Culturally Centered CBT for Latinx Youth

Suicide Clinical Trial

Official title:

A Culturally Centered CBT Protocol for Suicidal Ideation and Suicide Attempts Among Latinx Youth

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04278157
• Other study ID #: 1437564-1
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 2, 2020
• Est. completion date: July 31, 2025

Study information

• Verified date: April 2023
• Source: Bradley Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 114
• Est. completion date: July 31, 2025
• Est. primary completion date: January 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Suicidal Ideation
• Suicide

Intervention

Behavioral:
• Socio-Cognitive Behavioral Therapy for Suicidal Behavior (SCBT-SB)
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.
• Treatment as Usual
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.

Locations

Country	Name	City	State
United States	Hasbro Children's Hospital (Inpatient Psychiatric Unit)	Providence	Rhode Island
United States	Bradley Hospital	Riverside	Rhode Island

Sponsors (2)

Lead Sponsor	Collaborator
Bradley Hospital	Brown University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Change from baseline to 3 month, 6 month, and 12 month follow up points.
Primary	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.	Change from baseline to 3 month, 6 month, and 12 month follow up points.
Primary	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.	Change from baseline to 3 month, 6 month, and 12 month follow up points.
Secondary	Suicide Attempts	Number of total actual and interrupted suicide attempts using the Columbia-Suicide Severity Rating Scale (C-SSRS)	Change from baseline to 6 months follow-up
Secondary	Suicide Attempts	Actual and interrupted suicide attempts (yes or no) using the Columbia-Suicide Severity Rating Scale (C-SSRS)	Change from 6 months to 12 months follow-up
Secondary	Suicide Attempts	Actual and interrupted suicide attempts (yes or no) using the Columbia-Suicide Severity Rating Scale (C-SSRS)	Change from baseline to 12 months follow-up