DepressionNCT04819295
Latinx Teen Depression Treatment Study
An observational study of Depression, run by Duke University at 1 site in United States.
Trial summary
The purpose of this study is determine facilitators of and barriers to receiving evidence-based psychotherapy for depression for Latinx adolescents from multiple stakeholder perspectives. Read more about this study
- Who is it for?
- Ages 13 to 17 years
- Conditions the study is for
- Depression
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Apr 2021to 30 Sep 2022
- 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
- All sexes
- Child
Study population: Latnix adolescents and their parents, including healthcare providers who are involved in psychotherapy treatments.
Who may be able to join
- Aged 13-17
- self-identify as Hispanic/Latinx
- diagnosed with Major Depressive Disorder or Persistent Depressive Disorder/Dysthymia
- referred to psychotherapy or prescribed medication for depression.
- Healthcare providers:
- Self-identify as regularly providing clinical care to Latinx adolescents with depression
- be in a role in which they can refer to or provide depression treatment.
Who cannot join
- Teens will be excluded if they are experiencing intense psychological distress or imminent thoughts of suicide or have any condition in which, in the opinion of the investigator, precludes the study team from obtaining informed assent of the teen
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Barriers, Facilitators, and Preferences Regarding Depression Treatment From the Perspectives of Latinx Adolescents, Parents, and Healthcare Providers
The purpose of this study is determine facilitators of and barriers to receiving evidence-based psychotherapy for depression for Latinx adolescents from multiple stakeholder perspectives.
- Conditions
- Depression
- Keywords
- Latinx adolescents, psychotherapy, Focus groups
- 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 |
|---|---|---|
| Latinx Adolescents | Not described | |
| Parents of Latinx Adolescents | Not described | |
| Healthproviders | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of preferences for depression treatment generated from focus groups
Measured: Baseline
Secondary outcomes (1)
Number of barriers to depression treatment among Latinx Adolescents from 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 posted26 Mar 2021
- Study start20 Apr 2021
- Primary completion30 Sep 2022
- Study completion30 Sep 2022
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
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Allison Stafford, Ph.D, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04819295
- Sponsor's protocol ID
- Pro00107485
- Status last verified
- Mar 2022
- First submitted
- 24 Mar 2021
- Last updated
- 8 Nov 2022
- 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 8 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Barriers, Facilitators, and Preferences Regarding Depression Treatment From the Perspectives of Latinx Adolescents, Parents, and Healthcare Providers
- ClinicalTrials.gov ID
- NCT04819295
- Acronym / sponsor ID
- Pro00107485
- Conditions
- Depression
- Keywords
- Latinx adolescents, psychotherapy, Focus groups
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 20 Apr 2021 (actual)
- Primary completion
- 30 Sep 2022 (actual)
- Study completion
- 30 Sep 2022 (actual)
- First posted
- 26 Mar 2021 (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.
The purpose of this study is determine facilitators of and barriers to receiving evidence-based psychotherapy for depression for Latinx adolescents from multiple stakeholder perspectives.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Latinx Adolescents | – | – |
| Parents of Latinx Adolescents | – | – |
| Healthproviders | – | – |
Who may qualify
- Ages
- 13 to 17 years
- Sex
- All
- Age groups
- Child
- Study population
- Latnix adolescents and their parents, including healthcare providers who are involved in psychotherapy treatments.
Key inclusion criteria (7 listed)
- Aged 13-17
- self-identify as Hispanic/Latinx
- diagnosed with Major Depressive Disorder or Persistent Depressive Disorder/Dysthymia
- referred to psychotherapy or prescribed medication for depression.
- Self-identify as regularly providing clinical care to Latinx adolescents with depression
Key exclusion criteria (1 listed)
- Teens will be excluded if they are experiencing intense psychological distress or imminent thoughts of suicide or have any condition in which, in the opinion of the investigator, precludes the study team from obtaining informed assent of the teen
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 preferences for depression treatment generated from focus groups
Time frame: Baseline
1 secondary outcome
Number of barriers to depression treatment among Latinx Adolescents from 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 8 Nov 2022.
- 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.
Allison Stafford, Ph.D principal investigator
Duke University
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?
The sponsor lists 7 inclusion and 1 exclusion criteria. 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 8 Nov 2022. 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 preferences for depression treatment generated from focus groups (time frame: Baseline). 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 8 Nov 2022.