NCT04278157

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
114

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 13, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 20, 2020

Completed
7 days until next milestone

Study Start

First participant enrolled

February 27, 2020

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 25, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 25, 2024

Completed
Last Updated

February 6, 2025

Status Verified

February 1, 2025

Enrollment Period

4.7 years

First QC Date

February 13, 2020

Last Update Submit

February 4, 2025

Conditions

Keywords

Suicidal IdeationSuicide AttemptLatina, Latino, Latinx youth

Outcome Measures

Primary Outcomes (3)

  • 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.

  • 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.

  • 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 Outcomes (3)

  • Suicide Attempts

    Change from baseline to 6 months follow-up

  • Suicide Attempts

    Change from 6 months to 12 months follow-up

  • Suicide Attempts

    Change from baseline to 12 months follow-up

Study Arms (2)

SCBT-SB

EXPERIMENTAL

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

Behavioral: Socio-Cognitive Behavioral Therapy for Suicidal Behavior (SCBT-SB)

Treatment as Usual

ACTIVE COMPARATOR

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

Behavioral: Treatment as Usual

Interventions

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.

SCBT-SB

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.

Treatment as Usual

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hasbro Children's Hospital (Inpatient Psychiatric Unit)

Providence, Rhode Island, 02903, United States

Location

Bradley Hospital

Riverside, Rhode Island, 02915, United States

Location

Related Publications (2)

  • Duarte-Velez Y, Torres-Davila P, Spirito A, Polanco N, Bernal G. Development of a treatment protocol for Puerto Rican adolescents with suicidal behaviors. Psychotherapy (Chic). 2016 Mar;53(1):45-56. doi: 10.1037/pst0000044.

    PMID: 26928136BACKGROUND
  • Duarte-Velez Y, Jimenez-Colon G, Jones RN, Spirito A. Socio-Cognitive Behavioral Therapy for Latinx Adolescent with Suicidal Behaviors: A Pilot Randomized Trial. Child Psychiatry Hum Dev. 2024 Jun;55(3):754-767. doi: 10.1007/s10578-022-01439-z. Epub 2022 Oct 1.

    PMID: 36183051BACKGROUND

MeSH Terms

Conditions

SuicideSuicidal IdeationSuicide, Attempted

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Self-Injurious BehaviorBehavioral SymptomsBehavior

Study Officials

  • Yovanska Duarte-Velez, PhD

    Bradley Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 13, 2020

First Posted

February 20, 2020

Study Start

February 27, 2020

Primary Completion

November 25, 2024

Study Completion

November 25, 2024

Last Updated

February 6, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
One year following collection and final analyses.
Access Criteria
By email contact with PI.

Locations