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Navigating Mental Health Treatment for Black Youth

Primary Purpose

Adolescent Behavior, Suicidal Ideation

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Adapted-STAT ED
Standard Enhanced Treatment
Sponsored by
Children's Hospital of Philadelphia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Adolescent Behavior focused on measuring Youth Suicide, Cultural Adaptation, Mental Health Treatment, Health Disparities, Black Adolescents, Patient navigation

Eligibility Criteria

10 Years - 18 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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. Requires acute or intensive inpatient treatment for safety or medical reasons
  6. 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

Sites / Locations

  • The Children's Hospital of PhiladelphiaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Adapted STAT-ED

Standard Enhanced Treatment

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
April 5, 2022
Last Updated
October 17, 2023
Sponsor
Children's Hospital of Philadelphia
Collaborators
University of Pennsylvania, National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT05334381
Brief Title
Navigating Mental Health Treatment for Black Youth
Official Title
Navigating Mental Health Treatment for Black Youth With Suicidal Risk
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 28, 2023 (Actual)
Primary Completion Date
March 2024 (Anticipated)
Study Completion Date
September 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Children's Hospital of Philadelphia
Collaborators
University of Pennsylvania, National Institute of Mental Health (NIMH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adolescent Behavior, Suicidal Ideation
Keywords
Youth Suicide, Cultural Adaptation, Mental Health Treatment, Health Disparities, Black Adolescents, Patient navigation

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Adapted STAT-ED
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard Enhanced Treatment
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Adapted-STAT ED
Intervention Description
Patient navigator assigned to provide culturally informed motivational interviews, brief case management, psychoeducation and telephone contacts
Intervention Type
Behavioral
Intervention Name(s)
Standard Enhanced Treatment
Intervention Description
Follow up phone calls following discharge from the emergency department to confirm mental health treatment referral recommendations
Primary Outcome Measure Information:
Title
Mental health treatment initiation
Description
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.
Time Frame
up to 6 months
Secondary Outcome Measure Information:
Title
Suicidal ideation and behavior
Description
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.
Time Frame
up to 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rhonda Boyd, PhD
Phone
215-590-3945
Email
boydr@chop.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Makiya Lloyd
Phone
215-590-4650
Email
lloydm3@chop.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rhonda Boyd, PhD
Organizational Affiliation
Children's Hospital of Philadelphia
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Children's Hospital of Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rhonda C. Boyd, PhD
Phone
215-590-3945
Email
boydr@email.chop.edu
First Name & Middle Initial & Last Name & Degree
Rhonda C. Boyd, PhD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31860104
Citation
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.
Results Reference
background
PubMed Identifier
31830523
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.
Results Reference
background

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Navigating Mental Health Treatment for Black Youth

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