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| ID | Type | Description | Link |
|---|---|---|---|
| 1P50MH127511-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| University of Pennsylvania | OTHER |
| National Institute of Mental Health (NIMH) | NIH |
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This study looks to conduct a systematic adaptation of Suicidal Teens Accessing Treatment (STAT-ED) for Black youth presenting in the emergency department who have suicide risk. A randomized controlled trial of STAT-ED adapted for Black youth and their caregivers will examine whether patient navigation intervention can increase mental health treatment initiation and number of visits.
Recent research has shown significant increases in suicides among Black youth and suicide attempts among Black high school students. Standard mental health treatment referrals were found to be not as effective among Black youth. This study in collaboration between Children's Hospital of Philadelphia and the University of Pennsylvania looks to determine if adapting standard Suicidal Teens Accessing Treatment (STAT-ED) to address barriers to initiating treatment for Black youth and their caregivers will increase mental health treatment initiation and number of treatment visits.
The primary objective is to conduct a systematic adaptation of STAT-ED for Black youth presenting in the emergency department who have suicidal risk. As well as to examine preliminary efficacy of the intervention on primary (mental health treatment initiation and number of visits) and secondary (suicidal ideation) outcomes using a prospective randomized controlled trial design.
The secondary objective is to examine implementation outcomes of adapted STAT-ED for Black youth and caregivers compared to enhanced treatment as usual.
Participants will be recruited from the Children's Hospital of Philadelphia emergency department and randomized to receive either adapted STAT-ED or enhanced treatment as usual following discharge from their emergency visit. 50 eligible youth and 50 eligible caregivers (50 youth-caregiver dyads) will be consented, enrolled, and randomized to produce 85 evaluable subjects. Treatment assignment will be done at the time of enrollment. Those chosen for the adapted STAT-ED will be assigned a patient navigator to provide culturally informed motivational interviews, assistance with appointments, barrier deduction discussions, and mental health information. The cultural adaptation will directly incorporate patients' preferences for treatment, such as treatment modalities, and address negative perceptions about treatment and stigma.
Descriptive statistics for demographics, motivation, suicidal ideation and affect will be measured at baseline. We will then assess use of treatment and services, motivation for treatment, suicidal ideation, and intervention acceptability at 2 months post-enrollment. At 6 months post-enrollment, the same measures as the 2 month follow-up will be assessed once more. The assessment scores will then be compared between the experimental and control treatment groups.
The results of this application would be expected to contribute important new knowledge on barriers faced by Black youth and their caregivers while initiating mental health treatment and examine if a culturally informed intervention will increase mental health treatment initiation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adapted STAT-ED | Experimental | Patient navigation intervention (Suicidal Teens Accessing Treatment) with caregivers and/or adolescents that includes psychoeducation, motivational interviewing, problem solving logistical barriers, and assistance with making, following up with mental health appointments, and providing assistance with additional resources. Intervention is delivered by study social worker by telephone, video, texting or in-person. |
|
| Standard Enhanced Treatment As Usual | Active Comparator | Telephone contacts to check in, assist and remind caregivers and/or adolescents about mental health care referrals and appointments. Telephone contacts are consistent with current emergency department practice. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adapted STAT-ED | Behavioral | Patient navigator assigned to provide culturally informed motivational interviews, brief case management, psychoeducation and telephone contacts. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mental Health Treatment Initiation | ED STARS mental health service use is a 8-item interview that measures mental health services children receive and actions taken by family to obtain services. This measure was used with over 6000 adolescents from the Pediatric Emergency Care Applied Research Network (PECARN) that spanned diverse geographic regions of the US. Caregeivers will complete this interview unless youth is participating without a parent. The outcome represents the number of participants who received outpatient behavioral health treatment. | at approximately 2 months and 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Suicidal Ideation and Behavior | Suicide Ideation Questionnaire-Junior (SIQ-Jr) is a youth report measure of frequency of suicidal thoughts over the last month. The SIQ-Jr is a 15-item questionnaire and is designed for students in Grades 7-9. Reliability coefficients are .93 to .94. SIQ-Jr has high internal consistency, test-retest reliability, predictive validity for suicidal behavior, and is sensitive to change. Scores range from 0 to 90. Higher scores indicate greater suicidal ideation. The cut-off score of 31 or higher is considered clinically significant. |
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Youth Inclusion Criteria:
Youth Exclusion Criteria:
Caregiver Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rhonda Boyd, PhD | Children's Hospital of Philadelphia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31860104 | Background | 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. | |
| 31830523 | Background |
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Fifty-four individuals (31 families) were were randomized to conditions. Randomization occurred at the family level not the individual level.
Participants included youth who presented to the emergency department with suicide risk and a caregiver. In most cases, both youth and caregiver provided informed consent. In a few cases, caregivers participated without youth or youth participated without caregiver.
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| ID | Title | Description |
|---|---|---|
| FG000 | Adapted STAT-ED | Patient navigation intervention (Suicidal Teens Accessing Treatment) with caregivers and/or adolescents that includes psychoeducation, motivational interviewing, problem solving logistical barriers, and assistance with making, following up with mental health appointments, and providing assistance with additional resources. Intervention is delivered by study social worker by telephone, video, texting or in-person. Adapted STAT-ED: Patient navigator assigned to provide culturally informed motivational interviews, brief case management, psychoeducation and telephone contacts. |
| FG001 | Standard Enhanced Treatment As Usual | Telephone contacts to check in, assist and remind caregivers and/or adolescents about mental health care referrals and appointments. Telephone contacts are consistent with current emergency department practice. Standard Enhanced Treatment As Usual: Follow up phone calls following discharge from the emergency department to assist with mental health treatment referral recommendations. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Adapted STAT-ED (Youth) | Patient navigation intervention (Suicidal Teens Accessing Treatment) with caregivers and/or adolescents that includes psychoeducation, motivational interviewing, problem solving logistical barriers, and assistance with making, following up with mental health appointments, and providing assistance with additional resources. Intervention is delivered by study social worker by telephone, video, texting or in-person. Adapted STAT-ED: Patient navigator assigned to provide culturally informed motivational interviews, brief case management, psychoeducation and telephone contacts. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Age data are reported separately for youth and caregiver participants. As a result, 0 caregivers were included in the youth age calculation and 0 youth were included in the caregiver age calculation. |
| 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 | Mental Health Treatment Initiation | ED STARS mental health service use is a 8-item interview that measures mental health services children receive and actions taken by family to obtain services. This measure was used with over 6000 adolescents from the Pediatric Emergency Care Applied Research Network (PECARN) that spanned diverse geographic regions of the US. Caregeivers will complete this interview unless youth is participating without a parent. The outcome represents the number of participants who received outpatient behavioral health treatment. | This study included two follow-up assessments: 2- and 6-months post-baseline. The overall number of participants analyzed reflects the number of participants who provided data beyond baseline (either at the 2-month or 6-month assessment, or both). Numbers analyzed below reflect the number of participants who provided data at each assessment. | Posted | Count of Participants | Participants | at approximately 2 months and 6 months |
|
up to 6 months
Only adverse events for the youth participants were monitored.
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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 | Adapted STAT-ED | Patient navigation intervention (Suicidal Teens Accessing Treatment) with caregivers and/or adolescents that includes psychoeducation, motivational interviewing, problem solving logistical barriers, and assistance with making, following up with mental health appointments, and providing assistance with additional resources. Intervention is delivered by study social worker by telephone, video, texting or in-person. Adapted STAT-ED: Patient navigator assigned to provide culturally informed motivational interviews, brief case management, psychoeducation and telephone contacts. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hospitalization | Psychiatric disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Emergency department return visit | Psychiatric disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jason Jones | Children's Hospital of Philadelphia | 267-425-1326 | jonesjd@chop.edu |
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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 | Jul 10, 2023 | Oct 12, 2023 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 1, 2024 | Dec 9, 2025 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D000294 | Adolescent Behavior |
| D059020 | Suicidal Ideation |
| ID | Term |
|---|---|
| D001519 | Behavior |
| D013405 | Suicide |
| D016728 | Self-Injurious Behavior |
| D001526 | Behavioral Symptoms |
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| Standard Enhanced Treatment As Usual | Behavioral | Follow up phone calls following discharge from the emergency department to assist with mental health treatment referral recommendations. |
|
| at approximately 2 months and 6 months |
| King CA, Brent D, Grupp-Phelan J, Shenoi R, Page K, Mahabee-Gittens EM, Chernick LS, Melzer-Lange M, Rea M, McGuire TC, Littlefield A, Casper TC; Pediatric Emergency Care Applied Research Network (PECARN). Five Profiles of Adolescents at Elevated Risk for Suicide Attempts: Differences in Mental Health Service Use. J Am Acad Child Adolesc Psychiatry. 2020 Sep;59(9):1058-1068.e5. doi: 10.1016/j.jaac.2019.10.015. Epub 2019 Dec 9. |
| BG001 | Adapted STAT-ED (Caregiver) | Patient navigation intervention (Suicidal Teens Accessing Treatment) with caregivers and/or adolescents that includes psychoeducation, motivational interviewing, problem solving logistical barriers, and assistance with making, following up with mental health appointments, and providing assistance with additional resources. Intervention is delivered by study social worker by telephone, video, texting or in-person. Adapted STAT-ED: Patient navigator assigned to provide culturally informed motivational interviews, brief case management, psychoeducation and telephone contacts. |
| BG002 | Standard Enhanced Treatment As Usual (Youth) | Telephone contacts to check in, assist and remind caregivers and/or adolescents about mental health care referrals and appointments. Telephone contacts are consistent with current emergency department practice. Standard Enhanced Treatment As Usual: Follow up phone calls following discharge from the emergency department to assist with mental health treatment referral recommendations |
| BG003 | Standard Enhanced Treatment As Usual (Caregiver) | Telephone contacts to check in, assist and remind caregivers and/or adolescents about mental health care referrals and appointments. Telephone contacts are consistent with current emergency department practice. Standard Enhanced Treatment As Usual: Follow up phone calls following discharge from the emergency department to assist with mental health treatment referral recommendations |
| BG004 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Adapted STAT-ED |
Patient navigation intervention (Suicidal Teens Accessing Treatment) with caregivers and/or adolescents that includes psychoeducation, motivational interviewing, problem solving logistical barriers, and assistance with making, following up with mental health appointments, and providing assistance with additional resources. Intervention is delivered by study social worker by telephone, video, texting or in-person. Adapted STAT-ED: Patient navigator assigned to provide culturally informed motivational interviews, brief case management, psychoeducation and telephone contacts. |
| OG001 | Standard Enhanced Treatment As Usual | Telephone contacts to check in, assist and remind caregivers and/or adolescents about mental health care referrals and appointments. Telephone contacts are consistent with current emergency department practice. Standard Enhanced Treatment As Usual: Follow up phone calls following discharge from the emergency department to assist with mental health treatment referral recommendations. |
|
|
| Secondary | Suicidal Ideation and Behavior | Suicide Ideation Questionnaire-Junior (SIQ-Jr) is a youth report measure of frequency of suicidal thoughts over the last month. The SIQ-Jr is a 15-item questionnaire and is designed for students in Grades 7-9. Reliability coefficients are .93 to .94. SIQ-Jr has high internal consistency, test-retest reliability, predictive validity for suicidal behavior, and is sensitive to change. Scores range from 0 to 90. Higher scores indicate greater suicidal ideation. The cut-off score of 31 or higher is considered clinically significant. | This study included two follow-up assessments: 2- and 6-months post-baseline. The overall number of participants analyzed reflects the number of participants who provided data beyond baseline (either at the 2-month or 6-month assessment, or both). Numbers analyzed below reflect the number of participants who provided data at each assessment. | Posted | Mean | Standard Deviation | units on a scale | at approximately 2 months and 6 months |
|
|
|
| 0 |
| 12 |
| 5 |
| 12 |
| 1 |
| 12 |
| EG001 | Standard Enhanced Treatment As Usual | Telephone contacts to check in, assist and remind caregivers and/or adolescents about mental health care referrals and appointments. Telephone contacts are consistent with current emergency department practice. Standard Enhanced Treatment As Usual: Follow up phone calls following discharge from the emergency department to assist with mental health treatment referral recommendations. | 0 | 14 | 3 | 14 | 3 | 14 |
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|
| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| 6-month follow-up |
|
|