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临床试验/NCT07278752
NCT07278752Enrolling By Invitation不适用

Social Media Concerns Related to Emotional Experiences in Naturalistic Settings (SCREENS)

University of Texas Southwestern Medical Center1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2026年5月26日最近更新:
适应症

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
100
试验地点
1
主要终点
Concise Health Risk Tracking Self-Report (CHRT-SR)

研究概览

简要总结

The objective of this study is to advance understanding of the relationships between social media use (SMU) and internalizing symptoms among a diverse sample of depressed and/or suicidal youth. Youth (ages 13-18) enrolled in the TX-YDSRN registry study will be recruited for participation in SCREENS. After reviewing the Information Sheet, participants will complete baseline measures assessing internalizing symptoms (e.g., depression, anxiety, suicidal ideation/behavior), and trauma history. They will then complete ecological momentary assessments (EMAs) twice daily for 30 days via the mHealth app, capturing internalizing symptoms, emotional responses to social media, and in-person social support. The mHealth app will also collect the amount of social media use during this 30-day period. From Month 1 through Month 6, participants will receive monthly self-report surveys administered through REDCap.

100 participants

This study will enroll youth from the TX-YDSRN registry study who meet all the following criteria:

  • Be between 13 and 18 years of age at the time of enrollment.
  • Be currently enrolled in the TX-YDSRN registry study and willing to allow sharing of data from that study.
  • Own a smartphone and agree to download and use the study mHealth application for the duration of study participation.
  • Be willing and able to participate in all study requirements and allocate sufficient time to complete study questionnaires and measures.

Visits include a Screening Visit, Baseline Visit, EMA 2x daily for 30 days, 6 remote follow-up survey visits.

Multiple streams of outcome measures will be utilized for this protocol, including self-report measures, research assessor-completed measure, and EMA measures.

Adverse event (AE) recording, 9 item Patient Health Questionnaire Adolescent Version (PHQ-A), Concise Health Risk Tracking Self Report (CHRT-SR).

详细描述

The study aims to enroll 100 participants recruited from the TX-YDSRN registry study. TX-YDSRN registry study, an ongoing state-wide longitudinal data repository funded by Texas Child Mental Healthcare Consortium (TCMHCC). TX-YDSRN is comprised of 12 participating HRIs across Texas.

Eligible and active TX-YDSRN participants will be invited to participate in this study. Efforts will be made to ensure a diverse and representative sample, including participants of varying sexes, ethnicities, races, and socioeconomic backgrounds. The TX-YDSRN's established recruitment network and community partnerships since 2020 support broad and inclusive enrollment.

Advances in mobile health (mHealth) technologies offer new ways to monitor depression and suicidal ideation outside of clinical settings. Through smartphones and devices from wearable health technology leaders such as Garmin or Fitbit, this study aims to remotely track clinical indicators among youth. These technologies collect data such as physical activity, social interaction, sleep, social media experiences, social media use amount, and mood in real-time, providing an ecologically valid picture of the participants' daily lives. This approach can enhance early detection of clinical deterioration, empowering both participants and caregivers with timely, actionable feedback.

Using HIPAA-compliant software on smartphones, the app will track digital markers such as location, movement, call/text frequency, screen time, and survey responses as proxies for social interaction, in-person social support, anxiety, suicidal ideation/behavior, emotional responses to social media, and mood. Data is encrypted, stored on secure servers ensuring confidentiality. Similarly, wearables will track digital biomarkers such as sleep patterns, heart rate, and activity levels. Together, these metrics offer continuous, longitudinal data on various potential markers for physical and psychological health such as the following:

  • Activity Levels: Reduced physical activity and social engagement may indicate worsening depression. Tracking changes in the radius of daily movement can help detect reduced interest and motivation to engage in important or valued activities.
  • Sleep Patterns: Sleep issues (insomnia, hypersomnia, disruption, restlessness) often signal mood changes. By monitoring sleep latency, duration, and quality, we can identify early warning signs of depression.
  • Social Interaction: Decreases in communication frequency and network size, changes in screen time, can indicate social withdrawal.
  • Mood Variability: Regular assessments of mood, fatigue, and energy help capture emotional variability. Non-responsiveness itself can be a potential marker of worsening of depression.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
13 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Be between 13 and 18 years of age at the time of enrollment.
  • Be currently enrolled in the TX-YDSRN registry study and willing to allow sharing of data from that study.
  • Own a smartphone and agree to download and use the study mHealth application for the duration of study participation.
  • Be willing and able to participate in all study requirements and allocate sufficient time to complete study questionnaires and measures.

排除标准

  • Have medical, psychiatric, or other condition for which study participation would not be in their best interest or that could interfere or confound study assessments.
  • Require immediate psychiatric hospitalization or present an imminent suicide risk at the time of screening.
  • Unwilling or unable to download or comply with mHealth app requirements.

结局指标

主要结局

Concise Health Risk Tracking Self-Report (CHRT-SR)

时间窗: 6 months

The CHRT is a scale that evaluates specific thoughts about suicide and thoughts and feelings associated with an increased risk for suicide. The self-report CHRT is a 16-item scale that evaluates specific thoughts about suicide and thoughts and feelings associated with an increased risk for suicide. Its psychometric properties have been well-established in children and adolescents.

Patient Health Questionnaire-A (PHQ-A)

时间窗: 6 months

The PHQ-A is a nine-item, self-report inventory that assesses for symptoms in all nine symptom domains of a major depressive episode. It is the PHQ-9 modified for adolescents 12-18 years

Generalized Anxiety Disorder Scale - 7 items (GAD-7)

时间窗: 6 months

The GAD-7 is self-report that assesses for symptoms in 7 symptom domains of generalized anxiety, with an additional question on anxiety-related functional impairment.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Madhukar H. Trivedi, MD

Professor

University of Texas Southwestern Medical Center

研究点 (1)

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