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Latino/a Adolescents With Suicidal Behavior

Primary Purpose

Suicide

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
S-CBT
Treatment as Usual
Sponsored by
Brown University
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, Latinx teens

Eligibility Criteria

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

Inclusion Criteria:

  • Latino/a
  • Admitted to the inpatient unit for suicidal ideation or suicidal behaviors

Exclusion Criteria:

  • Severe psychosis or psychoses independent of depression
  • Department of Children and Families (DCYF) involvement
  • Status as a ward of the state

Sites / Locations

  • Bradley Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

InVita

Treatment as Usual

Arm Description

Participants receive the Socio-Cognitive Behavior Therapy (S-CBT) treatment.

Intensive outpatient therapy of standard care for adolescents and their parents

Outcomes

Primary Outcome Measures

Number of Suicide Behaviors (attempts, aborted & interrupted attempts, preparatory acts) and Suicide Events (hospitalizations, ER visits)
Number of behaviors or events measured using the Columbia Suicide Severity Rating Scale (C-SSRS)
Suicidality
Measured using the Suicidal Ideation Questionnaire (SIQ-JR)

Secondary Outcome Measures

Psychiatric Symptoms [Axis I Diagnoses]
Axis I diagnoses as evaluated from the Children's Inventory for Psychiatric Syndromes (ChIPS) and Youth Self-Report (YSR)
Depressive Symptoms
Level of depressive symptomatology measured using the Children's Depression Inventory (CDI)

Full Information

First Posted
March 28, 2016
Last Updated
January 27, 2020
Sponsor
Brown University
Collaborators
University of Puerto Rico
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1. Study Identification

Unique Protocol Identification Number
NCT02820636
Brief Title
Latino/a Adolescents With Suicidal Behavior
Official Title
Treatment for Latino/a Adolescents With Suicidal Behavior
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
January 2016 (Actual)
Primary Completion Date
July 2018 (Actual)
Study Completion Date
July 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brown University
Collaborators
University of Puerto Rico

4. Oversight

5. Study Description

Brief Summary
The study is about developing the best aftercare treatment possible for Latino/a adolescents who have been hospitalized in a psychiatric unit due to a suicidal crisis (suicidal thoughts or attempts). The treatment's purpose is to help adolescents and their caregivers develop skills to prevent future suicidal crises. Latino/a adolescents usually report more suicidal behavior than other ethnic groups. The question that the investigators want to answer is if a new treatment (socio-cognitive behavioral therapy-(SCBT)) developed to their specific needs, taking into account their culture and aspects of adolescence, performs better than the treatment that they usually receive. Forty six adolescents were recruited from the Bradley Hospital adolescent inpatient unit or the Hasbro Inpatient Medical & Psychiatric Program, or referred to Gateway Healthcare after discharge from other inpatient units in Rhode Island; half of them were assigned randomly to the treatment they would usually receive (TAU) and the other half to the new treatment (SCBT). In both groups, caregivers and adolescents completed questionnaires and interviews before the beginning of treatment and at 3, 6, and 12 months after the treatment begin. Questions to the participants were related to their presenting symptoms, family, social group, problems, and other similar topics. Also, participants were asked about their satisfaction with the treatment they were receiving. The purpose of the questionnaires and interviews are to follow their progress in therapy. At the end, comparisons will be made between the group who participated in TAU and the group who participated in the SCBT, based on the assessment results from the adolescents and caregivers.
Detailed Description
The primary aim of the proposed research is to evaluate the feasibility of a socio-cognitive-behavioral therapy protocol for suicidal behavior (SCBT-SB) with Latino/a adolescents in comparison to treatment as usual (TAU). The SCBT-SB protocol was develop in Puerto Rico, but was expand to Latinx populations in U.S. based on a previous qualitative study. The SCBT-SB include developmental and cultural factors in order to optimize treatment outcomes in suicidal Latino/a adolescents. Study design: A pilot randomized controlled trial (RCT) of the SCBT-SB versus TAU was conducted in a real world scenario. Participants were 46 Latino/a adolescents (13-17) admitted to a Psychiatric Unit for suicide ideation or suicide attempts, who were referred to outpatient care, and at least one legal guardian. RCT's primary question is: Is the SCBT-SB protocol feasible in terms of satisfaction, acceptability, recruitment, retention, and therapist adherence? RCT's secondary question is: What is the magnitude of difference in suicidality and psychopathology symptoms between the SCBT-SB and the TAU at three, six, and 12 months following baseline?

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, Latinx teens

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
InVita
Arm Type
Experimental
Arm Description
Participants receive the Socio-Cognitive Behavior Therapy (S-CBT) treatment.
Arm Title
Treatment as Usual
Arm Type
Active Comparator
Arm Description
Intensive outpatient therapy of standard care for adolescents and their parents
Intervention Type
Behavioral
Intervention Name(s)
S-CBT
Intervention Description
The SCBT-SB protocol has 3 phases. Phase I, which is fixed (core sessions), includes 9 sessions (1 family, 5 individual & 3 caretakers sessions). Topics include: understanding the suicidal crisis, identity in adolescence, chain analysis, communication skills, the power of thought and decision making, parenting skills, rearing in a different culture, and family communication. Phase II is flexible and consists of coping skills modules (thoughts, emotional regulation, social interactions, activities, substance abuse, family communication & trauma). The treatment plan is adjusted to adolescents' needs. Family and primary caregiver sessions are flexible, depending on the family/caregivers' needs. Participants have received an adequate course of treatment if they at least complete the core sessions. This protocol should take 3-6 months. Once the active phase ends, booster sessions are recommended.
Intervention Type
Behavioral
Intervention Name(s)
Treatment as Usual
Intervention Description
Intensive outpatient therapy with teens and their parents using a variety of eclectic treatments that characterize standard care for adolescents.
Primary Outcome Measure Information:
Title
Number of Suicide Behaviors (attempts, aborted & interrupted attempts, preparatory acts) and Suicide Events (hospitalizations, ER visits)
Description
Number of behaviors or events measured using the Columbia Suicide Severity Rating Scale (C-SSRS)
Time Frame
Change from Baseline to 6 Month (6M) and 12 Month (12M)
Title
Suicidality
Description
Measured using the Suicidal Ideation Questionnaire (SIQ-JR)
Time Frame
Change from Baseline to 6 Month (6M) and 12 Month (12M)
Secondary Outcome Measure Information:
Title
Psychiatric Symptoms [Axis I Diagnoses]
Description
Axis I diagnoses as evaluated from the Children's Inventory for Psychiatric Syndromes (ChIPS) and Youth Self-Report (YSR)
Time Frame
Change from Baseline to 6M and 12M
Title
Depressive Symptoms
Description
Level of depressive symptomatology measured using the Children's Depression Inventory (CDI)
Time Frame
Change from Baseline to 6M and 12M

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Latino/a Admitted to the inpatient unit for suicidal ideation or suicidal behaviors Exclusion Criteria: Severe psychosis or psychoses independent of depression Department of Children and Families (DCYF) involvement Status as a ward of the state
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
02915 02915, Ph.D.
Organizational Affiliation
Brown University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bradley Hospital
City
East Providence
State/Province
Rhode Island
ZIP/Postal Code
02915
Country
United States

12. IPD Sharing Statement

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Latino/a Adolescents With Suicidal Behavior

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