Latino/a Adolescents With Suicidal Behavior

NCT ID: NCT02820636

Last Updated: 2020-01-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-31
• Study Completion Date: 2018-07-31

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?

Conditions

Suicide

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

InVita

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

Group Type: EXPERIMENTAL

S-CBT

Intervention Type: BEHAVIORAL

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.

Treatment as Usual

Intensive outpatient therapy of standard care for adolescents and their parents

Group Type: ACTIVE_COMPARATOR

Treatment as Usual

Intervention Type: BEHAVIORAL

Intensive outpatient therapy with teens and their parents using a variety of eclectic treatments that characterize standard care for adolescents.

Interventions

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.

Intervention Type: BEHAVIORAL

Treatment as Usual

Intensive outpatient therapy with teens and their parents using a variety of eclectic treatments that characterize standard care for adolescents.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 13 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Puerto Rico

OTHER

Sponsor Role: collaborator

Brown University

OTHER

Sponsor Role: lead

Responsible Party

Yovanska Duarte-Velez

Assistant Professor (Research)

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

02915 02915, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Brown University

Locations

Bradley Hospital

East Providence, Rhode Island, United States

Countries

United States

Other Identifiers

K23MH097772

Identifier Type: NIH

Identifier Source: org_study_id

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