Social Media Intervention for Online Victimized Youth

Not Applicable

Not yet recruiting

• Conditions: Depression; Suicidal Ideation

• Registration Number: NCT06835985
• Lead Sponsor: University of Pittsburgh

Brief Summary

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.

Detailed Description

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.

B. Control Group: Participants will only receive brief psychoeducation, without access to SMILEY

In support of the feasibility of recruitment, among patients with a PHQ-9-M scores ≥ 11 in our specialty mental health clinic for depression, 25% reported at least one OV event in the past month. Participants will be 35% Black and 10% Hispanic; given previous research, investigators expect 30% will identify as SGM. To safeguard privacy for SGM adolescents who are not out to caregivers, SGM identity will be assessed with the adolescent alone and it is not an inclusion criterion for this study. Exclusion criteria for youth are the same as for the ETUDES Center Primary Care Study, namely, mania, psychosis, developmental disability precluding comprehension of study procedures, and lack of English fluency.

Investigators anticipate that feasibility will be high (completion 50%; attrition 20%, ratings 80%); acceptability (ratings 80%); appropriateness (ratings 80%). Youth who receive SMILEY will show greater reductions in perceived stress related to OV (secondary outcome). Improvements in depression severity and risk for STB (tertiary outcomes) will be greater among youth randomized to SMILEY. Outcomes will be equitable by race and SGM identity. Exploratory (mechanistic): SMILEY will lead to decreased STB risk through improved social media self-efficacy and distress tolerance.

Intervention Delivery: Self-paced interaction with the SMILEY chatbot over 4 weeks. A research clinician will provide psychoeducation for youth and caregivers using web resources. Topics include social media self-efficacy (e.g., screen time management and positive online interactions) and guidance on how to respond to and cope with online victimization. Though usage and interactions will be self-paced, investigators expect participants will engage 2-3 times per week, for 5-10 minutes each session. Participants may receive reminders from the chatbot to engage, and if inactive for 1 week, a research assistant will assist with technical issues. Reports summarizing content may be provided to adolescents, caregivers, and providers at the end of the intervention.

Study Timeline

• Study First Submitted: 2025-02-14
• Study First Submitted QC: 2025-02-14
• Study First Posted: 2025-02-19
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-22
• Last Update Posted: 2025-04-24
• Study Start: 2025-05-15
• Primary Completion: 2026-02-28
• Study Completion: 2027-07-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 75

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Engagement with the chatbot	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	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.

Secondary Outcome Measures

Name	Time	Method
Levels of distress tolerance	12 months	Levels of distress tolerance will be measured by the Distress Tolerance Scale (DTS). Response options and scores include: "Strongly Disagree (1)," "Mildly Disagree (2)," "Agree and Disagree Equally (3)," "Mildly Agree (4)," and "Strongly Agree (5)." Scores range from 1 to 5, with higher scores indicating higher levels of distress tolerance and lower scores indicating lower levels of distress tolerance.
Levels of general self-efficacy	12 months	Levels of general self-efficacy will be measured by the General Self-Efficacy Scale (GSE). Response options and scores include: "Not at all true (1)," "Hardly true (2)," "Moderately true," and "Exactly true (4)." Scores range from 10 to 40, with higher scores indicating higher levels of self-efficacy and lower scores indicating lower levels of self-efficacy.

Trial Locations

Locations (2)

Children's Hospital of Philadelphia; 🇺🇸 Philadelphia, Pennsylvania, United States

Western Psychiatric Hospital; 🇺🇸 Pittsburgh, Pennsylvania, United States