ClinicalTrials.gg
CompletedNCT03318666SOVAUpdated Oct 26, 2021

Supporting Our Valued Adolescents Pilot Randomized Controlled Trial

An interventional study of Supporting Our Valued Adolescents (SOVA) and Enhanced Usual Care in Depression and Anxiety, sponsored by University of Pittsburgh. Completed at 1 site in United States. Open to participants aged 12 Years to 19 Years. Per ClinicalTrials.gov, last updated 2021-10-26.

Sponsored by University of Pittsburgh · Not applicable, Interventional, and Health services research

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Phase
Not applicable
Study type
Interventional
Enrollment
38
Allocation
Randomized
Ages
12 Years to 19 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 105 studies in Depression by University of Pittsburgh — 15 open to participants now, 17 under way, none of them phase 3. Depression · University of Pittsburgh.

Enrollment
79th of 98
38 · median 90
Started
2018
with 1 other
No phase
72 of 105
15 open now
Registered
63rd of 105
by date

Among the 105 studies in Depression by University of Pittsburgh, this one is the 79th largest by enrollment of the 98 interventional ones that give a count, is one of 2 that started in 2018, is one of 72 with no phase, and was the 63rd registered.

Depression

8,582 studies on the registry are indexed under Depression; 1,723 are open to participants now.

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Open to participants now

15 of the 105 studies in Depression by University of Pittsburgh are open now, in 1 country. Recruiting first, the newest first:

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Where they have run

Who these studies take

Of the 1,089 Depression studies recruiting now, 470 (43%) set no upper age limit and 519 (48%) stop at 75 or younger; 203 take children under 18; 311 take healthy volunteers.

This study: 12 Years to 19 Years · all sexes · no healthy volunteers.

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02

Study summary

The purpose of this pilot study is to provide preliminary findings testing the Supporting Our Valued Adolescents (SOVA) intervention, two social media sites (one for adolescents, one for parents) aiming to address negative health beliefs, knowledge about depression or anxiety, parent-adolescent communication, in a moderated online peer community, with the goal of increasing adolescent use of mental health services.

Read the detailed description

Although recent evidence shows integrated care models increase service use, implementing these models is resource intense. Even in primary care settings with access to services and routine screening for depression and anxiety, patient engagement is low. This can be explained by a low perceived need for services present in both adolescents and parents. Key target mechanisms which may increase service use include: (1) parents' and adolescents' health beliefs and knowledge, (2) emotional/informational support, and (3) communication about mental health with each other. The "SOVA" or "Supporting Our Valued Adolescents" intervention aims to address these key mechanisms through two moderated social media websites (one for parents, one for adolescents) which include daily blog posts, online peer to peer interactions, and discussion guides. SOVA had undergone an iterative process of design - using stakeholder-engagement and human computer interaction techniques (PCOR K12 HS 22989-1). The goal of this process was to build a usable intervention which is stakeholder-informed. Preliminary work has found that 100 adolescents/young adults with a history of depression or anxiety symptoms and parents find the SOVA websites to have good usability. The investigators will use a pilot randomized controlled trial of SOVA to refine recruitment and retention strategies, measure implementation outcomes and investigate potential mechanisms of action in depressed and/or anxious adolescents not currently engaged in treatment and their parents; and examine parent-adolescent communication factors about mental health and relationship quality in the context of a web-based intervention.

03

Conditions studied

  • Depression
  • Anxiety

Keywords

  • Adolescent
  • Adolescent Medicine
  • Mental Health Services
  • eHealth
  • Online systems
  • Primary Health Care
  • Social media
  • Social support
04

Who can participate

Ages eligible
12 Years to 19 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Adolescent:

  • Ages 12-19
  • AHCP identifies depressive and/or anxiety symptoms
  • Scores at least 5 or greater on the PHQ-9 (depression) and/or GAD-7 (anxiety) consistent with at least mild symptoms
  • AHCP recommends adolescent to initiate a new treatment episode (no treatment in past 3 months)
  • Can read and write in English
  • Have completed the 6th grade
  • Assent (\<18 y/o)/Consent to study (18 or 19 y/o)

Parent:

  • Adolescent child meets inclusion/exclusion criteria and agrees to enroll in the study
  • Can read and write in English
  • Have completed the 6th grade
  • Consent to study

Adolescent Healthcare Provider:

  • Healthcare provider (physician, nurse practitioner, physician assistant) providing clinical services in the Center for Adolescent and Young Adult Health
  • Consents to study

Exclusion criteria

Exclusion Criteria:

-

Adolescent:

  • Actively suicidal requiring crisis/hospitalization defined as: currently having suicidal thoughts and a plan AND AHCP recommends immediate crisis services and/or evaluation for hospitalization
  • History of receiving a psychiatric medication and/or psychotherapy for depression and/or anxiety in the past 3 months
  • No access to internet
  • No active email account

Parent:

  • No access to internet
  • No active email account

Adolescent Healthcare Provier:

  • None
05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Care provider, Outcomes assessor)
Enrollment
38 participants (actual)

Study arms

  • Active comparator
    Enhanced Usual Care (EUC)

    Both arms will receive this intervention

    Other: Enhanced Usual Care

  • Experimental
    Supporting Our Valued Adolescents (SOVA)

    This arm will receive the SOVA intervention in addition to Enhanced Usual Care

    Behavioral: Supporting Our Valued Adolescents (SOVA) · Other: Enhanced Usual Care

Interventions

  • BehavioralSupporting Our Valued Adolescents (SOVA)

    The SOVA intervention includes: * a welcome email to the websites (adolescents also get a SOVA intro video and mobile app) * adolescents will have access to the website specifically for adolescents: sova.pitt.edu * parents will have access to the website specifically for parents: wisesova.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. Parents and adolescents cannot log on to each other's sites. The sites are moderated by our research team. The SOVA websites include articles composed by SOVA Peer Ambassadors who are adolescents and young adults who have experienced symptoms of depression or anxiety and contribute monthly articles and regular comments.

  • OtherEnhanced Usual Care

    A social worker at the Center for Adolescent and Young Adult Health (CAYAH) clinic helps to facilitate referrals from the adolescent healthcare provider (AHCP) and contacts patients who do not schedule for within-CAYAH appointments.The study will send an extra email to the parent and adolescent that contains the content of the depart summary as well as a list of psychoeducational materials, how to contact the AHCP, CAYAH social worker, and crisis resources and the AHCP's treatment recommendation which are obtained from the electronic health record. Also, each individual will receive a phone call from a research assistant who will communicate the information in the email and offer to inform the social worker or AHCP of questions the patient or parent may have.

06

What researchers measure

Primary outcomes

  1. Study retention

    proportion of dyads accessing 6-week to those who access baseline surveys

    Time frame: 6 weeks

Secondary outcomes

  1. Intervention acceptability

    interviews with adolescent healthcare providers

    Time frame: at study completion, an average of 1year

  2. Health beliefs: Stigma

    The Depression Stigma Scale (Griffiths 2004) measurizes 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.

    Time frame: 6 weeks

  3. Health Beliefs: Beliefs about Antidepressants - Resistance

    The Resistance to Antidepressant Use Questionnaire (Cohane, 2008) measures an individual's resistance toward taking antidepressant medication if prescribed. It is a continuous measure and the total score ranges from 0 to 18, with a higher score indicating greater resistance.

    Time frame: 6 weeks

  4. Health Beliefs: Beliefs about Antidepressants - Meanings

    The Antidepressant Meanings Scale (Cohane, 2008) measures an individual's level of negative attitudes toward taking an antidepressant medication if prescribed. It is a continuous measure and the total score ranges from 0 to 24, with a higher score indicating more negative attitudes.

    Time frame: 6 weeks

  5. Health Beliefs: Beliefs About Therapy - Adolescents

    Barriers to Adolescents Seeking Help Scale (Wilson 2005/Kuhl 1997) measures perceptions about seeking treatment from a mental health provider. The total score ranges from 1 to 11, a higher score indicated greater barriers.

    Time frame: 6 weeks

  6. Health Beliefs: Beliefs About Therapy - Parents

    The Parental version of the Barriers to Help Seeking Scale (Bates, 2010) measures parental perceptions about their child seeking treatment from a mental health provider. The total score ranges from 1 to 11, a higher score indicated greater barriers.

    Time frame: 6 weeks

  7. Depression Knowledge

    The Depression literacy questionnaire (Gulliver 2012) measures knowledge about depression diagnosis and treatment. The total score ranges from 0-22, with a higher score indicating greater knowledge of depression.

    Time frame: 6 weeks

  8. Anxiety Knowledge

    The Anxiety literacy questionnaire (Gulliver 2012) measures knowledge about depression diagnosis and treatment. The total score ranges from 0-22, with a higher score indicating greater knowledge of anxiety.

    Time frame: 6 weeks

  9. Peer emotional/informational support

    The Medical Outcome Study Social Support Scale (Sherbourne, 1991) has a single subscale named the Emotional/informational subscale which measures types of social support which either provide emotional support or provide information. This subscale ranges from 0-100, with higher levels associated with greater support.

    Time frame: 6 weeks

  10. Peer social support

    Actual/Observed emotional/informational support from online coding of peer and moderator comments for types of social support

    Time frame: 6 weeks

  11. Parent-Adolescent Communication Quality-Parent Form-Openness Subscale

    The Parent-Adolescent Communication Scale measures two subscales of parent communication. This measure obtains this information from the parent perspective. The degree of openness subscale has 10 questions with a range from 10 through 50 - higher scores indicating more openness in communication.

    Time frame: 6 weeks

  12. Parent-Adolescent Communication Quality-Parent Form-Extent of Problems Subscale

    The Parent-Adolescent Communication Scale measures two subscales of parent communication. This measure obtains this information from the parent perspective. The extent of communication problems subscale has a range from 10 through 50 - higher scores indicating greater extent of problems with communication.

    Time frame: 6 weeks

  13. Parent-Adolescent Communication Quality-Adolescent Form-Openness Subscale

    The Parent-Adolescent Communication Scale measures two subscales of parent communication. This measure obtains this information from the adolescent perspective. The degree of openness subscale has 10 questions with a range from 10 through 50 - higher scores indicating more openness in communication.

    Time frame: 6 weeks

  14. Parent-Adolescent Communication Quality-Adolescent Form-Extent of Problems Subscale

    The Parent-Adolescent Communication Scale measures two subscales of parent communication. This measure obtains this information from the adolescent perspective. The extent of communication problems subscale has a range from 10 through 50 - higher scores indicating greater extent of problems with communication.

    Time frame: 6 weeks

  15. Perceived Need for Treatment - Open ended question

    Open-ended question about whether adolescent/child needs any mental health service

    Time frame: 6 weeks

  16. Perceived Need for Treatment - Survey Measure

    The General-Practice Users Perceived-Need Inventory (McNab, 2004) will be used to measure perceived need for treatment. There is no scoring.

    Time frame: 6 weeks

  17. Actual Receipt of Mental Health Services

    Combined measure using Electronic Health Record Chart Review and parent/adolescent self-report as well as the Actual Help Seeking Questionnaire (Rickwood 2005) which does not involve scoring.

    Time frame: 6 weeks and 3 months

  18. Depressive Symptoms

    Patient Health Questionnaire-9 measures depression severity with a score ranging from 0 to 27, a higher score indicating greater severity.

    Time frame: 6 weeks

  19. Anxiety Symptoms

    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.

    Time frame: 6 weeks

  20. Functioning

    The Multidimensional Adolescent Functioning Scale (Wardennar 2013) has 3 subscales of functioning for adolescents - in general, related to family, and related to peers. The total score subscales for general are 0-40; for family are 0-28; and for peer are 0-24 with a higher score indicating higher functioning. The subscales can be totalled for a range of 0-92.

    Time frame: 6 weeks

  21. Relationship Quality

    Parent-child connectedness scale, 5 questions on a 5-point Likert scale, higher scores indicated greater connectedness

    Time frame: 6 weeks

  22. Adolescent Help Seeking - Adolescent Perception

    Actual Help Seeking Questionnaire, a list of individuals help may have been sought from with indication of whether this person was seen for an emotional problem in the past 2 weeks yes or no

    Time frame: 6 weeks

  23. Adolescent Help Seeking - Parent Perception of Adolescent Help Seeking

    Actual Help Seeking Questionnaire, a list of individuals help may have been sought from with indication of whether this person was seen for an emotional problem in the past 2 weeks yes or no

    Time frame: 6 weeks

  24. Parent Help Seeking (for Parent themselves)

    Actual Help Seeking Questionnaire, a list of individuals help may have been sought from with indication of whether this person was seen for an emotional problem in the past 2 weeks yes or no

    Time frame: 6 weeks

  25. Parent perception of Adolescent Functioning

    Columbia Impairment Scale, Parent rates on a 0-4 scale how much of a problem different aspects of adolescent functioning have been, 13 item questionnaire, higher score indicates greater problems with functioning

    Time frame: 6 weeks

07

Study locations

1 site
  • Center for Adolescent and Young Adult Health
    Pittsburgh, Pennsylvania 15213, United States
08

References and documents

Publications

  • Radovic A, DeMand AL, Gmelin T, Stein BD, Miller E. SOVA: Design of a stakeholder informed social media website for depressed adolescents and their parents. J Technol Hum Serv. 2018;35(3):169-182. doi: 10.1080/15228835.2017.1347552. Epub 2017 Jul 24. PubMed 29743822 ↗
  • Radovic A, Li Y, Landsittel D, Stein BD, Miller E. A Social Media Website (Supporting Our Valued Adolescents) to Support Treatment Uptake for Adolescents With Depression and/or Anxiety and Their Parents: Protocol for a Pilot Randomized Controlled Trial. JMIR Res Protoc. 2019 Jan 23;8(1):e12117. doi: 10.2196/12117. PubMed 30672741 ↗
  • Radovic A, Odenthal K, Flores AT, Miller E, Stein BD. Prescribing Technology to Increase Uptake of Depression Treatment in Primary Care: A Pre-implementation Focus Group Study of SOVA (Supporting Our Valued Adolescents). J Clin Psychol Med Settings. 2020 Dec;27(4):766-782. doi: 10.1007/s10880-019-09669-5. PubMed 31630347 ↗
  • Radovic A, Li Y, Landsittel D, Odenthal KR, Stein BD, Miller E. A Social Media Website (Supporting Our Valued Adolescents) to Support Treatment Uptake for Adolescents With Depression or Anxiety: Pilot Randomized Controlled Trial. JMIR Ment Health. 2022 Oct 7;9(10):e35313. doi: 10.2196/35313. PubMed 36206044 ↗

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Apr 2018 to primary completion in Apr 2020, 23 months.

Of 3,471 non-industry interventional studies with no phase under Depression, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 41. This study's 23 months is close to that.

Counting every sponsor, half of 3,569 studies reached it within 21 months; a quarter within 9 and three quarters within 41.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 13, 2017
First posted
Oct 24, 2017
StartActual
Apr 17, 2018
Primary completionActual
Apr 6, 2020
CompletionActual
Apr 6, 2020
Last update
Oct 26, 2021
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 26, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03318666
Responsible party
Ana Radovic (Assistant Professor, University of Pittsburgh) — Principal investigator
First posted
Oct 24, 2017
Start date
Apr 17, 2018
Primary completion
Apr 6, 2020
Completion
Apr 6, 2020
Last update
Oct 26, 2021

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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