SuicideFBCINCT02610309
Family-based Crisis Intervention With Suicidal Adolescents in the ED
A study testing Family-Based Crisis Intervention in people with Suicide, run by Boston Children's Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 13 to 18 years
- Conditions the study is for
- Suicide
- What is being tested?
- Family-Based Crisis Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 143 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2012to May 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- adolescent presenting to the ED with suicidality
- presence of a consenting parent or legal guardian with whom the adolescent resided.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Boston Children's Hospital
Boston, Massachusetts, 02115
About this study
Official title: Family-based Crisis Intervention With Suicidal Adolescents in the Emergency Department: A Randomized Clinical Trial
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.
Read the 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.
- Conditions
- Suicide
- Being tested
- Family-Based Crisis Intervention
- Keywords
- family-based crisis intervention, adolescent suicide
- Medical subject headings
- Suicide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Family-Based Crisis InterventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Family-Based Crisis Intervention | Experimental | 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. Receives: Behavioral: Family-Based Crisis Intervention |
| Treatment As Usual | No intervention | Treatment as usual included an emergency psychiatry evaluation (standard care). |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: one day, one week, and one month
Secondary outcomes (2)
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.
Measured: one month
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.
Measured: one day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2015 (estimated)
- Study startJan 2012
- Primary completionMay 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SuicideStudies of the same condition, open and under way.
- More trials run by Boston Children's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 143 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elizabeth Wharff, Boston Children's Hospital
- Investigators
- Elizabeth A Wharff, PhD, Principal investigator, Boston Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02610309
- Sponsor's protocol ID
- P00000105
- Acronym
- FBCI
- Status last verified
- Nov 2015
- First submitted
- 13 Nov 2015
- Last updated
- 20 Nov 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Family-based Crisis Intervention With Suicidal Adolescents in the Emergency Department: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT02610309
- Acronym / sponsor ID
- FBCI / P00000105
- Conditions
- Suicide
- Keywords
- family-based crisis intervention, adolescent suicide
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 143 participants (actual)
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 20 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Family-Based Crisis Intervention | Experimental | Behavioral: Family-Based Crisis InterventionThe 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 | No intervention | –Treatment as usual included an emergency psychiatry evaluation (standard care). |
Who may qualify
- Ages
- 13 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- adolescent presenting to the ED with suicidality
- presence of a consenting parent or legal guardian with whom the adolescent resided.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Family-Based Crisis InterventionThis 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. | Behavioural | Family-Based Crisis Intervention |
Primary outcome
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.
2 secondary outcomes
Family Empowerment Scale (FES)
Time frame: one month
Client Satisfaction Questionnaire (CSQ-8)
Time frame: one day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elizabeth A Wharff, PhD principal investigator
Boston Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Family-Based Crisis Intervention in people with Suicide, run by Boston Children's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disposition at discharge from the ED (psychiatric hospitalization or other) (time frame: one day, one week, and one month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2015.