Adolescent BehaviorNCT05334381
Navigating Mental Health Treatment for Black Youth
A study testing Adapted STAT-ED and Standard Enhanced Treatment As Usual in people with Adolescent Behavior and Suicidal Ideation, run by Children's Hospital of Philadelphia at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 6 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Adolescent Behavior, Suicidal Ideation
- What is being tested?
- Adapted STAT-ED and Standard Enhanced Treatment As Usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Sep 2023to 28 Dec 2024
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Youth Inclusion Criteria:
- Identify as Black
- Are between ages of 6-18 years
- Endorse suicidal ideation and/or behaviors, or non-suicidal self harm within the last year at an ED or crisis response center visit
- Live within Pennsylvania, Delaware, or New Jersey
- Must be able to read and understand English
Youth Exclusion Criteria:
- Does not identify Black as one of their races
- Under 6 or over 18 years old
- Does not speak English
- No history of suicidal ideation, suicidal behavior, or non-suicidal self harm
- Currently engaged in mental health treatment
Caregiver Inclusion Criteria:
- Parent or legal guardian of eligible youth
- Must be able to read and understand English
Trial locations and contacts
1 site in 1 country.
United States1 site
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
About this study
Official title: Navigating Mental Health Treatment for Black Youth With Suicidal Risk
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.
Read the detailed description
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.
- Conditions
- Adolescent Behavior, Suicidal Ideation
- Being tested
- Adapted STAT-ED, Standard Enhanced Treatment As Usual
- Keywords
- Youth Suicide, Cultural Adaptation, Mental Health Treatment, Health Disparities, Black Adolescents, Patient navigation
- Medical subject headings
- Adolescent Behavior, Suicidal Ideation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adapted STAT-EDBehavioural
Patient navigator assigned to provide culturally informed motivational interviews, brief case management, psychoeducation and telephone contacts.
Standard Enhanced Treatment As UsualBehavioural
Follow up phone calls following discharge from the emergency department to assist with mental health treatment referral recommendations.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Adapted STAT-ED |
| 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. Receives: Behavioral: Standard Enhanced Treatment As Usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: at approximately 2 months and 6 months
Secondary outcomes (1)
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.
Measured: at approximately 2 months and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2022
- Study start28 Sep 2023
- Primary completion28 Dec 2024
- Study completion28 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Adolescent BehaviorStudies of the same condition, open and under way.
- More trials run by Children's Hospital of PhiladelphiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Philadelphia
- Sponsor type
- University, hospital or other
- Collaborators
- University of Pennsylvania, National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Rhonda Boyd, PhD, Principal investigator, Children's Hospital of Philadelphia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05334381
- Sponsor's protocol ID
- 21-019141
- Other IDs
- 1P50MH127511-01
- Status last verified
- Apr 2026
- First submitted
- 5 Apr 2022
- Last updated
- 1 May 2026
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 31860104King 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.
PubMed 31830523