Clinical trial NCT02820636: Latino/a Adolescents With Suicidal Behavior
Official title: Treatment for Latino/a Adolescents With Suicidal Behavior
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Suicide
Keywords: Suicidal ideation
Suicide attempt
Latinx teens
Lead sponsor: Brown University
Sponsor class: OTHER
Collaborators: name: University of Puerto Rico
First posted: 2016-07-01
Enrollment: 46
Sex: ALL
Minimum age (years): 13
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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?

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

Primary outcomes:
measure: Number of Suicide Behaviors (attempts, aborted & interrupted attempts, preparatory acts) and Suicide Events (hospitalizations, ER visits)
timeFrame: Change from Baseline to 6 Month (6M) and 12 Month (12M)
measure: Suicidality
timeFrame: Change from Baseline to 6 Month (6M) and 12 Month (12M)
Secondary outcomes:
measure: Psychiatric Symptoms [Axis I Diagnoses]
timeFrame: Change from Baseline to 6M and 12M
measure: Depressive Symptoms
timeFrame: Change from Baseline to 6M and 12M
Other outcomes:
Locations:
city: East Providence
country: United States
facility: Bradley Hospital
state: Rhode Island
Study officials:
affiliation: Brown University
name: 02915 02915, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: