跳至主要内容
临床试验/NCT06835985
NCT06835985Enrolling By Invitation不适用

sIRB: Social Media Intervention for Online Victimized Youth

University of Pittsburgh2 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2025年5月6日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
75
试验地点
2
主要终点
Engagement with the chatbot

研究概览

简要总结

This feasibility pilot trial seeks to examine the feasibility and target engagement of a coping skills and psychoeducational intervention delivered via an automated conversational chatbot named SMILEY in reducing frequency and stress associated with online victimization among marginalized youth, including those who are Black, Hispanic, and LGBTQ+, and experiencing depression and online victimization.

The primary inquiry of this study is whether SMILEY can enhance the safety and decrease stress levels in online environments for marginalized youth coping with depression and online victimization.

Participants will engage with materials, including interactive web resources, to learn safe social media practices and provide coping skills for experiencing online victimization. These materials will cover topics such as managing online time, addressing negative comments, and fostering positive connections.

Participants will interact with SMILEY at their own pace over 4 weeks. This interaction will provide information and guidance on dealing with online victimization and the associated stress.

详细描述

This study proposes to determine the feasibility and target engagement of a specialized chatbot intervention named SMILEY in reducing online victimization and stress among marginalized youth, including those who are Black, Hispanic, and LGBTQ+, and experiencing depression and online victimization. The primary inquiry of this study is whether SMILEY can enhance the safety and decrease stress levels in online environments for marginalized youth coping with depression and online victimization.

Pilot trial: Randomizing 2 to 1 in this study using Efron's biased coin toss procedure. Age groups will be balanced (12-14 years old versus 15-18 years old) given that the nature of online victimization and platforms on which it occurs differ across adolescent development, racial/ethnic minority backgrounds, and sexual and gender minority backgrounds.

Sample size and power considerations: Participants (n=75; 2:1 randomization) will be identified during screening for the ETUDES Center Primary Care Study who meet inclusion criteria.

Participant groups:

A. Intervention Group: Participants will engage with SMILEY for support, in addition to receiving brief psychoeducation.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

盲法说明

Participants will know which of the two interventions they are being assigned.

入排标准

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

入选标准

  • Adolescents age 12-18
  • Current moderate to severe depression (PHQ-9-M ≥ 11)
  • Patients must screen positive for depression, PHQ-9-M score ≥ 11, and online victimization (OV). A positive screen will be OV that occurred "a few times" for at least one type of OV or "once" for at least two types of OV.

排除标准

  • Conditions that might impair their ability to effectively deploy interventions, including current manic or psychotic episode, presence of a life-threatening medical condition requiring immediate treatment, intellectual or developmental disability precluding comprehension of study procedure
  • Referring providers will be advised that adolescents must be capable of safely participating, specifically that they do not need urgent medical or psychiatric treatment.

研究组 & 干预措施

SMILEY + Brief Psychoeducation

Experimental

SMILEY (Social Media Intervention for Online Victimized Youth): A self-paced HIPAA-compliant chatbot intervention administered through Facebook Messenger that delivers psychoeducational and coping skills content to improve social media self-efficacy and distress tolerance among Black, SGM and other minority youth with moderate to severe depression who experience online victimization.

干预措施: Chatbot Intervention (Other)

SMILEY + Brief Psychoeducation

Experimental

SMILEY (Social Media Intervention for Online Victimized Youth): A self-paced HIPAA-compliant chatbot intervention administered through Facebook Messenger that delivers psychoeducational and coping skills content to improve social media self-efficacy and distress tolerance among Black, SGM and other minority youth with moderate to severe depression who experience online victimization.

干预措施: Brief Psychoeducation (Other)

Brief Psychoeducation

Active Comparator

Research clinician will deliver psychoeducation for youth and caregivers supported by web-based resources. Content will introduce basic concepts of social media self-efficacy (screen time guidance, technological coping skills, and encouragement of positive online interactions) and guidance on how to respond to and cope with online victimization.

干预措施: Brief Psychoeducation (Other)

结局指标

主要结局

Engagement with the chatbot

时间窗: 12 months

Engagement will be measured by the timestamps of usage of the intervention. Timestamps will be generated when there is a message from the user and a corresponding message from the chatbot.

Perceived satisfaction of the chatbot

时间窗: 12 months

Perceived satisfaction of the chatbot will be measured by the Post-Study System Usability Questionnaire (PSSUQ). Response options and scores include: "Strongly Agree (1)" to "Strongly Disagree (7)." Scores range from 1 to 7, with higher scores indicating lower levels of satisfaction and lower scores indicating higher levels satisfaction.

Engagement with the chatbot

时间窗: Baseline

Engagement will be measured by the timestamps of usage of the intervention. Timestamps will be generated when there is a message from the user and a corresponding message from the chatbot.

Engagement with the chatbot

时间窗: 1 month

Engagement will be measured by the timestamps of usage of the intervention. Timestamps will be generated when there is a message from the user and a corresponding message from the chatbot.

Engagement with the chatbot

时间窗: 3 months

Engagement will be measured by the timestamps of usage of the intervention. Timestamps will be generated when there is a message from the user and a corresponding message from the chatbot.

Engagement with the chatbot

时间窗: 6 months

Engagement will be measured by the timestamps of usage of the intervention. Timestamps will be generated when there is a message from the user and a corresponding message from the chatbot.

Perceived satisfaction of the chatbot

时间窗: Baseline

Perceived satisfaction of the chatbot will be measured by the Post-Study System Usability Questionnaire (PSSUQ). Response options and scores include: "Strongly Agree (1)" to "Strongly Disagree (7)." Scores range from 1 to 7, with higher scores indicating lower levels of satisfaction and lower scores indicating higher levels satisfaction.

Perceived satisfaction of the chatbot

时间窗: 1 month

Perceived satisfaction of the chatbot will be measured by the Post-Study System Usability Questionnaire (PSSUQ). Response options and scores include: "Strongly Agree (1)" to "Strongly Disagree (7)." Scores range from 1 to 7, with higher scores indicating lower levels of satisfaction and lower scores indicating higher levels satisfaction.

Perceived satisfaction of the chatbot

时间窗: 3 months

Perceived satisfaction of the chatbot will be measured by the Post-Study System Usability Questionnaire (PSSUQ). Response options and scores include: "Strongly Agree (1)" to "Strongly Disagree (7)." Scores range from 1 to 7, with higher scores indicating lower levels of satisfaction and lower scores indicating higher levels satisfaction.

Perceived satisfaction of the chatbot

时间窗: 6 months

Perceived satisfaction of the chatbot will be measured by the Post-Study System Usability Questionnaire (PSSUQ). Response options and scores include: "Strongly Agree (1)" to "Strongly Disagree (7)." Scores range from 1 to 7, with higher scores indicating lower levels of satisfaction and lower scores indicating higher levels satisfaction.

次要结局

  • Levels of general self-efficacy(12 months)
  • Levels of distress tolerance(12 months)
  • Levels of general self-efficacy(Baseline)
  • Levels of general self-efficacy(1 month)
  • Levels of general self-efficacy(3 months)
  • Levels of general self-efficacy(6 months)
  • Levels of distress tolerance(Baseline)
  • Levels of distress tolerance(1 month)
  • Levels of distress tolerance(3 months)
  • Levels of distress tolerance(6 months)

研究者

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

César Escobar-Viera

Assistant Professor

University of Pittsburgh

研究点 (2)

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