Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
55 participants
INTERVENTIONAL
2023-09-28
2024-12-28
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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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.
Adapted-STAT ED
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.
Standard Enhanced Treatment
Follow up phone calls following discharge from the emergency department to confirm mental health treatment referral recommendations
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
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
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
6 Years
18 Years
ALL
Yes
Sponsors
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University of Pennsylvania
OTHER
National Institute of Mental Health (NIMH)
NIH
Children's Hospital of Philadelphia
OTHER
Responsible Party
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Principal Investigators
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Rhonda Boyd, PhD
Role: PRINCIPAL_INVESTIGATOR
Children's Hospital of Philadelphia
Locations
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The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Countries
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References
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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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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21-019141
Identifier Type: -
Identifier Source: org_study_id
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