Family Navigator Intervention

Treatment as Usual Clinical Trial

Official title:

The Development of a Family Navigator Intervention and Prevention Protocol to Reduce Risk of Suicide and Self-injurious Behavior for Youth Aged 10 to 14 Years

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05954585
• Other study ID #: COBRE.RIH100
• Status: Recruiting
• Phase: N/A
• Start date: December 2, 2023
• Est. completion date: May 14, 2025

Study information

• Verified date: January 2024
• Source: Rhode Island Hospital
• Contact: Mary Kathryn Cancilliere, PhD
• Phone: 401-444-7443
• Email: Marykathryn.cancilliere[@]lifespan.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will develop and examine the feasibility and acceptability of a family navigator protocol while leveraging digital health communication. It will employ an ecological model within a socio-cultural theoretic framework of mental health service disparities and barriers to treatment.

Description:

The purpose of this study is to develop and pilot a Family Navigator intervention with technology-enhanced information sharing for families with youth (80 youth-caregiver dyads) who were discharged from the emergency after an admission for SSIB. This novel intervention aims to reduce suicidal and non-suicidal self-injurious behavior risk and prevalence rates by way of increasing attendance to community-based mental health services for youth aged 10 to 14.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. completion date: May 14, 2025
• Est. primary completion date: May 14, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years and older

Eligibility

Inclusion Criteria:

• youth 10 to 14 years old living at home with legal guardian/caregiver

Exclusion Criteria:

• presentation including psychosis, sexual assault, or child abuse,
• are in police or child protective services' custody,
• are unable to assent due to severity of illness or developmental disabilities, >cannot communicate in English or Spanish, or
• if no caregiver or legal guardian is able to provide consent.

Related Conditions & MeSH terms

• Treatment as Usual

Intervention

Behavioral:
• Treatment as usual
Emergency department treatment as usual
• Family Navigator
Family Navigator will speak with families about individual and systemic issues for linkage to mental health care biweekly for 3 months or until the youth's first mental health appt has been attended, whichever comes first.

Locations

Country	Name	City	State
United States	Rhode Island Hospital	Providence	Rhode Island

Sponsors (1)

Lead Sponsor	Collaborator
Rhode Island Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mental Health Services	adapted CASA	6 months
Secondary	Suicidal ideation	Suicidal Ideation Questionnaire	6 months
Secondary	Suicidal behavior	Suicidal Ideation Questionnaire	6 months