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| ID | Type | Description | Link |
|---|---|---|---|
| K23MH137405 | U.S. NIH Grant/Contract | View source |
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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:
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adapted Brief Interpersonal Psychotherapy for Adolescents (IPT-A LAZOS) | Behavioral | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Change in anxiety symptoms | Due to the co-occurrence of depressive symptoms with anxiety among adolescents, the investigators will measure anxiety symptoms. The Generalized Anxiety Disorder (GAD-7), a 7-item self-report scale to assess anxiety, will be used to measure anxiety symptoms. A score of 10 or above typically indicates clinically significant anxiety symptoms and the need for further evaluation. The items (7) are summed, with scores ranging from 0 to 21, where 0-4 indicates minimal anxiety, 5-9 mild anxiety, 10-14 moderate anxiety, and 15-21 severe anxiety. Higher scores indicate greater anxiety severity (a worse outcome). |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Carolina Vélez-Grau, PhD and LCSW | Contact | 16175522539 | velezgra@bc.edu | |
| Krystel Francis, BA | Contact | francik@bc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Carolina Vélez-Grau, PHD, LCSW | Boston College | Principal Investigator |
| Laura Mufson, PhD | Columbia University | Study Chair |
| Susan Witte, PhD |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Boston College | Chestnut Hill | Massachusetts | 02467 | United States |
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.
Data will be available at the end of the study in 2029.
Based on the NDA, the qualified scientific community will have access to de-identified data from the study.
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| ID | Term |
|---|---|
| D059020 | Suicidal Ideation |
| D003863 | Depression |
| ID | Term |
|---|---|
| D013405 | Suicide |
| D016728 | Self-Injurious Behavior |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| Usual Community Center Services | Other | 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. |
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| 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). | Up to 7 weeks. |
| Up to 7 weeks. |
| Change in experiences with discrimination | The Adolescent Discrimination Distress Index (ADDI; Fisher, Scyatta, & Fenton, 2000) is a 15-item measure that assesses adolescent distress in response to perceived instances of racially motivated discrimination in institutional (e.g., stores, restaurants), educational (e.g., teacher evaluations), and peer contexts. It was developed to examine the nature and impact of racial and ethnic discrimination on development in multiethnic samples of youth. Students indicate whether they have experienced each type of discrimination because of their race or ethnicity and, if so, they rate how much it upset them, on a 5-point scale ranging from not at all to extremely. Total score range (15-75 using a sum). Higher scores indicate higher levels of distress (a worse outcome). | Up to 7 weeks. |
| Columbia University |
| Study Chair |