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Clinical Trials/NCT06066697
NCT06066697TerminatedNot Applicable

SOVA Ambassadors Community Setting

University of Pittsburgh1 site in 1 country12 target enrollmentStarted: October 25, 2023Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Terminated
Enrollment
12
Locations
1
Primary Endpoint
Feasibility of Intervention

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Health Services Research
Masking
Single (Outcomes Assessor)

Masking Description

The statistician conducting analyses will be blinded to randomized arm.

Eligibility Criteria

Ages
14 Years to 21 Years (Child, Adult)
Sex
All
Accepts Healthy Volunteers
No

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)

Arms & Interventions

SOVA Peer Ambassador Program

Experimental

Participants will be given login information for a website sova.pitt.edu. They will be given weekly emails notifications about new posts. The participant will be onboarded as a blogging peer ambassador. The participant will be expected to contribute content to the website at least once a month by

  1. writing a blog article
  2. sending information (de-identified photo or video or music) to post

• If they choose this option they will be encouraged to submit their own photo, video, or music to the website or they will be encouraged to write a response to a photo, video, or music piece. 3. being interviewed by the RA and then the RA "ghostwriting" an article about the interview which they pre-approve prior to it being posted.

Intervention: SOVA Ambassador (Behavioral)

attention control: brief psychoeducational independent assignments

Active Comparator

Participants will be sent a REDCap form where they will receive a link to a SOVA article to read and a question for them to answer about what they read that will be accessible only to the study team. They will be asked to do this a couple times a month and will be reminded about their participation.

Intervention: Self-Reflection (Behavioral)

Outcomes

Primary Outcomes

Feasibility of Intervention

Time Frame: 12 weeks

Average number of articles written per participant; Research team extract data from websites and observation notes

Secondary Outcomes

  • Feasibility of Control Arm(12 weeks)
  • Acceptability of Intervention(12 weeks)
  • Acceptability of Implementation Strategy(Baseline)
  • Acceptability of Randomization(12 weeks)
  • Depression Severity(6 weeks)
  • Depression Severity(12 weeks)
  • Anxiety Severity(6 weeks)
  • Anxiety Severity(12 weeks)
  • Resilience/Positive Youth Development(6 weeks)
  • Resilience/Positive Youth Development(12 weeks)
  • Self-Esteem(6 weeks)
  • Self-Esteem(12 weeks)
  • Emotional Self-Efficacy(6 weeks)
  • Emotional Self-Efficacy(12 weeks)
  • Social Support(6 weeks)
  • Social Support(12 weeks)
  • Social Isolation(6 weeks)
  • Social Isolation(12 weeks)
  • Stigma(6 weeks)
  • Stigma(12 weeks)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Ana Radovic

Assistant Professor

University of Pittsburgh

Study Sites (1)

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