INcreasing Adolescent Social and Community SupporT - Full Trial
- Conditions
- Loneliness
- Registration Number
- NCT07154225
- Lead Sponsor
- University College, London
- 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 update 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 is based, for wellbeing support. The INACT pilot sought to test the feasibility and acceptability of a Social Prescribing pathway via schools to support young people who are lonely through a randomised controlled trial. Findings suggested that study procedures, including the measures were appropriate and that Social Prescribing was deemed by young people, social prescribers and school staff as feasible, acceptable and suitable and there was evidence of impact in the social prescribing arm when compared to signposting. Given the positive pilot findings, the aim of the INACT full trial is to build upon the pilot work and conduct a clinical and cost effectiveness trial into the impact of Social Prescribing in schools for loneliness and low community connection, compared to signposting.
Methods: A minimum of 215 pupils reporting loneliness will be recruited across 30 mainstream 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. The clinical and cost effectiveness of Social Prescribing for young people with loneliness will be assessed using measures of loneliness, mental health, wellbeing, quality of life, and service use. Data will be collected at baseline and 3, 6, and 12 months later. Qualitative interviews will also be conducted to explore barriers, facilitators, mechanisms of change and impact.
Discussion: INACT will provide evidence of the clinical and cost effectiveness of Social Prescribing in schools for supporting young people experiencing loneliness. It will also establish what types of community and social activities young people engage in and what factors affect participation.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 215
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Loneliness Baseline, 3, 6 and 12 months Measured using the Good Childhood Index containing 3 questions on a 3-point Likert scale (scoring between 3-9). Higher scores indicate higher reported loneliness. Baseline, 3, 6 and 12 months
- Secondary Outcome Measures
Name Time Method Wellbeing Baseline, 3, 6 and 12 months Measures using the Wellbeing subscale (Kidscreenn-52) which contains 6 questions each on a five-point Likert scale (scoring between 6-30). Higher scores indicate greater well-being.
Mental health (emotional difficulties) Baseline, 3, 6 and 12 months Measured using the Emotional difficulties subscale (Me and My feelings questionnaire) which contains 10 questions on a 3-point Likert scale (scoring between 0-20). Higher scores indicate higher emotional difficulties.
Service use Baseline, 3, 6 and 12 months Measures using the Client Service Receipt of Inventory which contains 11 questions on a five-point Likert scale. Scoring can be looked at by individual items (i.e. score between 1-5) or by scoring all items (i.e. scores between 11-55). Higher scores indicate more contact with a service/services.
Quality of Life Baseline, 3, 6 and 12 months Measured using the CHU-9D which contains 9 questions on a five-point Likert scale (scoring between 1-5). Higher scores indicate higher quality of life.
Stress Baseline, 3, 6 and 12 months Measured using the Perceived Stress Scale 4 which assesses stress using 4 questions on a five-point Likert scale (scoring between 0-16). Higher scores indicate higher levels of perceived stress (secondary school pupils only)
Emotion Regulation Baseline, 3, 6 and 12 months Emotion Regulation Index for Children and Adolescents is assessed using 16 items on a five-point Likert scale (scoring between 1-5). Higher scores indicate greater emotion regulation.
Intervention Acceptability 3, 6, and 12 months Measured using a single item adapted from the NHS Friends and Family Test on a five-point Likert scale . Higher scores indicate higher acceptability. Social prescribing arm only.
Intervention Feasibility (School Staff and Link Workers), Approx 3 months after intervention delivery has begun Measured using the Feasibility of Intervention Measure (FIM) which contains 4 questions each on a five-point Likert scale (scoring between 4-20). Higher scores indicate higher intervention feasibility.
Intervention Acceptability (School Staff and Link Workers) Approx 3 months after intervention delivery has begun Measured using the Acceptability of Intervention Measure (AIM) which contains 4 questions each on a five-point Likert scale (scoring between 4-20). Higher scores indicate higher intervention acceptability.
Intervention Appropriateness (School Staff and Link Workers) Approx 3 months after intervention delivery has begun Measured using the Intervention Appropriateness Measure (IAM) which contains 4 questions each on a five-point Likert scale (scoring between 4-20). Higher scores indicate higher intervention appropriateness. 3 months