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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03583073
Other study ID # R34MH115457
Secondary ID 1R34MH115457-01A
Status Completed
Phase N/A
First received
Last updated
Start date September 1, 2018
Est. completion date April 30, 2023

Study information

Verified date September 2023
Source Brown University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

Among adolescents in the Juvenile Justice System (JJS), an estimated 3% have a psychotic illness, and it can be reasonably assumed that many more experience subthreshold psychotic-spectrum symptoms that may be indicative of risk. Evidence suggests that as many as 25% of those with first episode psychosis (FEP) have their first contact with care through criminal justice agencies. Duration of untreated psychosis (DUP), a negative prognostic factor, has been shown to be longer among those within the criminal justice system. This suggests that youth with psychotic symptoms who end up in the JJS may not receive appropriate mental health care. This study will first track mental health referrals for JJ youth with psychosis-spectrum symptoms in Phase 1, a standard care condition, and then an enhanced referral and linkage to care model will be investigated in Phase 2 of the study. The current study will be conducted in the Rhode Island Family Court Juvenile Intake Department where all youth receive a mental health screen (Massachusetts Youth Screening Instrument - 2nd Ed; MAYSI -2). All youth who screen positive on the MAYSI-2 Thought Disturbance scale, and a second gate screening with the Prodromal Questionnaire - Brief Version (PQ-B), will be given referral information for Coordinated Specialty Care (CSC) services by JJS staff. Enrolled families will also participate in the research assessment, regardless of whether they pursue the CSC referral, which involves the Structured Interview for Psychosis-risk Syndromes [SIPS] and other measures to thoroughly assess history of psychotic symptoms, comorbid difficulties, and mental health care engagement. A comparison sample of youth who screen negative on the MAYSI-2 Thought Disturbance subscale will also be assessed with the SIPS to determine accuracy of the MAYSI-2/PQ-B screen in the identification of psychosis-risk. During the first phase of the study, JJS staff will follow standard procedures in referring youth to the state CSC. In the second phase of the study, JJS will be instructed in an enhanced referral/linkage to care protocol, including a "warm hand-off" where referrals will be put in direct and immediate contact with CSC staff. CSC staff will also be trained in procedures to increase the likelihood of follow through with the referral to the CSC. Three month follow-up qualitative interviews and quantitative assessments regarding referral pathways, bottlenecks and gaps in care, youth psychiatric symptoms, and JJS contacts will be conducted. This design maps onto the stated goals of PAR 16- 264 including: 1) Identify baseline rates of DUP within the JJS (and the investigators will also look at rates of psychosis-spectrum symptoms and disorders); 2) Map referral pathways to CSC; 3) Identify implementation and service level factors that create bottlenecks and gaps in linkage to the CSC; 4) Investigate the relationship between treatment linkage and psychotic symptoms/DUP; and, 5) Pilot test feasible strategies for reducing DUP.


Recruitment information / eligibility

Status Completed
Enrollment 160
Est. completion date April 30, 2023
Est. primary completion date January 30, 2023
Accepts healthy volunteers No
Gender All
Age group 12 Years to 17 Years
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: - 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

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Enhanced Referral/Linkage to Care
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.
Standard Care
Referral to the Coordinated Specialty Care (CSC) clinic

Locations

Country Name City State
United States Brown University Providence Rhode Island
United States Rhode Island Family Court Providence Rhode Island

Sponsors (2)

Lead Sponsor Collaborator
Brown University National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Treatment linkage/retention in CSC services The Child and Adolescent Services Assessment [CASA] is a parent-report instrument designed to assess at follow-up the use of mental health services for youth across 31 settings including inpatient, outpatient, and informal services. Collateral information on treatment attendance (attendance at first treatment appointment and total number of treatment sessions attended) will also be collected by contacting each juveniles' treatment provider at the 3-month follow-up. A release of information is requested at baseline, for both primary care physicians (PCP) and their mental health provider/agency, as part of the court intake process. The consent form will also contain language allowing the research team to collect this information from the youth's treatment providers. 3-month follow-up
Secondary Psychosis-spectrum symptoms and diagnoses The Structured Interview for Psychosis-risk Syndromes (SIPS) is a semi-structured interview that assesses psychosis-spectrum experiences. The SIPS takes approximately 45-90 minutes to complete and assesses the presence and severity of positive, negative, disorganized, and general symptoms. Respondents are determined to meet criteria for psychosis-spectrum disorders/syndromes based on their endorsement and description of five positive symptoms including odd or delusional thoughts, paranoia/suspiciousness, grandiosity, perceptual abnormalities, and disorganized communication. Factors such as the frequency and intensity of positive symptoms, along with the level of conviction (belief that the experience is real) and interference (i.e. associated distress or impairment), are used to determine whether individuals meet criteria for full-threshold psychosis or any of three risk syndromes. Symptom severity ratings and diagnostic status will used to track illness over the follow-up period. 3-month follow-up
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