NCT05334381

Brief 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 can increase mental health treatment initiation and number of visits.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 5, 2022

Completed
14 days until next milestone

First Posted

Study publicly available on registry

April 19, 2022

Completed
1.4 years until next milestone

Study Start

First participant enrolled

September 28, 2023

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 28, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 28, 2024

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

May 1, 2026

Completed
Last Updated

May 1, 2026

Status Verified

April 1, 2026

Enrollment Period

1.3 years

First QC Date

April 5, 2022

Results QC Date

December 22, 2025

Last Update Submit

April 29, 2026

Conditions

Keywords

Youth SuicideCultural AdaptationMental Health TreatmentHealth DisparitiesBlack AdolescentsPatient navigation

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Suicidal Ideation and Behavior

    at approximately 2 months and 6 months

Study Arms (2)

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.

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.

Behavioral: Standard Enhanced Treatment As Usual

Interventions

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

Standard Enhanced Treatment As Usual
Adapted STAT-EDBEHAVIORAL

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

Adapted STAT-ED

Eligibility Criteria

Age6 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • Parent or legal guardian of eligible youth
  • Must be able to read and understand English

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (2)

  • 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.

    PMID: 31860104BACKGROUND
  • 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.

    PMID: 31830523BACKGROUND

MeSH Terms

Conditions

Adolescent BehaviorSuicidal Ideation

Condition Hierarchy (Ancestors)

BehaviorSuicideSelf-Injurious BehaviorBehavioral Symptoms

Results Point of Contact

Title
Dr. Jason Jones
Organization
Children's Hospital of Philadelphia

Study Officials

  • Rhonda Boyd, PhD

    Children's Hospital of Philadelphia

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 5, 2022

First Posted

April 19, 2022

Study Start

September 28, 2023

Primary Completion

December 28, 2024

Study Completion

December 28, 2024

Last Updated

May 1, 2026

Results First Posted

May 1, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations