Family Navigator Intervention

Sponsor

Rhode Island Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05954585

Collaborator

(none)

160

Enrollment

Arms

21.4

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Treatment as Usual Family Navigator	Behavioral: Treatment as usual Behavioral: Family Navigator	N/A

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

Anticipated Enrollment :

160 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Masking Description:

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

Primary Purpose:

Health Services Research

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

Anticipated Study Start Date :

Aug 1, 2023

Anticipated Primary Completion Date :

May 14, 2025

Anticipated Study Completion Date :

May 14, 2025

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Treatment as usual	Behavioral: 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.
Experimental: Family Navigator	Behavioral: Treatment as usual Emergency department treatment as usual

Arm

Intervention/Treatment

Active Comparator: Treatment as usual

Behavioral: 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.

Experimental: Family Navigator

Behavioral: Treatment as usual

Emergency department treatment as usual

Outcome Measures

Primary Outcome Measures

Mental Health Services [6 months]
adapted CASA

Secondary Outcome Measures

Suicidal ideation [6 months]
Suicidal Ideation Questionnaire
Suicidal behavior [6 months]
Suicidal Ideation Questionnaire

Eligibility Criteria

Criteria

Ages Eligible for Study:

10 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria: Inclusion criteria include youth 10 to 14 years old living at home with legal guardian/caregiver.

Exclusion Criteria: Youth will be excluded from the study if they have a 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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Rhode Island Hospital

Investigators

Study Director: Michael Mello, MD, PI COBRE

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Mary Kathryn Cancilliere, Research Scientist / Assistant Professor, Rhode Island Hospital

ClinicalTrials.gov Identifier:

NCT05954585

Other Study ID Numbers:

COBRE.RIH100

First Posted:

Jul 20, 2023

Last Update Posted:

Jul 20, 2023

Last Verified:

Jul 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Mary Kathryn Cancilliere, Research Scientist / Assistant Professor, Rhode Island Hospital

emergency department, suicide, youth, family navigator

Study Results

No Results Posted as of Jul 20, 2023