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SOVA Ambassadors Community Setting

Primary Purpose

Depression

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
SOVA Ambassador
Self-Reflection
Sponsored by
University of Pittsburgh
About
Eligibility
Locations
Arms
Outcomes
Full info

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 Healthcare, Social Media, Social Support

Eligibility Criteria

14 Years - 21 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Ages 14 to 21 Can read and understand English Has completed 6th grade Scores at least 5 or greater on the PHQ-8 (depression) and/or 5 or greater on GAD-7 (anxiety) consistent with at least mild symptoms Exclusion Criteria: no access to internet Has an intellectual or physical ability which prohibits reading text on the internet (can participate if able to use with assistance, e.g. can use text to speech) No active email account (can participate if plans to create one)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    SOVA Peer Ambassador Program

    attention control: brief psychoeducational independent assignments

    Arm Description

    Participants will be given login information for a website sova.pitt.edu. They will be given weekly emails notifications about new posts. The participant will be onboarded as a blogging peer ambassador. The participant will be expected to contribute content to the website at least once a month by writing a blog article sending information (de-identified photo or video or music) to post • If they choose this option they will be encouraged to submit their own photo, video, or music to the website or they will be encouraged to write a response to a photo, video, or music piece. being interviewed by the RA and then the RA "ghostwriting" an article about the interview which they pre-approve prior to it being posted.

    Participants will be sent a REDCap form where they will receive a link to a SOVA article to read and a question for them to answer about what they read that will be accessible only to the study team. They will be asked to do this a couple times a month and will be reminded about their participation.

    Outcomes

    Primary Outcome Measures

    Feasibility of Intervention
    Average number of articles written per participant; Research team extract data from websites and observation notes

    Secondary Outcome Measures

    Feasibility of Control Arm
    Average number of submissions to questions on the REDCap form per participant in the Attention control arm Research team extract data from REDCap
    Acceptability of Intervention
    Acceptability of Intervention Measure; Open-ended question
    Acceptability of Implementation Strategy
    Open-ended question
    Acceptability of Randomization
    Single item open-ended question
    Change from Baseline in Depression Severity
    Patient Health Questionnaire-9 (Kroenke, 2001) measures depression severity with a score ranging from 0 to 27, a higher score indicating greater severity.
    Change from Baseline in Depression Severity
    Patient Health Questionnaire-9 (Kroenke, 2001) measures depression severity with a score ranging from 0 to 27, a higher score indicating greater severity.
    Change from Baseline in Anxiety Severity
    Generalized Anxiety Disorders 7-item Questionnaire (Spitzer, 2007) measures extent of anxiety symptoms. The total score ranges from 0 to 21 with a higher score indicating greater severity.
    Change from Baseline in Anxiety Severity
    Generalized Anxiety Disorders 7-item Questionnaire (Spitzer, 2007) measures extent of anxiety symptoms. The total score ranges from 0 to 21 with a higher score indicating greater severity.
    Change from Baseline in Resilience/Positive Youth Development
    Positive Youth Development will be assessed using The Positive Youth Development Very Short Form (PYD-VSF) (Geldhof et al., 2014). The PYD-VSF is a questionnaire that measures adolescent strengths based on the Lerner and Lerner Five Cs of PYD (Lerner et al., 2005): competence (3 items, total score ranging from 3 to 12) (α = 0.12), connection (4 items, total score ranging from 4 to 20) (α = 0.78), confidence (3 items, total score ranging from 3 to 13) (α = 0.78), caring (3 items, total score ranging from 3 to 15) (α = 0.85), and character (4 items, total score ranging from 4 to 19) (α = 0.45). The PYD-SF was shown to have structural validity evidence that ran parallel with its derivative, the PYD-Short Form, among a population of adolescents (Geldhof et al., 2014).
    Change from Baseline in Resilience/Positive Youth Development
    Positive Youth Development will be assessed using The Positive Youth Development Very Short Form (PYD-VSF) (Geldhof et al., 2014). The PYD-VSF is a questionnaire that measures adolescent strengths based on the Lerner and Lerner Five Cs of PYD (Lerner et al., 2005): competence (3 items, total score ranging from 3 to 12) (α = 0.12), connection (4 items, total score ranging from 4 to 20) (α = 0.78), confidence (3 items, total score ranging from 3 to 13) (α = 0.78), caring (3 items, total score ranging from 3 to 15) (α = 0.85), and character (4 items, total score ranging from 4 to 19) (α = 0.45). The PYD-SF was shown to have structural validity evidence that ran parallel with its derivative, the PYD-Short Form, among a population of adolescents (Geldhof et al., 2014).
    Change from Baseline in Self-Esteem
    The 10-item Rosenberg Self-Esteem Scale (RSES) (Rosenberg, 1965) (α = 0.93) will be administered to assess participants' self-esteem. Items on the Rosenberg Self-Esteem Scale ask about self-worth and self-acceptance and are scored using a four-point scale from 1 = strongly disagree, to 4 = strongly agree. The scores on each question are summed together, with higher scores indicating greater self-esteem. The RSES is the most widely used measure of global self-esteem in the literature (Blascovich & Tomaka, 1991) and demonstrates concurrent, predictive and construct validity with being significantly correlated with other measures of self-esteem and predictive measures of depression and anxiety (Morris Rosenberg, 1979).
    Change from Baseline in Self-Esteem
    The 10-item Rosenberg Self-Esteem Scale (RSES) (Rosenberg, 1965) (α = 0.93) will be administered to assess participants' self-esteem. Items on the Rosenberg Self-Esteem Scale ask about self-worth and self-acceptance and are scored using a four-point scale from 1 = strongly disagree, to 4 = strongly agree. The scores on each question are summed together, with higher scores indicating greater self-esteem. The RSES is the most widely used measure of global self-esteem in the literature (Blascovich & Tomaka, 1991) and demonstrates concurrent, predictive and construct validity with being significantly correlated with other measures of self-esteem and predictive measures of depression and anxiety (Morris Rosenberg, 1979).
    Change from Baseline in Emotional Self-Efficacy
    Emotional self-efficacy will be assessed using The Mental Health Self-Efficacy Scale (MHSES) (α = 0.82). MHSES was developed according to guidelines by Bandura as to how to create self-efficacy questionnaires (Bandura, 2006) . The questionnaire contains five items asking about the participant's confidence level in performing mental health self-care behaviors. Scoring of the MHSES is based on a five-point Likert scale (0 = disagree very much, to 5 = agree very much).
    Change from Baseline in Emotional Self-Efficacy
    Emotional self-efficacy will be assessed using The Mental Health Self-Efficacy Scale (MHSES) (α = 0.82). MHSES was developed according to guidelines by Bandura as to how to create self-efficacy questionnaires (Bandura, 2006) . The questionnaire contains five items asking about the participant's confidence level in performing mental health self-care behaviors. Scoring of the MHSES is based on a five-point Likert scale (0 = disagree very much, to 5 = agree very much).
    Change from Baseline in Social Support
    The Medical Outcome Study Social Support Scale (Sherbourne, 1991) measures types of social support. This subscale ranges from 0-100, with higher levels associated with greater support. We will use the emotional/informational subscale from this report. (Measured in adolescent and parents)
    Change from Baseline in Social Support
    The Medical Outcome Study Social Support Scale (Sherbourne, 1991) measures types of social support. This subscale ranges from 0-100, with higher levels associated with greater support. We will use the emotional/informational subscale from this report. (Measured in adolescent and parents)
    Change from Baseline in Social Isolation
    The revised UCLA Loneliness Scale will be administered to all participants to measure social isolation (α = 0.93). This 20-item scale measures one's feelings of social isolation and is scored using a four-point scale (1 = never; 2 = rarely; 3 = sometimes; 4 = often) (Russell, Peplau, & Cutrona, 1980). The revised measure was updated to counter possible effects of response bias and was shown to have evidence for concurrent and discriminant validity among college students (Russell et al., 1980).
    Change from Baseline in Social Isolation
    The revised UCLA Loneliness Scale will be administered to all participants to measure social isolation (α = 0.93). This 20-item scale measures one's feelings of social isolation and is scored using a four-point scale (1 = never; 2 = rarely; 3 = sometimes; 4 = often) (Russell, Peplau, & Cutrona, 1980). The revised measure was updated to counter possible effects of response bias and was shown to have evidence for concurrent and discriminant validity among college students (Russell et al., 1980).
    Change from Baseline in Stigma
    The Depression Stigma Scale (Griffiths 2004) measures 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.
    Change from Baseline in Stigma
    The Depression Stigma Scale (Griffiths 2004) measures 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.

    Full Information

    First Posted
    September 27, 2023
    Last Updated
    September 27, 2023
    Sponsor
    University of Pittsburgh
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06066697
    Brief Title
    SOVA Ambassadors Community Setting
    Official Title
    SOVA Ambassadors Community Setting
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 15, 2023 (Anticipated)
    Primary Completion Date
    September 1, 2024 (Anticipated)
    Study Completion Date
    December 1, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Pittsburgh

    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 study is to examine participant adherence to intervention feasibility and acceptability of intervention, attention control, and implementation strategy.
    Detailed Description
    A 1:1 pilot randomized controlled trial of the SOVA Peer Ambassador Program compared to attention control: brief psychoeducational independent assignments (i.e. reading SOVA articles and responding to open-ended questions without content creation and without peer interaction) (N=40) and evaluate feasibility of implementation strategy.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Depression
    Keywords
    Adolescent, Adolescent Medicine, Mental Health Services, eHealth, Online Systems, Primary Healthcare, Social Media, Social Support

    7. Study Design

    Primary Purpose
    Health Services Research
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Masking Description
    The statistician conducting analyses will be blinded to randomized arm.
    Allocation
    Randomized
    Enrollment
    40 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    SOVA Peer Ambassador Program
    Arm Type
    Experimental
    Arm Description
    Participants will be given login information for a website sova.pitt.edu. They will be given weekly emails notifications about new posts. The participant will be onboarded as a blogging peer ambassador. The participant will be expected to contribute content to the website at least once a month by writing a blog article sending information (de-identified photo or video or music) to post • If they choose this option they will be encouraged to submit their own photo, video, or music to the website or they will be encouraged to write a response to a photo, video, or music piece. being interviewed by the RA and then the RA "ghostwriting" an article about the interview which they pre-approve prior to it being posted.
    Arm Title
    attention control: brief psychoeducational independent assignments
    Arm Type
    Active Comparator
    Arm Description
    Participants will be sent a REDCap form where they will receive a link to a SOVA article to read and a question for them to answer about what they read that will be accessible only to the study team. They will be asked to do this a couple times a month and will be reminded about their participation.
    Intervention Type
    Behavioral
    Intervention Name(s)
    SOVA Ambassador
    Intervention Description
    The SOVA Ambassador intervention includes: adolescents will have access to the website specifically for adolescents: sova.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. Participants that receive this intervention will contribute monthly articles and regular comments.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Self-Reflection
    Intervention Description
    Participant will be given an article from the sova.pitt.edu website and a prompt to write about privately.
    Primary Outcome Measure Information:
    Title
    Feasibility of Intervention
    Description
    Average number of articles written per participant; Research team extract data from websites and observation notes
    Time Frame
    12 weeks
    Secondary Outcome Measure Information:
    Title
    Feasibility of Control Arm
    Description
    Average number of submissions to questions on the REDCap form per participant in the Attention control arm Research team extract data from REDCap
    Time Frame
    12 weeks
    Title
    Acceptability of Intervention
    Description
    Acceptability of Intervention Measure; Open-ended question
    Time Frame
    12 weeks
    Title
    Acceptability of Implementation Strategy
    Description
    Open-ended question
    Time Frame
    Baseline
    Title
    Acceptability of Randomization
    Description
    Single item open-ended question
    Time Frame
    12 weeks
    Title
    Change from Baseline in Depression Severity
    Description
    Patient Health Questionnaire-9 (Kroenke, 2001) measures depression severity with a score ranging from 0 to 27, a higher score indicating greater severity.
    Time Frame
    6 weeks
    Title
    Change from Baseline in Depression Severity
    Description
    Patient Health Questionnaire-9 (Kroenke, 2001) measures depression severity with a score ranging from 0 to 27, a higher score indicating greater severity.
    Time Frame
    12 weeks
    Title
    Change from Baseline in Anxiety Severity
    Description
    Generalized Anxiety Disorders 7-item Questionnaire (Spitzer, 2007) 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
    Change from Baseline in Anxiety Severity
    Description
    Generalized Anxiety Disorders 7-item Questionnaire (Spitzer, 2007) measures extent of anxiety symptoms. The total score ranges from 0 to 21 with a higher score indicating greater severity.
    Time Frame
    12 weeks
    Title
    Change from Baseline in Resilience/Positive Youth Development
    Description
    Positive Youth Development will be assessed using The Positive Youth Development Very Short Form (PYD-VSF) (Geldhof et al., 2014). The PYD-VSF is a questionnaire that measures adolescent strengths based on the Lerner and Lerner Five Cs of PYD (Lerner et al., 2005): competence (3 items, total score ranging from 3 to 12) (α = 0.12), connection (4 items, total score ranging from 4 to 20) (α = 0.78), confidence (3 items, total score ranging from 3 to 13) (α = 0.78), caring (3 items, total score ranging from 3 to 15) (α = 0.85), and character (4 items, total score ranging from 4 to 19) (α = 0.45). The PYD-SF was shown to have structural validity evidence that ran parallel with its derivative, the PYD-Short Form, among a population of adolescents (Geldhof et al., 2014).
    Time Frame
    6 weeks
    Title
    Change from Baseline in Resilience/Positive Youth Development
    Description
    Positive Youth Development will be assessed using The Positive Youth Development Very Short Form (PYD-VSF) (Geldhof et al., 2014). The PYD-VSF is a questionnaire that measures adolescent strengths based on the Lerner and Lerner Five Cs of PYD (Lerner et al., 2005): competence (3 items, total score ranging from 3 to 12) (α = 0.12), connection (4 items, total score ranging from 4 to 20) (α = 0.78), confidence (3 items, total score ranging from 3 to 13) (α = 0.78), caring (3 items, total score ranging from 3 to 15) (α = 0.85), and character (4 items, total score ranging from 4 to 19) (α = 0.45). The PYD-SF was shown to have structural validity evidence that ran parallel with its derivative, the PYD-Short Form, among a population of adolescents (Geldhof et al., 2014).
    Time Frame
    12 weeks
    Title
    Change from Baseline in Self-Esteem
    Description
    The 10-item Rosenberg Self-Esteem Scale (RSES) (Rosenberg, 1965) (α = 0.93) will be administered to assess participants' self-esteem. Items on the Rosenberg Self-Esteem Scale ask about self-worth and self-acceptance and are scored using a four-point scale from 1 = strongly disagree, to 4 = strongly agree. The scores on each question are summed together, with higher scores indicating greater self-esteem. The RSES is the most widely used measure of global self-esteem in the literature (Blascovich & Tomaka, 1991) and demonstrates concurrent, predictive and construct validity with being significantly correlated with other measures of self-esteem and predictive measures of depression and anxiety (Morris Rosenberg, 1979).
    Time Frame
    6 weeks
    Title
    Change from Baseline in Self-Esteem
    Description
    The 10-item Rosenberg Self-Esteem Scale (RSES) (Rosenberg, 1965) (α = 0.93) will be administered to assess participants' self-esteem. Items on the Rosenberg Self-Esteem Scale ask about self-worth and self-acceptance and are scored using a four-point scale from 1 = strongly disagree, to 4 = strongly agree. The scores on each question are summed together, with higher scores indicating greater self-esteem. The RSES is the most widely used measure of global self-esteem in the literature (Blascovich & Tomaka, 1991) and demonstrates concurrent, predictive and construct validity with being significantly correlated with other measures of self-esteem and predictive measures of depression and anxiety (Morris Rosenberg, 1979).
    Time Frame
    12 weeks
    Title
    Change from Baseline in Emotional Self-Efficacy
    Description
    Emotional self-efficacy will be assessed using The Mental Health Self-Efficacy Scale (MHSES) (α = 0.82). MHSES was developed according to guidelines by Bandura as to how to create self-efficacy questionnaires (Bandura, 2006) . The questionnaire contains five items asking about the participant's confidence level in performing mental health self-care behaviors. Scoring of the MHSES is based on a five-point Likert scale (0 = disagree very much, to 5 = agree very much).
    Time Frame
    6 weeks
    Title
    Change from Baseline in Emotional Self-Efficacy
    Description
    Emotional self-efficacy will be assessed using The Mental Health Self-Efficacy Scale (MHSES) (α = 0.82). MHSES was developed according to guidelines by Bandura as to how to create self-efficacy questionnaires (Bandura, 2006) . The questionnaire contains five items asking about the participant's confidence level in performing mental health self-care behaviors. Scoring of the MHSES is based on a five-point Likert scale (0 = disagree very much, to 5 = agree very much).
    Time Frame
    12 weeks
    Title
    Change from Baseline in Social Support
    Description
    The Medical Outcome Study Social Support Scale (Sherbourne, 1991) measures types of social support. This subscale ranges from 0-100, with higher levels associated with greater support. We will use the emotional/informational subscale from this report. (Measured in adolescent and parents)
    Time Frame
    6 weeks
    Title
    Change from Baseline in Social Support
    Description
    The Medical Outcome Study Social Support Scale (Sherbourne, 1991) measures types of social support. This subscale ranges from 0-100, with higher levels associated with greater support. We will use the emotional/informational subscale from this report. (Measured in adolescent and parents)
    Time Frame
    12 weeks
    Title
    Change from Baseline in Social Isolation
    Description
    The revised UCLA Loneliness Scale will be administered to all participants to measure social isolation (α = 0.93). This 20-item scale measures one's feelings of social isolation and is scored using a four-point scale (1 = never; 2 = rarely; 3 = sometimes; 4 = often) (Russell, Peplau, & Cutrona, 1980). The revised measure was updated to counter possible effects of response bias and was shown to have evidence for concurrent and discriminant validity among college students (Russell et al., 1980).
    Time Frame
    6 weeks
    Title
    Change from Baseline in Social Isolation
    Description
    The revised UCLA Loneliness Scale will be administered to all participants to measure social isolation (α = 0.93). This 20-item scale measures one's feelings of social isolation and is scored using a four-point scale (1 = never; 2 = rarely; 3 = sometimes; 4 = often) (Russell, Peplau, & Cutrona, 1980). The revised measure was updated to counter possible effects of response bias and was shown to have evidence for concurrent and discriminant validity among college students (Russell et al., 1980).
    Time Frame
    12 weeks
    Title
    Change from Baseline in Stigma
    Description
    The Depression Stigma Scale (Griffiths 2004) measures 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
    Change from Baseline in Stigma
    Description
    The Depression Stigma Scale (Griffiths 2004) measures 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
    12 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    14 Years
    Maximum Age & Unit of Time
    21 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Ages 14 to 21 Can read and understand English Has completed 6th grade Scores at least 5 or greater on the PHQ-8 (depression) and/or 5 or greater on GAD-7 (anxiety) consistent with at least mild symptoms Exclusion Criteria: no access to internet Has an intellectual or physical ability which prohibits reading text on the internet (can participate if able to use with assistance, e.g. can use text to speech) No active email account (can participate if plans to create one)
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Ana Radovic, MD, MSc
    Phone
    4126927227
    Email
    ana.radovic@chp.edu
    First Name & Middle Initial & Last Name or Official Title & Degree
    Kayla R Odenthal, MSW
    Email
    kayla.odenthal2@chp.edu
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Ana Radovic, MD, MSc
    Organizational Affiliation
    University of Pittsburgh
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    Trial outcome data can be accessed by contacting the study principal investigator.

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