An interventional study of Adapted STAT-ED and Standard Enhanced Treatment As Usual in Adolescent Behavior and Suicidal Ideation, sponsored by Children's Hospital of Philadelphia. Completed at 1 site in United States. Open to participants aged 6 Years to 18 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-01.
Sponsored by Children's Hospital of Philadelphia · Not applicable, Interventional, and Health services research
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.
305 studies on the registry are indexed under Adolescent Behavior; 47 are open to participants now.
This study's enrollment of 54 is below the median of 172 across 256 interventional studies indexed under Adolescent Behavior.
Browse Adolescent Behavior studies →Children's Hospital of Philadelphia is the lead sponsor of 489 studies on the registry; 90 are open to participants now.
Of its 28 completed or terminated interventional studies of FDA-regulated products, 22 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
Youth Inclusion Criteria:
Youth Exclusion Criteria:
Caregiver Inclusion Criteria:
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.
Behavioral: Adapted STAT-ED
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.
Behavioral: Standard Enhanced Treatment As Usual
Patient navigator assigned to provide culturally informed motivational interviews, brief case management, psychoeducation and telephone contacts.
Follow up phone calls following discharge from the emergency department to assist with mental health treatment referral recommendations.
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.
Time frame: at approximately 2 months and 6 months
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.
Time frame: at approximately 2 months and 6 months
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.
| Milestone | Adapted STAT-ED | Standard Enhanced Treatment As Usual |
|---|---|---|
| Started | 26 | 28 |
| Youth | 12 | 14 |
| Caregivers | 14 | 14 |
| Completed | 21 | 22 |
| Not completed | 5 | 6 |
| Withdrew: Lost to follow-up | 5 | 6 |
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.
| Participants | Adapted STAT-ED | Standard Enhanced Treatment As Usual |
|---|---|---|
| 2-month follow-up | 9 | 10 |
| 6-month follow-up | 7 | 7 |
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.
| units on a scale | Adapted STAT-ED | Standard Enhanced Treatment As Usual |
|---|---|---|
| 2-month follow-up | 22.38 ± 24.92 | 39.44 ± 23.87 |
| 6-month follow-up | 12.00 ± 15.00 | 29.14 ± 15.78 |
Collected over up to 6 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Adapted STAT-ED | 0/12 (0%) | 5/12 (41.7%) | 1/12 (8.3%) |
| Standard Enhanced Treatment As Usual | 0/14 (0%) | 3/14 (21.4%) | 3/14 (21.4%) |
| Event | Adapted STAT-ED | Standard Enhanced Treatment As Usual |
|---|---|---|
| HospitalizationPsychiatric disorders | 5/12 | 3/14 |
| Event | Adapted STAT-ED | Standard Enhanced Treatment As Usual |
|---|---|---|
| Emergency department return visitPsychiatric disorders | 1/12 | 3/14 |
| Age, Continuous(years) | Adapted STAT-ED (Youth) | Adapted STAT-ED (Caregiver) | Standard Enhanced Treatment As Usual (Youth) | Standard Enhanced Treatment As Usual (Caregiver) | Total |
|---|---|---|---|---|---|
| Youth Age | 14.25 ± 2.35 | — | 13.73 ± 2.28 | — | 14.00 ± 2.29 |
| Caregiver Age | — | 44.69 ± 9.49 | — | 38.14 ± 8.43 | 41.30 ± 9.39 |
| Sex: Female, Male(Participants) | Adapted STAT-ED (Youth) | Adapted STAT-ED (Caregiver) | Standard Enhanced Treatment As Usual (Youth) | Standard Enhanced Treatment As Usual (Caregiver) | Total |
|---|---|---|---|---|---|
| Female | 10 | 13 | 11 | 11 | 45 |
| Male | 2 | 1 | 3 | 3 | 9 |
| Race (NIH/OMB)(Participants) | Adapted STAT-ED (Youth) | Adapted STAT-ED (Caregiver) | Standard Enhanced Treatment As Usual (Youth) | Standard Enhanced Treatment As Usual (Caregiver) | Total |
|---|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 | 0 |
| Black or African American | 10 | 14 | 14 | 13 | 51 |
| White | 0 | 0 | 0 | 0 | 0 |
| More than one race | 2 | 0 | 0 | 0 | 2 |
| Unknown or Not Reported | 0 | 0 | 0 | 1 | 1 |
| Ethnicity (NIH/OMB)(Participants) | Adapted STAT-ED (Youth) | Adapted STAT-ED (Caregiver) | Standard Enhanced Treatment As Usual (Youth) | Standard Enhanced Treatment As Usual (Caregiver) | Total |
|---|---|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 | 0 | 0 |
| Not Hispanic or Latino | 12 | 13 | 14 | 14 | 53 |
| Unknown or Not Reported | 0 | 1 | 0 | 0 | 1 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
This study is completed, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Children's Hospital of Philadelphia →