SOVA Ambassadors Community Setting

Sponsor
University of Pittsburgh (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06066697
Collaborator
(none)
40
2
13.6

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: SOVA Ambassador
  • Behavioral: Self-Reflection
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Masking Description:
The statistician conducting analyses will be blinded to randomized arm.
Primary Purpose:
Health Services Research
Official Title:
SOVA Ambassadors Community Setting
Anticipated Study Start Date :
Oct 15, 2023
Anticipated Primary Completion Date :
Sep 1, 2024
Anticipated Study Completion Date :
Dec 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: SOVA Peer Ambassador Program

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
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.

Active Comparator: attention control: brief psychoeducational independent assignments

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
Participant will be given an article from the sova.pitt.edu website and a prompt to write about privately.

Outcome Measures

Primary Outcome Measures

  1. Feasibility of Intervention [12 weeks]

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

Secondary Outcome Measures

  1. Feasibility of Control Arm [12 weeks]

    Average number of submissions to questions on the REDCap form per participant in the Attention control arm Research team extract data from REDCap

  2. Acceptability of Intervention [12 weeks]

    Acceptability of Intervention Measure; Open-ended question

  3. Acceptability of Implementation Strategy [Baseline]

    Open-ended question

  4. Acceptability of Randomization [12 weeks]

    Single item open-ended question

  5. Change from Baseline in Depression Severity [6 weeks]

    Patient Health Questionnaire-9 (Kroenke, 2001) measures depression severity with a score ranging from 0 to 27, a higher score indicating greater severity.

  6. Change from Baseline in Depression Severity [12 weeks]

    Patient Health Questionnaire-9 (Kroenke, 2001) measures depression severity with a score ranging from 0 to 27, a higher score indicating greater severity.

  7. Change from Baseline in Anxiety Severity [6 weeks]

    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.

  8. Change from Baseline in Anxiety Severity [12 weeks]

    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.

  9. Change from Baseline in Resilience/Positive Youth Development [6 weeks]

    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).

  10. Change from Baseline in Resilience/Positive Youth Development [12 weeks]

    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).

  11. Change from Baseline in Self-Esteem [6 weeks]

    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. Change from Baseline in Self-Esteem [12 weeks]

    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).

  13. Change from Baseline in Emotional Self-Efficacy [6 weeks]

    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).

  14. Change from Baseline in Emotional Self-Efficacy [12 weeks]

    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).

  15. Change from Baseline in Social Support [6 weeks]

    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)

  16. Change from Baseline in Social Support [12 weeks]

    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)

  17. Change from Baseline in Social Isolation [6 weeks]

    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).

  18. Change from Baseline in Social Isolation [12 weeks]

    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).

  19. Change from Baseline in Stigma [6 weeks]

    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.

  20. Change from Baseline in Stigma [12 weeks]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
14 Years to 21 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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)

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • University of Pittsburgh

Investigators

  • Principal Investigator: Ana Radovic, MD, MSc, University of Pittsburgh

Study Documents (Full-Text)

More Information

Publications

None provided.
Responsible Party:
Ana Radovic, Assistant Professor, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT06066697
Other Study ID Numbers:
  • STUDY23020021
First Posted:
Oct 4, 2023
Last Update Posted:
Oct 4, 2023
Last Verified:
Sep 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Ana Radovic, Assistant Professor, University of Pittsburgh
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 4, 2023