum age (years): 9
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study utilises a two-group (intervention vs. active control) parallel randomised design, with YP as the unit of randomisation.
Primary purpose: TREATMENT

Brief summary: Background: Social prescribing is a mechanism of connecting patients with non-medical forms of support within the community and has been shown to improve loneliness. Yet uptake from young people has been lower than for adults. This is thought to be due to accessibility issues as young people are less likely to draw on primary care, where social prescribing in based, for wellbeing support. INACT will pilot a social prescribing pathway via schools to support young people who are lonely. It will test the feasibility and acceptability of delivering and evaluating it through a randomised controlled trial.

Methods: 78 pupils reporting loneliness will be recruited across 12 mainstream (6 primary and 6 secondary) schools in England and be randomly allocated to signposting or social prescribing. Pupils in the control group will receive signposting to sources of support from school staff. The co-produced social prescribing intervention includes up to 6 sessions with a Link Worker who will work with individuals to understand 'what matters to them' and connect them with local sources of support. Data will be collected at baseline, 3- and 6-months later. Acceptability and feasibility will be assessed via recruitment and retention, as well as via qualitative interviews. Interviews will also explore barriers, facilitators and mechanisms of change. Potential primary and secondary outcomes for a future trial will be completed to assess response and completeness, including measures of loneliness, mental health and wellbeing.

Discussion: INACT will provide preliminary evidence of the feasibility and acceptability of both the research design and social prescribing intervention. Results will inform a potential future randomised trial.


Eligibility criteria: Inclusion Criteria:

* Children and young people in a participating school and in Years 4, 5 or 7, 8
* Parental consent and young person assent is provided
* A score of 6 or above on the Good Childhood Index loneliness questions

Exclusion Criteria:

* Private schools
* Children and young people with severe learning disabilities

Primary outcomes:
measure: Loneliness
timeFrame: 3 Months
measure: Intervention Feasibility (School Staff and Link Workers)
timeFrame: 6 months
measure: Intervention Acceptability (School Staff and Link Workers)
timeFrame: 6 months
measure: Intervention Appropriateness (School Staff and Link Workers)
timeFrame: 6 months
Secondary outcomes:
measure: Peer loneliness
timeFrame: 3 and 6 months
measure: Wellbeing
timeFrame: 3 and 6 months
measure: Mental health (emotional difficulties)
timeFrame: 3 and 6 months
measure: Service Use
timeFrame: 3 and 6 months
measure: Stress
timeFrame: 3 and 6 months
measure: Loneliness
timeFrame: 6 Months
Other outcomes:
measure: Family Support
timeFrame: Baseline only
measure: School Support
timeFrame: Baseline only
measure: Social support
timeFrame: 3 and 6 months
measure: Local Environment
timeFrame: 3 and 6 months
measure: Activity Engagement
timeFrame: 3 and 6 months
measure: Bullying
timeFrame: 3 and 6 months
measure: Bullying
timeFrame: 3 and 6 months
measure: Social structure and quality
timeFrame: 3 and 6 months
measure: Problem Solving
timeFrame: 3 and 6 months
measure: Flow
timeFrame: 3 and 6 months
measure: Therapeutic Alliance
timeFrame: 3 and 6 months
Locations:
city: Greater London
country: United Kingdom
facility: University College London
Study officials:
References: