- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06656663
INcreasing Adolescent Social and Community SupporT - Pilot (INACT)
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
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Greater London, United Kingdom, WC1E 7HB
- University College London
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
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
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.
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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.
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3 Months
|
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Intervention Feasibility (School Staff and Link Workers)
Time Frame: 6 months
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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
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6 months
|
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Intervention Acceptability (School Staff and Link Workers)
Time Frame: 6 months
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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
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6 months
|
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Intervention Appropriateness (School Staff and Link Workers)
Time Frame: 6 months
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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
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3 and 6 months
|
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Wellbeing
Time Frame: 3 and 6 months
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Kidscreen-52 is assessed using 6 questions each on a five-point Likert scale (scoring between 6-30).
Higher scores indicate greater well-being.
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3 and 6 months
|
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Mental health (emotional difficulties)
Time Frame: 3 and 6 months
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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
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3 and 6 months
|
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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.
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Baseline only
|
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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
|
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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
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3 and 6 months
|
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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
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3 and 6 months
|
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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.
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3 and 6 months
|
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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
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3 and 6 months
|
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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.
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3 and 6 months
|
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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.
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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
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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
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3 and 6 months
|
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Therapeutic Alliance
Time Frame: 3 and 6 months
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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
Sponsor
Collaborators
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 6735/017
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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