INcreasing Adolescent Social and Community SupporT - Pilot (INACT)

December 3, 2024 updated by: University College, London

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.

Study Overview

Status

Active, not recruiting

Conditions

Study Type

Interventional

Enrollment (Estimated)

78

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Greater London, United Kingdom, WC1E 7HB
        • University College London

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Signposting
Those in the control group will receive signposting to activities and local sources of support in their communities. This will consist of school pastoral staff meeting with YP identified as lonely and providing them with a leaflet detailing the same local sources of support identified by the LW from asset mapping.
Those in the control group will receive signposting to activities and local sources of support in their communities. This will consist of school pastoral staff meeting with YP identified as lonely and providing them with a leaflet detailing the same local sources of support identified by the LW from asset mapping.
Experimental: Social Prescribing
SP is a person-centred approach to wellbeing involving the co-development of a non-clinical prescription, between an individual (i.e. young person) and Link Workers (LWs), based on the perceived difficulties for the referral and the YPs values, needs and preferences. LWs have a good knowledge of their local areas, via community asset mapping and networking, allowing them to connect individuals with different types of available support and activities. Typically, SP ranges from 6-12 sessions (average 8 sessions: unpublished data from sites) with a LW over an 8-week period. Sessions may take place online, via phone call, or in person. As part of this process, LWs draw on psychological skills such as motivational interviewing and behavioural activation as well as employ problem solving and goal setting. Following the identification of issues and preferences, the LW will discuss with the YP what the available local activities and support structures are that best match their preferences.
SP is a person-centred approach to wellbeing involving the co-development of a non-clinical prescription, between an individual (i.e. young person) and LW, based on the perceived difficulties for the referral and the YPs values, needs and preferences. LWs have an excellent knowledge of their local areas, via community asset mapping and networking, allowing them to connect individuals with different types of available support and activities. Typically, SP ranges from 6-12 sessions (average 8 sessions: unpublished data from sites) with a LW over an 8-week period. Sessions may take place online, via phone call, or in person. As part of this process, LWs draw on psychological skills such as motivational interviewing and behavioural activation as well as employ problem solving and goal setting. Following the identification of issues and preferences, the LW will discuss with the YP what the available local activities and support structures are that best match their preferences.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Loneliness
Time Frame: 3 Months
Good Childhood Index is assessed using 3 questions on a 3-point Likert scale (scoring between 3-9). Higher scores indicate higher reported loneliness.
3 Months
Intervention Feasibility (School Staff and Link Workers)
Time Frame: 6 months
Feasibility of Intervention Measure (FIM) is assessed using 4 questions each on a five-point Likert scale (scoring between 4-20). Higher scores indicate higher intervention feasibility
6 months
Intervention Acceptability (School Staff and Link Workers)
Time Frame: 6 months
Acceptability of Intervention Measure (AIM) is assessed using 4 questions each on a five-point Likert scale (scoring between 4-20). Higher scores indicate higher intervention acceptability
6 months
Intervention Appropriateness (School Staff and Link Workers)
Time Frame: 6 months
Intervention Appropriateness Measure (IAM) is assessed using 4 questions each on a five-point Likert scale (scoring between 4-20). Higher scores indicate higher intervention appropriateness
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Peer loneliness
Time Frame: 3 and 6 months
LACA - Peer Subscale is assessed using 12 questions each on a four-point Likert scale (scoring between 12-48). Higher scores indicate higher peer loneliness
3 and 6 months
Wellbeing
Time Frame: 3 and 6 months
Kidscreen-52 is assessed using 6 questions each on a five-point Likert scale (scoring between 6-30). Higher scores indicate greater well-being.
3 and 6 months
Mental health (emotional difficulties)
Time Frame: 3 and 6 months
Me and My feelings is assessed using 10 questions on a 3-point Likert scale (scoring between 0-20). Higher scores indicate higher emotional difficulties
3 and 6 months
Service Use
Time Frame: 3 and 6 months
Client Service Receipt of Inventory is assessed using 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.
3 and 6 months
Stress
Time Frame: 3 and 6 months
Perceived Stress Scale 4 is assessed using 4 questions on a five-point Likert scale (scoring between 0-16). Higher scores indicate higher levels of perceived stress
3 and 6 months
Loneliness
Time Frame: 6 Months
Good Childhood Index is assessed using 3 questions on a three-point Likert scale (scoring between 3-9). Higher scores indicate higher reported loneliness.
6 Months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Family Support
Time Frame: Baseline only
Moderator using questions from the Student Resilience Survey which is assessed using 4 questions each on a five-point likert scale (scoring between 4-20). Higher scores indicate higher family support.
Baseline only
School Support
Time Frame: Baseline only
Moderator using questions from the Student Resilience Survey which is assessed using 4 questions each on a five-point Likert scale (scoring between 4-20). Higher scores indicate higher school support.
Baseline only
Social support
Time Frame: 3 and 6 months
Moderator using CYRM-R which is assessed using 4 questions each on a five-point Likert scale (scoring between 4-20). Higher scores indicate higher social support
3 and 6 months
Local Environment
Time Frame: 3 and 6 months
Moderator using questions from the HBSC 2022 assessed using 4 questions each on a five-point Likert scale (scoring between 4-20). Higher scores indicate a more positive view of ones local environment
3 and 6 months
Activity Engagement
Time Frame: 3 and 6 months
Moderator using questions from the BeeWell survey which is assessed using 11 questions each on a six-point Likert scale (scoring between 11-66). Higher scores indicate higher daily engagement with more activities. Each item can also be scored individually and indicates more frequent engagement with that activity.
3 and 6 months
Bullying
Time Frame: 3 and 6 months
Moderator using kidscreen-52 (primary school pupils) which is assessed using 3 questions each on a five-point Likert scale (scoring between 3-15). Higher scores indicate higher levels of bullying
3 and 6 months
Bullying
Time Frame: 3 and 6 months
Moderator using the BeeWell survey (secondary school pupils) which is assessed using 3 questions each on a four-point Likert scale (scoring between 0-9). Higher scores indicate higher levels of bullying.
3 and 6 months
Social structure and quality
Time Frame: 3 and 6 months
Moderator using questions adapted from PISA 2022 and MCS4 which is assessed using five questions. One of which requires an open-ended numerical value and four questions which are rated on a five-point Likert scale (scoring between 0-16). Higher scores indicate a greater social structure and friendship quality.
3 and 6 months
Problem Solving
Time Frame: 3 and 6 months
Mechanism using the Student Resilience Survey which is assessed using 3 questions each on a five-point Likert scale (scoring between 3-15). Higher scores indicate higher problem solving with others
3 and 6 months
Flow
Time Frame: 3 and 6 months
Mechanism using the General Flow Proneness Scale (secondary school pupils only) which is assessed using 13 questions each on a five-point Likert scale (scoring between 13-65). Higher scores indicate higher flow experience
3 and 6 months
Therapeutic Alliance
Time Frame: 3 and 6 months
Mechanism using the Session Feedback Questionnaire which is assessed using 4 questions each on a five-point Likert scale (scoring between 4-20). Higher scores indicate higher therapeutic alliance. This is for individuals in the social prescribing intervention only
3 and 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 12, 2024

Primary Completion (Estimated)

July 1, 2025

Study Completion (Estimated)

August 31, 2025

Study Registration Dates

First Submitted

October 18, 2024

First Submitted That Met QC Criteria

October 22, 2024

First Posted (Actual)

October 24, 2024

Study Record Updates

Last Update Posted (Estimated)

December 6, 2024

Last Update Submitted That Met QC Criteria

December 3, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • 6735/017

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Some IPD data will be shared but we specific data is being currently discussed with the funder. We will update this record when we know more.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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