NCT03583073

Brief Summary

This study will investigate the occurrence of psychosis-spectrum disorders among youth in the Juvenile Justice System and track mental health referrals for these youth in Phase 1, a standard care condition. Then, in Phase 2, an enhanced referral and linkage to care model will be employed, with the aim of bolstering motivation for and engagement in mental health treatment. It is hypothesized that the enhanced referral protocol will promote completion of mental health care referrals.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
77

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 28, 2018

Completed
13 days until next milestone

First Posted

Study publicly available on registry

July 11, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2018

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2023

Completed
1.6 years until next milestone

Results Posted

Study results publicly available

November 27, 2024

Completed
Last Updated

November 27, 2024

Status Verified

November 1, 2024

Enrollment Period

4.4 years

First QC Date

June 28, 2018

Results QC Date

June 7, 2024

Last Update Submit

November 16, 2024

Conditions

Keywords

psychosisclinical high risk

Outcome Measures

Primary Outcomes (1)

  • Number of Participants Who Used Outpatient Mental Health Services

    Number of Participants who Used Any Outpatient Mental Health Services by Participant's Caregiver Report

    3-month follow-up

Secondary Outcomes (1)

  • Psychosis-spectrum Positive Symptoms

    3-month follow-up

Study Arms (2)

Standard Care/Baseline Control

ACTIVE COMPARATOR

Standard care is the typical process of referral to mental health services for Juvenile Justice (JJ) youth who screen positive for mental heath concerns at intake. For this study, baseline control participants will be referred to the Coordinated Specialty Care (CSC) clinic due to their endorsement of psychosis-spectrum symptoms.

Behavioral: Standard Care

Enhanced Referral/Linkage to Care

EXPERIMENTAL

The experimental condition will include a psychoeducational and motivational enhancement protocol completed at the JJS intake appointment, paired with a "warm hand-off" referral to the CSC for evaluation and initiation of mental health services.

Behavioral: Enhanced Referral/Linkage to Care

Interventions

The JJ worker reviews with the family psychoeducation material about the role of mental health care in emotional/behavioral problems. The JJ intake worker will contact the CSC program directly with the family for a "warm hand-off". The CSC worker will speak with the parent and arrange for an intake evaluation. For families already receiving treatment, the CSC referral will be for consultation. Via phone, the CSC clinician will use a motivational interviewing style to encourage families to attend the appointment. Three and seven days after referral, the JJ worker will text the caregiver to see if the CSC appointment was kept. If not, the JJ worker will text the parent the CSC phone number and also ask permission to contact the CSC to assist the family in setting up another appointment.

Enhanced Referral/Linkage to Care
Standard CareBEHAVIORAL

Referral to the Coordinated Specialty Care (CSC) clinic

Standard Care/Baseline Control

Eligibility Criteria

Age12 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Adolescent being seen in the Juvenile Justice System
  • Legal guardian available to consent for juvenile's participation
  • Adolescent assents to participate
  • Adolescent is English speaking
  • Parent/guardian may be English or Spanish-speaking
  • Adolescent flags positive on the MAYSI-2 Thought Disturbance subscale or the PQ-B

You may not qualify if:

  • Adolescent has observable developmental delays that would interfere with obtaining assent and/or accurate assessment
  • Adolescent meets hospital level of care for imminent risk due to severity of symptoms

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Rhode Island Family Court

Providence, Rhode Island, 02903, United States

Location

Brown University

Providence, Rhode Island, 02912, United States

Location

MeSH Terms

Conditions

Psychotic Disorders

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Results Point of Contact

Title
Anthony Spirito
Organization
Brown U

Study Officials

  • Anthony Spirito, PhD

    Brown University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: The intervention will have two phases: 1) a Standard Care (baseline control) condition, followed by, 2) an Enhanced Referral/Linkage to Care condition. Because this is a roll-out trial, the two conditions will be compared using a non-randomized open trial design.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 28, 2018

First Posted

July 11, 2018

Study Start

September 1, 2018

Primary Completion

January 30, 2023

Study Completion

April 30, 2023

Last Updated

November 27, 2024

Results First Posted

November 27, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations