- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02610309
Family-based Crisis Intervention With Suicidal Adolescents in the ED (FBCI)
Family-based Crisis Intervention With Suicidal Adolescents in the Emergency Department: A Randomized Clinical Trial
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02115
- Boston Children's Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / 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.
|
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).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
one day, one week, and one month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
one month
|
|
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.
|
one day
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Elizabeth A Wharff, PhD, Boston Children's Hospital
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- P00000105
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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