- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05499182
Latino Teen Depression Treatment Study
December 7, 2023 updated by: Duke University
Identification of Implementation Strategies to Promote Depression Treatment Use Among Latino Adolescents
Despite experiencing higher rates of depressive symptoms (Center for Disease Control and Prevention, 2020) and similar rates of Major Depressive Disorder (MDD; Substance Abuse and Mental Health Services Administration (SAMHSA), 2019), Latino adolescents in the U.S. are significantly less likely than their non-Latino White peers to receive treatment for MDD (SAMHSA, 2019).
The purpose of this study is to identify a stakeholder-preferred implementation strategy that may improve psychotherapy attendance among Latino adolescents.
Latino adolescent-parent dyads and healthcare providers will be recruited from healthcare settings and social media.
Focus groups will be conducted with healthcare providers (n=5), and individual interviews will be conducted with Latino adolescents with a diagnosis of depression (n=15) and their parents (n=15).
Study Overview
Status
Recruiting
Conditions
Study Type
Observational
Enrollment (Estimated)
35
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Allison M Stafford, PhD
- Phone Number: (317) 498-7333
- Email: allison.stafford@duke.edu
Study Contact Backup
- Name: Norma Garcia Ortiz
- Phone Number: 919-684-9331
- Email: norma.garcia.ortiz@duke.edu
Study Locations
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Tennessee
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Nashville, Tennessee, United States, 37232
- Recruiting
- Researchmatch.org
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Contact:
- Allison M Stafford, PhD
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
13 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Sampling Method
Non-Probability Sample
Study Population
Three samples will be recruited on a national scale: Latino male teens diagnosed with depression, their parents/guardians, and healthcare providers (behavioral health and primary care) who regularly care for Latino adolescents.
Description
Inclusion Criteria for Teens:
- Male gender
- Aged 13-17 years
- Diagnosed with Major Depressive Disorder or Persistent Depressive Disorder
- Referred to psychotherapy and/or prescribed antidepressant medications for depression
Exclusion Criteria for Teens:
- Experiencing imminent thoughts of self-harm or suicide
- Experiencing acute psychological distress (e.g., uncontrolled crying)
Inclusion Criteria for Parents:
- Parent or legal guardian of teen
- Able to read and speak English or Spanish
Exclusion Criteria for Parents:
- Unable to read/speak English or Spanish
Inclusion Criteria for Healthcare Providers:
- Self-identification as regularly providing clinical care to Latino adolescents with depression
- Be in a role in which they can provide or refer patients to depression treatment
Exclusion Criteria for Healthcare Providers
- Unable to provide or refer to depression treatment
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
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Teens
Teens are: 1) Male 2) Aged 13-17; 3) self-identified as Hispanic/Latino; 4) diagnosed with Major Depressive Disorder or Persistent Depressive Disorder/Dysthymia; and 5) referred to psychotherapy or prescribed medication for depression.
Teens will be excluded if they are experiencing intense psychological distress or imminent thoughts of suicide.
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Parents
Parents will 1) Be parents or legal guardians of teens; and 2) Speak and read English or Spanish.
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Healthcare Providers
Healthcare providers will 1) Self-identify as regularly providing clinical care to Latino adolescents with depression; and 2) be in a role in which they can refer to or provide depression treatment.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Preferred implementation strategy to improve depression treatment use generated from qualitative interviews/focus groups
Time Frame: Baseline
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Implementation strategy preference options will include: 1) Near Peer Depression Support Groups; 2) Parent-Teen Depression Treatment Activation Training; and 3) Depression Care Navigation Services.
We will determine which strategy is most preferred by asking stakeholders, "Which of these strategies would work best for you/your family/Latino teens?"
We will add up the responses to determine the preferred strategy with the highest frequency.
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Baseline
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of barriers to depression treatment use generated from qualitative interviews/focus groups
Time Frame: Baseline
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Baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Allison M Stafford, PhD, Duke University School of Nursing
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 13, 2022
Primary Completion (Estimated)
June 30, 2024
Study Completion (Estimated)
June 30, 2024
Study Registration Dates
First Submitted
August 9, 2022
First Submitted That Met QC Criteria
August 10, 2022
First Posted (Actual)
August 12, 2022
Study Record Updates
Last Update Posted (Estimated)
December 11, 2023
Last Update Submitted That Met QC Criteria
December 7, 2023
Last Verified
October 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Pro00110026
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
Due to the qualitative nature of this study, we will not be sharing participant data with other researchers.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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