Family Navigator Intervention

January 22, 2024 updated by: Mary Kathryn Cancilliere, Rhode Island Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / 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 Type

Interventional

Enrollment (Estimated)

160

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Rhode Island
      • Providence, Rhode Island, United States, 02903
        • Recruiting
        • Rhode Island Hospital
        • Contact:
          • Mary Kathryn Cancilliere, PhD
          • Phone Number: 401-444-7443
        • Principal Investigator:
          • Mary Kathryn Cancilliere, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Treatment as usual
Emergency department treatment as usual
Behavioral: Treatment as usual
Emergency department treatment as usual
Experimental: Family Navigator
Follow provision provided by a Family Navigator for the length of the treatment or until youth attends community-based mental health care
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mental Health Services
Time Frame: 6 months
adapted CASA
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Suicidal ideation
Time Frame: 6 months
Suicidal Ideation Questionnaire
6 months
Suicidal behavior
Time Frame: 6 months
Suicidal Ideation Questionnaire
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rhode Island Hospital

Investigators

  • Study Director: Michael Mello, MD, PI COBRE

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 2, 2023

Primary Completion (Estimated)

May 14, 2025

Study Completion (Estimated)

May 14, 2025

Study Registration Dates

First Submitted

July 12, 2023

First Submitted That Met QC Criteria

July 12, 2023

First Posted (Actual)

July 20, 2023

Study Record Updates

Last Update Posted (Estimated)

January 24, 2024

Last Update Submitted That Met QC Criteria

January 22, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • COBRE.RIH100

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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