Social Media Intervention for Online Victimized Youth

NCT06835985 | Enrolling By Invitation DMC

• 2 other identifiers: STUDY22040038P50MH115838
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 2

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.

Conditions

Depression; Suicidal Ideation

Keywords

online victimization; chatbot; social media intervention

Outcome Measures

Primary Outcomes (10)

• Engagement with the chatbot

  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.

  Baseline

• Engagement with the chatbot

  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.

  1 month

• Engagement with the chatbot

  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.

  3 months

• Engagement with the chatbot

  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.

  6 months

• Engagement with the chatbot

  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.

  12 months

• Perceived satisfaction of the chatbot

  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.

  Baseline

• Perceived satisfaction of the chatbot

  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.

  1 month

• Perceived satisfaction of the chatbot

  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.

  3 months

• Perceived satisfaction of the chatbot

  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.

  6 months

• Perceived satisfaction of the chatbot

  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.

  12 months

Secondary Outcomes (10)

• 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 general self-efficacy

  12 months

Other Outcomes (10)

• Severity of depression

  Baseline

• Severity of depression

  1 month

• Severity of depression

  3 months

Study Arms (2)

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.

Other: Chatbot Intervention; Other: Brief Psychoeducation

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.

Other: Brief Psychoeducation

Interventions

Brief Psychoeducation OTHER

When youth onboard the study, a 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.

Brief Psychoeducation; SMILEY + Brief Psychoeducation

Chatbot Intervention OTHER

Participants screened for suicidality during the ETUDES Center Primary Care Study and who disclose experiencing online victimization will be onboarded by a research clinician on how to use SMILEY, the web-based intervention that delivers psychoeducation, basic concepts of social media self-efficiency, and guidance on how to respond to and cope with online victimization. The chatbot and/or research clinician will send out periodic reminders to users to remind them to engage with the chatbot over four weeks. Technical troubleshooting concerns will be carried out by research clinician and chatbot developer team.

Also known as: SMILEY

SMILEY + Brief Psychoeducation

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Institute of Mental Health (NIMH): collaborator
• Children's Hospital of Philadelphia: collaborator
• University of Oregon: collaborator
• University of Pittsburgh: lead

Study Sites (2)

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

Western Psychiatric Hospital

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Depression; Suicidal Ideation

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Suicide; Self-Injurious Behavior

Study Officials

• César G Escobar-Viera, MD, PhD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

• Candice Biernesser, PhD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Participants will know which of the two interventions they are being assigned.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Participants will only be assigned to one of two interventions to compare SMILEY + brief psychoeducation (intervention) vs. brief psychoeducation (control).

Study Record Dates

• First Submitted: February 14, 2025
• First Posted: February 19, 2025
• Study Start: May 6, 2025
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): July 31, 2027
• Last Updated: March 5, 2026

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Time Frame: July, 2024

Locations

US (2)