The REWIRE Behaviour Study

NCT07429357 | Not Yet Recruiting DMC

• 1 other identifier: REWIRE26
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (8)

• Phase 1: Social Media Use

  Social media use will be measured through the iPhone/Android screen time settings. Participants will be asked to provide objective data of their daily overall mobile screen time use, as well as screenshots of social media use. Type of social media use will be measured using 7 questions measuring passive vs active and public vs private use, as well as problematic usage patterns.

  Weeks 2-13

• Phase 1: Adherence

  Adherence will be measured using the objective social media use/screen data submitted by each participant, defined as social media use reduction 50% of the required time.

  Week 13

• Phase 1: Enrollment and Attrition Rates

  Enrollment and attrition rates will be kept track of and accounted for throughout the duration of the study. Attrition will be considered once the participant informs researchers they are discontinuing or discontinues submission of daily reports.

  Week 13

• Phase 1: Acceptability and Usability

  Measured with a modified version of the client satisfaction questionnaire (CSQ). The CSQ is a valid, reliable, 8-item questionnaire used to measure client satisfaction with a particular program or service. The questionnaire has been modified to assess participant satisfaction with the app and is measured with a Likert scale 1 to 4. Higher scores indicating greater satisfaction.

  Week 13

• Phase 1: Treatment Credibility and Expectancy

  Treatment credibility and expectancy will be assessed with the Credibility and Expectancy Questionnaire (CEQ). Credibility Subscale (Items 1-3): Summed range of 3 to 27. Expectancy Subscale (Items 4-6): Summed range of 3 to 27. Higher scores generally correlate with better treatment adherence, lower dropout rates, and improved symptom reduction.

  Week 13

• Phase 1: Barriers and Facilitators

  The potential usefulness and benefits of the social media reduction program will be explored via interviews with participants at the end of the intervention, obtaining patient perspective and thoughts on the program.

  Week 13

• Phase 2: Anxiety

  Anxiety symptoms will be measured using the General Anxiety Disorder-7 (GAD-7) scale which is a likert scale from 0 (not at all) to 3 (nearly every day). A higher score indicates more severe anxiety symptoms.

  Week 7 & 13

• Phase 2: Depression

  Depression will be measured using the Center for Epidemiologic Studies Depression Scale - 10 (CES-D) questionnaire which is a likert scale from 1 (Rarely or non of the time) to 4 (all of the time). A higher score indicates more severe depressive symptoms.

  Week 7 & 13

Secondary Outcomes (26)

• Phase 2: Social Media Use

  Weeks 2-13

• Phase 2: Adherence

  Week 13

• Phase 2: Enrollment and Attrition Rates

  Week 13

• Phase 2: Acceptability and Usability

  Week 13

• Phase 2: Treatment Credibility and Expectancy

  Week 13

Study Arms (3)

Phase 1: Pilot

EXPERIMENTAL

Participants in this arm will take part in an initial pilot phase designed to evaluate feasibility, usability, and participant engagement with the REWIRE program prior to the randomized controlled trial. This phase is intended to identify barriers and facilitators to participation and to inform any refinements to study procedures before proceeding to Phase 2.

Behavioral: Pilot - REWIRE Program

Phase 2: Control Group

ACTIVE COMPARATOR

Participants assigned to this arm will serve as the comparison group for the randomized controlled trial and will receive an education-based program without active behavioural change targets. This arm is designed to control for attention, expectancy, and self-monitoring effects.

Behavioral: Psychoeducation Control

Phase 2: Intervention Group

EXPERIMENTAL

Participants assigned to this arm will receive the active REWIRE intervention, which aims to improve mental health outcomes by modifying patterns of social media use and daily behaviour. This arm will be compared to the control group to evaluate the effectiveness of the intervention.

Behavioral: REWIRE Intervention

Interventions

Pilot - REWIRE Program BEHAVIORAL

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.

Phase 1: Pilot

Psychoeducation Control BEHAVIORAL

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.

Phase 2: Control Group

REWIRE Intervention BEHAVIORAL

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.

Phase 2: Intervention Group

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Own a smartphone.
• Use social media for \>3 hours/day.
• Are aged 12-17 years.
• Are experiencing feelings of anxiety or depression.
• Have a caregiver who is able and willing to participate in the study alongside them.
• Have the ability to communicate in English.
• Must sign and date the informed consent form, or provide assent and have a Substitute Decision Maker provide informed consent

You may not qualify if:

• Own a smartphone.
• Use their smartphone for \>1 hour/day.
• Are accompanying a youth participant enrolled in the study.
• Have the ability to communicate in English.
• Are willing to sign informed consent forms.

Sponsors & Collaborators

• Gary Goldfield: lead

Study Sites (1)

Children's Hospital of Eastern Ontario

Ottawa, Ontario, K1H 8L1, Canada

Location

Study Officials

• Gary Goldfield

  Children's Hospital of Eastern Ontario

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Karina Branje

CONTACT

613-737-7600 ext. 4899; kbranje@cheo.on.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Phase 1: Single arm intervention Phase 2: Parallel arm intervention

Study Record Dates

• First Submitted: February 10, 2026
• First Posted: February 24, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): December 1, 2029
• Last Updated: February 24, 2026

Record last verified: 2026-02

Locations

CA (1)