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
|Condition or disease||Intervention/treatment||Phase|
|Suicide||Behavioral: Family-Based Crisis Intervention||Not Applicable|
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 :||Interventional (Clinical Trial)|
|Actual Enrollment :||143 participants|
|Intervention Model:||Parallel Assignment|
|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|
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).
- 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.
- 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.
- 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.
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
|United States, Massachusetts|
|Boston Children's Hospital|
|Boston, Massachusetts, United States, 02115|
|Principal Investigator:||Elizabeth A Wharff, PhD||Boston Children’s Hospital|