- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06066697
SOVA Ambassadors Community Setting
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
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Pennsylvania
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Pittsburgh, Pennsylvania, United States, 15213
- University of Pittsburgh
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Description
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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / 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
|
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.
|
Participant will be given an article from the sova.pitt.edu
website and a prompt to write about privately.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Feasibility of Intervention
Time Frame: 12 weeks
|
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
Time Frame: 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
|
12 weeks
|
|
Acceptability of Intervention
Time Frame: 12 weeks
|
Acceptability of Intervention Measure; Open-ended question (asked the SOVA Website meets my approval)
|
12 weeks
|
|
Acceptability of Implementation Strategy
Time Frame: Baseline
|
Open-ended question: How acceptable to you was it to participate in this program?
(referring to mental health program used as an implementation strategy) asked at baseline
|
Baseline
|
|
Acceptability of Randomization
Time Frame: 12 weeks
|
Single item open-ended question inquiring how acceptable it was to being randomly chosen to participate in the SOVA Ambassador arm versus the control arm
|
12 weeks
|
|
Depression Severity
Time Frame: 6 weeks
|
Patient Health Questionnaire-9 measures depression severity a higher score indicating greater severity. The PHQ-8 version was used with the 9th item omitted, score range is 0 to 24 |
6 weeks
|
|
Depression Severity
Time Frame: 12 weeks
|
Patient Health Questionnaire-9 measures depression severity a higher score indicating greater severity. The PHQ-8 version was used with the 9th item omitted, score range is 0 to 24 |
12 weeks
|
|
Anxiety Severity
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.
|
6 weeks
|
|
Anxiety Severity
Time Frame: 12 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.
|
12 weeks
|
|
Resilience/Positive Youth Development
Time Frame: 6 weeks
|
Positive Youth Development will be assessed using The Positive Youth Development Very Short Form (PYD-VSF).
The confidence subscale is reported which has 3 items with a total score ranging from 3 to 13 (α = 0.78), a higher score associated with a greater level of confidence.
|
6 weeks
|
|
Resilience/Positive Youth Development
Time Frame: 12 weeks
|
Positive Youth Development will be assessed using The Positive Youth Development Very Short Form (PYD-VSF).
The confidence subscale is reported which has 3 items with a total score ranging from 3 to 13 (α = 0.78), a higher score associated with a greater level of confidence.
|
12 weeks
|
|
Self-Esteem
Time Frame: 6 weeks
|
The 10-item Rosenberg Self-Esteem Scale (RSES) (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.
Scores range from 10-40 with a higher score equating to higher self esteem.
|
6 weeks
|
|
Self-Esteem
Time Frame: 12 weeks
|
The 10-item Rosenberg Self-Esteem Scale (RSES) (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.
Scores range from 10-40
|
12 weeks
|
|
Emotional Self-Efficacy
Time Frame: 6 weeks
|
Emotional self-efficacy will be assessed using The Mental Health Self-Efficacy Scale (MHSES) (α = 0.82) Clarke 2014.
MHSES was developed according to guidelines by Bandura as to how to create self-efficacy questionnaires (Bandura, 2006) .
The questionnaire contains six items asking about the participant's confidence level in performing mental health self-care behaviors.
Scoring of the MHSES is based on a 10-point Likert scale ranging from 1 ("Not at all confident") to 10 ("Totally confident").
Scores are a mean score ranging 1-10 with higher scores meaning higher mental health self-efficacy.
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6 weeks
|
|
Emotional Self-Efficacy
Time Frame: 12 weeks
|
Emotional self-efficacy will be assessed using The Mental Health Self-Efficacy Scale (MHSES) (α = 0.82) Clarke 2014.
MHSES was developed according to guidelines by Bandura as to how to create self-efficacy questionnaires (Bandura, 2006) .
The questionnaire contains six items asking about the participant's confidence level in performing mental health self-care behaviors.
Scoring of the MHSES is based on a 10-point Likert scale ranging from 1 ("Not at all confident") to 10 ("Totally confident").
Scores are a mean score ranging 1-10 with higher scores meaning higher mental health self-efficacy.
|
12 weeks
|
|
Social Support
Time Frame: 6 weeks
|
The Medical Outcome Study Social Support Scale measures types of social support.
Higher levels associated with greater support.
We will use the emotional/informational subscale from this report and calculate the mean per item score on a range of 1 to 5.
|
6 weeks
|
|
Social Support
Time Frame: 12 weeks
|
The Medical Outcome Study Social Support Scale measures types of social support.
Higher levels associated with greater support.
We will use the emotional/informational subscale from this report and calculate the mean per item score on a range of 1 to 5.
|
12 weeks
|
|
Social Isolation
Time Frame: 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) .
Score range 20-80, higher score is higher isolation.
|
6 weeks
|
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Social Isolation
Time Frame: 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) .
Score range 20-80, higher score is higher isolation.
|
12 weeks
|
|
Stigma
Time Frame: 6 weeks
|
The Depression Stigma Scale 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
|
|
Stigma
Time Frame: 12 weeks
|
The Depression Stigma Scale 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
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Ana Radovic, MD, MSc, University of Pittsburgh
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY23020021
- R21MD016143 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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