Family Navigator Intervention | NCT05954585

Studies
Family Navigator Intervention

NCT05954585

Sponsor

Rhode Island Hospital

Status

Terminated

Last Update Posted

Feb 20, 2025Actual

Enrollment

54Actual

Phase

Not Applicable

Conditions

Treatment as Usual
Family Navigator

Interventions

Treatment as usual
Family Navigator

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2025

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Graduated off COBRE grant

Expanded Access Info

Start Date

Dec 2, 2023Actual

Primary Completion Date

May 31, 2024Actual

Completion Date

May 31, 2024Actual

First Submitted Date

Jul 12, 2023

First Submission Date that Met QC Criteria

Jul 12, 2023

First Posted Date

Jul 20, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 18, 2025

Last Update Posted Date

Feb 20, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Mary Kathryn Cancilliere, Research Scientist / Assistant Professor, Rhode Island HospitalPrincipal Investigator

Lead Sponsor

Rhode Island HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

54Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Treatment as usual	Active Comparator	Emergency department treatment as usual	Behavioral: Treatment as usual
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	Behavioral: Family Navigator

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Treatment as usual	Behavioral	Emergency department treatment as usual	Treatment as usual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Mental Health Services	adapted CASA	6 months

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

10 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Mary Kathryn Cancilliere, PhD	Rhode Island Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Rhode Island Hospital		Providence	Rhode Island	02903	United States

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Type	Date	Date Unknown
Release	Jun 5, 2025
Reset	Jun 23, 2025

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Jun 5, 2025			Jun 23, 2025

Condition Browse Module

MeSH Terms

ID	Term
D004630	Emergencies
D013405	Suicide

Ancestor Terms

ID	Term
D020969	Disease Attributes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D016728	Self-Injurious Behavior

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D013812	Therapeutics

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided