NCT01779414

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
169

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 2, 2013

Completed
28 days until next milestone

First Posted

Study publicly available on registry

January 30, 2013

Completed
2 days until next milestone

Study Start

First participant enrolled

February 1, 2013

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
Last Updated

August 1, 2016

Status Verified

July 1, 2016

Enrollment Period

3.2 years

First QC Date

January 2, 2013

Last Update Submit

July 28, 2016

Conditions

Keywords

Suicide Ideation

Outcome Measures

Primary Outcomes (1)

  • 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.

    Three years

Study Arms (2)

Enhanced Usual Care

NO INTERVENTION

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.

STAT-ED Intervention

EXPERIMENTAL

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

Interventions

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.

STAT-ED Intervention

Eligibility Criteria

Age12 Years - 17 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Suicide

Condition Hierarchy (Ancestors)

Self-Injurious BehaviorBehavioral SymptomsBehavior

Study Officials

  • Jacqueline Grupp-Phelan, M.D., M.P.H.

    Children's Hospital Medical Center, Cincinnati

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 2, 2013

First Posted

January 30, 2013

Study Start

February 1, 2013

Primary Completion

May 1, 2016

Study Completion

May 1, 2016

Last Updated

August 1, 2016

Record last verified: 2016-07

Locations