Navigating Mental Health Treatment for Black Youth

Sponsor
Children's Hospital of Philadelphia (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05334381
Collaborator
University of Pennsylvania (Other), National Institute of Mental Health (NIMH) (NIH)
100
2
23

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Adapted-STAT ED
  • Behavioral: Standard Enhanced Treatment
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Health Services Research
Official Title:
Navigating Mental Health Treatment for Black Youth With Suicidal Risk
Anticipated Study Start Date :
Oct 1, 2022
Anticipated Primary Completion Date :
Mar 1, 2024
Anticipated Study Completion Date :
Sep 1, 2024

Arms and Interventions

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.

Behavioral: Adapted-STAT ED
Patient navigator assigned to provide culturally informed motivational interviews, brief case management, psychoeducation and telephone contacts

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.

Behavioral: Standard Enhanced Treatment
Follow up phone calls following discharge from the emergency department to confirm mental health treatment referral recommendations

Outcome Measures

Primary Outcome Measures

  1. Mental health treatment initiation [up to 6 months]

    Briefest Service Assessment for Children and Adolescents (SACA) is a 29-item interview that measures the types of mental health services children receive and the treatments they receive within service settings. Caregivers will complete the SACA. The parent version has good to excellent lifetime and satisfactory to good past-year test-retest reliability. Scores range from poor to excellent (k=0.25-0.83 with half at 0.50 or greater).

Secondary Outcome Measures

  1. Suicidal ideation and behavior [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
10 Years to 18 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Children's Hospital of Philadelphia
  • University of Pennsylvania
  • National Institute of Mental Health (NIMH)

Investigators

  • Principal Investigator: Rhonda Boyd, PhD, Children's Hospital of Philadelphia

Study Documents (Full-Text)

More Information

Publications

Responsible Party:
Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier:
NCT05334381
Other Study ID Numbers:
  • 21-019141
  • 1P50MH127511-01
First Posted:
Apr 19, 2022
Last Update Posted:
Apr 19, 2022
Last Verified:
Apr 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Children's Hospital of Philadelphia
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 19, 2022