- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03318666
Supporting Our Valued Adolescents Pilot Randomized Controlled Trial (SOVA)
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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Pennsylvania
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Pittsburgh, Pennsylvania, United States, 15213
- Center for Adolescent and Young Adult Health
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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:
-
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Enhanced Usual Care (EUC)
Both arms will receive this intervention
|
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.
|
Experimental: Supporting Our Valued Adolescents (SOVA)
This arm will receive the SOVA intervention in addition to Enhanced 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.
The SOVA intervention includes:
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Study retention
Time Frame: 6 weeks
|
proportion of dyads accessing 6-week to those who access baseline surveys
|
6 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Intervention acceptability
Time Frame: at study completion, an average of 1year
|
interviews with adolescent healthcare providers
|
at study completion, an average of 1year
|
Health beliefs: Stigma
Time Frame: 6 weeks
|
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.
|
6 weeks
|
Health Beliefs: Beliefs about Antidepressants - Resistance
Time Frame: 6 weeks
|
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.
|
6 weeks
|
Health Beliefs: Beliefs about Antidepressants - Meanings
Time Frame: 6 weeks
|
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.
|
6 weeks
|
Health Beliefs: Beliefs About Therapy - Adolescents
Time Frame: 6 weeks
|
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.
|
6 weeks
|
Health Beliefs: Beliefs About Therapy - Parents
Time Frame: 6 weeks
|
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.
|
6 weeks
|
Depression Knowledge
Time Frame: 6 weeks
|
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.
|
6 weeks
|
Anxiety Knowledge
Time Frame: 6 weeks
|
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.
|
6 weeks
|
Peer emotional/informational support
Time Frame: 6 weeks
|
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.
|
6 weeks
|
Peer social support
Time Frame: 6 weeks
|
Actual/Observed emotional/informational support from online coding of peer and moderator comments for types of social support
|
6 weeks
|
Parent-Adolescent Communication Quality-Parent Form-Openness Subscale
Time Frame: 6 weeks
|
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.
|
6 weeks
|
Parent-Adolescent Communication Quality-Parent Form-Extent of Problems Subscale
Time Frame: 6 weeks
|
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.
|
6 weeks
|
Parent-Adolescent Communication Quality-Adolescent Form-Openness Subscale
Time Frame: 6 weeks
|
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.
|
6 weeks
|
Parent-Adolescent Communication Quality-Adolescent Form-Extent of Problems Subscale
Time Frame: 6 weeks
|
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.
|
6 weeks
|
Perceived Need for Treatment - Open ended question
Time Frame: 6 weeks
|
Open-ended question about whether adolescent/child needs any mental health service
|
6 weeks
|
Perceived Need for Treatment - Survey Measure
Time Frame: 6 weeks
|
The General-Practice Users Perceived-Need Inventory (McNab, 2004) will be used to measure perceived need for treatment.
There is no scoring.
|
6 weeks
|
Actual Receipt of Mental Health Services
Time Frame: 6 weeks and 3 months
|
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.
|
6 weeks and 3 months
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Depressive Symptoms
Time Frame: 6 weeks
|
Patient Health Questionnaire-9 measures depression severity with a score ranging from 0 to 27, a higher score indicating greater severity.
|
6 weeks
|
Anxiety Symptoms
Time Frame: 6 weeks
|
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.
|
6 weeks
|
Functioning
Time Frame: 6 weeks
|
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.
|
6 weeks
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Relationship Quality
Time Frame: 6 weeks
|
Parent-child connectedness scale, 5 questions on a 5-point Likert scale, higher scores indicated greater connectedness
|
6 weeks
|
Adolescent Help Seeking - Adolescent Perception
Time Frame: 6 weeks
|
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
|
6 weeks
|
Adolescent Help Seeking - Parent Perception of Adolescent Help Seeking
Time Frame: 6 weeks
|
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
|
6 weeks
|
Parent Help Seeking (for Parent themselves)
Time Frame: 6 weeks
|
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
|
6 weeks
|
Parent perception of Adolescent Functioning
Time Frame: 6 weeks
|
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
|
6 weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
General 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PRO17070601
- 1K23MH111922-01A1 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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