- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05334381
Navigating Mental Health Treatment for Black Youth
Navigating Mental Health Treatment for Black Youth With Suicidal Risk
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Rhonda Boyd, PhD
- Phone Number: 215-590-3945
- Email: boydr@chop.edu
Study Contact Backup
- Name: Makiya Lloyd
- Phone Number: 215-590-4650
- Email: lloydm3@chop.edu
Study Locations
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19104
- Recruiting
- The Children's Hospital of Philadelphia
-
Contact:
- Rhonda C. Boyd, PhD
- Phone Number: 215-590-3945
- Email: boydr@email.chop.edu
-
Principal Investigator:
- Rhonda C. Boyd, PhD
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Youth Inclusion Criteria:
- Identify as Black
- Are between ages of 10-18 years
- Endorse suicidal ideation and/or behaviors within the last year at an ED visit
- Live within Philadelphia County or nearby Pennsylvania suburb
- Must be able to read and understand English
Youth Exclusion Criteria:
- Does not identify Black as one of their races
- Under 10 or over 18 years old
- Does not speak English
- No history of suicidal ideation or behavior
- Currently engaged in mental health treatment
Caregiver Inclusion Criteria:
- Parent or legal guardian of eligible youth
- Must be able to read and understand English
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
|
Patient navigator assigned to provide culturally informed motivational interviews, brief case management, psychoeducation and telephone contacts
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Active Comparator: 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.
|
Follow up phone calls following discharge from the emergency department to confirm mental health treatment referral recommendations
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mental health treatment initiation
Time Frame: up to 6 months
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Suicidal ideation and behavior
Time Frame: up to 6 months
|
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
|
Collaborators and Investigators
Investigators
- Principal Investigator: Rhonda Boyd, PhD, Children's Hospital of Philadelphia
Publications and helpful links
General 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 21-019141
- 1P50MH127511-01 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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