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Completed

NCT Number: NCT05334381

Navigating Mental Health Treatment for Black Youth

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.

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Key information

Age range

6 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Adapted STAT-ED

Behavioral

Patient navigator assigned to provide culturally informed motivational interviews, brief case management, psychoeducation and telephone contacts.

Standard Enhanced Treatment As Usual

Behavioral

Follow up phone calls following discharge from the emergency department to assist with mental health treatment referral recommendations.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Children's Hospital of Philadelphia

Other

Collaborators

  • National Institute of Mental Health (NIMH)
  • University of Pennsylvania

Registry information

Official study title

Navigating Mental Health Treatment for Black Youth With Suicidal Risk

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Apr 19, 2022
Registry last updated
May 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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