NCT06656663

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
78

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 18, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 24, 2024

Completed
19 days until next milestone

Study Start

First participant enrolled

November 12, 2024

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2025

Completed
Last Updated

December 6, 2024

Status Verified

December 1, 2024

Enrollment Period

8 months

First QC Date

October 18, 2024

Last Update Submit

December 3, 2024

Conditions

Keywords

Social PrescribingLonelinessSchoolPupilsLink Worker

Outcome Measures

Primary Outcomes (4)

  • Loneliness

    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)

    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)

    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)

    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 Outcomes (6)

  • Peer loneliness

    3 and 6 months

  • Wellbeing

    3 and 6 months

  • Mental health (emotional difficulties)

    3 and 6 months

  • Service Use

    3 and 6 months

  • Stress

    3 and 6 months

  • +1 more secondary outcomes

Other Outcomes (11)

  • Family Support

    Baseline only

  • School Support

    Baseline only

  • Social support

    3 and 6 months

  • +8 more other outcomes

Study Arms (2)

Social Prescribing

EXPERIMENTAL

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.

Behavioral: Social Prescribing

Signposting

ACTIVE COMPARATOR

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.

Behavioral: Signposting

Interventions

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.

Social Prescribing
SignpostingBEHAVIORAL

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.

Signposting

Eligibility Criteria

Age9 Years - 13 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University College London

Greater London, WC1E 7HB, United Kingdom

Location

Related Publications (1)

  • Hayes D, Burton A, Bu F, Humphrey N, Qualter P, Han E, Sticpewich L, Wright J, Bone JK, Maguire S, Gonzalez Umpierrez LC, Stapley E, Tibber MS, Fancourt D. INcreasing Adolescent social and Community supporT (INACT): Pilot study protocol. PLoS One. 2025 Mar 26;20(3):e0317823. doi: 10.1371/journal.pone.0317823. eCollection 2025.

Related Links

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: This study utilises a two-group (intervention vs. active control) parallel randomised design, with YP as the unit of randomisation.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 18, 2024

First Posted

October 24, 2024

Study Start

November 12, 2024

Primary Completion

July 1, 2025

Study Completion

August 31, 2025

Last Updated

December 6, 2024

Record last verified: 2024-12

Locations