ClinicalTrials.gov
ClinicalTrials.gov Menu

Supporting Our Valued Adolescents Pilot Randomized Controlled Trial (SOVA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03318666
Recruitment Status : Recruiting
First Posted : October 24, 2017
Last Update Posted : April 20, 2018
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Ana Radovic, University of Pittsburgh

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.

Condition or disease Intervention/treatment Phase
Depression Anxiety Behavioral: Supporting Our Valued Adolescents (SOVA) Other: Enhanced Usual Care Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Care Provider, Outcomes Assessor)
Primary Purpose: Health Services Research
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
Actual Study Start Date : April 17, 2018
Estimated Primary Completion Date : April 2019
Estimated Study Completion Date : August 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Enhanced Usual Care (EUC)
Both arms will receive this intervention
Other: 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.

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)

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.


Other: 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.




Primary Outcome Measures :
  1. Study retention [ Time Frame: 6 weeks ]
    proportion of dyads accessing 6-week to those who access baseline surveys


Secondary Outcome Measures :
  1. Intervention acceptability [ Time Frame: at study completion, an average of 1year ]
    interviews with adolescent healthcare providers

  2. 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.

  3. 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.

  4. 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.

  5. 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. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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

  11. 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.

  12. 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.

  13. 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.

  14. 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.

  15. Perceived Need for Treatment - Open ended question [ Time Frame: 6 weeks ]
    Open-ended question about whether adolescent/child needs any mental health service

  16. 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.

  17. 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.

  18. 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.

  19. 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.

  20. 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.

  21. Relationship Quality [ Time Frame: 6 weeks ]
    Parent-child connectedness scale, 5 questions on a 5-point Likert scale, higher scores indicated greater connectedness

  22. 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

  23. 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

  24. 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

  25. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   14 Years to 19 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Adolescent:

  • Ages 14-19
  • 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
  • Parental permission if <18 y/o
  • Assent (<18 y/o)/Consent to study (18 or 19 y/o)
  • Parent agrees to enroll in study

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03318666


Contacts
Contact: Ana Radovic, MD, MSc 4126927227 ana.radovic@chp.edu
Contact: Cassandra Long, MSW 4126926949 cassandra.long@chp.edu

Locations
United States, Pennsylvania
Center for Adolescent and Young Adult Health Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Ana Radovic-Stakic, MD, MSc         
Sponsors and Collaborators
University of Pittsburgh
National Institute of Mental Health (NIMH)

Publications:
Responsible Party: Ana Radovic, Assistant Professor, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT03318666     History of Changes
Other Study ID Numbers: PRO17070601
1K23MH111922-01A1 ( U.S. NIH Grant/Contract )
First Posted: October 24, 2017    Key Record Dates
Last Update Posted: April 20, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Ana Radovic, University of Pittsburgh:
Adolescent
Adolescent Medicine
Mental Health Services
eHealth
Online systems
Primary Health Care
Social media
Social support

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders