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STAT-ED: Suicidal Teens Accessing Treatment After an Emergency Department Visit

This study is not yet open for participant recruitment.
Verified January 2013 by Children's Hospital Medical Center, Cincinnati
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier:
NCT01779414
First received: January 2, 2013
Last updated: January 28, 2013
Last verified: January 2013
History of Changes
  Purpose

This study looks to implement a novel intervention (STAT-ED) for children who screen positive to suicide ideation. The intervention looks to collect data from several different measures and then randomize participants into one of two groups: a control group where the participant will be set up with a mental health referral from a psychiatric social worker; or if randomized into the STAT-ED intervention, the adolescent and parent will receive a brief motivational interview, barrier reduction discussion, referral and limited case management by the study social worker to enhance outpatient mental health follow up after discharge from the ED.

The hypothesis of the study is patients who are randomized into the STAT-ED intervention group will have a significantly higher rate of initiating mental health treatment and will attend more mental health treatment sessions in the two months after the ED visit compared with adolescents in the control group. Secondary aims of this study look to determine whether the effectiveness of the STAT-ED intervention differs by age, gender, or ethnicity; and evaluate predictors and mediators of mental health treatment engagement.


Condition Intervention
Suicide
 Other: STAT-ED Intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: STAT-ED: Suicidal Teens Accessing Treatment After an Emergency Department Visit

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Children's Hospital Medical Center, Cincinnati:

Primary Outcome Measures:
  • STAT-ED Intervention Superior to EUC Group [ Time Frame: Three years ] [ Designated as safety issue: No ]
    Adolescents receiving the STAT-ED intervention will have a significantly higher rate of initiating mental health treatment and will attend more mental health treatment sessions in the two months after the ED visit compared with adolescents in the EUC condition. STAT-ED will also be superior to the EUC arm in reducing suicidal ideation and depression symptoms at two months and six months.


Secondary Outcome Measures:
  • Demographic Differences [ Time Frame: Three years ] [ Designated as safety issue: No ]
    To determine whether the effectiveness of the STAT-ED intervention differs by age, gender, ethnicity, or other demographic variables.


Other Outcome Measures:
  • Predictors and Mediators of Mental Health Treatment Engagement [ Time Frame: Three years ] [ Designated as safety issue: No ]
    Evaluate predictors and mediators of mental health treatment engagement. We hypothesize that mental health treatment engagement in both arms will be predicted by higher clinical suicide severity, lower family barriers to treatment, and lower service access barriers. High scores in the action stage of change will predict successful mental health treatment engagement, in general, but particularly for those enrolled in STAT-ED.


Estimated Enrollment: 160
Study Start Date: February 2013
Estimated Study Completion Date: February 2016
Estimated Primary Completion Date: February 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Enhanced Usual Care
Participants in this arm of the study will receive a standard, usual care psychological risk assessment by a social worker and then recommended to a mental health referral.
Experimental: STAT-ED Intervention
Participants in this group will receive a motivational interview conducted by a study trained social worker, where the social worker and the family will discuss the participants issues, thoughts and feelings about receiving treatment, barriers to treatment and methods of overcoming those barriers. The study trained social worker will also make a referral for a mental health follow-up for the patient.
 Other: STAT-ED Intervention
Participants in this group will receive a motivational interview conducted by a study trained social worker, where the social worker and the family will discuss the participants issues, thoughts and feelings about receiving treatment, barriers to treatment and methods of overcoming those barriers. The study trained social worker will also make a referral for a mental health follow-up for the patient.

Detailed Description:

The STAT-ED study is a two site study conducted by Cincinnati Children's Hospital and Nationwide Children's Hospital that is looking to test the effectiveness of a brief treatment engagement intervention termed Suicidal Teens Accessing Treatment After an ED Visit (STAT-ED) for adolescents seeking treatment in the ED for non-psychiatric concerns but identified via systematic screening as being at risk for suicide. In this study, investigators from both institutions will recruit and randomize 160 adolescents (80 per site) to either(a) the STAT-ED intervention or (b) enhanced usual care group (EUC). The EUC group consist of a brief consultation by an ED social worker and a mental health referral for the participant facilitated by the Psychiatric Intake Response Center. The STAT-ED intervention targets family engagement, problem solving, motivational interviewing, assistance with referral and limited case management during the transition from the ED to outpatient care with the goal of maximizing the initiation of mental health treatment and aftercare among youth screening positive for previously unrecognized suicide risk. A study trained research coordinator who is blinded to the participants treatment allocation will contact the participants via telephone at two months and six months post ED visit in order to ascertain initiation and attendance of the mental health follow-up, as well as an assessment of suicidal ideation and depression.

  Eligibility

Ages Eligible for Study:   12 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patients who arrive in the ED who are between the ages of 12-17 years old
  • Screen positive on the Ask Suicide-Screening Questions (ASQ) tool
  • Have had no contact with a mental health provider in the 90 days preceding the current ED visit
  • Are stable as determined by vital signs and triage criteria

Exclusion Criteria:

  • Patients who present in the ED with a chief complaint of suicidal behavior
  • Those who present in the ED with a primary or secondary psychiatric concern
  • Those without access to a telephone/cell phone
  • Those unable to adequately understand the study process
  • Those families unable to speak or read English adequately to participate in study procedures
  • Patients who have altered mental status either due to illness or medication (pain medications)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01779414

Contacts
Contact: Jacqueline Grupp-Phelan, M.D., M.P.H. 513-636-3465 Jacqueline.grupp-phelan@cchmc.org
Contact: Jeffrey Bridge, Ph.D. 614-722-3066 Jeff.Bridge@nationwidechildrens.org

Locations
United States, Ohio
Cincinnati Children's Hospital Medical Center Not yet recruiting
Cincinnati, Ohio, United States, 45229
Contact: Jacqueline Grupp-Phelan, M.D., M.P.H.     513-636-3465     Jacqueline.grupp-phelan@cchmc.org    
Principal Investigator: Jacqueline Grupp-Phelan, M.D., M.P.H.            
Nationwide Children's Hospital Not yet recruiting
Columbus, Ohio, United States, 43205
Contact: Jeff Bridge, Ph.D.     614-722-3066     Jeff.Bridge@nationwidechildrens.org    
Principal Investigator: Jeff Bridge, Ph.D.            
Sponsors and Collaborators
Children's Hospital Medical Center, Cincinnati
National Institutes of Health (NIH)
Investigators
Principal Investigator: Jacqueline Grupp-Phelan, M.D., M.P.H. Children's Hospital Medical Center, Cincinnati
  More Information

No publications provided

Responsible Party: Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier: NCT01779414     History of Changes
Other Study ID Numbers: CINC-2012-3660
Study First Received: January 2, 2013
Last Updated: January 28, 2013
Health Authority: United States: Cincinnati Children's Hospital Medical Center

Keywords provided by Children's Hospital Medical Center, Cincinnati:
Suicide Ideation

Additional relevant MeSH terms:
Emergencies
Suicide
Disease Attributes
 Pathologic Processes
Self-Injurious Behavior
Behavioral Symptoms

ClinicalTrials.gov processed this record on May 16, 2013