Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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.
 
ClinicalTrials.gov Identifier: NCT03583073
Recruitment Status : Recruiting
First Posted : July 11, 2018
Last Update Posted : February 5, 2019
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Anthony Spirito, Brown University

Tracking Information
First Submitted Date  ICMJE June 28, 2018
First Posted Date  ICMJE July 11, 2018
Last Update Posted Date February 5, 2019
Actual Study Start Date  ICMJE September 1, 2018
Estimated Primary Completion Date August 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 10, 2018)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03583073 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 10, 2018)
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Psychosis Screening in Juvenile Justice
Official Title  ICMJE Reducing the Duration of Untreated Illness Among Youth in the Juvenile Justice System With Psychosis-Spectrum Disorders
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE
  • Psychotic Disorders
  • Psychosis Nos/Other
Intervention  ICMJE
  • 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.
  • Behavioral: Standard Care
    Referral to the Coordinated Specialty Care (CSC) clinic
Study Arms  ICMJE
  • 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.
    Intervention: Behavioral: Standard Care
  • 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.
    Intervention: Behavioral: Enhanced Referral/Linkage to Care
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 10, 2018)
270
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 30, 2022
Estimated Primary Completion Date August 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Anthony Spirito, PhD 401-444-1919 anthony_spirito@brown.edu
Contact: Kathleen Kemp, PhD (401) 793-8269 kkemp@lifespan.org
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03583073
Other Study ID Numbers  ICMJE R34MH115457( U.S. NIH Grant/Contract )
1R34MH115457-01A1 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Anthony Spirito, Brown University
Study Sponsor  ICMJE Brown University
Collaborators  ICMJE National Institute of Mental Health (NIMH)
Investigators  ICMJE
Principal Investigator: Anthony Spirito, PhD Brown University
PRS Account Brown University
Verification Date February 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP