Trial Outcomes & Findings for Navigating Mental Health Treatment for Black Youth (NCT NCT05334381)

Last Updated: 2026-05-01

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

54 participants

Primary outcome timeframe

at approximately 2 months and 6 months

Results posted on

2026-05-01

Participant Flow

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.

Fifty-four individuals (31 families) were were randomized to conditions. Randomization occurred at the family level not the individual level.

Participant milestones

Participant milestones
Measure	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.	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.
Overall Study STARTED	26	28
Overall Study Youth	12	14
Overall Study Caregivers	14	14
Overall Study COMPLETED	21	22
Overall Study NOT COMPLETED	5	6

Reasons for withdrawal

Reasons for withdrawal
Measure	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.	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.
Overall Study Lost to Follow-up	5	6

Baseline Characteristics

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.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Adapted STAT-ED (Youth) n=12 Participants 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.	Adapted STAT-ED (Caregiver) n=14 Participants 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.	Standard Enhanced Treatment As Usual (Youth) n=14 Participants 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	Standard Enhanced Treatment As Usual (Caregiver) n=14 Participants 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	Total n=54 Participants Total of all reporting groups
Age, Continuous Youth Age	14.25 years STANDARD_DEVIATION 2.35 • n=12 Participants • 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.	—	13.73 years STANDARD_DEVIATION 2.28 • n=14 Participants • 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.	—	14.00 years STANDARD_DEVIATION 2.29 • n=26 Participants • 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.
Age, Continuous Caregiver Age	—	44.69 years STANDARD_DEVIATION 9.49 • n=14 Participants • 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.	—	38.14 years STANDARD_DEVIATION 8.43 • n=14 Participants • 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.	41.30 years STANDARD_DEVIATION 9.39 • n=28 Participants • 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.
Sex: Female, Male Female	10 Participants n=12 Participants	13 Participants n=14 Participants	11 Participants n=14 Participants	11 Participants n=14 Participants	45 Participants n=54 Participants
Sex: Female, Male Male	2 Participants n=12 Participants	1 Participants n=14 Participants	3 Participants n=14 Participants	3 Participants n=14 Participants	9 Participants n=54 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=12 Participants	0 Participants n=14 Participants	0 Participants n=14 Participants	0 Participants n=14 Participants	0 Participants n=54 Participants
Race (NIH/OMB) Asian	0 Participants n=12 Participants	0 Participants n=14 Participants	0 Participants n=14 Participants	0 Participants n=14 Participants	0 Participants n=54 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=12 Participants	0 Participants n=14 Participants	0 Participants n=14 Participants	0 Participants n=14 Participants	0 Participants n=54 Participants
Race (NIH/OMB) Black or African American	10 Participants n=12 Participants	14 Participants n=14 Participants	14 Participants n=14 Participants	13 Participants n=14 Participants	51 Participants n=54 Participants
Race (NIH/OMB) White	0 Participants n=12 Participants	0 Participants n=14 Participants	0 Participants n=14 Participants	0 Participants n=14 Participants	0 Participants n=54 Participants
Race (NIH/OMB) More than one race	2 Participants n=12 Participants	0 Participants n=14 Participants	0 Participants n=14 Participants	0 Participants n=14 Participants	2 Participants n=54 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=12 Participants	0 Participants n=14 Participants	0 Participants n=14 Participants	1 Participants n=14 Participants	1 Participants n=54 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=12 Participants	0 Participants n=14 Participants	0 Participants n=14 Participants	0 Participants n=14 Participants	0 Participants n=54 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	12 Participants n=12 Participants	13 Participants n=14 Participants	14 Participants n=14 Participants	14 Participants n=14 Participants	53 Participants n=54 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=12 Participants	1 Participants n=14 Participants	0 Participants n=14 Participants	0 Participants n=14 Participants	1 Participants n=54 Participants

PRIMARY outcome

Timeframe: at approximately 2 months and 6 months

Population: 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.

Outcome measures

Outcome measures
Measure	Adapted STAT-ED n=11 Participants 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.	Standard Enhanced Treatment As Usual n=13 Participants 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.
Mental Health Treatment Initiation 2-month follow-up	9 Participants	10 Participants
Mental Health Treatment Initiation 6-month follow-up	7 Participants	7 Participants

SECONDARY outcome

Timeframe: at approximately 2 months and 6 months

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.

Outcome measures

Outcome measures
Measure	Adapted STAT-ED n=9 Participants 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.	Standard Enhanced Treatment As Usual n=11 Participants 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.
Suicidal Ideation and Behavior 2-month follow-up	22.38 units on a scale Standard Deviation 24.92	39.44 units on a scale Standard Deviation 23.87
Suicidal Ideation and Behavior 6-month follow-up	12.00 units on a scale Standard Deviation 15.00	29.14 units on a scale Standard Deviation 15.78

Adverse Events

Adapted STAT-ED

Serious events: 5 serious events

Other events: 1 other events

Deaths: 0 deaths

Standard Enhanced Treatment As Usual

Serious events: 3 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Adapted STAT-ED n=12 participants at risk 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.	Standard Enhanced Treatment As Usual n=14 participants at risk 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.
Psychiatric disorders Hospitalization	41.7% 5/12 • Number of events 5 • up to 6 months Only adverse events for the youth participants were monitored.	21.4% 3/14 • Number of events 4 • up to 6 months Only adverse events for the youth participants were monitored.

Other adverse events

Other adverse events
Measure	Adapted STAT-ED n=12 participants at risk 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.	Standard Enhanced Treatment As Usual n=14 participants at risk 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.
Psychiatric disorders Emergency department return visit	8.3% 1/12 • Number of events 1 • up to 6 months Only adverse events for the youth participants were monitored.	21.4% 3/14 • Number of events 5 • up to 6 months Only adverse events for the youth participants were monitored.

Additional Information

Dr. Jason Jones

Children's Hospital of Philadelphia

Phone: 267-425-1326

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place