SuicideSTAT-EDNCT01779414
STAT-ED: Suicidal Teens Accessing Treatment After an Emergency Department Visit
A study testing STAT-ED Intervention in people with Suicide, run by Children's Hospital Medical Center, Cincinnati at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 12 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Suicide
- What is being tested?
- STAT-ED Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 169 participants
- Where
- 2 sitesUnited States
- Study dates
- Feb 2013to May 2016
- 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 12 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
Nationwide Children's Hospital
Columbus, Ohio, 43205
About this study
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.
Read the 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.
- Conditions
- Suicide
- Being tested
- STAT-ED Intervention
- Keywords
- Suicide Ideation
- Medical subject headings
- Suicide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
STAT-ED InterventionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: STAT-ED Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Three years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2013 (estimated)
- Study startFeb 2013
- Primary completionMay 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SuicideStudies of the same condition, open and under way.
- More trials run by Children's Hospital Medical Center, CincinnatiThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 169 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Sponsor
- Investigators
- Jacqueline Grupp-Phelan, M.D., M.P.H., Principal investigator, Children's Hospital Medical Center, Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01779414
- Sponsor's protocol ID
- CINC-2012-3660
- Acronym
- STAT-ED
- Status last verified
- Jul 2016
- First submitted
- 2 Jan 2013
- Last updated
- 1 Aug 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 31860104
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- STAT-ED: Suicidal Teens Accessing Treatment After an Emergency Department Visit
- ClinicalTrials.gov ID
- NCT01779414
- Acronym / sponsor ID
- STAT-ED / CINC-2012-3660
- Conditions
- Suicide
- Keywords
- Suicide Ideation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 169 participants (actual)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- Feb 2013
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 30 Jan 2013 (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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Other: STAT-ED InterventionParticipants 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. |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (7 listed)
- 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
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 |
|---|---|---|
| STAT-ED InterventionParticipants 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 |
Primary outcome
STAT-ED Intervention Superior to EUC Group
Time frame: Three years
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.
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 1 Aug 2016.
- Derived from this study: PubMed 31860104Grupp-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.
Related trials for Suicide
Not yet recruiting
A Pre-post Study of a Lethal Means Safety Planning Intervention for Youth at Elevated Suicide Risk in the Emergency Department
Suicidal Ideas, Suicidal Ideation
RecruitingObservational study
Student Precarity and Psychiatry
Depressive Disorder, Major, Generalized Anxiety Disorder
Not yet recruiting
SERENE Low-Intensity Focused Ultrasound for Cognitive Control
Suicidal Ideation, Cognitive Control
Not yet recruiting
A MRT to Optimize a JITAI for Alcohol Craving and Suicide Ideation
Alcohol Use Disorder (AUD), Suicide Ideation
Enrolling by invitation
Pilot Study of a Modified Safety Planning Intervention for Elementary School-Aged Children - Main Study
Suicidal Ideation, Suicidal Behaviors
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.
Jacqueline Grupp-Phelan, M.D., M.P.H. principal investigator
Children's Hospital Medical Center, Cincinnati
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing STAT-ED Intervention in people with Suicide, run by Children's Hospital Medical Center, Cincinnati at 2 sites 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 4 inclusion and 7 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 1 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
STAT-ED Intervention Superior to EUC Group (time frame: Three years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01779414, which also lists 1 linked publication.
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 1 Aug 2016.