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| Name | Class |
|---|---|
| Patient-Centered Outcomes Research Institute | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Inpatient Treatment | Inpatient psychiatric treatment |
| |
| OCIC Treatment | In-person outpatient crisis intervention |
| |
| Telehealth Therapy Treatment | Virtual outpatient therapy |
| |
| No Show Group | Participant who do not attend recommended treatment |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mental Health Treatment | Behavioral | Treatment of suicidal ideation |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 Months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment Satisfaction Scores Measured by Treatment Arm | The Client Satisfaction Questionnaire (CSQ), was used to compare the level of treatment satisfaction across three treatment groups. Data collected from children were used in outcome analysis. The four-point Likert scale, with scores from 1 to 4 for each item, provides a total score range of 8 to 32, with higher scores indicating greater satisfaction. |
Inclusion Criteria:
Exclusion Criteria:
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Adolescents experiencing suicidal ideation and require a higher level of care.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwell Health | Queens | New York | 11004 | United States | ||
| Cincinnati Children's Hospital Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27111185 | Background | Curtin SC, Warner M, Hedegaard H. Increase in Suicide in the United States, 1999-2014. NCHS Data Brief. 2016 Apr;(241):1-8. | |
| 28771461 | Background | QuickStats: 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. |
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All data will be de-identified from individual data. Data will only be shared with researchers within the research team.
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| ID | Title | Description |
|---|---|---|
| FG000 | Inpatient Treatment | Inpatient psychiatric treatment Mental Health Treatment: Treatment of suicidal ideation |
| FG001 | OCIC Treatment | In-person outpatient crisis intervention Mental Health Treatment: Treatment of suicidal ideation |
| FG002 | Telehealth Therapy Treatment | Virtual outpatient therapy Mental Health Treatment: Treatment of suicidal ideation |
| FG003 | No Show Group | Participant who do not attend recommended treatment |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Inpatient Treatment | Inpatient psychiatric treatment Mental Health Treatment: Treatment of suicidal ideation |
| BG001 | OCIC Treatment | In-person outpatient crisis intervention Mental Health Treatment: Treatment of suicidal ideation |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | 95% Confidence Interval | hospitalizations | 6 Months |
|
6 months
Adverse events were characterized as an increase in suicidal thoughts that resulted in an evaluation in the emergency department, staying overnight in the emergency department, or an emergency visit with a clinician or assessment via phone. Serious adverse events were characterized as an increase in suicidal thoughts that resulted in an inpatient psychiatric hospitalization.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Inpatient Treatment | Inpatient psychiatric treatment Mental Health Treatment: Treatment of suicidal ideation |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Inpatient psychiatric hospitalization | Psychiatric disorders | Systematic Assessment | Participant was admitted to an inpatient psychiatric unit. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Increase in Suicidal Thoughts Resulting in ED Visit or Other Psychiatric Evaluation | Psychiatric disorders | Systematic Assessment | Adverse events were characterized as an increase in suicidal thoughts that resulted in an evaluation in the emergency department, staying overnight in the emergency department, or an emergency visit with a clinician or assessment via phone. |
This study is an observational study, which is limited in comparison to an interventional study.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Rosalie Hemphill LSW | Cincinnati Children's Hospital Medical Center | 5044940883 | rosalie.hemphill@cchmc.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 1, 2021 | Mar 2, 2022 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Feb 1, 2021 | Mar 2, 2022 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D059020 | Suicidal Ideation |
| ID | Term |
|---|---|
| D013405 | Suicide |
| D016728 | Self-Injurious Behavior |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| 6 Months |
| 2 weeks |
| Cincinnati |
| Ohio |
| 45229 |
| United States |
| Nationwide Children's Hospital | Columbus | Ohio | 43205 | United States |
| UT Southwestern Medical Center | Dallas | Texas | 75390 | United States |
| 18093032 | Background | Green 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. |
| 40922794 | Derived | Combs 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. |
| BG002 | Telehealth Therapy Treatment | Virtual outpatient therapy Mental Health Treatment: Treatment of suicidal ideation |
| BG003 | No Show Group | Participant who do not attend recommended treatment |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex/Gender, Customized | Gender Identity | Count of Participants | Participants |
|
| Sex: Female, Male | Gender at Birth | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| CHRT-SR Score | The Concise Health Risk Tracking© Self Report (CHRT-SR), a self-report that focuses on the past week, was designed to assess the severity of current suicide risk. The CHRT-SR assesses both suicidal ideation and other current clinical factors associated with suicide attempts. Scores range from 1 to 56. The higher the overall score represents a worse outcome. | Mean | Full Range | scores on a scale |
|
| Telehealth Therapy Treatment |
Virtual outpatient therapy Mental Health Treatment: Treatment of suicidal ideation |
| OG003 | No Show Group | Participant who do not attend recommended treatment |
|
|
| Secondary | 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. | Posted | Mean | 95% Confidence Interval | Scores on a scale | 6 Months |
|
|
|
| Other Pre-specified | Treatment Satisfaction Scores Measured by Treatment Arm | The Client Satisfaction Questionnaire (CSQ), was used to compare the level of treatment satisfaction across three treatment groups. Data collected from children were used in outcome analysis. The four-point Likert scale, with scores from 1 to 4 for each item, provides a total score range of 8 to 32, with higher scores indicating greater satisfaction. | Posted | Mean | 95% Confidence Interval | Scores on a scale | 2 weeks |
|
|
|
| 0 |
| 87 |
| 20 |
| 87 |
| 12 |
| 87 |
| EG001 | OCIC Treatment | In-person outpatient crisis intervention Mental Health Treatment: Treatment of suicidal ideation | 0 | 77 | 13 | 77 | 9 | 77 |
| EG002 | Telehealth Therapy Treatment | Virtual outpatient therapy Mental Health Treatment: Treatment of suicidal ideation | 0 | 76 | 12 | 76 | 13 | 76 |
| EG003 | No Show Group | Participant who do not attend recommended treatment | 0 | 9 | 3 | 9 | 3 | 9 |
|
|
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