Suicidal IdeationNCT07383831
Task-Shifting Adapted IPT-A for Youth Suicide Prevention
A study testing Adapted Brief Interpersonal Psychotherapy for Adolescents (IPT-A LAZOS) and Usual Community Center Services in people with Suicidal Ideation and Depressive Symptoms, run by Boston College at 1 site in United States.
Trial 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 (BIPT-A), adapted and task-shifted to lay providers (mentors, youth trusted adults) in youth community centers (YCCs) as an… Read more about this study
- Who is it for?
- Ages 12 to 17 years
- Conditions the study is for
- Suicidal Ideation, Depressive Symptoms, Adolescent Mental Health
- What is being tested?
- Adapted Brief Interpersonal Psychotherapy for Adolescents (IPT-A LAZOS) and Usual Community Center Services
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2026to 31 Jul 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 12 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Krystel Francis, BA contact
United States1 site
Boston College
Chestnut Hill, Massachusetts, 02467
Carolina Vélez-Grau, PhD, LCSW, 6175522539, velezgra@bc.edu
velezgra@bc.edu
About this study
Official title: Youth Mentor-Led Brief Interpersonal Psychotherapy for Youth Suicide Prevention
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 (BIPT-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 BIPT-A impacts mechanisms of change (depressive symptoms, belongingness, and burdensomeness or feeling like a burden to others).
Read more
The main questions to answer are:
- Is adapted BIPT-A, when delivered by trained lay providers (youth mentors), feasible and acceptable in youth community centers?
- Does adapted BIPT-A, delivered by lay providers, change key risk factors (i.e., key mechanisms: depressive symptoms, low belongingness, and perceived burdensomeness) associated with suicide ideation? The investigators will compare adolescents randomized to adapted BIPT-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 BIPT-A or usual care. Adolescent participants in the intervention arm will participate in 6 weekly, adapted BIPT-A sessions with a trained youth mentor. Intervention focuses on education, affect identification, and interpersonal skills.
- Being tested
- Adapted Brief Interpersonal Psychotherapy for Adolescents (IPT-A LAZOS), Usual Community Center Services
- Medical subject headings
- Suicidal Ideation, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adapted Brief Interpersonal Psychotherapy for Adolescents (IPT-A LAZOS)Behavioural
Also called IPT-A, BIPT-A
Adolescents in this intervention will receive 6 weekly sessions of an adapted brief version of Interpersonal Psychotherapy for Adolescents (BIPT-A), delivered by trained lay providers (i.e., 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).
Usual Community Center ServicesOther
Also called Usual Care, Standard Youth Programming
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 (BIPT-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. Receives: 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. Receives: Other: Usual Community Center Services |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: Up to 7 weeks
Secondary outcomes (2)
Change in depressive symptoms
Depressive symptoms are one of the study's mechanisms of change associated with passive suicide ideation.
Depressive symptoms will be measured with the Patient Health Questionnaire-9 Adolescent version (PHQ-A), a 9-item self-report scale. PHQ-A has been validated with the adolescent and Hispanic populations. Most studies use ≥10 as the cutoff score, indicating clinically significant depressive symptoms among adolescents. The total score is the sum of all 9 items (0-27), where 0-4 is minimal or no depression, 5-9 mild depression, 10-14 moderate depression, 15-19 moderately severe depression, and 20-27 severe depression. In summary, higher scores indicate greater severity of depressive symptoms (a worse outcome).
Measured: Up to 7 weeks.
Change in interpersonal factors associated with passive suicide ideation.
Thwarted Belongingness (TB) and Perceived Burdensomeness (PB) are two factors associated with passive suicide ideation. These two factors are mechanisms of change targeted by the intervention.
The Interpersonal Needs Assessment (INQ-15) measures the extent to which individuals believe they belong (i.e., TB using 9 items) or perceive themselves as a burden to others (i.e., PB using 6 items), which are scored separately, one for TB and one for PB.
Scholars use either the sum score or the average. This study will use mean scores because they preserve the 1-7 scale and provide easier, consistent interpretation. Higher scores indicate higher Thwarted Belongingness and Perceived Burdensomeness (worse outcomes).
Measured: Up to 7 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2026
- Study start1 Oct 2026 (estimated)
- Primary completion1 Dec 2027 (estimated)
- Study completion31 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Suicidal IdeationStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Boston College
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Carolina Vélez-Grau, PHD, LCSW, Principal investigator, Boston CollegeLaura Mufson, PhD, Study chair, Columbia UniversitySusan Witte, PhD, Study chair, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07383831
- Sponsor's protocol ID
- 24.274
- Other IDs
- K23MH137405
- Status last verified
- Jul 2026
- First submitted
- 25 Jan 2026
- Last updated
- 28 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The National Institute of Mental Health (NIMH) Data Archive (NDA) will be used. NDA is an NIH-funded collaborative resource that contains harmonized human subjects research data. Data submitted to the NDA is stripped of identifiers.
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Youth Mentor-Led Brief Interpersonal Psychotherapy for Youth Suicide Prevention
- ClinicalTrials.gov ID
- NCT07383831
- Acronym / sponsor ID
- 24.274
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Boston CollegeUniversity, hospital or other
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 1 Dec 2027 (estimated)
- Study completion
- 31 Jul 2028 (estimated)
- First posted
- 3 Feb 2026 (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 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 (BIPT-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 BIPT-A impacts mechanisms of change (depressive symptoms, belongingness, and burdensomeness or feeling like a burden to others).
The main questions to answer are:
- Is adapted BIPT-A, when delivered by trained lay providers (youth mentors), feasible and acceptable in youth community centers?
- Does adapted BIPT-A, delivered by lay providers, change key risk factors (i.e., key mechanisms: depressive symptoms, low belongingness, and perceived burdensomeness) associated with suicide ideation? The investigators will compare adolescents randomized to adapted BIPT-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 BIPT-A or usual care. Adolescent participants in the intervention arm will participate in 6 weekly, adapted BIPT-A sessions with a trained youth mentor. Intervention focuses on education, affect identification, and interpersonal skills.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adapted IPT-A Delivered by Youth Mentors | Experimental | Behavioral: Adapted Brief Interpersonal Psychotherapy for Adolescents (IPT-A LAZOS)Participants in this arm will receive 6 weekly sessions of an adapted, brief Interpersonal Psychotherapy for Adolescents (BIPT-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. |
| Usual Community Center Services | Active comparator | Other: Usual Community Center ServicesParticipants 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. |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Parent consent
- Adolescent consent
- Enrolled in youth community centers
- Self-identified as Hispanic or Latine
- Between 12 and 17 years old.
Key exclusion criteria (3 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Adapted Brief Interpersonal Psychotherapy for Adolescents (IPT-A LAZOS)Also: IPT-A, BIPT-AAdolescents in this intervention will receive 6 weekly sessions of an adapted brief version of Interpersonal Psychotherapy for Adolescents (BIPT-A), delivered by trained lay providers (i.e., 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). | Behavioural | Adapted IPT-A Delivered by Youth Mentors |
| Usual Community Center ServicesAlso: Usual Care, Standard Youth ProgrammingParticipants 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. | Other | Usual Community Center Services |
Primary outcome
Feasibility of the intervention
Time frame: Up to 7 weeks.
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).
Acceptability of the intervention
Time frame: Up to 7 weeks
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.
2 secondary outcomes
Change in depressive symptoms
Time frame: Up to 7 weeks.
Change in interpersonal factors associated with passive suicide ideation.
Time frame: Up to 7 weeks.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2026.
- Individual participant dataSharing planned: Yes. The National Institute of Mental Health (NIMH) Data Archive (NDA) will be used. NDA is an NIH-funded collaborative resource that contains harmonized human subjects research data. Data submitted to the NDA is stripped of identifiers.
Related trials for Suicidal Ideation
Not yet recruiting
A Pre-post Study of a Lethal Means Safety Planning Intervention for Youth at Elevated Suicide Risk in the Emergency Department
Suicidal Ideas, Suicidal Ideation
RecruitingObservational study
Student Precarity and Psychiatry
Depressive Disorder, Major, Generalized Anxiety Disorder
Not yet recruiting
SERENE Low-Intensity Focused Ultrasound for Cognitive Control
Suicidal Ideation, Cognitive Control
Not yet recruiting
A MRT to Optimize a JITAI for Alcohol Craving and Suicide Ideation
Alcohol Use Disorder (AUD), Suicide Ideation
Enrolling by invitation
Pilot Study of a Modified Safety Planning Intervention for Elementary School-Aged Children - Main Study
Suicidal Ideation, Suicidal Behaviors
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.
Krystel Francis, BA contact
Carolina Vélez-Grau, PHD, LCSW principal investigator
Boston College
Laura Mufson, PhD study chair
Columbia University
Susan Witte, PhD study chair
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adapted Brief Interpersonal Psychotherapy for Adolescents (IPT-A LAZOS) and Usual Community Center Services in people with Suicidal Ideation and Depressive Symptoms, run by Boston College 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 3 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: opening soon, as of the sponsor's last update on 28 Jul 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Carolina Vélez-Grau, PhD and LCSW (16175522539, velezgra@bc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of the intervention (time frame: Up to 7 weeks.). The study lists 2 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 28 Jul 2026.