Psychotic DisordersJJ-PsychosisNCT03583073
Psychosis Screening in Juvenile Justice
A study testing Enhanced Referral/Linkage to Care in people with Psychotic Disorders and Psychosis Nos/Other, run by Brown University at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 12 to 17 years
- Conditions the study is for
- Psychotic Disorders, Psychosis Nos/Other
- What is being tested?
- Enhanced Referral/Linkage to Care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 77 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Sep 2018to 30 Apr 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Rhode Island Family Court
Providence, Rhode Island, 02903
Brown University
Providence, Rhode Island, 02912
About this study
Official title: Reducing the Duration of Untreated Illness Among Youth in the Juvenile Justice System With Psychosis-Spectrum Disorders
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.
Read the 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.
- Conditions
- Psychotic Disorders, Psychosis Nos/Other
- Being tested
- Enhanced Referral/Linkage to Care, Standard Care
- Keywords
- psychosis, clinical high risk
- Medical subject headings
- Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enhanced Referral/Linkage to CareBehavioural
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 CareBehavioural
Referral to the Coordinated Specialty Care (CSC) clinic
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Enhanced Referral/Linkage to Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Who Used Outpatient Mental Health Services
Number of Participants who Used Any Outpatient Mental Health Services by Participant's Caregiver Report
Measured: 3-month follow-up
Secondary outcomes (1)
Psychosis-spectrum Positive Symptoms
Psychosis-spectrum subscale of The Structured Interview for Psychosis-risk Syndromes (SIPS) has five positive symptoms including odd or delusional thoughts, paranoia/suspiciousness, grandiosity, perceptual abnormalities, and disorganized communication. Each symptom is scored on a scale from 0 to 6 and a total suscale score is calculated, ranging from 0 to 30. Higher scores indicate greater severity of positive symptoms and potentially higher risk for developing psychosis.
Measured: 3-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2018
- Study start1 Sep 2018
- Primary completion30 Jan 2023
- Study completion30 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Psychotic DisordersStudies of the same condition, open and under way.
- More trials run by Brown UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Outcomes assessor
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brown University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Anthony Spirito, Brown University
- Investigators
- Anthony Spirito, PhD, Principal investigator, Brown University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03583073
- Sponsor's protocol ID
- R34MH115457
- Other IDs
- 1R34MH115457-01A1
- Acronym
- JJ-Psychosis
- Status last verified
- Nov 2024
- First submitted
- 28 Jun 2018
- Last updated
- 27 Nov 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing the Duration of Untreated Illness Among Youth in the Juvenile Justice System With Psychosis-Spectrum Disorders
- ClinicalTrials.gov ID
- NCT03583073
- Acronym / sponsor ID
- JJ-Psychosis / R34MH115457
- Conditions
- Psychotic Disorders, Psychosis Nos/Other
- Keywords
- psychosis, clinical high risk
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- Brown UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 30 Jan 2023 (actual)
- Study completion
- 30 Apr 2023 (actual)
- First posted
- 11 Jul 2018 (actual)
- Results
- Posted 27 Nov 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Standard Care/Baseline Control | Active comparator | Behavioral: Standard CareStandard 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. |
| Enhanced Referral/Linkage to Care | Experimental | Behavioral: Enhanced Referral/Linkage to CareThe 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. |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Enhanced Referral/Linkage to CareThe 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. | Behavioural | Enhanced Referral/Linkage to Care |
| Standard CareReferral to the Coordinated Specialty Care (CSC) clinic | Behavioural | Standard Care/Baseline Control |
Primary outcome
Number of Participants Who Used Outpatient Mental Health Services
Time frame: 3-month follow-up
Number of Participants who Used Any Outpatient Mental Health Services by Participant's Caregiver Report
1 secondary outcome
Psychosis-spectrum Positive Symptoms
Time frame: 3-month follow-up
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Psychotic Disorders
RecruitingPhase 3
A Study to Evaluate the Long-term Safety and Tolerability of Xanomeline and Trospium Chloride for the Treatment of Psychiatric Disorders in Children and Adolescents
Schizophrenia, Autism-Related Irritability
Not yet recruitingObservational study
Sleep Monitoring for Early Detection of Relapse in People With Schizophrenia or Bipolar Disorder Receiving Usual Treatment
Bipolar Disorder (BD), SCHIZOPHRENIA 1 (Disorder)
Not yet recruitingPhase 1
Pharmacokinetics and Relative Bioavailability of Intranasal vs Intramuscular Olanzapine in Healthy Adult Participants
Healthy Adult Participants
Active, not recruiting
Designing and Evaluating a Classroom-Based Mental Health Programme for Adolescents.
Mental Health Promotion
RecruitingPhase 2/3
ACP-204 in Adults With Alzheimer's Disease Psychosis
Alzheimer's Disease Psychosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anthony Spirito, PhD principal investigator
Brown University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Enhanced Referral/Linkage to Care in people with Psychotic Disorders and Psychosis Nos/Other, run by Brown University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Nov 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Who Used Outpatient Mental Health Services (time frame: 3-month follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Nov 2024.