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Treatment for Latino/a Adolescents With Suicidal Behavior

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ClinicalTrials.gov Identifier: NCT02820636
Recruitment Status : Unknown
Verified June 2016 by Yovanska Duarte-Velez, University of Puerto Rico.
Recruitment status was:  Recruiting
First Posted : July 1, 2016
Last Update Posted : July 1, 2016
Sponsor:
Collaborator:
Brown University
Information provided by (Responsible Party):
Yovanska Duarte-Velez, University of Puerto Rico

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. Fifty adolescents will be 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 will be 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 will have to complete questionnaires and interviews before the beginning of treatment and at 3, 6, and 12 months after the treatment begin. Questions to the participants will be related to their presenting symptoms, family, social group, problems, and other similar topics. Also, participants will be asked about their satisfaction with the treatment they are 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 Latino 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 will be conducted in a real world scenario. Participants will be 50 Latino/a adolescents (13-17) admitted to a Psychiatric Unit for suicide ideation or suicide attempts, who have been 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)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : August 2015
Estimated Primary Completion Date : August 2017

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 7 sessions (1 family, 4 individual & 2 caretakers sessions). Topics include: understanding the suicidal crisis, getting to know the participants, chain analysis, communication skills, the power of thought and decision making, parenting skills, and family communication. Phase II is flexible and consists of coping skills modules (thoughts, affect regulation, peer relationships, activities, substance abuse & family communication). The treatment plan is adjusted to adolescents' needs. A trauma session is also included as necessary. Phase III consists of closing family and primary caretaker sessions, that are flexible, depending on the caregivers' needs. Participants have received an adequate course of treatment if they complete the core sessions, a basic coping skills module, and the closing 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 with teens and their parents using a variety of eclectic treatments that characterize standard care for adolescents
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)



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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


Contacts
Contact: Yovanska Duarte-Velez, Ph.D. 7874048232 yovanska_duarte-velez@brown.edu

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

Responsible Party: Yovanska Duarte-Velez, Assistant Professor, University of Puerto Rico
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: July 1, 2016
Last Verified: June 2016

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