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NCT02050867
Validation of the Ask Suicide-Screening Questions (ASQ) in the Inpatient Medical Setting
trial in Children in 562 participants. Terminated before completion.
12 September 2019
Quick facts
| Lead sponsor | National Institute of Mental Health (NIMH) |
|---|---|
| Status | Terminated |
| Study type | OBSERVATIONAL |
| Enrollment | 562 |
| Start date | 29 January 2014 |
| Primary completion | 12 September 2019 |
| Estimated completion | 12 September 2019 |
| Sites | 1 location across United States |
Conditions studied
- Children — all drugs for Children →
- Adolescents — all drugs for Adolescents →
Sponsor
National Institute of Mental Health (NIMH)
Who can join
Adults 10 to 21, any sex, with Children or Adolescents. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Physicians and nurses working in non-mental health settings require tools to guide them in recognizing patients at risk. While screening children and adolescents is emerging as a priority of the Joint Commission, there are currently no suicide screening instruments designed specifically for assessing suicide risk in a pediatric inpatient medical population. Recently, our study team developed the Ask Suicide-Screening Questions (ASQ), a 4-item suicide risk screening instrument with excellent sensitivity, specificity, and negative predictive value for use in pediatric emergency departments (Protocol #08-M-N070). However, use of the ASQ in an inpatient medical setting has not been tested. The aim of this study is to determine the utility of the ASQ among pediatric medical inpatients in children s hospitals. While most inpatients will not be at imminent risk for suicide, we hypothesize that the ASQ will capture a number of patients who screen positive and are not only at risk for suicidal behavior in the future, but are also experiencing significant emotional distress and therefore warrant further psychiatric evaluation and follow-up treatment. This will be a multisite study, comprised of medically ill inpatients at three non-NIH affiliated sites (Children s National Medical Center, Boston Children s Hospital, and Nationwide Children s Hospital), with a total sample size of 600 (200 per site). We will administer several short measures of suicide risk the ASQ, the Suicidal Ideation Questionnaire, a brief depression screen, the Patients Health Questionnaire Adolescent version (PHQ-A) to all eligible inpatients aged 10-21 years. The ultimate goal of this project is to provide non-mental health clinicians with a brief, accurate assessment tool for detecting risk of suicide in pediatric medical inpatients and in turn, connecting those in need with mental health services. After validating the ASQ with pediatric medical inpatients, we will then examine the practical implications of nurses administering the ASQ as standard of care during the admission process on a pediatric medical inpatient unit. Future studies will focus on validating the ASQ in non-English speaking patients, addressing a critical gap in suicide prevention research. In addition, examining the long-term clinical impact of screening general medical patients for suicide risk with the ASQ and linking those in need with mental health services and/or other interventions will be important next steps. Please note: This is a multi-site study that is being conducted at three non-NIH sites, all children s hospitals, two of which have already received IRB approval (Boston Children s Hospital and Children s National Medical Center) and one which is in the process of submission (Nationwide Children s Hospital). No NIH patients will be enrolled at the Clinical Center. Consent and patient data collection will take place on inpatient medical units at those three sites; data will be sent to NIMH, and stored and analyzed here.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Validation and Feasibility of the ASQ Among Pediatric Medical and Surgical Inpatients.
Horowitz LM, Wharff EA, Mournet AM, Ross AM, et al · · 2020 · cited 45× · PMID 32826283 · DOI 10.1542/hpeds.2020-0087
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT02050867 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by National Institute of Mental Health (NIMH)
- Last refreshed: 16 September 2019
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