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Clinical Trials/NCT05954585
NCT05954585TerminatedNot Applicable

The Development of a Family Navigator Intervention and Prevention Protocol to Reduce Risk of Suicide and Self-injurious Behavior for Youth Aged 8 to 14 Years

Rhode Island Hospital1 site in 1 country54 target enrollmentStarted: December 2, 2023Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Terminated
Enrollment
54
Locations
1
Primary Endpoint
Mental Health Services

Study Overview

Brief 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.

Detailed 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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Health Services Research
Masking
Single (Outcomes Assessor)

Masking Description

The person conducting follow-up assessments will be masked as to the intervention assignments.

Eligibility Criteria

Ages
10 Years to — (Child, Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Arms & Interventions

Family Navigator

Experimental

Follow provision provided by a Family Navigator for the length of the treatment or until youth attends community-based mental health care

Intervention: Family Navigator (Behavioral)

Treatment as usual

Active Comparator

Emergency department treatment as usual

Intervention: Treatment as usual (Behavioral)

Outcomes

Primary Outcomes

Mental Health Services

Time Frame: 6 months

adapted CASA

Secondary Outcomes

  • Suicidal ideation(6 months)
  • Suicidal behavior(6 months)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Mary Kathryn Cancilliere

Research Scientist / Assistant Professor

Rhode Island Hospital

Study Sites (1)

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