Family Navigator Intervention

NCT ID: NCT05954585

Last Updated: 2025-02-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-02

Study Completion Date

2024-05-31

Brief Summary

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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

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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.

Conditions

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Treatment as Usual Family Navigator

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

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

Study Groups

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Treatment as usual

Emergency department treatment as usual

Group Type ACTIVE_COMPARATOR

Treatment as usual

Intervention Type BEHAVIORAL

Emergency department treatment as usual

Family Navigator

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

Group Type EXPERIMENTAL

Family Navigator

Intervention Type BEHAVIORAL

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.

Interventions

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Treatment as usual

Emergency department treatment as usual

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rhode Island Hospital

OTHER

Sponsor Role lead

Responsible Party

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Mary Kathryn Cancilliere

Research Scientist / Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mary Kathryn Cancilliere, PhD

Role: PRINCIPAL_INVESTIGATOR

Rhode Island Hospital

Locations

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Rhode Island Hospital

Providence, Rhode Island, United States

Site Status

Countries

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United States

Other Identifiers

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RIH.100

Identifier Type: -

Identifier Source: org_study_id

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