NCT07383831

Brief Summary

The goal of this randomized pragmatic clinical trial is to examine the feasibility, acceptability, and mechanisms of change of a brief adaptation of Interpersonal Psychotherapy for Adolescents (IPT-A), adapted and task-shifted to lay providers (mentors, youth trusted adults) in youth community centers (YCCs) as an upstream approach to suicide. It focuses on Hispanic adolescents ages 12-17 enrolled in these YCCs. The pragmatic clinical trial will evaluate the acceptability and feasibility of adapted IPT-A delivered by mentors in YCCs and whether adapted IPT-A impacts mechanisms of change (depression symptoms, belongingness, and feeling like a burden to others). The main questions to answer are:

  • Is adapted IPT-A, when delivered by trained youth mentors, feasible and acceptable in youth community centers?
  • Does adapted IPT-A change key risk factors (i.e., mechanisms: depressive symptoms, low belongingness, and perceived burdensomeness) associated with suicide ideation? The investigators will compare adolescents randomized to adapted IPT-A (6 sessions) delivered by a trained youth mentor with those receiving usual services at the community center (one individual session focused on active listening). Participants will:
  • Be screened for subthreshold depression using the Patient Health Questionnaire adolescent version (PHQ-A). Adolescent participants will be included if they score between 4 and 9 (mild depression). Participants with a PHQ-A score of 10 or higher (severe depression) will not be eligible and will be referred to a licensed mental health provider for appropriate care.
  • Be randomized to adapted IPT-A or usual care. Adolescent participants in the intervention arm will participate in 6 weekly, adapted IPT-A sessions with a trained youth mentor. Intervention focuses on education, affect identification, and interpersonal skills.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P25-P50 for not_applicable

Timeline
24mo left

Started Aug 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 25, 2026

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 3, 2026

Completed
6 months until next milestone

Study Start

First participant enrolled

August 1, 2026

Expected
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2027

8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2028

Last Updated

May 5, 2026

Status Verified

April 1, 2026

Enrollment Period

1.3 years

First QC Date

January 25, 2026

Last Update Submit

April 29, 2026

Conditions

Outcome Measures

Primary Outcomes (2)

  • Feasibility of the intervention

    The Feasibility of Intervention Measure (FIM) is a 4-item self-report survey (Weiner et al., 2017) used to assess whether the intervention can be successfully carried out (feasible). The scores for the 4 items are averaged, yielding a total score of 1-5, where 1-2 indicates low perceived feasibility, 3 indicates moderate, and 4-5 indicates high perceived feasibility. In summary, higher scores indicate higher perceived feasibility (a better outcome).

    Up to 7 weeks.

  • Acceptability of the intervention

    The Acceptability and Appropriateness of Intervention Measure (AIM) is an 8-item self-report survey that assesses whether the intervention is satisfactory (acceptability) and relevant (appropriateness). The measure is divided into 4-item subscales: acceptability and appropriateness. These constructs are evaluated separately, with an average score ranging from 1 (low) to 5 (high) (Weiner et al., 2017). Higher scores indicate higher satisfaction (acceptability) and relevance (appropriateness), meaning a better outcome.

    Up to 7 weeks

Secondary Outcomes (2)

  • Change in depressive symptoms

    Up to 7 weeks.

  • Change in interpersonal factors associated with passive suicide ideation.

    Up to 7 weeks.

Other Outcomes (2)

  • Change in anxiety symptoms

    Up to 7 weeks.

  • Change in experiences with discrimination

    Up to 7 weeks.

Study Arms (2)

Adapted IPT-A Delivered by Youth Mentors

EXPERIMENTAL

Participants in this arm will receive 6 weekly sessions of an adapted, brief Interpersonal Psychotherapy for Adolescents (IPT-A) delivered by trained youth mentors (n=5) at the partnering youth community centers. The intervention focuses on improving interpersonal functioning, communication skills, and supportive relationships to reduce depressive symptoms, low belongingness, and perceived burdensomeness.

Behavioral: Adapted Brief Interpersonal Psychotherapy for Adolescents (IPT-A LAZOS)

Usual Community Center Services

ACTIVE COMPARATOR

Participants in this arm will continue to receive the standard youth programming and services offered at the participating community centers. This is an individual session focused on active listening.

Other: Usual Community Center Services

Interventions

Participants in this arm will continue to receive the standard youth programs and services offered by the youth community centers, including mentoring, academic support, and recreational activities. They will not receive BIPT-A.

Also known as: Usual Care, Standard Youth Programming
Usual Community Center Services

Adolescents in this intervention will receive 6 weekly sessions of an adaptation of Interpersonal Psychotherapy for Adolescents (IPT-A) delivered by trained youth mentors in youth community centers. The adaptation used a community-participatory research approach to culturally and contextually meet the needs of immigrant-origin inner-city adolescents. The adapted intervention keeps core elements (education, affect identification, and interpersonal skills) and bolsters these skills to target belongingness and burdensomeness, which are factors associated with suicide ideation. Sessions follow a structured, manualized approach. The goal is to reduce depressive symptoms, increase sense of belongingness, and decrease perceived burdensomeness among adolescents with subthreshold depression (score between 4-9 in the PHQ-A).

Also known as: IPT-A
Adapted IPT-A Delivered by Youth Mentors

Eligibility Criteria

Age12 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Parent consent
  • Adolescent consent
  • Enrolled in youth community centers
  • Self-identified as Hispanic or Latine
  • Between 12 and 17 years old.
  • Scoring threshold for depression (4-9) as indicated in the PHQ-A.
  • No current report of suicide ideation with plan or self-harming behaviors

You may not qualify if:

  • Not consented to participate in the study
  • Scoring 10 or higher in the PHQ-A, indicating depressive disorder
  • Active suicide ideation (i.e., having thoughts of killing oneself, thinking about how in the past month).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Boston College

Chestnut Hill, Massachusetts, 02467, United States

Location

MeSH Terms

Conditions

Suicidal IdeationDepression

Condition Hierarchy (Ancestors)

SuicideSelf-Injurious BehaviorBehavioral SymptomsBehavior

Study Officials

  • Carolina Vélez-Grau, PHD, LCSW

    Boston College

    PRINCIPAL INVESTIGATOR
  • Laura Mufson, PhD

    Columbia University

    STUDY CHAIR
  • Susan Witte, PhD

    Columbia University

    STUDY CHAIR

Central Study Contacts

Carolina Vélez-Grau, PhD and LCSW

CONTACT

Krystel Francis, BA

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 25, 2026

First Posted

February 3, 2026

Study Start (Estimated)

August 1, 2026

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

July 31, 2028

Last Updated

May 5, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will share

We will use the National Institute of Mental Health (NIMH) Data Archive (NDA). NDA is an NIH-funded collaborative resource that contains harmonized human subjects research data. Data submitted to the NDA is stripped of identifiers.

Shared Documents
ANALYTIC CODE
Time Frame
Data will be available at the end of the study in 2029.
Access Criteria
Based on the NDA, the qualified scientific community will have access to de-identified data from the study.
More information

Locations