DepressionNCT06066697
SOVA Ambassadors Community Setting
A study testing SOVA Ambassador and Self-Reflection in people with Depression, run by University of Pittsburgh at 1 site in United States.
Trial summary
The purpose of this study is to examine participant adherence to intervention feasibility and acceptability of intervention, attention control, and implementation strategy. Read more about this study
- Who is it for?
- Ages 14 to 21 years
- Conditions the study is for
- Depression
- What is being tested?
- SOVA Ambassador and Self-Reflection
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Oct 2023to 22 Nov 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
About this study
The purpose of this study is to examine participant adherence to intervention feasibility and acceptability of intervention, attention control, and implementation strategy.
Read the 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.
- Conditions
- Depression
- Being tested
- SOVA Ambassador, Self-Reflection
- Keywords
- Adolescent, Adolescent Medicine, Mental Health Services, eHealth, Online Systems, Primary Healthcare, Social Media, Social Support
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SOVA AmbassadorBehavioural
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.
Self-ReflectionBehavioural
Participant will be given an article from the sova.pitt.edu website and a prompt to write about privately.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Self-Reflection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of Intervention
Average number of articles written per participant; Research team extract data from websites and observation notes
Measured: 12 weeks
Secondary outcomes (20)
Feasibility of Control Arm
Average number of submissions to questions on the REDCap form per participant in the Attention control arm Research team extract data from REDCap
Measured: 12 weeks
Acceptability of Intervention
Acceptability of Intervention Measure; Open-ended question (asked the SOVA Website meets my approval)
Measured: 12 weeks
Acceptability of Implementation Strategy
Open-ended question: How acceptable to you was it to participate in this program? (referring to mental health program used as an implementation strategy) asked at baseline
Measured: Baseline
Acceptability of Randomization
Single item open-ended question inquiring how acceptable it was to being randomly chosen to participate in the SOVA Ambassador arm versus the control arm
Measured: 12 weeks
Depression Severity
Patient Health Questionnaire-9 measures depression severity a higher score indicating greater severity.
The PHQ-8 version was used with the 9th item omitted, score range is 0 to 24
Measured: 6 weeks
Depression Severity
Patient Health Questionnaire-9 measures depression severity a higher score indicating greater severity.
The PHQ-8 version was used with the 9th item omitted, score range is 0 to 24
Measured: 12 weeks
Anxiety Severity
Generalized Anxiety Disorders 7-item Questionnaire measures extent of anxiety symptoms. The total score ranges from 0 to 21 with a higher score indicating greater severity.
Measured: 6 weeks
Anxiety Severity
Generalized Anxiety Disorders 7-item Questionnaire measures extent of anxiety symptoms. The total score ranges from 0 to 21 with a higher score indicating greater severity.
Measured: 12 weeks
Resilience/Positive Youth Development
Positive Youth Development will be assessed using The Positive Youth Development Very Short Form (PYD-VSF). The confidence subscale is reported which has 3 items with a total score ranging from 3 to 13 (α = 0.78), a higher score associated with a greater level of confidence.
Measured: 6 weeks
Resilience/Positive Youth Development
Positive Youth Development will be assessed using The Positive Youth Development Very Short Form (PYD-VSF). The confidence subscale is reported which has 3 items with a total score ranging from 3 to 13 (α = 0.78), a higher score associated with a greater level of confidence.
Measured: 12 weeks
Self-Esteem
The 10-item Rosenberg Self-Esteem Scale (RSES) (α = 0.93) will be administered to assess participants' self-esteem. Items on the Rosenberg Self-Esteem Scale ask about self-worth and self-acceptance and are scored using a four-point scale from 1 = strongly disagree, to 4 = strongly agree. The scores on each question are summed together, with higher scores indicating greater self-esteem. Scores range from 10-40 with a higher score equating to higher self esteem.
Measured: 6 weeks
Self-Esteem
The 10-item Rosenberg Self-Esteem Scale (RSES) (α = 0.93) will be administered to assess participants' self-esteem. Items on the Rosenberg Self-Esteem Scale ask about self-worth and self-acceptance and are scored using a four-point scale from 1 = strongly disagree, to 4 = strongly agree. The scores on each question are summed together, with higher scores indicating greater self-esteem. Scores range from 10-40
Measured: 12 weeks
Emotional Self-Efficacy
Emotional self-efficacy will be assessed using The Mental Health Self-Efficacy Scale (MHSES) (α = 0.82) Clarke 2014. MHSES was developed according to guidelines by Bandura as to how to create self-efficacy questionnaires (Bandura, 2006) . The questionnaire contains six items asking about the participant's confidence level in performing mental health self-care behaviors. Scoring of the MHSES is based on a 10-point Likert scale ranging from 1 ("Not at all confident") to 10 ("Totally confident"). Scores are a mean score ranging 1-10 with higher scores meaning higher mental health self-efficacy.
Measured: 6 weeks
Emotional Self-Efficacy
Emotional self-efficacy will be assessed using The Mental Health Self-Efficacy Scale (MHSES) (α = 0.82) Clarke 2014. MHSES was developed according to guidelines by Bandura as to how to create self-efficacy questionnaires (Bandura, 2006) . The questionnaire contains six items asking about the participant's confidence level in performing mental health self-care behaviors. Scoring of the MHSES is based on a 10-point Likert scale ranging from 1 ("Not at all confident") to 10 ("Totally confident"). Scores are a mean score ranging 1-10 with higher scores meaning higher mental health self-efficacy.
Measured: 12 weeks
Social Support
The Medical Outcome Study Social Support Scale measures types of social support. Higher levels associated with greater support. We will use the emotional/informational subscale from this report and calculate the mean per item score on a range of 1 to 5.
Measured: 6 weeks
Social Support
The Medical Outcome Study Social Support Scale measures types of social support. Higher levels associated with greater support. We will use the emotional/informational subscale from this report and calculate the mean per item score on a range of 1 to 5.
Measured: 12 weeks
Social Isolation
The revised UCLA Loneliness Scale will be administered to all participants to measure social isolation (α = 0.93). This 20-item scale measures one's feelings of social isolation and is scored using a four-point scale (1 = never; 2 = rarely; 3 = sometimes; 4 = often) . Score range 20-80, higher score is higher isolation.
Measured: 6 weeks
Social Isolation
The revised UCLA Loneliness Scale will be administered to all participants to measure social isolation (α = 0.93). This 20-item scale measures one's feelings of social isolation and is scored using a four-point scale (1 = never; 2 = rarely; 3 = sometimes; 4 = often) . Score range 20-80, higher score is higher isolation.
Measured: 12 weeks
Stigma
The Depression Stigma Scale measures stigmatizing attitudes toward depression treatment. It is a continuous measure and the total score ranges from 0-36. There are two subscales: the personal stigma subscale which totals 0-18 and the perceived stigma subscale which totals 0-18. These two are summed for the total stigma score. A higher score indicates a worse outcome.
Measured: 6 weeks
Stigma
The Depression Stigma Scale measures stigmatizing attitudes toward depression treatment. It is a continuous measure and the total score ranges from 0-36. There are two subscales: the personal stigma subscale which totals 0-18 and the perceived stigma subscale which totals 0-18. These two are summed for the total stigma score. A higher score indicates a worse outcome.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2023
- Study start25 Oct 2023
- Primary completion22 Nov 2024
- Study completion22 Nov 2024
Why it stopped: As a result of insufficient remaining funds and the expiration of the project timeline
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Responsible party
- Principal investigator, Ana Radovic, University of Pittsburgh
- Investigators
- Ana Radovic, MD, MSc, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06066697
- Sponsor's protocol ID
- STUDY23020021
- Other IDs
- R21MD016143
- Status last verified
- Dec 2025
- First submitted
- 27 Sep 2023
- Last updated
- 16 Jan 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Trial outcome data can be accessed by contacting the study principal investigator.
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SOVA Ambassadors Community Setting
- ClinicalTrials.gov ID
- NCT06066697
- Acronym / sponsor ID
- STUDY23020021
- Conditions
- Depression
- Keywords
- Adolescent, Adolescent Medicine, Mental Health Services, eHealth, Online Systems, Primary Healthcare, Social Media, Social Support
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: As a result of insufficient remaining funds and the expiration of the project timeline
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Study start
- 25 Oct 2023 (actual)
- Primary completion
- 22 Nov 2024 (actual)
- Study completion
- 22 Nov 2024 (actual)
- First posted
- 4 Oct 2023 (actual)
- Results
- Posted 16 Jan 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SOVA Peer Ambassador Program | Experimental | Behavioral: SOVA AmbassadorParticipants 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. |
| attention control: brief psychoeducational independent assignments | Active comparator | Behavioral: Self-ReflectionParticipants 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. |
Who may qualify
- Ages
- 14 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SOVA AmbassadorThe 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. | Behavioural | SOVA Peer Ambassador Program |
| Self-ReflectionParticipant will be given an article from the sova.pitt.edu website and a prompt to write about privately. | Behavioural | attention control: brief psychoeducational independent assignments |
Primary outcome
Feasibility of Intervention
Time frame: 12 weeks
Average number of articles written per participant; Research team extract data from websites and observation notes
20 secondary outcomes
Feasibility of Control Arm
Time frame: 12 weeks
Acceptability of Intervention
Time frame: 12 weeks
Acceptability of Implementation Strategy
Time frame: Baseline
Acceptability of Randomization
Time frame: 12 weeks
Depression Severity
Time frame: 6 weeks
Depression Severity
Time frame: 12 weeks
Anxiety Severity
Time frame: 6 weeks
Anxiety Severity
Time frame: 12 weeks
Resilience/Positive Youth Development
Time frame: 6 weeks
Resilience/Positive Youth Development
Time frame: 12 weeks
Self-Esteem
Time frame: 6 weeks
Self-Esteem
Time frame: 12 weeks
Emotional Self-Efficacy
Time frame: 6 weeks
Emotional Self-Efficacy
Time frame: 12 weeks
Social Support
Time frame: 6 weeks
Social Support
Time frame: 12 weeks
Social Isolation
Time frame: 6 weeks
Social Isolation
Time frame: 12 weeks
Stigma
Time frame: 6 weeks
Stigma
Time frame: 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Trial outcome data can be accessed by contacting the study principal investigator.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ana Radovic, MD, MSc principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SOVA Ambassador and Self-Reflection in people with Depression, run by University of Pittsburgh at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 16 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Jan 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of Intervention (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2026.