- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02820636
Latino/a Adolescents With Suicidal Behavior
January 27, 2020 updated by: Yovanska Duarte-Velez, Brown University
Treatment for Latino/a Adolescents With Suicidal Behavior
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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
Enrollment (Actual)
46
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Rhode Island
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East Providence, Rhode Island, United States, 02915
- Bradley Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
13 years to 17 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: InVita
Participants receive the Socio-Cognitive Behavior Therapy (S-CBT) treatment.
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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.
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Active Comparator: Treatment as Usual
Intensive outpatient therapy of standard care for adolescents and their parents
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Intensive outpatient therapy with teens and their parents using a variety of eclectic treatments that characterize standard care for adolescents.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
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Number of behaviors or events measured using the Columbia Suicide Severity Rating Scale (C-SSRS)
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Change from Baseline to 6 Month (6M) and 12 Month (12M)
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Suicidality
Time Frame: Change from Baseline to 6 Month (6M) and 12 Month (12M)
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Measured using the Suicidal Ideation Questionnaire (SIQ-JR)
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Change from Baseline to 6 Month (6M) and 12 Month (12M)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Psychiatric Symptoms [Axis I Diagnoses]
Time Frame: Change from Baseline to 6M and 12M
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Axis I diagnoses as evaluated from the Children's Inventory for Psychiatric Syndromes (ChIPS) and Youth Self-Report (YSR)
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Change from Baseline to 6M and 12M
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Depressive Symptoms
Time Frame: Change from Baseline to 6M and 12M
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Level of depressive symptomatology measured using the Children's Depression Inventory (CDI)
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Change from Baseline to 6M and 12M
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: 02915 02915, Ph.D., Brown University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2016
Primary Completion (Actual)
July 1, 2018
Study Completion (Actual)
July 1, 2018
Study Registration Dates
First Submitted
March 28, 2016
First Submitted That Met QC Criteria
June 28, 2016
First Posted (Estimate)
July 1, 2016
Study Record Updates
Last Update Posted (Actual)
January 29, 2020
Last Update Submitted That Met QC Criteria
January 27, 2020
Last Verified
January 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- K23MH097772 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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