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

Primary Purpose

Suicide

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
STAT-ED Intervention
Sponsored by
Children's Hospital Medical Center, Cincinnati
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Suicide focused on measuring Suicide Ideation

Eligibility Criteria

12 Years - 17 Years (Child)All SexesAccepts Healthy Volunteers

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 (triage levels 2-5)

Exclusion Criteria:

  • Patients who present in the ED with a chief complaint of suicidal behavior will be excluded to comply with the requirements of the RFA.
  • 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)
  • Patients who live greater than 100 miles away form the enrolling site

Sites / Locations

  • Cincinnati Children's Hospital Medical Center
  • Nationwide Children's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Enhanced Usual Care

STAT-ED Intervention

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

STAT-ED Intervention Superior to EUC Group
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

Full Information

First Posted
January 2, 2013
Last Updated
July 28, 2016
Sponsor
Children's Hospital Medical Center, Cincinnati
Collaborators
National Institutes of Health (NIH)
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1. Study Identification

Unique Protocol Identification Number
NCT01779414
Brief Title
STAT-ED: Suicidal Teens Accessing Treatment After an Emergency Department Visit
Acronym
STAT-ED
Official Title
STAT-ED: Suicidal Teens Accessing Treatment After an Emergency Department Visit
Study Type
Interventional

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
February 2013 (undefined)
Primary Completion Date
May 2016 (Actual)
Study Completion Date
May 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Children's Hospital Medical Center, Cincinnati
Collaborators
National Institutes of Health (NIH)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Suicide
Keywords
Suicide Ideation

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
169 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Enhanced Usual Care
Arm Type
No Intervention
Arm Description
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.
Arm Title
STAT-ED Intervention
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
STAT-ED Intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
STAT-ED Intervention Superior to EUC Group
Description
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.
Time Frame
Three years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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 (triage levels 2-5) Exclusion Criteria: Patients who present in the ED with a chief complaint of suicidal behavior will be excluded to comply with the requirements of the RFA. 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) Patients who live greater than 100 miles away form the enrolling site
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jacqueline Grupp-Phelan, M.D., M.P.H.
Organizational Affiliation
Children's Hospital Medical Center, Cincinnati
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cincinnati Children's Hospital Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States
Facility Name
Nationwide Children's Hospital
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43205
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
31860104
Citation
Grupp-Phelan J, Stevens J, Boyd S, Cohen DM, Ammerman RT, Liddy-Hicks S, Heck K, Marcus SC, Stone L, Campo JV, Bridge JA. Effect of a Motivational Interviewing-Based Intervention on Initiation of Mental Health Treatment and Mental Health After an Emergency Department Visit Among Suicidal Adolescents: A Randomized Clinical Trial. JAMA Netw Open. 2019 Dec 2;2(12):e1917941. doi: 10.1001/jamanetworkopen.2019.17941.
Results Reference
derived

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

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