Research on Education With Individualized REwarding Behaviour (REWIRE): A Comparison of Two Youth Mental Health Programs
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 220
- 试验地点
- 1
- 主要终点
- Phase 1: Social Media Use
研究概览
简要总结
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.
详细描述
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.
Adolescence 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.
REWIRE 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.
This study uses a two-phase design:
Phase 1 (Pilot Feasibility Phase):
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 12 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
Phase 1: Pilot
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.
干预措施: Pilot - REWIRE Program (Behavioral)
Phase 2: Control Group
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.
干预措施: Psychoeducation Control (Behavioral)
Phase 2: Intervention Group
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.
干预措施: REWIRE Intervention (Behavioral)
结局指标
主要结局
Phase 1: Social Media Use
时间窗: Weeks 2-13
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.
Phase 1: Adherence
时间窗: Week 13
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.
Phase 1: Enrollment and Attrition Rates
时间窗: Week 13
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.
Phase 1: Acceptability and Usability
时间窗: Week 13
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.
Phase 1: Treatment Credibility and Expectancy
时间窗: Week 13
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.
Phase 1: Barriers and Facilitators
时间窗: Week 13
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.
Phase 2: Anxiety
时间窗: Week 7 & 13
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.
Phase 2: Depression
时间窗: Week 7 & 13
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.
次要结局
- 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)
- Phase 2: Barriers and Facilitators(Week 13)
- Phase 2: Default Network and Central Executive Network(Week 13)
- Phase 2: Physical Activity(Weeks 2-13)
- Phase 2: Cognition - executive function(Week 7 & 13)
- Phase 2: Sleep Quality(Week 7 & 13)
- Phase 2: Cognition - attention(Week 7 & 13)
- Phase 2: Cognition - full battery(Week 7 & 13)
- Phase 2: Social Phobia(Week 7 & 13)
- Phase 2: Loneliness(Week 7 & 13)
- Phase 2: Disordered Eating(Week 7 & 13)
- Phase 2: Body Image(Week 7 & 13)
- Phase 2: Fear of Missing Out(Week 7 & 13)
- Phase 2: Social Media Misuse(Week 7 & 13)
- Phase 2: Emotional Intelligence(Week 7 & 13)
- Phase 2: Resilience(Week 7 & 13)
- Phase 2: Suicidal Ideation(Week 7 & 13)
- Phase 2: Well-Being(Week 7 & 13)
- Phase 2: Social Media Integration(Week 7 & 13)
- Phase 2: Social Activities(Weeks 2-13)
- Phase 2: Recreational Acitivity(Weeks 2-13)
- Phase 2: Sedentary Screen Time(Weeks 2-13)
研究者
Gary Goldfield
Principal Investigator
Children's Hospital of Eastern Ontario