The REWIRE Behaviour Study
NCT07429357 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 220
Last updated 2026-02-24
Summary
This two-phase, double-blind, balanced, parallel-group randomized controlled trial involves youth aged 12 to 17 years who experience symptoms of anxiety or depression and use social media for more than three hours per day.
In Phase 1, a small pilot group will participate in the REWIRE program to assess its feasibility, usability, and engagement before launching Phase 2. Results of the pilot will inform whether any modifications to the intervention are required and identify ways to increase adherence and reduce barriers.
In Phase 2, approximately 100 youth and their caregivers will be randomly assigned to one of two groups to evaluate the REWIRE program on anxiety and depression symptoms. One group will participate in the REWIRE program, which aims to reduce social media use to about half of usual levels while encouraging participation in positive offline activities such as spending time with friends, hobbies, physical activity, or time outdoors. The comparison group will receive psychoeducation about social media and health, but will not be asked to change their social media use. Both youth and caregivers will attend weekly group sessions over 12-weeks. Participants will also track their physical activity, complete questionnaires about mental health, daily activities, and social media use, and will provide daily smartphone usage screenshots. Youth will additionally take part in brain imaging scans and neurocognitive assessments before and after the program to explore how changes in social media use may be related to brain function. At the end of Phase 2, 20 participants will be randomly selected for interviews to explore their experiences with the intervention.
Additional secondary outcomes in Phase 2 include social phobia, social comparison, Fear of Missing Out (FOMO), loneliness, body esteem, disordered eating, social media disorder symptoms, cyberbullying, reinforcing efficacy of social media, impulsivity, suicidal ideations, well-being, executive functioning and cognition, while further assessing the feasibility.
Conditions
- Anxiety Depression
- Social Media
Interventions
- BEHAVIORAL
-
Pilot - REWIRE Program
Participants will receive the REWIRE program, a structured, family-supported behavioural program focused on reducing social media use while increasing engagement in enjoyable, non-screen activities. The program includes weekly group sessions for youth and caregivers, individualized goal-setting, monitoring of physical activity and daily social media use via smartphone screenshots, and completion of questionnaires assessing mental health, daily activities, and program acceptability.
- BEHAVIORAL
-
Psychoeducation Control
Participants will attend weekly group sessions focused on providing information about social media use, lifestyle behaviours, and mental health. Youth and caregivers will complete repeated questionnaires and daily smartphone usage screenshots throughout the study period and monitor their physical activity, but no limits or reduction goals will be placed on social media use.
- BEHAVIORAL
-
REWIRE Intervention
The intervention consists of a 12-week, family-based behavioural program that supports youth in reducing their social media use to approximately 50% of baseline levels while increasing participation in positive offline activities such as hobbies, physical activity, and in-person social interactions. The program includes weekly youth and caregiver group sessions, individualized goal-setting and progress review, daily monitoring of physical activity and social media use through smartphone screenshots, and completion of mental health and behavioural assessments.
Sponsors & Collaborators
-
Gary Goldfield
lead OTHER
Principal Investigators
-
Gary Goldfield · Children's Hospital of Eastern Ontario
Study Design
- Allocation
- RANDOMIZED
- Purpose
- SUPPORTIVE_CARE
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 12 Years
- Max Age
- 17 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-03-31
- Primary Completion
- 2026-06-30
- Completion
- 2029-12-31
Countries
- Canada
Study Locations
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