Supporting Our Valued Adolescents Pilot Randomized Controlled Trial (SOVA)

October 23, 2021 updated by: Ana Radovic, University of Pittsburgh

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.

Study Overview

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.

Study Type

Interventional

Enrollment (Actual)

38

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 19 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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:

  • 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.

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
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
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

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 17, 2018

Primary Completion (Actual)

April 6, 2020

Study Completion (Actual)

April 6, 2020

Study Registration Dates

First Submitted

October 13, 2017

First Submitted That Met QC Criteria

October 18, 2017

First Posted (Actual)

October 24, 2017

Study Record Updates

Last Update Posted (Actual)

October 26, 2021

Last Update Submitted That Met QC Criteria

October 23, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

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)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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