Suicidal Ideation
Conditions
Brief 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. 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.
Interventions
BEHAVIORALMental Health Treatment
Treatment of suicidal ideation
Sponsors
Patient-Centered Outcomes Research Institute
Children's Hospital Medical Center, Cincinnati
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
12 Years to 18 Years
Healthy volunteers
Yes
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Recurrent Suicidal Events Measured by Treatment Arm | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Which Treatment Leads to Better Life Satisfaction | 6 Months | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Treatment Satisfaction Scores Measured by Treatment Arm | 2 weeks | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Inpatient Treatment Inpatient psychiatric treatment
Mental Health Treatment: Treatment of suicidal ideation | 87 |
| OCIC Treatment In-person outpatient crisis intervention
Mental Health Treatment: Treatment of suicidal ideation | 77 |
| Telehealth Therapy Treatment Virtual outpatient therapy
Mental Health Treatment: Treatment of suicidal ideation | 76 |
| No Show Group Participant who do not attend recommended treatment | 9 |
| Total | 249 |
Baseline characteristics
| Characteristic | Inpatient Treatment | OCIC Treatment | Telehealth Therapy Treatment | No Show Group | Total |
|---|---|---|---|---|---|
| Age, Continuous | 15.2946 years | 14.8463 years | 14.8671 years | 14.9781 years | 15.0467 years |
| CHRT-SR Score | 38.0114 scores on a scale | 32.0657 scores on a scale | 33.0266 scores on a scale | 36.7777 scores on a scale | 34.2634 scores on a scale |
| Ethnicity (NIH/OMB) Hispanic or Latino | 18 Participants | 17 Participants | 13 Participants | 2 Participants | 50 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 69 Participants | 60 Participants | 63 Participants | 7 Participants | 199 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized American Indian or Alaskan Native | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Asian | 1 Participants | 3 Participants | 0 Participants | 0 Participants | 4 Participants |
| Race/Ethnicity, Customized Black or African American | 10 Participants | 11 Participants | 12 Participants | 0 Participants | 33 Participants |
| Race/Ethnicity, Customized Mixed Race | 6 Participants | 5 Participants | 8 Participants | 1 Participants | 20 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Other | 12 Participants | 8 Participants | 5 Participants | 1 Participants | 26 Participants |
| Race/Ethnicity, Customized White | 57 Participants | 50 Participants | 51 Participants | 7 Participants | 165 Participants |
| Sex: Female, Male Female | 67 Participants | 56 Participants | 58 Participants | 7 Participants | 188 Participants |
| Sex: Female, Male Male | 20 Participants | 21 Participants | 18 Participants | 2 Participants | 61 Participants |
| Sex/Gender, Customized Choose not to disclose | 2 Participants | 1 Participants | 2 Participants | 1 Participants | 6 Participants |
| Sex/Gender, Customized Female | 60 Participants | 46 Participants | 46 Participants | 5 Participants | 157 Participants |
| Sex/Gender, Customized Male | 20 Participants | 19 Participants | 17 Participants | 2 Participants | 58 Participants |
| Sex/Gender, Customized Non-binary | 2 Participants | 5 Participants | 6 Participants | 1 Participants | 14 Participants |
| Sex/Gender, Customized Other | 0 Participants | 2 Participants | 0 Participants | 0 Participants | 2 Participants |
| Sex/Gender, Customized Transgender Female (MTF) | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex/Gender, Customized Transgender Male (FTM) | 3 Participants | 4 Participants | 5 Participants | 0 Participants | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 87 | 0 / 77 | 0 / 76 | 0 / 9 |
| other Total, other adverse events | 12 / 87 | 9 / 77 | 13 / 76 | 3 / 9 |
| serious Total, serious adverse events | 20 / 87 | 13 / 77 | 12 / 76 | 3 / 9 |
Outcome results
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.
Time frame: 6 Months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Inpatient Treatment | Number of Recurrent Suicidal Events Measured by Treatment Arm | 0.66 hospitalizations |
| OCIC Treatment | Number of Recurrent Suicidal Events Measured by Treatment Arm | 0.45 hospitalizations |
| Telehealth Therapy Treatment | Number of Recurrent Suicidal Events Measured by Treatment Arm | 0.20 hospitalizations |
| No Show Group | Number of Recurrent Suicidal Events Measured by Treatment Arm | 0.60 hospitalizations |
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.
Time frame: 6 Months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Inpatient Treatment | Which Treatment Leads to Better Life Satisfaction | 15.75 Scores on a scale |
| OCIC Treatment | Which Treatment Leads to Better Life Satisfaction | 16.74 Scores on a scale |
| Telehealth Therapy Treatment | Which Treatment Leads to Better Life Satisfaction | 15.4 Scores on a scale |
| No Show Group | Which Treatment Leads to Better Life Satisfaction | 14 Scores on a scale |
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.
Time frame: 2 weeks
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Inpatient Treatment | Treatment Satisfaction Scores Measured by Treatment Arm | 23.06 Scores on a scale |
| OCIC Treatment | Treatment Satisfaction Scores Measured by Treatment Arm | 21.78 Scores on a scale |
| Telehealth Therapy Treatment | Treatment Satisfaction Scores Measured by Treatment Arm | 20.9 Scores on a scale |
| No Show Group | Treatment Satisfaction Scores Measured by Treatment Arm | 17.62 Scores on a scale |