DepressionNCT04164537
Latina Adolescent Depression Treatment Study
An observational study of Depression, run by Duke University at 1 site in United States.
Trial summary
Despite experiencing higher rates of depressive symptoms and similar rates of Major Depressive Disorder (MDD), Latina (female) adolescents in the U.S. are significantly less likely than their non-Latina White peers to receive treatment for MDD. Read more about this study
- Who is it for?
- Ages 13 to 17 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Depression
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2019to 30 Jun 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 17 years
- Women only
- Healthy volunteers accepted
- Child
Study population: Latina adolescent young women experiencing depression and their parents will be recruited from community and integrated primary care settings. Healthcare providers will be recruited from an integrated primary care clinic.
Adolescent Inclusion Criteria:
- Ages 13-17
- Self-identify as Hispanic/Latina
- Be first generation (i.e. born outside the US) or second generation immigrants (i.e. one or both parents born outside the US)
- Have been diagnosed with Major Depressive Disorder or Persistent Depressive Disorder/Dysthymia
- Have been referred to psychotherapy or prescribed medication for depression
Adolescent Exclusion Criteria:
- Currently experiencing acute psychological distress
Parent Inclusion Criteria
- Parent of Latina adolescent experiencing depression
Parent Exclusion Criteria
- Not fluent in English or Spanish
Healthcare Provider Inclusion Criteria
- Self-identify as regularly providing clinical care to Latina adolescents with depression
- Be in a role in which they can refer to or provide depression treatment
Trial locations and contacts
1 site in 1 country.
United States1 site
Lincoln Community Health Center
Durham, North Carolina, 27707
About this study
Official title: Patient, Family, and Provider Perspectives on Latina Adolescents' Depression Treatment Engagement
Despite experiencing higher rates of depressive symptoms and similar rates of Major Depressive Disorder (MDD), Latina (female) adolescents in the U.S. are significantly less likely than their non-Latina White peers to receive treatment for MDD. The purpose of this study is to identify facilitators of and barriers to depression treatment engagement among Latina adolescents across patient-, family-, and healthcare provider-levels from the perspectives of these individuals. Latina adolescent-parent dyads and healthcare providers will be recruited from community and healthcare settings. Separate individual semi-structured interviews will be conducted with Latina adolescents (n=12) and their parents (n=12). Two focus groups will be conducted with primary care providers (n=6) and mental health providers (n=6) who frequently care for Latina youth. Qualitative content analysis will be used to analyze the transcripts to determine common themes in facilitators and barriers across stakeholder groups.
- Conditions
- Depression
- Keywords
- Hispanic Americans, Adolescent
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Latina adolescents and parents | Latina adolescent young women experiencing depression and their parents will be recruited from community and primary care settings for one-time individual interviews. | |
| Healthcare providers | Primary care and mental health providers who commonly work with Latina adolescent patients will be recruited for focus groups from an integrated primary care clinic. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of barriers to depression treatment among Latina adolescents generated from patient interviews and provider focus groups
Measured: Baseline
Number of facilitators of depression treatment among Latina adolescents generated from patient interviews and provider focus groups
Measured: Baseline
Number of preferences for depression treatment generated from patient interviews and provider focus groups
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2019
- Study start1 Jul 2019
- Primary completion30 Jun 2021
- Study completion30 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute on Minority Health and Health Disparities (NIMHD)
- Responsible party
- Sponsor
- Investigators
- Rosa Gonzalez-Guarda, PhD, Principal investigator, Duke University School of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04164537
- Sponsor's protocol ID
- Pro00103001
- Other IDs
- U54MD012530
- Status last verified
- Jul 2021
- First submitted
- 13 Nov 2019
- Last updated
- 6 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient, Family, and Provider Perspectives on Latina Adolescents' Depression Treatment Engagement
- ClinicalTrials.gov ID
- NCT04164537
- Acronym / sponsor ID
- Pro00103001
- Conditions
- Depression
- Keywords
- Hispanic Americans, Adolescent
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute on Minority Health and Health Disparities (NIMHD)
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 15 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Despite experiencing higher rates of depressive symptoms and similar rates of Major Depressive Disorder (MDD), Latina (female) adolescents in the U.S. are significantly less likely than their non-Latina White peers to receive treatment for MDD. The purpose of this study is to identify facilitators of and barriers to depression treatment engagement among Latina adolescents across patient-, family-, and healthcare provider-levels from the perspectives of these individuals. Latina adolescent-parent dyads and healthcare providers will be recruited from community and healthcare settings. Separate individual semi-structured interviews will be conducted with Latina adolescents (n=12) and their parents (n=12). Two focus groups will be conducted with primary care providers (n=6) and mental health providers (n=6) who frequently care for Latina youth. Qualitative content analysis will be used to analyze the transcripts to determine common themes in facilitators and barriers across stakeholder groups.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Latina adolescents and parents | – | –Latina adolescent young women experiencing depression and their parents will be recruited from community and primary care settings for one-time individual interviews. |
| Healthcare providers | – | –Primary care and mental health providers who commonly work with Latina adolescent patients will be recruited for focus groups from an integrated primary care clinic. |
Who may qualify
- Ages
- 13 to 17 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Latina adolescent young women experiencing depression and their parents will be recruited from community and integrated primary care settings. Healthcare providers will be recruited from an integrated primary care clinic.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of barriers to depression treatment among Latina adolescents generated from patient interviews and provider focus groups
Time frame: Baseline
Number of facilitators of depression treatment among Latina adolescents generated from patient interviews and provider focus groups
Time frame: Baseline
Number of preferences for depression treatment generated from patient interviews and provider focus groups
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rosa Gonzalez-Guarda, PhD principal investigator
Duke University School of Nursing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Depression, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of barriers to depression treatment among Latina adolescents generated from patient interviews and provider focus groups (time frame: Baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2021.