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Psychosis Screening in Juvenile Justice (JJ-Psychosis)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03583073
Recruitment Status : Recruiting
First Posted : July 11, 2018
Last Update Posted : February 5, 2019
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Anthony Spirito, Brown University

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.

Condition or disease Intervention/treatment Phase
Psychotic Disorders Psychosis Nos/Other Behavioral: Enhanced Referral/Linkage to Care Behavioral: Standard Care Not Applicable

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 270 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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.
Masking: Single (Outcomes Assessor)
Primary Purpose: Other
Official Title: Reducing the Duration of Untreated Illness Among Youth in the Juvenile Justice System With Psychosis-Spectrum Disorders
Actual Study Start Date : September 1, 2018
Estimated Primary Completion Date : August 31, 2021
Estimated Study Completion Date : March 30, 2022

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: Standard Care/Baseline Control
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
Referral to the Coordinated Specialty Care (CSC) clinic

Experimental: Enhanced Referral/Linkage to Care
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
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.

Primary Outcome Measures :
  1. Treatment linkage/retention in CSC services [ Time Frame: 3-month follow-up ]
    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.

Secondary Outcome Measures :
  1. Psychosis-spectrum symptoms and diagnoses [ Time Frame: 3-month follow-up ]
    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.

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03583073

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Contact: Anthony Spirito, PhD 401-444-1919
Contact: Kathleen Kemp, PhD (401) 793-8269

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United States, Rhode Island
Rhode Island Family Court Recruiting
Providence, Rhode Island, United States, 02903
Contact: Kathleen Kemp, PhD    401-793-8269   
Contact: Kevin Richard, BA    401-458-5262   
Brown Univerity Recruiting
Providence, Rhode Island, United States, 02912
Principal Investigator: Anthony Spirito, PhD         
Sponsors and Collaborators
Brown University
National Institute of Mental Health (NIMH)
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Principal Investigator: Anthony Spirito, PhD Brown University

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Responsible Party: Anthony Spirito, Professor, Brown University Identifier: NCT03583073     History of Changes
Other Study ID Numbers: R34MH115457 ( U.S. NIH Grant/Contract )
1R34MH115457-01A1 ( U.S. NIH Grant/Contract )
First Posted: July 11, 2018    Key Record Dates
Last Update Posted: February 5, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Anthony Spirito, Brown University:
clinical high risk
Additional relevant MeSH terms:
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Psychotic Disorders
Mental Disorders
Schizophrenia Spectrum and Other Psychotic Disorders