SOVA Ambassadors Community Setting

Depression Clinical Trial

Official title:

SOVA Ambassadors Community Setting

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06066697
• Other study ID #: STUDY23020021
• Status: Recruiting
• Phase: N/A
• Start date: October 25, 2023
• Est. completion date: December 1, 2024

Study information

• Verified date: November 2023
• Source: University of Pittsburgh
• Contact: Ana Radovic, MD, MSc
• Phone: 4126927227
• Email: ana.radovic[@]chp.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 1, 2024
• Est. primary completion date: September 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years to 21 Years

Eligibility

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)

Related Conditions & MeSH terms

• Depression

Intervention

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

Locations

Country	Name	City	State
United States	University of Pittsburgh	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pittsburgh

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of Intervention	Average number of articles written per participant; Research team extract data from websites and observation notes	12 weeks
Secondary	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
Secondary	Acceptability of Intervention	Acceptability of Intervention Measure; Open-ended question	12 weeks
Secondary	Acceptability of Implementation Strategy	Open-ended question	Baseline
Secondary	Acceptability of Randomization	Single item open-ended question	12 weeks
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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) (a = 0.12), connection (4 items, total score ranging from 4 to 20) (a = 0.78), confidence (3 items, total score ranging from 3 to 13) (a = 0.78), caring (3 items, total score ranging from 3 to 15) (a = 0.85), and character (4 items, total score ranging from 4 to 19) (a = 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
Secondary	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) (a = 0.12), connection (4 items, total score ranging from 4 to 20) (a = 0.78), confidence (3 items, total score ranging from 3 to 13) (a = 0.78), caring (3 items, total score ranging from 3 to 15) (a = 0.85), and character (4 items, total score ranging from 4 to 19) (a = 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
Secondary	Change from Baseline in Self-Esteem	The 10-item Rosenberg Self-Esteem Scale (RSES) (Rosenberg, 1965) (a = 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
Secondary	Change from Baseline in Self-Esteem	The 10-item Rosenberg Self-Esteem Scale (RSES) (Rosenberg, 1965) (a = 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
Secondary	Change from Baseline in Emotional Self-Efficacy	Emotional self-efficacy will be assessed using The Mental Health Self-Efficacy Scale (MHSES) (a = 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
Secondary	Change from Baseline in Emotional Self-Efficacy	Emotional self-efficacy will be assessed using The Mental Health Self-Efficacy Scale (MHSES) (a = 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
Secondary	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
Secondary	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
Secondary	Change from Baseline in Social Isolation	The revised UCLA Loneliness Scale will be administered to all participants to measure social isolation (a = 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
Secondary	Change from Baseline in Social Isolation	The revised UCLA Loneliness Scale will be administered to all participants to measure social isolation (a = 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
Secondary	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
Secondary	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