NCT02820636

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 28, 2016

Completed
3 months until next milestone

First Posted

Study publicly available on registry

July 1, 2016

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2018

Completed
Last Updated

January 29, 2020

Status Verified

January 1, 2020

Enrollment Period

2.5 years

First QC Date

March 28, 2016

Last Update Submit

January 27, 2020

Conditions

Keywords

Suicidal ideationSuicide attemptLatinx teens

Outcome Measures

Primary Outcomes (2)

  • Number of Suicide Behaviors (attempts, aborted & interrupted attempts, preparatory acts) and Suicide Events (hospitalizations, ER visits)

    Number of behaviors or events measured using the Columbia Suicide Severity Rating Scale (C-SSRS)

    Change from Baseline to 6 Month (6M) and 12 Month (12M)

  • Suicidality

    Measured using the Suicidal Ideation Questionnaire (SIQ-JR)

    Change from Baseline to 6 Month (6M) and 12 Month (12M)

Secondary Outcomes (2)

  • Psychiatric Symptoms [Axis I Diagnoses]

    Change from Baseline to 6M and 12M

  • Depressive Symptoms

    Change from Baseline to 6M and 12M

Study Arms (2)

InVita

EXPERIMENTAL

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

Behavioral: S-CBT

Treatment as Usual

ACTIVE COMPARATOR

Intensive outpatient therapy of standard care for adolescents and their parents

Behavioral: Treatment as Usual

Interventions

S-CBTBEHAVIORAL

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.

InVita

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

Treatment as Usual

Eligibility Criteria

Age13 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Latino/a
  • Admitted to the inpatient unit for suicidal ideation or suicidal behaviors

You may not qualify if:

  • Severe psychosis or psychoses independent of depression
  • Department of Children and Families (DCYF) involvement
  • Status as a ward of the state

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bradley Hospital

East Providence, Rhode Island, 02915, United States

Location

MeSH Terms

Conditions

SuicideSuicidal IdeationSuicide, Attempted

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Self-Injurious BehaviorBehavioral SymptomsBehavior

Study Officials

  • 02915 02915, Ph.D.

    Brown University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor (Research)

Study Record Dates

First Submitted

March 28, 2016

First Posted

July 1, 2016

Study Start

January 1, 2016

Primary Completion

July 1, 2018

Study Completion

July 1, 2018

Last Updated

January 29, 2020

Record last verified: 2020-01

Locations