The REWIRE Behaviour Study
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age12-17
SponsorGary Goldfield
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Own a smartphone.
Use social media for >3 hours/day.
Are aged 12-17 years.
Are experiencing feelings of anxiety or depression.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Pilot - REWIRE Program
BehavioralParticipants 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.
Psychoeducation Control
BehavioralParticipants 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.
REWIRE Intervention
BehavioralThe 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.
Treatment groups
220 Participants
are divided into 3 treatment groupsGroup A: Phase 1: PilotExperimental treatment 1 intervention
Group B: Phase 2: Control GroupActive comparator 1 intervention
Group C: Phase 2: Intervention GroupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Weeks 2-132
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.
Time frame
Week 133
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.
Time frame
Week 134
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.
Time frame
Week 13Secondary outcomes
1
Phase 2: 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.
Time frame
Weeks 2-132
Phase 2: 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.
Time frame
Week 133
Phase 2: 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.
Time frame
Week 134
Phase 2: 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.
Time frame
Week 13Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Gary Goldfield
Lead sponsor
Children's Hospital of Eastern Ontario
Sponsor institution
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: