Supporting Our Valued Adolescents Pilot Randomized Controlled Trial (SOVA)
Primary Purpose
Depression, Anxiety
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Supporting Our Valued Adolescents (SOVA)
Enhanced Usual Care
Sponsored by
About this trial
This is an interventional health services research trial for Depression focused on measuring Adolescent, Adolescent Medicine, Mental Health Services, eHealth, Online systems, Primary Health Care, Social media, Social support
Eligibility Criteria
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
Sites / Locations
- Center for Adolescent and Young Adult Health
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Enhanced Usual Care (EUC)
Supporting Our Valued Adolescents (SOVA)
Arm Description
Both arms will receive this intervention
This arm will receive the SOVA intervention in addition to Enhanced Usual Care
Outcomes
Primary Outcome Measures
Study retention
proportion of dyads accessing 6-week to those who access baseline surveys
Secondary Outcome Measures
Intervention acceptability
interviews with adolescent healthcare providers
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.
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.
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.
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.
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.
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.
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.
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.
Peer social support
Actual/Observed emotional/informational support from online coding of peer and moderator comments for types of social support
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.
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.
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.
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.
Perceived Need for Treatment - Open ended question
Open-ended question about whether adolescent/child needs any mental health service
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.
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.
Depressive Symptoms
Patient Health Questionnaire-9 measures depression severity with a score ranging from 0 to 27, a higher score indicating greater severity.
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.
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.
Relationship Quality
Parent-child connectedness scale, 5 questions on a 5-point Likert scale, higher scores indicated greater connectedness
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
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
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
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
Full Information
NCT ID
NCT03318666
First Posted
October 13, 2017
Last Updated
October 23, 2021
Sponsor
University of Pittsburgh
Collaborators
National Institute of Mental Health (NIMH)
1. Study Identification
Unique Protocol Identification Number
NCT03318666
Brief Title
Supporting Our Valued Adolescents Pilot Randomized Controlled Trial
Acronym
SOVA
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
April 17, 2018 (Actual)
Primary Completion Date
April 6, 2020 (Actual)
Study Completion Date
April 6, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pittsburgh
Collaborators
National Institute of Mental Health (NIMH)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Anxiety
Keywords
Adolescent, Adolescent Medicine, Mental Health Services, eHealth, Online systems, Primary Health Care, Social media, Social support
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
38 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Enhanced Usual Care (EUC)
Arm Type
Active Comparator
Arm Description
Both arms will receive this intervention
Arm Title
Supporting Our Valued Adolescents (SOVA)
Arm Type
Experimental
Arm Description
This arm will receive the SOVA intervention in addition to Enhanced Usual Care
Intervention Type
Behavioral
Intervention Name(s)
Supporting Our Valued Adolescents (SOVA)
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Enhanced Usual Care
Intervention Description
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.
Primary Outcome Measure Information:
Title
Study retention
Description
proportion of dyads accessing 6-week to those who access baseline surveys
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Intervention acceptability
Description
interviews with adolescent healthcare providers
Time Frame
at study completion, an average of 1year
Title
Health beliefs: Stigma
Description
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
Title
Health Beliefs: Beliefs about Antidepressants - Resistance
Description
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
Title
Health Beliefs: Beliefs about Antidepressants - Meanings
Description
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
Title
Health Beliefs: Beliefs About Therapy - Adolescents
Description
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
Title
Health Beliefs: Beliefs About Therapy - Parents
Description
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
Title
Depression Knowledge
Description
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
Title
Anxiety Knowledge
Description
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
Title
Peer emotional/informational support
Description
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
Title
Peer social support
Description
Actual/Observed emotional/informational support from online coding of peer and moderator comments for types of social support
Time Frame
6 weeks
Title
Parent-Adolescent Communication Quality-Parent Form-Openness Subscale
Description
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
Title
Parent-Adolescent Communication Quality-Parent Form-Extent of Problems Subscale
Description
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
Title
Parent-Adolescent Communication Quality-Adolescent Form-Openness Subscale
Description
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
Title
Parent-Adolescent Communication Quality-Adolescent Form-Extent of Problems Subscale
Description
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
Title
Perceived Need for Treatment - Open ended question
Description
Open-ended question about whether adolescent/child needs any mental health service
Time Frame
6 weeks
Title
Perceived Need for Treatment - Survey Measure
Description
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
Title
Actual Receipt of Mental Health Services
Description
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
Title
Depressive Symptoms
Description
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
Title
Anxiety Symptoms
Description
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
Title
Functioning
Description
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
Title
Relationship Quality
Description
Parent-child connectedness scale, 5 questions on a 5-point Likert scale, higher scores indicated greater connectedness
Time Frame
6 weeks
Title
Adolescent Help Seeking - Adolescent Perception
Description
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
Title
Adolescent Help Seeking - Parent Perception of Adolescent Help Seeking
Description
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
Title
Parent Help Seeking (for Parent themselves)
Description
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
Title
Parent perception of Adolescent Functioning
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Center for Adolescent and Young Adult Health
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
29743822
Citation
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.
Results Reference
background
PubMed Identifier
30672741
Citation
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.
Results Reference
background
PubMed Identifier
31630347
Citation
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.
Results Reference
background
PubMed Identifier
36206044
Citation
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.
Results Reference
derived
Learn more about this trial
Supporting Our Valued Adolescents Pilot Randomized Controlled Trial
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