NCT02610309

Brief Summary

The Family Based Crisis Intervention (FBCI) is an emergency psychiatry intervention designed to sufficiently stabilize suicidal adolescents within a single ED visit so that they may return home safely with their families. This study is a randomized clinical trial of FBCI v. TAU in an urban Emergency Department.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
143

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2012

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, 2012

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

November 13, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 20, 2015

Completed
Last Updated

November 20, 2015

Status Verified

November 1, 2015

Enrollment Period

2.3 years

First QC Date

November 13, 2015

Last Update Submit

November 18, 2015

Conditions

Keywords

family-based crisis interventionadolescent suicide

Outcome Measures

Primary Outcomes (1)

  • Disposition at discharge from the ED (psychiatric hospitalization or other)

    The primary outcome measure is disposition (psychiatric hospitalization vs. less restrictive level of care) after receiving the FBCI intervention or TAU. Psychiatric hospitalization was reassessed at 1 day, 1 week and 1 month intervals after randomization.

    one day, one week, and one month

Secondary Outcomes (2)

  • Family Empowerment Scale (FES)

    one month

  • Client Satisfaction Questionnaire (CSQ-8)

    one day

Study Arms (2)

Family-Based Crisis Intervention

EXPERIMENTAL

The Family-Based Crisis Intervention (FBCI) is a single-session intervention that takes place in the Emergency Department. Adolescents randomized to the experimental condition received a standard psychiatric evaluation followed by the experimental intervention. FBCI was administered by licensed psychiatric social workers who were trained in the intervention. The research clinician provided FBCI to the suicidal adolescent and his/her parent(s)/guardian(s) in a 60-90 minute session in which she helped the adolescent and family develop a joint crisis narrative of the problem and taught them cognitive-behavioral skill-building, therapeutic readiness, psycho-education about depression, and safety planning.

Behavioral: Family-Based Crisis Intervention

Treatment As Usual

NO INTERVENTION

Treatment as usual included an emergency psychiatry evaluation (standard care).

Interventions

This intensive ED-based intervention with suicidal adolescents and their families includes cognitive behavioral skill building, psychoeducation, enhancing therapeutic readiness, safety planning, and co-creation of a joint crisis narrative.

Family-Based Crisis Intervention

Eligibility Criteria

Age13 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • adolescent presenting to the ED with suicidality
  • presence of a consenting parent or legal guardian with whom the adolescent resided.

You may not qualify if:

  • either adolescent or parent/guardian lacked fluency in English;
  • adolescent was not medically stable, including intoxication;
  • adolescent demonstrated cognitive limitations prohibiting completion of research instruments;
  • adolescent presented with active psychosis;
  • adolescent required physical or medication restraint in the ED.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Suicide

Condition Hierarchy (Ancestors)

Self-Injurious BehaviorBehavioral SymptomsBehavior

Study Officials

  • Elizabeth A Wharff, PhD

    Boston Children's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Researcher

Study Record Dates

First Submitted

November 13, 2015

First Posted

November 20, 2015

Study Start

January 1, 2012

Primary Completion

May 1, 2014

Study Completion

May 1, 2014

Last Updated

November 20, 2015

Record last verified: 2015-11

Locations