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Family-based Crisis Intervention With Suicidal Adolescents in the ED (FBCI)

Primary Purpose

Suicide

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Family-Based Crisis Intervention
Sponsored by
Boston Children's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Suicide focused on measuring family-based crisis intervention, adolescent suicide

Eligibility Criteria

13 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Boston Children's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Family-Based Crisis Intervention

Treatment As Usual

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Family Empowerment Scale (FES)
The FES is a 34-item self-report instrument designed to measure the level of empowerment in parents/guardians of a child/adolescent with emotional difficulties. Based upon a bi-dimensional definition of perceived and expressed empowerment, the FES contains three separate subscales: family, community/political, and service system. The FES demonstrates good reliability (internal consistency alpha values of .88, .87, and .88 on each of the three subscales). Validity of the FES subscales has been supported by multi-rater classification of items by expert panelists (inter-rater kappa coefficients of agreement yielded values of .83, .77, and .73 for each of the three subscales) as well as strong evidence of known-groups validity.15 The parents/guardians completed the FES at post-test, 3 day, 1 week, and one month timepoints.
Client Satisfaction Questionnaire (CSQ-8)
The CSQ-8 is an 8 item questionnaire that was developed to assess global client satisfaction. Items assess quality of service received, kind of service received, willingness to recommend to a friend, amount of help received, overall satisfaction, and willingness to come back for future service. Participants responded using a 4-point Likert scale scored from 1 to 4, and total scores range from 8 to 32. Higher scores indicate greater satisfaction. The parent/guardian completed the CSQ-8 as part of the post-test only.

Full Information

First Posted
November 13, 2015
Last Updated
November 18, 2015
Sponsor
Boston Children's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02610309
Brief Title
Family-based Crisis Intervention With Suicidal Adolescents in the ED
Acronym
FBCI
Official Title
Family-based Crisis Intervention With Suicidal Adolescents in the Emergency Department: A Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
November 2015
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
May 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Boston Children's Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Suicide
Keywords
family-based crisis intervention, adolescent suicide

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
143 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Family-Based Crisis Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Treatment As Usual
Arm Type
No Intervention
Arm Description
Treatment as usual included an emergency psychiatry evaluation (standard care).
Intervention Type
Behavioral
Intervention Name(s)
Family-Based Crisis Intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Disposition at discharge from the ED (psychiatric hospitalization or other)
Description
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.
Time Frame
one day, one week, and one month
Secondary Outcome Measure Information:
Title
Family Empowerment Scale (FES)
Description
The FES is a 34-item self-report instrument designed to measure the level of empowerment in parents/guardians of a child/adolescent with emotional difficulties. Based upon a bi-dimensional definition of perceived and expressed empowerment, the FES contains three separate subscales: family, community/political, and service system. The FES demonstrates good reliability (internal consistency alpha values of .88, .87, and .88 on each of the three subscales). Validity of the FES subscales has been supported by multi-rater classification of items by expert panelists (inter-rater kappa coefficients of agreement yielded values of .83, .77, and .73 for each of the three subscales) as well as strong evidence of known-groups validity.15 The parents/guardians completed the FES at post-test, 3 day, 1 week, and one month timepoints.
Time Frame
one month
Title
Client Satisfaction Questionnaire (CSQ-8)
Description
The CSQ-8 is an 8 item questionnaire that was developed to assess global client satisfaction. Items assess quality of service received, kind of service received, willingness to recommend to a friend, amount of help received, overall satisfaction, and willingness to come back for future service. Participants responded using a 4-point Likert scale scored from 1 to 4, and total scores range from 8 to 32. Higher scores indicate greater satisfaction. The parent/guardian completed the CSQ-8 as part of the post-test only.
Time Frame
one day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elizabeth A Wharff, PhD
Organizational Affiliation
Boston Children's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Boston Children's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States

12. IPD Sharing Statement

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Family-based Crisis Intervention With Suicidal Adolescents in the ED

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