NCT07022561

Brief Summary

The goal of this clinical trial is to learn if the Social Prescription (SP) intervention helps improve mental health and wellbeing in youth. It will also assess the feasibility and acceptability of implementing SP in a community setting. The main questions it aims to answer are:

  • Is the SP intervention feasible and acceptable for youth, caregivers, and staff?
  • Does the SP intervention improve mental health outcomes, reduce stress, and increase wellbeing and social connectedness in youth? Researchers will compare the Social Prescription (SP) intervention to an education control group to evaluate its effectiveness in improving youth mental health and wellbeing. Participants will:
  • Be randomized to receive either the SP intervention or be placed in an education control group
  • Complete wellbeing and mental health questionnaires at the beginning of the study and again after 12 weeks
  • Participate in qualitative interviews to share their experiences after participating in SP

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
170

participants targeted

Target at P75+ for not_applicable

Timeline
15mo left

Started Jul 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet 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 Progress41%
Jul 2025Sep 2027

First Submitted

Initial submission to the registry

June 6, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 15, 2025

Completed
16 days until next milestone

Study Start

First participant enrolled

July 1, 2025

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2027

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2027

Last Updated

June 15, 2025

Status Verified

May 1, 2025

Enrollment Period

2.1 years

First QC Date

June 6, 2025

Last Update Submit

June 6, 2025

Conditions

Keywords

social prescribingchildren and youth mental healthinterventionwellbeing

Outcome Measures

Primary Outcomes (5)

  • Revised Children's Anxiety and Depression Scale

    The Revised Children's Anxiety and Depression Scale (RCADS) is a self-report questionnaire that measures symptoms of anxiety and depression in children and adolescents aged 8 to 18.

    From enrollment to end of treatment or control period at 12 weeks.

  • Perceived Stress Scale

    The Perceived Stress Scale is a widely used to help understand how different situations affect our feelings and our perceived stress.

    From enrollment to end of treatment or control period at 12 weeks.

  • Warwick-Edinburgh Mental Wellbeing Scale

    The Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS) was developed to enable the monitoring of mental wellbeing in the general population and the evaluation of projects, programmes and policies which aim to improve mental wellbeing.

    From enrollment to end of treatment or control period at 12 weeks

  • Social Connectedness Scale

    The Social Connectedness Scale measures the extent to which individuals feel connected to others in their social environment.

    From enrollment to end of treatment or control period at 12 weeks

  • Student Resilience Survey

    Student Resilience Survey measuring students' perceptions of their individual characteristics as well as protective factors embedded in the environment:

    From enrollment to end of treatment or control period at 12 weeks

Secondary Outcomes (3)

  • Acceptability of Intervention Measure

    From enrollment to end of treatment or control period at 12 weeks

  • Intervention Appropriateness Measure

    From enrollment to end of treatment or control period at 12 weeks

  • Feasibility of Intervention Measure

    From enrollment to end of treatment or control period at 12 weeks

Study Arms (2)

Social prescribing intervention

EXPERIMENTAL

Youth randomly assigned to the social prescribing intervention group will have access to a social prescribing activity during their 12 weeks of participation.

Behavioral: Social Prescribing

Educational control

NO INTERVENTION

Youth randomly assigned to the educational control will not be provided a social prescribing intervention program, but they will be provided an educational booklet about the importance of connections.

Interventions

A social prescribing intervention is a non-clinical approach to improving health and wellbeing by connecting individuals to community-based services and activities that address social, emotional, and practical needs. These may include arts programs, physical activity, peer support, volunteering, or nature-based activities. Facilitated by a link worker or navigator, social prescribing is tailored to the individual and aims to enhance mental health, reduce isolation, and support overall wellness beyond traditional medical care.

Social prescribing intervention

Eligibility Criteria

Age11 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • between 11-17 years of age
  • on the waitlist for mental health services
  • are not an immediate safety threat to themselves or others as assessed by the HEADS ED questionnaire

You may not qualify if:

  • Children \< 11 years old
  • Adolescents \> 17 years old

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Ottawa

Ottawa, Ontario, K1N 6N5, Canada

Location

Related Publications (1)

  • Kempe S, Bennett S, MacLeod O, Mohamed N, Cloutier P, Muhl C, Hayes D, Mitsakakis N, Goldfield G, Racine N. Social prescriptions for advancing resilience in kids (SPARK): study protocol for a randomized controlled trial. BMC Psychol. 2025 Oct 10;13(1):1126. doi: 10.1186/s40359-025-03465-7.

Study Officials

  • Nicole Racine, PhD

    University of Ottawa

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Susan Bennett, PhD

CONTACT

Olivia MacLeod, PhD

CONTACT

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

June 6, 2025

First Posted

June 15, 2025

Study Start

July 1, 2025

Primary Completion (Estimated)

July 30, 2027

Study Completion (Estimated)

September 1, 2027

Last Updated

June 15, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

We will not be sharing individual participant data outside of our affiliations and institutions.

Locations