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Active, Not Recruiting

NCT Number: NCT06656663

INcreasing Adolescent Social and Community SupporT - Pilot

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Loneliness

Age range

9 year–13 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University College London

Greater London, WC1E 7HB, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Social Prescribing

Behavioral

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.

Signposting

Behavioral

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.

Primary outcomes

  1. 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.

  2. 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

  3. 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

  4. 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

Secondary outcomes

  1. 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

  2. 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. 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

  4. 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.

  5. 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

  6. 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.

Other outcomes

  1. 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.

  2. 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.

  3. 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

  4. 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

  5. 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.

  6. 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

  7. 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.

  8. 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.

  9. 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

  10. 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

  11. 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

Sponsors and collaborators

Lead sponsor

University College, London

Other

Collaborators

  • University of Manchester

Registry information

Acronym: INACT

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Oct 24, 2024
Registry last updated
Dec 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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