Clinical trial NCT06066697: SOVA Ambassadors Community Setting
Official title: SOVA Ambassadors Community Setting
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Keywords: Adolescent
Adolescent Medicine
Mental Health Services
eHealth
Online Systems
Primary Healthcare
Social Media
Social Support
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: National Institute on Minority Health and Health Disparities (NIMHD)
First posted: 2023-10-04
Enrollment: 12
Sex: ALL
Minimum age (years): 14
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of this study is to examine participant adherence to intervention feasibility and acceptability of intervention, attention control, and implementation strategy.

Detailed description: A 1:1 pilot randomized controlled trial of the SOVA Peer Ambassador Program compared to attention control: brief psychoeducational independent assignments (i.e. reading SOVA articles and responding to open-ended questions without content creation and without peer interaction) (N=40) and evaluate feasibility of implementation strategy.

Eligibility criteria: Inclusion Criteria:

* Ages 14 to 21

Can read and understand English

Has completed 6th grade

Scores at least 5 or greater on the PHQ-8 (depression) and/or 5 or greater on GAD-7 (anxiety) consistent with at least mild symptoms

Exclusion Criteria:

* no access to internet

Has an intellectual or physical ability which prohibits reading text on the internet (can participate if able to use with assistance, e.g. can use text to speech)

No active email account (can participate if plans to create one)

Primary outcomes:
measure: Feasibility of Intervention
timeFrame: 12 weeks
Secondary outcomes:
measure: Feasibility of Control Arm
timeFrame: 12 weeks
measure: Acceptability of Intervention
timeFrame: 12 weeks
measure: Acceptability of Implementation Strategy
timeFrame: Baseline
measure: Acceptability of Randomization
timeFrame: 12 weeks
measure: Change from Baseline in Depression Severity
timeFrame: 6 weeks
measure: Change from Baseline in Depression Severity
timeFrame: 12 weeks
measure: Change from Baseline in Anxiety Severity
timeFrame: 6 weeks
measure: Change from Baseline in Anxiety Severity
timeFrame: 12 weeks
measure: Change from Baseline in Resilience/Positive Youth Development
timeFrame: 6 weeks
measure: Change from Baseline in Resilience/Positive Youth Development
timeFrame: 12 weeks
measure: Change from Baseline in Self-Esteem
timeFrame: 6 weeks
measure: Change from Baseline in Self-Esteem
timeFrame: 12 weeks
measure: Change from Baseline in Emotional Self-Efficacy
timeFrame: 6 weeks
measure: Change from Baseline in Emotional Self-Efficacy
timeFrame: 12 weeks
measure: Change from Baseline in Social Support
timeFrame: 6 weeks
measure: Change from Baseline in Social Support
timeFrame: 12 weeks
measure: Change from Baseline in Social Isolation
timeFrame: 6 weeks
measure: Change from Baseline in Social Isolation
timeFrame: 12 weeks
measure: Change from Baseline in Stigma
timeFrame: 6 weeks
measure: Change from Baseline in Stigma
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Ana Radovic, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References: