NCT07154225

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.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
215

participants targeted

Target at P75+ for not_applicable

Timeline
14mo left

Started Sep 2025

Typical duration 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

Study Progress38%
Sep 2025Jun 2027

First Submitted

Initial submission to the registry

August 26, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 4, 2025

Completed
11 days until next milestone

Study Start

First participant enrolled

September 15, 2025

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2027

Expected
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2027

Last Updated

May 12, 2026

Status Verified

May 1, 2026

Enrollment Period

1.4 years

First QC Date

August 26, 2025

Last Update Submit

May 7, 2026

Conditions

Keywords

LonelinessSocial PrescribingSchoolsPupils

Outcome Measures

Primary Outcomes (1)

  • Loneliness

    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

    Baseline, 3, 6 and 12 months

Secondary Outcomes (10)

  • Wellbeing

    Baseline, 3, 6 and 12 months

  • Mental health (emotional difficulties)

    Baseline, 3, 6 and 12 months

  • Service use

    Baseline, 3, 6 and 12 months

  • Quality of Life

    Baseline, 3, 6 and 12 months

  • Stress

    Baseline, 3, 6 and 12 months

  • +5 more secondary outcomes

Other Outcomes (11)

  • Family Support

    Baseline, 3, 6 and 12 months

  • School Support

    Baseline, 3, 6 and 12 months

  • Problem Solving

    Baseline, 3, 6 and 12 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 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.

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 - 14 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Schools:
  • A primary or secondary school willing to participate in INACT
  • In England
  • Have classes of pupils in eligible year groups to participate (Years 5, 7, 8)
  • Pupils and their parents/guardians:
  • Score 7 or above on the Good Childhood Index (indicating high loneliness)
  • Parents/guardians consent, and pupils assent, to get support

You may not qualify if:

  • Schools:
  • Private schools or sixth form/colleges
  • Specialist schools
  • Schools only offering alterative provision
  • Outside of England
  • Does not have classes of pupils in eligible year groups to participate (Years 4, 5, 7, 8)
  • Pupils and their parents/guardians:
  • Score below 7 on the Good Childhood Index (indicating low loneliness)
  • Parents/guardians do not consent, or pupils do not assent, to get support
  • Children and young people with severe learning disabilities who are unable to complete questionnaires

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Behavioural Science and Health, UCL

London, United Kingdom

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 26, 2025

First Posted

September 4, 2025

Study Start

September 15, 2025

Primary Completion (Estimated)

January 31, 2027

Study Completion (Estimated)

June 30, 2027

Last Updated

May 12, 2026

Record last verified: 2026-05

Locations