Clinical trial NCT02610309: Family-based Crisis Intervention With Suicidal Adolescents in the ED
Official title: Family-based Crisis Intervention With Suicidal Adolescents in the Emergency Department: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Suicide
Keywords: family-based crisis intervention
adolescent suicide
Lead sponsor: Boston Children's Hospital
Sponsor class: OTHER
First posted: 2015-11-20
Enrollment: 143
Sex: ALL
Minimum age (years): 13
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: In current practice, treatment as usual (TAU) for suicidal adolescents includes evaluation, with little or no intervention provided in the Emergency Department (ED), and disposition, usually to an inpatient psychiatry unit. 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. The intervention works intensively with both the adolescent and the family, so that the caregiver has the knowledge and skills to help the adolescent after discharge.

In this study, suicidal adolescents (ages 13-18) and their families presenting for psychiatric evaluation to a large pediatric ED were randomized to receive FBCI or treatment as usual (TAU). Patients and caregivers completed self-report measures of suicidality, family empowerment, and satisfaction with care provided at pre-test, post-test, and 3 follow up time-points over a one-month period. Clinicians contacted the adolescent and caregiver at these timepoints to administer the questionnaires and assure safety planning was being carried out.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Disposition at discharge from the ED (psychiatric hospitalization or other)
timeFrame: one day, one week, and one month
Secondary outcomes:
measure: Family Empowerment Scale (FES)
timeFrame: one month
measure: Client Satisfaction Questionnaire (CSQ-8)
timeFrame: one day
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Children's Hospital
state: Massachusetts
Study officials:
affiliation: Boston Children's Hospital
name: Elizabeth A Wharff, PhD
role: PRINCIPAL_INVESTIGATOR
References: