- 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 (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, United States, 19104
- The Children's Hospital of Philadelphia
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
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
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.
|
Patient navigator assigned to provide culturally informed motivational interviews, brief case management, psychoeducation and telephone contacts.
|
|
Active Comparator: Standard Enhanced Treatment As Usual
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.
|
Follow up phone calls following discharge from the emergency department to assist with 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: at approximately 2 months and 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.
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Suicidal Ideation and Behavior
Time Frame: at approximately 2 months and 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.
Scores range from 0 to 90.
Higher scores indicate greater suicidal ideation.
The cut-off score of 31 or higher is considered clinically significant.
|
at approximately 2 months and 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 (Actual)
Study Completion (Actual)
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.
Clinical Trials on Suicidal Ideation
-
Northwestern UniversityNot yet recruitingSuicidal Ideation and Behavior
-
University GhentRecruitingSuicide | Suicidal Ideation and Behavior | Crisis InterventionBelgium
-
Shira BarzilaySchneider Children's Medical Center, IsraelRecruiting
-
University of WashingtonUnited States Department of Defense; Military Suicide Research ConsortiumCompletedSuicidal and Self-injurious Behavior | Suicidal Ideation ActiveUnited States
-
The Catholic University of AmericaUniversity of Washington; VA Office of Research and DevelopmentCompletedSuicidal and Self-injurious Behavior | Suicidal Ideation Active
-
Emory UniversityGeorgia Institute of TechnologyCompletedSuicide, Suicidal IdeationUnited States
-
Henry M. Jackson Foundation for the Advancement...University of Pennsylvania; University of Michigan; Duke University; US Department... and other collaboratorsUnknownSuicide, Attempted | Suicidal Ideation ActiveUnited States
-
Columbia UniversityNational Institute of Mental Health (NIMH)RecruitingSuicidal Ideation and BehaviorUnited States
-
Bradley HospitalNational Institute of Mental Health (NIMH); Instituto Nacional de Psiquiatría...Not yet recruitingSuicidal Ideation/BehaviorMexico
-
Oriana Arellano FaúndezActive, not recruitingSuicidal Ideation | Suicidal Ideation and BehaviorsChile
Clinical Trials on Adapted STAT-ED
-
Children's Hospital Medical Center, CincinnatiNational Institutes of Health (NIH)Completed
-
Abbott Point of CareCompleted
-
Virginia Commonwealth UniversityEunice Kennedy Shriver National Institute of Child Health and Human Development...Terminated
-
Great Ormond Street Hospital for Children NHS Foundation...UnknownHeart Defects, CongenitalUnited Kingdom
-
Vanderbilt UniversityTerminated
-
University of PittsburghCompleted
-
Emory UniversityAbbottRecruitingBrain Injuries | Head InjuryUnited States
-
Szeged UniversityHungarian Basic Research Council; GINOPUnknownDiabetes Mellitus | Cardiac Surgical ProceduresHungary
-
AdventHealthUniversity of South Florida; Yale University; Beth Israel Deaconess Medical Center and other collaboratorsActive, not recruitingAssessment, Self | CompetenceUnited States
-
Hospices Civils de LyonCompletedPsychoactive Substances ConsumersFrance