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

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ClinicalTrials.gov Identifier: NCT02610309
Recruitment Status : Completed
First Posted : November 20, 2015
Last Update Posted : November 20, 2015
Sponsor:
Information provided by (Responsible Party):
Elizabeth Wharff, Boston Children’s Hospital

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.

Condition or disease Intervention/treatment Phase
Suicide Behavioral: Family-Based Crisis Intervention Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 143 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Family-based Crisis Intervention With Suicidal Adolescents in the Emergency Department: A Randomized Clinical Trial
Study Start Date : January 2012
Actual Primary Completion Date : May 2014
Actual Study Completion Date : May 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Suicide

Arm Intervention/treatment
Experimental: Family-Based Crisis Intervention
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
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.

No Intervention: Treatment As Usual
Treatment as usual included an emergency psychiatry evaluation (standard care).



Primary Outcome Measures :
  1. Disposition at discharge from the ED (psychiatric hospitalization or other) [ Time Frame: one day, one week, and one month ]
    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 :
  1. Family Empowerment Scale (FES) [ Time Frame: one month ]
    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.

  2. Client Satisfaction Questionnaire (CSQ-8) [ Time Frame: one day ]
    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.



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Ages Eligible for Study:   13 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02610309


Locations
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United States, Massachusetts
Boston Children's Hospital
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Boston Children’s Hospital
Investigators
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Principal Investigator: Elizabeth A Wharff, PhD Boston Children’s Hospital

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Responsible Party: Elizabeth Wharff, Clinical Researcher, Boston Children’s Hospital
ClinicalTrials.gov Identifier: NCT02610309     History of Changes
Other Study ID Numbers: P00000105
First Posted: November 20, 2015    Key Record Dates
Last Update Posted: November 20, 2015
Last Verified: November 2015
Keywords provided by Elizabeth Wharff, Boston Children’s Hospital:
family-based crisis intervention
adolescent suicide
Additional relevant MeSH terms:
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Suicide
Self-Injurious Behavior
Behavioral Symptoms