Suicidal IdeationPre-STARTNCT04625686
Observational Study to Compare Outcomes of Different Psychiatric Treatment of Suicidal Adolescents
An observational study of Suicidal Ideation, run by Children's Hospital Medical Center, Cincinnati at 4 sites in United States.
Trial summary
To address the unmet need of optimizing the treatment and management for adolescent suicidality, the investigators propose to evaluate the effectiveness and safety of telehealth services compared to inpatient and OCIC for suicidal adolescents in target population. Read more about this study
- Who is it for?
- Ages 12 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Suicidal Ideation
- What is being tested?
- Mental Health Treatment
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 249 participants
- Where
- 4 sitesUnited States
- Study dates
- 1 Oct 2020to 15 Dec 2021
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Adolescents experiencing suicidal ideation and require a higher level of care.
Who may be able to join
- Adolescents that are 12 through 18 years old.
- Adolescents that are brought to the Emergency Department for crisis evaluation due to suicidal thoughts or behaviors.
- Require a higher level of care.
- The presence of a legal guardian for consent.
- Capable of giving signed informed consent/assent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
Who cannot join
- Adolescents with suicidal thoughts who had prior OCIC treatment in the past 12 months.
- Adolescents without the ability to answer survey questions.
- Adolescents that are non-English speaking due to the scales and surveys that are used for this study only being available in English.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
Nationwide Children's Hospital
Columbus, Ohio, 43205
UT Southwestern Medical Center
Dallas, Texas, 75390
Northwell Health
Queens, New York, 11004
About this study
Official title: A Multi-Site, Non-Interventional Study to Compare the Outcomes of Psychiatric Treatment of Suicidal Adolescents in Different Treatment Settings
To address the unmet need of optimizing the treatment and management for adolescent suicidality, the investigators propose to evaluate the effectiveness and safety of telehealth services compared to inpatient and OCIC for suicidal adolescents in target population. To achieve this goal, the investigators propose a multi- site study to compare telehealth, OCIC, and inpatient care, and see which can lead to a lower risk of a suicidal event (primary outcome) as well as higher treatment satisfaction (TS) and satisfaction with life (SL) (secondary outcomes) of both the legal guardians/parents and patients.
Read the detailed description
The investigators have proposed an observational design. Eligible individuals will be identified during a crisis assessment, either in the emergency department or during an emergency phone or telehealth assessment. Once the individual has been assessed and assigned to the clinician for treatment, study staff will assess if the patient is appropriate for the study using the study eligibility criteria. Individuals who receive treatment in one of the following treatment arms will be eligible for this observation study: inpatient, in-person OCIC or telehealth crisis intervention service. Eligible individuals will be contacted by study staff to introduce and offer the study. If patient and guardian agree, they will complete surveys at baseline and every 2 weeks for 6 months to evaluate outcomes.
- Conditions
- Suicidal Ideation
- Being tested
- Mental Health Treatment
- Medical subject headings
- Suicidal Ideation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mental Health TreatmentBehavioural
Treatment of suicidal ideation
| Study group | Role | What they receive |
|---|---|---|
| Inpatient Treatment | Inpatient psychiatric treatment Receives: Behavioral: Mental Health Treatment | |
| OCIC Treatment | In-person outpatient crisis intervention Receives: Behavioral: Mental Health Treatment | |
| Telehealth Therapy Treatment | Virtual outpatient therapy Receives: Behavioral: Mental Health Treatment | |
| No Show Group | Participant who do not attend recommended treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Recurrent Suicidal Events Measured by Treatment Arm
Compare the number of recurrent suicidal event across three treatment groups. Suicidal events were measured by hospitalizations during the study time frame in analysis.
Measured: 6 Months
Secondary outcomes (1)
Which Treatment Leads to Better Life Satisfaction
The Patient-Reported Outcomes Measurement Information System (PROMIS) Pediatric Item Bank v1.0 - Short Form 4a was used to measure life satisfaction and response pattern scoring was calculated in RedCap.• Each question has five response options (1 to 5), with the total score ranging from 4 to 20, where higher values indicate better life satisfaction.
Measured: 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2020
- Study start1 Oct 2020
- Primary completion15 Dec 2021
- Study completion15 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Suicidal IdeationStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 249 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04625686
- Sponsor's protocol ID
- 2020-0686
- Acronym
- Pre-START
- Status last verified
- Aug 2024
- First submitted
- 6 Nov 2020
- Last updated
- 27 Jan 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: All data will be de-identified from individual data. Data will only be shared with researchers within the research team.
Publications
Curtin SC, Warner M, Hedegaard H. Increase in Suicide in the United States, 1999-2014. NCHS Data Brief. 2016 Apr;(241):1-8.
PubMed 27111185QuickStats: Suicide Rates*,dagger for Teens Aged 15-19 Years, by Sex - United States, 1975-2015. MMWR Morb Mortal Wkly Rep. 2017 Aug 4;66(30):816. doi: 10.15585/mmwr.mm6630a6. No abstract available.
PubMed 28771461Green J, Jacobs B, Beecham J, Dunn G, Kroll L, Tobias C, Briskman J. Inpatient treatment in child and adolescent psychiatry--a prospective study of health gain and costs. J Child Psychol Psychiatry. 2007 Dec;48(12):1259-67. doi: 10.1111/j.1469-7610.2007.01802.x.
PubMed 18093032Combs J, Lin PI, DelBello MP, Carle AC, Bridge JA, Axelson DA, Fornari V, Feuer V, Emslie GJ, Kennard BD, Porter SC, Sorter MT, Barzman D. Examining Alternative Treatment Settings for Adolescents With Suicidal Thoughts During the COVID-19 Pandemic. JAACAP Open. 2024 Nov 8;3(3):567-575. doi: 10.1016/j.jaacop.2024.10.005. eCollection 2025 Sep.
PubMed 40922794
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Site, Non-Interventional Study to Compare the Outcomes of Psychiatric Treatment of Suicidal Adolescents in Different Treatment Settings
- ClinicalTrials.gov ID
- NCT04625686
- Acronym / sponsor ID
- Pre-START / 2020-0686
- Conditions
- Suicidal Ideation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 249 participants (actual)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 15 Dec 2021 (actual)
- Study completion
- 15 Dec 2021 (actual)
- First posted
- 12 Nov 2020 (actual)
- Results
- Posted 27 Jan 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To address the unmet need of optimizing the treatment and management for adolescent suicidality, the investigators propose to evaluate the effectiveness and safety of telehealth services compared to inpatient and OCIC for suicidal adolescents in target population. To achieve this goal, the investigators propose a multi- site study to compare telehealth, OCIC, and inpatient care, and see which can lead to a lower risk of a suicidal event (primary outcome) as well as higher treatment satisfaction (TS) and satisfaction with life (SL) (secondary outcomes) of both the legal guardians/parents and patients.
Detailed description
The investigators have proposed an observational design. Eligible individuals will be identified during a crisis assessment, either in the emergency department or during an emergency phone or telehealth assessment. Once the individual has been assessed and assigned to the clinician for treatment, study staff will assess if the patient is appropriate for the study using the study eligibility criteria. Individuals who receive treatment in one of the following treatment arms will be eligible for this observation study: inpatient, in-person OCIC or telehealth crisis intervention service. Eligible individuals will be contacted by study staff to introduce and offer the study. If patient and guardian agree, they will complete surveys at baseline and every 2 weeks for 6 months to evaluate outcomes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Inpatient Treatment | – | Behavioral: Mental Health TreatmentInpatient psychiatric treatment |
| OCIC Treatment | – | Behavioral: Mental Health TreatmentIn-person outpatient crisis intervention |
| Telehealth Therapy Treatment | – | Behavioral: Mental Health TreatmentVirtual outpatient therapy |
| No Show Group | – | –Participant who do not attend recommended treatment |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Adolescents experiencing suicidal ideation and require a higher level of care.
Key inclusion criteria (5 listed)
- Adolescents that are 12 through 18 years old.
- Adolescents that are brought to the Emergency Department for crisis evaluation due to suicidal thoughts or behaviors.
- Require a higher level of care.
- The presence of a legal guardian for consent.
- Capable of giving signed informed consent/assent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
Key exclusion criteria (3 listed)
- Adolescents with suicidal thoughts who had prior OCIC treatment in the past 12 months.
- Adolescents without the ability to answer survey questions.
- Adolescents that are non-English speaking due to the scales and surveys that are used for this study only being available in English.
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 |
|---|---|---|
| Mental Health TreatmentTreatment of suicidal ideation | Behavioural | Inpatient Treatment, OCIC Treatment, Telehealth Therapy Treatment |
Primary outcome
Number of Recurrent Suicidal Events Measured by Treatment Arm
Time frame: 6 Months
Compare the number of recurrent suicidal event across three treatment groups. Suicidal events were measured by hospitalizations during the study time frame in analysis.
1 secondary outcome
Which Treatment Leads to Better Life Satisfaction
Time frame: 6 Months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 27111185Curtin SC, Warner M, Hedegaard H. Increase in Suicide in the United States, 1999-2014. NCHS Data Brief. 2016 Apr;(241):1-8.
- Background: PubMed 28771461QuickStats: Suicide Rates*,dagger for Teens Aged 15-19 Years, by Sex - United States, 1975-2015. MMWR Morb Mortal Wkly Rep. 2017 Aug 4;66(30):816. doi: 10.15585/mmwr.mm6630a6. No abstract available.
- Background: PubMed 18093032Green J, Jacobs B, Beecham J, Dunn G, Kroll L, Tobias C, Briskman J. Inpatient treatment in child and adolescent psychiatry--a prospective study of health gain and costs. J Child Psychol Psychiatry. 2007 Dec;48(12):1259-67. doi: 10.1111/j.1469-7610.2007.01802.x.
- Derived from this study: PubMed 40922794Combs J, Lin PI, DelBello MP, Carle AC, Bridge JA, Axelson DA, Fornari V, Feuer V, Emslie GJ, Kennard BD, Porter SC, Sorter MT, Barzman D. Examining Alternative Treatment Settings for Adolescents With Suicidal Thoughts During the COVID-19 Pandemic. JAACAP Open. 2024 Nov 8;3(3):567-575. doi: 10.1016/j.jaacop.2024.10.005. eCollection 2025 Sep.
- Individual participant dataSharing planned: No. All data will be de-identified from individual data. Data will only be shared with researchers within the research team.
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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.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Suicidal Ideation, run by Children's Hospital Medical Center, Cincinnati at 4 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 5 inclusion and 3 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 27 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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?
Yes. Results are posted in the registry (first posted 27 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Recurrent Suicidal Events Measured by Treatment Arm (time frame: 6 Months). 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 NCT04625686, which also lists 4 linked publications.
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 27 Jan 2025.