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Culturally Centered CBT for Latinx Youth

Primary Purpose

Suicide

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Socio-Cognitive Behavioral Therapy for Suicidal Behavior (SCBT-SB)
Treatment as Usual
Sponsored by
Bradley Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Suicide focused on measuring Suicidal Ideation, Suicide Attempt, Latina, Latino, Latinx youth

Eligibility Criteria

12 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Latinx, defined as have been born in a Latin country or having at least one biological parent, grandparent or an ancestor that was born in a Latin country
  • Severe Suicidal Ideation (SI), defined as a score of 22 or above on the SIQ-JR or having made a Suicide Attempts (SA) within the last 3 months
  • Caregivers and adolescents fluent in Spanish or English language and legal guardian willing to participate

Exclusion Criteria:

  • psychosis
  • substance use disorder, rated severe on the DSM-5
  • cognitive impairment represented by an IQ below 85

Sites / Locations

  • Hasbro Children's Hospital (Inpatient Psychiatric Unit)Recruiting
  • Bradley HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

SCBT-SB

Treatment as Usual

Arm Description

A culturally centered CBT treatment protocol called Socio-Cognitive Behavioral Therapy for Suicidal Behavior (SCBT-SB)

Treatment as usual is base on the standard care for teens and their parents under a community mental health center.

Outcomes

Primary Outcome Measures

Suicidal ideation
Suicidal ideation measured using the Suicide Ideation Questionnaire-Junior (SIQ-JR), the minimum score is 0 and the maximum 90. A higher score represents increase severity and frequency of suicidal thoughts.
Depressive symptoms by self-report
Level of depressive symptomatology using the Children Depression Inventory 2 (CDI-2), the minimum score is 0 and the maximum 56. A higher score means higher level of depressive symptoms.
Depressive symptoms by clinical interview
Depressive symptoms using the Children's Depression Rating Scale-Revised (CDRS-R), the minimum raw score is 17 and the maximum 113. A higher score means higher level of depressive symptoms.

Secondary Outcome Measures

Suicide Attempts
Number of total actual, aborted and interrupted suicide attempts using the Columbia-Suicide Severity Rating Scale (C-SSRS)

Full Information

First Posted
February 13, 2020
Last Updated
April 14, 2023
Sponsor
Bradley Hospital
Collaborators
Brown University
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1. Study Identification

Unique Protocol Identification Number
NCT04278157
Brief Title
Culturally Centered CBT for Latinx Youth
Official Title
A Culturally Centered CBT Protocol for Suicidal Ideation and Suicide Attempts Among Latinx Youth
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 2, 2020 (Actual)
Primary Completion Date
January 31, 2025 (Anticipated)
Study Completion Date
July 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bradley Hospital
Collaborators
Brown University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The primary aim of the proposed research is to test the effect of a culturally centered treatment protocol, the Socio-cognitive behavioral therapy (SCBT), versus Treatment as Usual on suicidal thoughts and attempts, and depressive symptoms, in a clinical sample of Latinx adolescents. The study is trying to determine, if we take into account perspectives of Latin immigrant families and minority youth, whether better outcomes can be found for this high risk group.
Detailed Description
The overall goal of this research program is to provide effective culturally relevant care to Latin families, and address the National Institute on Minority Health and Health Disparities (NIMHD) mission of reducing disparities in underserved and minority populations. Evidence-based and culturally centered treatments for Latinx teens (Latinx = gender inclusive term) with suicidal ideation and attempts (SIA) and their families are quite limited. Emerging evidence indicate that Cognitive behavioral therapy (CBT) is a promising treatment approach in reducing suicidal ideation and attempts in Non-Latinx White adolescents. However, culturally adapted treatments have been shown to benefit Latin families more that non-culturally adapted treatments. This study is innovative in its use of a culturally centered CBT treatment protocol (Socio-Cognitive Behavioral Therapy for Suicidal Behavior-SCBT-SB) to address the specific needs of Latinx teens and their families. The SCBT-SB, is a modified version of two CBT protocols, which addresses central issues in adolescent identity formation (e.g. ethnicity, sexual orientation), family interactions and communication, and parenting skills. The SCBT-SB was developed with Latinx youth with SIA in Puerto Rico and further modified for Latin families in the US. Feasibility of this modified version of the SCBT-SB was tested in the US by conducting a pilot randomized clinical trial (RCT) (n=46) of SCBT vs treatment-as-usual (TAU) with positive results. It was found that SCBT-SB was feasible to implement in a community mental health center with frontline therapists, acceptable to families, and showed reductions in suicidal ideation and depressive symptoms. The scientific premise of the proposed study is that immigration and acculturation (the process of assimilation to the host culture) and enculturation (maintaining cultural values and costumes) experiences have an impact on SIA in Latinx teens; and that personalization of an evidence-based treatment, according to cultural and immigration experiences, will result in better treatment outcomes than TAU. This application proposes a hybrid efficacy/effectiveness trial with 160 suicidal Latinx teens randomly assigned, following baseline assessment, to 2 treatment conditions, TAU and SCBT-SB. Follow-up assessment will take place at 3, 6 and 12 months after baseline. All treatment will take place at a community mental health clinic. The specific aims are: 1) To test the effect of the SCBT-SB versus TAU on suicidal ideation in a clinical sample of adolescents under conditions of strong external validity, and 2) To test the effect of the SCBT-SB versus TAU on depressive symptoms, given its high correlation with SIA. Exploratory aims are: 3) To examine the effect of SCBT-SB versus TAU on suicide attempts, and 4) To examine potential mediators (family environment) of treatment outcome. Successful completion of this study will positively impact treatment of Latinx immigrant adolescents at high risk of SIA in the US.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Suicide
Keywords
Suicidal Ideation, Suicide Attempt, Latina, Latino, Latinx youth

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
160 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
SCBT-SB
Arm Type
Experimental
Arm Description
A culturally centered CBT treatment protocol called Socio-Cognitive Behavioral Therapy for Suicidal Behavior (SCBT-SB)
Arm Title
Treatment as Usual
Arm Type
Active Comparator
Arm Description
Treatment as usual is base on the standard care for teens and their parents under a community mental health center.
Intervention Type
Behavioral
Intervention Name(s)
Socio-Cognitive Behavioral Therapy for Suicidal Behavior (SCBT-SB)
Intervention Description
The SCBT-SB is a manualized and flexible intervention that uses a modular approach to the treatment of adolescent suicidality. After the first mandatory module (Crisis module), and at the end of each subsequent module, the therapist works with the teen and caregivers to determine the next one. The Crisis Module is fixed and represent the intervention core skills with 9 sessions. The optional coping skills modules include Thoughts, Emotional Regulation, Family Communication, Social Interaction, Activity, Trauma, and Substance Use.
Intervention Type
Behavioral
Intervention Name(s)
Treatment as Usual
Intervention Description
Therapy that typically consist of eclectic individual therapy including CBT, emphasizing psychoeducation and providing support, with occasional conjoint parent sessions or individual caregiver sessions. The treatment as usual primarily focuses on generating solutions to the adolescent and caregivers most urgent concerns.
Primary Outcome Measure Information:
Title
Suicidal ideation
Description
Suicidal ideation measured using the Suicide Ideation Questionnaire-Junior (SIQ-JR), the minimum score is 0 and the maximum 90. A higher score represents increase severity and frequency of suicidal thoughts.
Time Frame
Change from baseline to 3 month, 6 month, and 12 month follow up points.
Title
Depressive symptoms by self-report
Description
Level of depressive symptomatology using the Children Depression Inventory 2 (CDI-2), the minimum score is 0 and the maximum 56. A higher score means higher level of depressive symptoms.
Time Frame
Change from baseline to 3 month, 6 month, and 12 month follow up points.
Title
Depressive symptoms by clinical interview
Description
Depressive symptoms using the Children's Depression Rating Scale-Revised (CDRS-R), the minimum raw score is 17 and the maximum 113. A higher score means higher level of depressive symptoms.
Time Frame
Change from baseline to 3 month, 6 month, and 12 month follow up points.
Secondary Outcome Measure Information:
Title
Suicide Attempts
Description
Number of total actual, aborted and interrupted suicide attempts using the Columbia-Suicide Severity Rating Scale (C-SSRS)
Time Frame
Change from baseline to 12 month follow up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Latinx, defined as have been born in a Latin country or having at least one biological parent, grandparent or an ancestor that was born in a Latin country Severe Suicidal Ideation (SI), defined as a score of 22 or above on the SIQ-JR or having made a Suicide Attempts (SA) within the last 3 months Caregivers and adolescents fluent in Spanish or English language and legal guardian willing to participate Exclusion Criteria: psychosis substance use disorder, rated severe on the DSM-5 cognitive impairment represented by an IQ below 85
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yovanska Duarte-Velez, PhD
Phone
401-432-1651
Email
yovanska.duart-velez@lifespan.org
First Name & Middle Initial & Last Name or Official Title & Degree
Gisela Jimenez-Colon, PhD
Phone
401-432-1059
Email
gjimenezcolon@lifespan.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yovanska Duarte-Velez, PhD
Organizational Affiliation
Bradley Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hasbro Children's Hospital (Inpatient Psychiatric Unit)
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gisela Jimenez-Colon, PhD
Phone
401-432-1059
Email
GJimenezColon@Lifespan.org
First Name & Middle Initial & Last Name & Degree
Lucas Nocera, BA
Email
LNocera@Lifespan.org
Facility Name
Bradley Hospital
City
Riverside
State/Province
Rhode Island
ZIP/Postal Code
02915
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gisela Jimenez-Colon, PhD
Phone
401-432-1059
Email
gjimenezcolon@lifespan.org
First Name & Middle Initial & Last Name & Degree
Lucas Nocera, BA
Email
LNocera@Lifespan.org

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Data will be made available to other researchers by request and as per NIH data sharing guidelines. The PI will also consult to anyone interested in replicating the intervention and study.
IPD Sharing Time Frame
One year following collection and final analyses.
IPD Sharing Access Criteria
By email contact with PI.

Learn more about this trial

Culturally Centered CBT for Latinx Youth

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