Clinical trial NCT06835985: Social Media Intervention for Online Victimized Youth
Official title: sIRB: Social Media Intervention for Online Victimized Youth
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Depression
Suicidal Ideation
Keywords: online victimization
chatbot
social media intervention
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
name: Children's Hospital of Philadelphia
name: University of Oregon
First posted: 2025-02-19
Enrollment: 75
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will only be assigned to one of two interventions to compare SMILEY + brief psychoeducation (intervention) vs. brief psychoeducation (control).
Primary purpose: TREATMENT

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\&amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;#39;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.

Eligibility criteria: 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.

Primary outcomes:
measure: Engagement with the chatbot
timeFrame: Baseline
measure: Engagement with the chatbot
timeFrame: 1 month
measure: Engagement with the chatbot
timeFrame: 3 months
measure: Engagement with the chatbot
timeFrame: 6 months
measure: Engagement with the chatbot
timeFrame: 12 months
measure: Perceived satisfaction of the chatbot
timeFrame: Baseline
measure: Perceived satisfaction of the chatbot
timeFrame: 1 month
measure: Perceived satisfaction of the chatbot
timeFrame: 3 months
measure: Perceived satisfaction of the chatbot
timeFrame: 6 months
measure: Perceived satisfaction of the chatbot
timeFrame: 12 months
Secondary outcomes:
measure: Levels of general self-efficacy
timeFrame: Baseline
measure: Levels of general self-efficacy
timeFrame: 1 month
measure: Levels of general self-efficacy
timeFrame: 3 months
measure: Levels of general self-efficacy
timeFrame: 6 months
measure: Levels of general self-efficacy
timeFrame: 12 months
measure: Levels of distress tolerance
timeFrame: Baseline
measure: Levels of distress tolerance
timeFrame: 1 month
measure: Levels of distress tolerance
timeFrame: 3 months
measure: Levels of distress tolerance
timeFrame: 6 months
measure: Levels of distress tolerance
timeFrame: 12 months
Other outcomes:
measure: Severity of depression
timeFrame: Baseline
measure: Severity of depression
timeFrame: 1 month
measure: Severity of depression
timeFrame: 3 months
measure: Severity of depression
timeFrame: 6 months
measure: Severity of depression
timeFrame: 12 months
measure: Severity of suicidal ideation and behavior
timeFrame: Baseline
measure: Severity of suicidal ideation and behavior
timeFrame: 1 month
measure: Severity of suicidal ideation and behavior
timeFrame: 3 months
measure: Severity of suicidal ideation and behavior
timeFrame: 6 months
measure: Severity of suicidal ideation and behavior
timeFrame: 12 months
Locations:
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Western Psychiatric Hospital
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: César G Escobar-Viera, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Pittsburgh
name: Candice Biernesser, PhD
role: PRINCIPAL_INVESTIGATOR
References: