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Treatment for Latino/a Adolescents With Suicidal Behavior

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ClinicalTrials.gov Identifier: NCT02820636
Recruitment Status : Active, not recruiting
First Posted : July 1, 2016
Last Update Posted : October 23, 2018
Sponsor:
Collaborator:
University of Puerto Rico
Information provided by (Responsible Party):
Yovanska Duarte-Velez, Brown University

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.

Condition or disease Intervention/treatment Phase
Suicide Behavioral: S-CBT Behavioral: Treatment as Usual Not Applicable

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?

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 46 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : August 2015
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : March 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Suicide

Arm Intervention/treatment
Experimental: InVita
Participants receive the Socio-Cognitive Behavior Therapy (S-CBT) treatment.
Behavioral: S-CBT
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.

Active Comparator: Treatment as Usual
Intensive outpatient therapy of standard care for adolescents and their parents
Behavioral: Treatment as Usual
Intensive outpatient therapy with teens and their parents using a variety of eclectic treatments that characterize standard care for adolescents.




Primary Outcome Measures :
  1. Number of Suicide Behaviors (attempts, aborted & interrupted attempts, preparatory acts) and Suicide Events (hospitalizations, ER visits) [ Time Frame: Change from Baseline to 6 Month (6M) and 12 Month (12M) ]
    Number of behaviors or events measured using the Columbia Suicide Severity Rating Scale (C-SSRS)

  2. Suicidality [ Time Frame: Change from Baseline to 6 Month (6M) and 12 Month (12M) ]
    Measured using the Suicidal Ideation Questionnaire (SIQ-JR)


Secondary Outcome Measures :
  1. Psychiatric Symptoms [Axis I Diagnoses] [ Time Frame: Change from Baseline to 6M and 12M ]
    Axis I diagnoses as evaluated from the Children's Inventory for Psychiatric Syndromes (ChIPS) and Youth Self-Report (YSR)

  2. Depressive Symptoms [ Time Frame: Change from Baseline to 6M and 12M ]
    Level of depressive symptomatology measured using the Children's Depression Inventory (CDI)



Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02820636


Locations
United States, Rhode Island
Bradley Hospital
East Providence, Rhode Island, United States, 02915
Sponsors and Collaborators
Brown University
University of Puerto Rico
Investigators
Principal Investigator: 02915 02915, Ph.D. Brown University

Responsible Party: Yovanska Duarte-Velez, Assistant Professor (Research), Brown University
ClinicalTrials.gov Identifier: NCT02820636     History of Changes
Other Study ID Numbers: K23MH097772 ( U.S. NIH Grant/Contract )
First Posted: July 1, 2016    Key Record Dates
Last Update Posted: October 23, 2018
Last Verified: October 2018

Additional relevant MeSH terms:
Suicide
Self-Injurious Behavior
Behavioral Symptoms