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Can a structured care pathway lift teen depression in primary care?

NCT ID NCT07806825

Disease control Sponsor: Universidad de los Andes, Chile Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 08, 2026 · Last updated Sep 09, 2026 · Updated 1 time

Summary

This pilot study tests whether a structured care program called CARIBOU can reduce depressive symptoms in adolescents aged 15 to 18 with major depression. The program combines cognitive behavioral therapy, caregiver support, and medication management when needed, all coordinated in primary care centers in Chile. Researchers will compare this approach to usual care, measuring changes in depression and anxiety symptoms, quality of life, and family functioning over 24 weeks. The study also checks whether the program is acceptable and feasible for teens, families, and healthcare providers.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
CARIBOU Integrated Care Pathway, a structured program combining psychoeducation, cognitive behavioral therapy, caregiver support, measurement-based care, and medication management when needed
What this could lead to
If effective, this approach could offer a practical, structured way to treat adolescent depression in primary care settings, potentially improving access to mental health care in Chile and similar regions.
What could go wrong
This is a small pilot study, so results may not be conclusive. The intervention is complex and depends on clinician training and adherence, which could affect outcomes. There is also a risk that the program may not be more effective than usual care.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 72 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jul 2027

An estimate. Start dates often move.

Expected to finish

Nov 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

15 to 18 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Adolescents aged 15 to 18 years (up to their 19th birthday). * Presenting at one of the participating primary care centers. * The primary care physician considers depressive symptoms to be a priority treatment target. * PHQ-9 score ≥5 at screening. * Meet DSM-5 criteria for Major Depressive Disorder or Persistent Depressive Disorder, confirmed using the MINI-KID. * Able to read and write in Spanish. * Able to provide informed assent/consent, with parent or legal guardian consent when applicable. Exclusion Criteria: * Severe depressive symptoms (PHQ-9 score ≥20). * Active psychotic symptoms (persistent delusions, hallucinations, or disorganized speech affecting functioning). * Bipolar disorder (type I or II). * Moderate or severe substance use disorder. * Autism spectrum disorder or intellectual disability. * Moderate or severe eating disorder. * Imminent suicide risk requiring immediate intervention (e.g., hospitalization). * Inability to read or write in Spanish. * Inability to provide informed consent/assent. * Under the care of state-based institutions without available family support. * Receiving ongoing individual psychotherapy or pharmacotherapy for depression or anxiety at another healthcare center

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Conditions

The condition(s) this trial relates to.

major depressive disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Major depressive disorder (MDD)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • CESFAM Madre Teresa de Calcuta; CESFAM Juan Pablo II; CESFAM San Alberto Hurtado; CESFAM

    Santiago, Santiago Metropolitan, Chile

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