Navigating Mental Health Treatment for Black Youth

NCT ID: NCT05334381

Last Updated: 2025-08-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

55 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-28

Study Completion Date

2024-12-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Adolescent Behavior Suicidal Ideation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Adapted STAT-ED

The intervention will assist the family in following up with mental health referral recommendations provided by ED staff and eliciting families' preferences in regards to race and gender of providers, convenience of provider, and type of treatment. This assistance could involve help with the initial telephone contact, getting to appointments, and preparing for the appointments. The patient navigator will communicate with the family in person, by telephone, and/or by text messaging as per family's preference. This once to twice a week communication with both the youth and their parent will promote mental health care initiation and identify barriers and problem-solving solutions.

Group Type EXPERIMENTAL

Adapted-STAT ED

Intervention Type BEHAVIORAL

Patient navigator assigned to provide culturally informed motivational interviews, brief case management, psychoeducation and telephone contacts

Standard Enhanced Treatment

After discharge from the Children's Hospital of Philadelphia emergency department, the participant will be given a list of resources and referrals for mental health treatment by the hospital social work team. Phone call contact will be made to follow up on the initiation of treatment from the referral recommendations given at discharge.

Group Type ACTIVE_COMPARATOR

Standard Enhanced Treatment

Intervention Type BEHAVIORAL

Follow up phone calls following discharge from the emergency department to confirm mental health treatment referral recommendations

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Adapted-STAT ED

Patient navigator assigned to provide culturally informed motivational interviews, brief case management, psychoeducation and telephone contacts

Intervention Type BEHAVIORAL

Standard Enhanced Treatment

Follow up phone calls following discharge from the emergency department to confirm mental health treatment referral recommendations

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Identify as Black
2. Are between ages of 6-18 years
3. Endorse suicidal ideation and/or behaviors, or non-suicidal self harm within the last year at an ED or crisis response center visit
4. Live within Pennsylvania, Delaware, or New Jersey
5. Must be able to read and understand English


1. Parent or legal guardian of eligible youth
2. Must be able to read and understand English

Exclusion Criteria

1. Does not identify Black as one of their races
2. Under 6 or over 18 years old
3. Does not speak English
4. No history of suicidal ideation, suicidal behavior, or non-suicidal self harm
5. Currently engaged in mental health treatment
Minimum Eligible Age

6 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Pennsylvania

OTHER

Sponsor Role collaborator

National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

Children's Hospital of Philadelphia

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Rhonda Boyd, PhD

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital of Philadelphia

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

The Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 31860104 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31830523 (View on PubMed)

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

1P50MH127511-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

21-019141

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Trauma-informed Care for Youth With HIV in Memphis
NCT07137026 ACTIVE_NOT_RECRUITING NA
PrEP Affect Regulation Treatment Innovation
NCT04899024 ACTIVE_NOT_RECRUITING NA