Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-30 @ 12:14 AM
Study NCT ID:
NCT07429357
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-24
First Post:
2026-02-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The REWIRE Behaviour Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Phase 1: Single arm intervention Phase 2: Parallel arm intervention'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 220}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-03', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2029-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-20', 'studyFirstSubmitDate': '2026-02-10', 'studyFirstSubmitQcDate': '2026-02-20', 'lastUpdatePostDateStruct': {'date': '2026-02-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Phase 1: Social Media Use', 'timeFrame': 'Weeks 2-13', 'description': '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.'}, {'measure': 'Phase 1: Adherence', 'timeFrame': 'Week 13', 'description': '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.'}, {'measure': 'Phase 1: Enrollment and Attrition Rates', 'timeFrame': 'Week 13', 'description': '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.'}, {'measure': 'Phase 1: Acceptability and Usability', 'timeFrame': 'Week 13', 'description': '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.'}, {'measure': 'Phase 1: Treatment Credibility and Expectancy', 'timeFrame': 'Week 13', 'description': '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.'}, {'measure': 'Phase 1: Barriers and Facilitators', 'timeFrame': 'Week 13', 'description': '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.'}, {'measure': 'Phase 2: Anxiety', 'timeFrame': 'Week 7 & 13', 'description': '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.'}, {'measure': 'Phase 2: Depression', 'timeFrame': 'Week 7 & 13', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Phase 2: Social Media Use', 'timeFrame': 'Weeks 2-13', 'description': '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.'}, {'measure': 'Phase 2: Adherence', 'timeFrame': 'Week 13', 'description': '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.'}, {'measure': 'Phase 2: Enrollment and Attrition Rates', 'timeFrame': 'Week 13', 'description': '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.'}, {'measure': 'Phase 2: Acceptability and Usability', 'timeFrame': 'Week 13', 'description': '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.'}, {'measure': 'Phase 2: Treatment Credibility and Expectancy', 'timeFrame': 'Week 13', 'description': '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.'}, {'measure': 'Phase 2: Barriers and Facilitators', 'timeFrame': 'Week 13', 'description': '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.'}, {'measure': 'Phase 2: Physical Activity', 'timeFrame': 'Weeks 2-13', 'description': 'Time spent in physical activity and sedentary behaviour will be measured by an accelerometer which is water resistant, not waterproof, so participants will be asked to remove it for swimming or bathing. To account for the possibility that not all youth will wear the accelerometer every day, the proportion of physical activity and sedentary behaviour per hour of wear time will be computed. Activity values will be adjusted for total wear time to control for intra-individual variation.'}, {'measure': 'Phase 2: Default Network and Central Executive Network', 'timeFrame': 'Week 13', 'description': 'We will use neuroimaging to assess whether the REWIRE intervention produces changes in neural activation in brain regions that modulate reward and executive functions.'}, {'measure': 'Phase 2: Cognition - executive function', 'timeFrame': 'Week 7 & 13', 'description': 'The NIH Toolbox Cognition is a validated, brief, and standardized computerized assessment designed to measure core domains of cognitive functioning. The NIH Toolbox will be administered at baseline and post-intervention to evaluate potential changes in executive function. Higher scores indicating better function, while lower scores may indicate impairment or decline.'}, {'measure': 'Phase 2: Sleep Quality', 'timeFrame': 'Week 7 & 13', 'description': 'Sleep quality will be assessed using the Brief Child Sleep Questionnaire (BCSQ) a 19-item version (rated on a 3-point Likert scale: 1=rarely, 2=sometimes, 3=usually). A higher score indicates more frequent occurrence of sleep problems and generally signifies poorer sleep quality or more severe sleep disturbances.'}, {'measure': 'Phase 2: Cognition - attention', 'timeFrame': 'Week 7 & 13', 'description': 'The NIH Toolbox Cognition is a validated, brief, and standardized computerized assessment designed to measure core domains of cognitive functioning. The NIH Toolbox will be administered at baseline and post-intervention to evaluate potential changes in executive attention. Higher scores indicate better attention and inhibitory control.'}, {'measure': 'Phase 2: Cognition - full battery', 'timeFrame': 'Week 7 & 13', 'description': 'The NIH Toolbox Cognition is a validated, brief, and standardized computerized assessment designed to measure core domains of cognitive functioning. It includes tasks assessing executive function, attention, working memory, processing speed, language, and episodic memory. Higher scores indicate better performance.'}, {'measure': 'Phase 2: Social Phobia', 'timeFrame': 'Week 7 & 13', 'description': "Symptoms of social anxiety disorder will be measured using the Social Phobia subscale, Revised Children's Anxiety and Depression Scale (RCADS) which is a likert scale from 0 (never) to 3 (always). A higher score indicates more severe symptoms of social anxiety disorder."}, {'measure': 'Phase 2: Loneliness', 'timeFrame': 'Week 7 & 13', 'description': 'Loneliness symptoms will be measured using the UCLA Loneliness Scale, which is a likert scale from 1 (never) to 4 (always). A higher score indicates more feelings of loneliness and social isolation.'}, {'measure': 'Phase 2: Disordered Eating', 'timeFrame': 'Week 7 & 13', 'description': 'Disordered Eating will be assessed using the Eating Disorder Examination Questionnaire (EDE-Q), which is a questionnaire designed to assess the range, frequency and severity of behaviours associated with a diagnosis of an eating disorder.'}, {'measure': 'Phase 2: Body Image', 'timeFrame': 'Week 7 & 13', 'description': "Body Image will be assessed using the Body Esteem Scale for Adults and Adolescents (BESAA), which is a likert scale from 0 (never) to 4 (always). A low score indicates more negative feelings toward one's own physical appearance and weight."}, {'measure': 'Phase 2: Fear of Missing Out', 'timeFrame': 'Week 7 & 13', 'description': 'Fear of Missing Out (FoMO) will be measured using the Fear of Missing Out Scale (FoMOs), which is a likert scale from 1 (Not at all true of me) to 5 (Extremely true of me). A higher score indicates a higher level of fear, anxiety, and desire to be constantly connected with what others are doing.'}, {'measure': 'Phase 2: Social Media Misuse', 'timeFrame': 'Week 7 & 13', 'description': 'Social Media Misuse will be measured using the Social Media Disorder Scale (SMDS), which uses "yes/no" questions (yes=1; no=0) to measure nine core addiction dimensions: Preoccupation, Tolerance, Withdrawal, Persistence, Escape, Problems, Deception, Displacement, and Conflict. A score of 5 or higher indicates potential social media disorder.'}, {'measure': 'Phase 2: Emotional Intelligence', 'timeFrame': 'Week 7 & 13', 'description': 'Emotional Intelligence will be measured using the Emotional Intelligence Test (EQ), scale which is a likert scale from 0 (never) to 4 (all the time). A higher score indicates less emotional maturity.'}, {'measure': 'Phase 2: Resilience', 'timeFrame': 'Week 7 & 13', 'description': 'Resilience will be measured using the Connor-Davidson 10, which is a likert scale from 0 (not true at all) to 4 (true nearly all the time). A higher score indicates greater ability to cope with stress, adversity, and trauma.'}, {'measure': 'Phase 2: Suicidal Ideation', 'timeFrame': 'Week 7 & 13', 'description': 'Suicidal Ideation will be measured using the Suicidal Ideation Questionnaire (SIQ), which is a likert scale from 0 (I never had this thought) to 6 (almost every day). A higher score reflects more severe suicidal thoughts and a need for further assessment.'}, {'measure': 'Phase 2: Well-Being', 'timeFrame': 'Week 7 & 13', 'description': 'Well-Being will be measured using the 14-item Scale of General Well-Being (14-SGWB) which is a likert scale from 0 (not true at all) to 4 (very true). A higher score indicates higher levels of general well-being.'}, {'measure': 'Phase 2: Social Media Integration', 'timeFrame': 'Week 7 & 13', 'description': "Social Media Integration in Daily Life will be measured using the Social Media Use Integration Scale (SMUIS) which is a likert scale from 1 (strongly disagree) to 5 (strongly agree). A higher score represents higher levels of integration into users' daily routines and emotional connections."}, {'measure': 'Phase 2: Social Activities', 'timeFrame': 'Weeks 2-13', 'description': 'Time spent on in-person social activities will be measured using a leisure time checklist.'}, {'measure': 'Phase 2: Recreational Acitivity', 'timeFrame': 'Weeks 2-13', 'description': 'Time spent on hobbies and recreational pursuits will be measured using a leisure time checklist.'}, {'measure': 'Phase 2: Sedentary Screen Time', 'timeFrame': 'Weeks 2-13', 'description': 'Time spent in sedentary screen time (SMU on other devices besides smartphones, passive and active social media use, and non-SMU screen time such as TV, computer, video games, etc.) will be measured using EMA.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Anxiety Depression', 'Social Media']}, 'descriptionModule': {'briefSummary': '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.\n\nIn 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.\n\nIn 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.\n\nAdditional 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.', 'detailedDescription': "The REWIRE study is a two-phase, interventional trial designed to evaluate the feasibility, mechanistic underpinnings, and clinical effects of a structured social media use (SMU) reduction program combined with reinforcement of individualized, non-screen alternative behaviours in adolescents experiencing emotional distress. The study is grounded in behavioural economic principles, family-based treatment (FBT) models, displacement theory, and social comparison theory, and integrates multimodal behavioural, cognitive, and neuroimaging methodologies.\n\nAdolescence represents a developmental window characterized by heightened sensitivity to social reward, ongoing maturation of prefrontal regulatory systems, and increased vulnerability to anxiety and depressive disorders. Converging behavioural and neuroimaging evidence suggests that heavy SMU engages neural circuits implicated in reward processing (e.g., ventral striatum), socio-emotional reactivity (e.g., amygdala), and self-referential processing (e.g., medial prefrontal cortex and default mode network). Experimental studies in adults indicate that restricting SMU can reduce symptoms of anxiety and depression; however, existing studies have been limited by short intervention durations, reliance on self-reported adherence, and lack of mechanistic evaluation in youth populations.\n\nREWIRE addresses these gaps by implementing a 12-week behavioural intervention with objective monitoring of SMU, integration of family-based reinforcement strategies, and examination of neurocognitive and neural correlates of behavioural change.\n\nThis study uses a two-phase design:\n\nPhase 1 (Pilot Feasibility Phase):\n\nA single-arm pilot involving approximately 10 youth-caregiver dyads to evaluate recruitment feasibility, adherence to the SMU reduction target, usability of procedures (e.g., daily screenshot submission, ecological momentary assessment \\[EMA\\] completion), and acceptability of intervention components. Findings from Phase 1 will inform procedural refinements prior to initiation of the randomized controlled trial (RCT).\n\nPhase 2 (Randomized Controlled Trial):\n\nA balanced, parallel-group RCT enrolling approximately 100 youth-caregiver dyads. Participants are randomized 1:1 using computer-generated block randomization implemented through REDCap by the CHEO Clinical Research Unit. Participants are blinded to study hypotheses and are informed that two youth mental health programs are being compared.\n\nBoth phases include a 1-week baseline monitoring period followed by a 12-week intervention/control period (13 weeks total participation).\n\nREWIRE Intervention Arm The intervention consists of a structured, manualized, family-based behavioural therapy program delivered over 12 weeks. Youth and caregivers attend separate weekly 30-minute in-person group sessions led by trained research staff under clinical supervision. In addition, youth receive individualized 15-minute weekly goal-setting and progress-review sessions.\n\nThe intervention targets:\n\n1. SMU Reduction to 50% of Baseline:\n\n Baseline SMU is calculated using 7-day objective smartphone usage data. The 50% reduction target is standardized relative to each participant's baseline, ensuring individualized but proportionally equivalent behavioural goals.\n2. Reinforcement of Individualized Alternative Behaviours:\n\n Substitute behaviours are selected based on baseline assessment of behavioural preferences (Pleasant Events Schedule) to maximize reinforcing value and substitutability. Activities may include in-person social interaction, physical activity, hobbies, creative engagement, sleep hygiene, volunteering, and outdoor activities.\n3. Behavioural Modification Techniques:\n\nIntervention strategies are adapted from empirically supported FBT frameworks and include:\n\n* Stimulus control (e.g., disabling notifications, device-free bedroom rules)\n* Contingency management and reinforcement schedules\n* Behavioural contracting\n* Parental modelling and structured support\n* Problem-solving and barrier identification\n* Realistic, graduated goal setting\n\nCaregivers act as behavioural change facilitators, consistent with FBT evidence demonstrating superior maintenance of lifestyle behaviour changes when caregivers are actively engaged.\n\nParticipants receive a structured REWIRE workbook outlining psychoeducation regarding screen overuse, behavioural regulation strategies, and structured routines.\n\nPsychoeducation Control Arm The control arm receives an attention-matched, 12-week psychoeducation program delivered in weekly in-person group sessions. Content focuses on general education regarding social media, screen time, lifestyle behaviours, and mental health, but does not include behavioural modification strategies, reduction targets, or reinforcement protocols.\n\nBoth arms engage in equivalent monitoring procedures (daily screenshot submission, EMA reporting, accelerometry), controlling for expectancy effects, self-monitoring effects, and staff contact time. This design provides a more stringent comparison than waitlist controls.\n\nThroughout the 12-week intervention period, participants:\n\n* Upload daily screenshots of smartphone app usage from all devices.\n* Complete brief daily EMA surveys assessing sleep duration, leisure activities, accelerometer wear compliance, and non-captured screen use.\n* Wear a wrist-worn accelerometer during waking hours to objectively quantify physical activity and sedentary behaviour.\n* This multimodal monitoring approach enhances adherence fidelity and minimizes recall bias.\n\nParticipants complete the NIH Toolbox Cognition Battery at baseline, mid-intervention, and post-intervention to assess executive function, attention, working memory, processing speed, episodic memory, and language. These data support exploratory brain-behaviour correlation analyses linking cognitive performance to neural and behavioural changes.\n\nThe study is designed to evaluate potential mediators and moderators of treatment response.\n\nMechanistic pathways include:\n\n* Displacement of sedentary screen time by sleep, physical activity, and in-person social engagement\n* Reduction in maladaptive social comparison\n* Changes in the reinforcing efficacy of social media\n* Enhanced executive control and emotional regulation\n\nModeration analyses will explore whether intervention effects vary by:\n\n* Gender\n* Baseline distress severity\n* Household income\n* Social media disorder symptoms\n* Intervention adherence\n\nParticipants are blinded to group allocation and study hypotheses. Randomization is centralized and automated. Data are entered and analyzed using coded identifiers. Both arms receive equal session frequency and monitoring demands to minimize expectancy and contact biases.\n\nQualitative exit interviews (randomly selected subset of participants) are analyzed using the Theoretical Domains Framework (TDF) to identify behavioural determinants influencing adherence and implementation feasibility. Interviews are transcribed verbatim and coded independently by two analysts using NVivo software.\n\nREWIRE is among the first randomized controlled trials to examine sustained SMU reduction in adolescents with emotional distress using objective adherence measures, family-based behavioural reinforcement, and multimodal neuroimaging assessment. By integrating behavioural economics, developmental neuroscience, and family-based intervention principles, this study seeks to determine whether modifying digital behaviour can produce measurable improvements in mental health, cognitive function, and neural circuitry.\n\nIf effective, REWIRE may represent a scalable, low-cost, interim intervention within stepped-care youth mental health models, particularly for adolescents facing prolonged wait times for conventional services."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Own a smartphone.\n* Use social media for \\>3 hours/day.\n* Are aged 12-17 years.\n* Are experiencing feelings of anxiety or depression.\n* Have a caregiver who is able and willing to participate in the study alongside them.\n* Have the ability to communicate in English.\n* Must sign and date the informed consent form, or provide assent and have a Substitute Decision Maker provide informed consent\n\nExclusion Criteria:\n\n* Own a smartphone.\n* Use their smartphone for \\>1 hour/day.\n* Are accompanying a youth participant enrolled in the study.\n* Have the ability to communicate in English.\n* Are willing to sign informed consent forms.'}, 'identificationModule': {'nctId': 'NCT07429357', 'acronym': 'REWIRE', 'briefTitle': 'The REWIRE Behaviour Study', 'organization': {'class': 'OTHER', 'fullName': "Children's Hospital of Eastern Ontario"}, 'officialTitle': 'Research on Education With Individualized REwarding Behaviour (REWIRE): A Comparison of Two Youth Mental Health Programs', 'orgStudyIdInfo': {'id': 'REWIRE26'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Phase 1: Pilot', 'description': '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.', 'interventionNames': ['Behavioral: Pilot - REWIRE Program']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Phase 2: Control Group', 'description': '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.', 'interventionNames': ['Behavioral: Psychoeducation Control']}, {'type': 'EXPERIMENTAL', 'label': 'Phase 2: Intervention Group', 'description': '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.', 'interventionNames': ['Behavioral: REWIRE Intervention']}], 'interventions': [{'name': 'Pilot - REWIRE Program', 'type': 'BEHAVIORAL', 'description': '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.', 'armGroupLabels': ['Phase 1: Pilot']}, {'name': 'Psychoeducation Control', 'type': 'BEHAVIORAL', 'description': '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.', 'armGroupLabels': ['Phase 2: Control Group']}, {'name': 'REWIRE Intervention', 'type': 'BEHAVIORAL', 'description': '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.', 'armGroupLabels': ['Phase 2: Intervention Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'K1H 8L1', 'city': 'Ottawa', 'state': 'Ontario', 'country': 'Canada', 'contacts': [{'name': 'Gary Goldfield', 'role': 'CONTACT', 'email': 'ggoldfield@cheo.on.ca', 'phone': '613-737-7600', 'phoneExt': '3288'}], 'facility': "Children's Hospital of Eastern Ontario", 'geoPoint': {'lat': 45.41117, 'lon': -75.69812}}], 'centralContacts': [{'name': 'Karina Branje', 'role': 'CONTACT', 'email': 'kbranje@cheo.on.ca', 'phone': '613-737-7600 ext. 4899'}], 'overallOfficials': [{'name': 'Gary Goldfield', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Children's Hospital of Eastern Ontario"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'This selection was made by accident, and we were unable to deselect it. Please reset the answer selection for the above.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gary Goldfield', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Gary Goldfield', 'investigatorAffiliation': "Children's Hospital of Eastern Ontario"}}}}