NCT06066697

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable depression

Timeline
Completed

Started Oct 2023

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 27, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 4, 2023

Completed
21 days until next milestone

Study Start

First participant enrolled

October 25, 2023

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 22, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 22, 2024

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

January 16, 2026

Completed
Last Updated

January 16, 2026

Status Verified

December 1, 2025

Enrollment Period

1.1 years

First QC Date

September 27, 2023

Results QC Date

November 19, 2025

Last Update Submit

December 24, 2025

Conditions

Keywords

AdolescentAdolescent MedicineMental Health ServiceseHealthOnline SystemsPrimary HealthcareSocial MediaSocial Support

Outcome Measures

Primary Outcomes (1)

  • Feasibility of Intervention

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

    12 weeks

Secondary Outcomes (20)

  • 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

  • +15 more secondary outcomes

Study Arms (2)

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.

Behavioral: SOVA Ambassador

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.

Behavioral: Self-Reflection

Interventions

SOVA AmbassadorBEHAVIORAL

The SOVA Ambassador intervention includes: adolescents will have access to the website specifically for adolescents: sova.pitt.edu These anonymous websites aim to: (1) challenge negative health beliefs and increase depression/anxiety knowledge through daily blog posts enhanced with peer commentary; (2) promote social support through online peer interactions; and (3) encourage parent-adolescent mental health communication through same day blog posts with questions for discussion. Participants that receive this intervention will contribute monthly articles and regular comments.

SOVA Peer Ambassador Program
Self-ReflectionBEHAVIORAL

Participant will be given an article from the sova.pitt.edu website and a prompt to write about privately.

attention control: brief psychoeducational independent assignments

Eligibility Criteria

Age14 Years - 21 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Limitations and Caveats

All collected data for pre-specified primary and secondary outcome measures were summarized and reported in the outcome measure data tables. The planned statistical analyses were not performed due to insufficient enrollment and additional pre-planned analyses being statistically inappropriate.

Results Point of Contact

Title
Ana Radovic MD, MSc
Organization
University of Pittsburgh

Study Officials

  • Ana Radovic, MD, MSc

    University of Pittsburgh

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The statistician conducting analyses will be blinded to randomized arm.
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

September 27, 2023

First Posted

October 4, 2023

Study Start

October 25, 2023

Primary Completion

November 22, 2024

Study Completion

November 22, 2024

Last Updated

January 16, 2026

Results First Posted

January 16, 2026

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will share

Trial outcome data can be accessed by contacting the study principal investigator.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR

Locations