Navigating Mental Health Treatment for Black Youth

Suicidal Ideation Clinical Trial

Official title:

Navigating Mental Health Treatment for Black Youth With Suicidal Risk

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05334381
• Other study ID #: 21-019141
• Secondary ID: 1P50MH127511-01
• Status: Recruiting
• Phase: N/A
• Start date: September 28, 2023
• Est. completion date: December 2024

Study information

• Verified date: June 2024
• Source: Children's Hospital of Philadelphia
• Contact: Rhonda Boyd, PhD
• Phone: 215-590-3945
• Email: boydr[@]chop.edu
• Is FDA regulated: No
• Study type: Interventional

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2024
• Est. primary completion date: September 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 10 Years to 18 Years

Eligibility

Youth Inclusion Criteria:

1. Identify as Black

2. Are between ages of 10-18 years

3. Endorse suicidal ideation and/or behaviors within the last year at an ED visit

4. Live within Philadelphia County or nearby Pennsylvania suburb

5. Must be able to read and understand English

Youth Exclusion Criteria:

1. Does not identify Black as one of their races

2. Under 10 or over 18 years old

3. Does not speak English

4. No history of suicidal ideation or behavior

5. Currently engaged in mental health treatment

Caregiver Inclusion Criteria:

1. Parent or legal guardian of eligible youth

2. Must be able to read and understand English

Related Conditions & MeSH terms

• Adolescent Behavior
• Suicidal Ideation

Intervention

Behavioral:
• Adapted-STAT ED
Patient navigator assigned to provide culturally informed motivational interviews, brief case management, psychoeducation and telephone contacts
• Standard Enhanced Treatment
Follow up phone calls following discharge from the emergency department to confirm mental health treatment referral recommendations

Locations

Country	Name	City	State
United States	The Children's Hospital of Philadelphia	Philadelphia	Pennsylvania

Sponsors (3)

Lead Sponsor	Collaborator
Children's Hospital of Philadelphia	National Institute of Mental Health (NIMH), University of Pennsylvania

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 (King et al., 2020). Cargeivers will complete this interview unless youth is participating without a parent.	up to 6 months
Secondary	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.	up to 6 months