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Completed

NCT Number: NCT02610309

Family-based Crisis Intervention With Suicidal Adolescents in the ED

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.

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Key information

Age range

13 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Family-Based Crisis Intervention

Behavioral

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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Boston Children's Hospital

Other

Registry information

Official study title

Family-based Crisis Intervention With Suicidal Adolescents in the Emergency Department: A Randomized Clinical Trial

Acronym: FBCI

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Nov 20, 2015
Registry last updated
Nov 20, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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