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DepressionSOVANCT03318666

Supporting Our Valued Adolescents Pilot Randomized Controlled Trial

A study testing Supporting Our Valued Adolescents (SOVA) in people with Depression and Anxiety, run by University of Pittsburgh at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 12 to 19 years
Conditions the study is for
Depression, Anxiety
What is being tested?
Supporting Our Valued Adolescents (SOVA)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
38 participants
Where
1 siteUnited States
Study dates
17 Apr 2018to 6 Apr 2020
Phase
Interventional
Are there results?
None posted in the registry

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 12 to 19 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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
Show all 16Show fewer
  • 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

Who cannot join

  • -
  • 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
Show all 11Show fewer
  • Parent:
  • No access to internet
  • No active email account
  • Adolescent Healthcare Provier:
  • None

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Center for Adolescent and Young Adult Health

    Pittsburgh, Pennsylvania, 15213

Other trials in United States

About this study

Official title: A Pilot Randomized Controlled Trial of SOVA (Supporting Our Valued Adolescents), a Social Media Intervention for Adolescents With Depression and Anxiety and Their Parents to Increase Use of Mental Health Services

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.

Conditions
Depression, Anxiety
Being tested
Supporting Our Valued Adolescents (SOVA), Enhanced Usual Care
Keywords
Adolescent, Adolescent Medicine, Mental Health Services, eHealth, Online systems, Primary Health Care, Social media, Social support
Medical subject headings
Depression, Anxiety Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Supporting Our Valued Adolescents (SOVA)Behavioural

    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.

  • Enhanced Usual CareOther

    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.

Study groups in NCT03318666
Study groupRoleWhat they receive
Enhanced Usual Care (EUC)Active comparatorBoth arms will receive this intervention
Receives: Other: Enhanced Usual Care
Supporting Our Valued Adolescents (SOVA)ExperimentalThis arm will receive the SOVA intervention in addition to Enhanced Usual Care
Receives: Behavioral: Supporting Our Valued Adolescents (SOVA); Other: Enhanced Usual Care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Study retention

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

    Measured: 6 weeks

Secondary outcomes (25)
  1. Intervention acceptability

    interviews with adolescent healthcare providers

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 6 weeks

  10. Peer social support

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

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 6 weeks

  15. Perceived Need for Treatment - Open ended question

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

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 6 weeks

  21. Relationship Quality

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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Oct 2017
  2. Study start17 Apr 2018
  3. Primary completion6 Apr 2020
  4. Study completion6 Apr 2020

Resources

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
Double blind
Who is masked
Care provider, Outcomes assessor
Enrolment
38 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03318666
Sponsor's protocol ID
PRO17070601
Other IDs
1K23MH111922-01A1
Acronym
SOVA
Status last verified
Oct 2021
First submitted
13 Oct 2017
Last updated
26 Oct 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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

Questions about this trial

What is this clinical trial studying?

A study testing Supporting Our Valued Adolescents (SOVA) in people with Depression and Anxiety, 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 16 inclusion and 11 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: finished, as of the sponsor's last update on 26 Oct 2021. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Study retention (time frame: 6 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03318666, which also lists 4 linked publications.

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 26 Oct 2021.

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SOVA Clinical Trial NCT03318666 | AzTrials