SOVA Ambassadors Community Setting

Study Overview
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Brief Summary
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The purpose of this study is to examine participant adherence to intervention feasibility and acceptability of intervention, attention control, and implementation strategy.

Detailed Description
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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.

Official Title
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SOVA Ambassadors Community Setting

Conditions
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Depression

Intervention / Treatment
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* Behavioral: SOVA Ambassador
* Behavioral: Self-Reflection


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 14 Years
Maximum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SOVA Peer Ambassador Program<br>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. | Behavioral: SOVA Ambassador<br>* 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.<br>|
| Active Comparator: attention control: brief psychoeducational independent assignments<br>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. | Behavioral: Self-Reflection<br>* Participant will be given an article from the sova.pitt.edu website and a prompt to write about privately.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of Intervention | Average number of articles written per participant; Research team extract data from websites and observation notes | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 12 weeks | 
| Acceptability of Intervention | Acceptability of Intervention Measure; Open-ended question | 12 weeks | 
| Acceptability of Implementation Strategy | Open-ended question | Baseline | 
| Acceptability of Randomization | Single item open-ended question | 12 weeks | 
| 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. | 6 weeks | 
| 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. | 12 weeks | 
| 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. | 6 weeks | 
| 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. | 12 weeks | 
| 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). | 6 weeks | 
| 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). | 12 weeks | 
| 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). | 6 weeks | 
| 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). | 12 weeks | 
| 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). | 6 weeks | 
| 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). | 12 weeks | 
| 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) | 6 weeks | 
| 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) | 12 weeks | 
| 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). | 6 weeks | 
| 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). | 12 weeks | 
| 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. | 6 weeks | 
| 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. | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Adolescent, Adolescent Medicine, Mental Health Services, eHealth, Online Systems, Primary Healthcare, Social Media, Social Support