Prodromal SchizophreniaNCT03970005
Evaluation of Step-Based Care for Individuals at Clinical High Risk for Psychosis
An observational study of Prodromal Schizophrenia, run by Ohio State University at 1 site in United States.
Trial summary
The Ohio State University Early Psychosis Intervention Center is implementing a specialized clinical program to serve individuals who meet clinical high risk criteria for a psychosis. The purpose of this study is to evaluate the long-term outcomes among individuals participating in this clinical service. Read more about this study
- Who is it for?
- Ages 12 to 25 years
- Conditions the study is for
- Prodromal Schizophrenia
- What is being tested?
- Step-Based Care Model
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Apr 2019to Sep 2030
- How long will I take part?
- 24 Months
- Phase
- Observational
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 25 years
- All sexes
- Child, Adult
Study population: This program evaluation will include all patients referred to The OSU EPICENTER CHR-P clinical program.
Who may be able to join
- Male and female patients between ages 12-25
- Individuals meeting clinical high-risk criteria for psychosis as determined using the Structured Interview for Psychosis Risk. Inclusive of individuals meeting any of the three CHR syndromes assessed by the SIPS (i.e., attenuated psychotic symptoms; brief intermittent psychosis, and genetic risk and functional deterioration) and/or individuals at all four current status specifiers for the SIPS (i.e., progression, persistence, partial remission, and full remission) given evidence that future worsening of symptoms and/or progression to psychosis is possible for individuals in each current status specifier category.
- Subjects with no evidence of a pre-existing intellectual disability defined as a premorbid IQ >70 as estimated using the Reading subtest of the Wide Range Achievement Test-4
- Fluent in English per self-report
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
The Ohio State University Early Psychosis Intervention Center is implementing a specialized clinical program to serve individuals who meet clinical high risk criteria for a psychosis. The purpose of this study is to evaluate the long-term outcomes among individuals participating in this clinical service.
Read the detailed description
The Ohio State University Early Psychosis Intervention Center (OSU EPICENTER) is implementing a specialized clinical program to serve individuals ages 12-25 who meet clinical high risk criteria for a psychosis (CHR-P). The purpose of this project is to evaluate (i) correlates of baseline characteristics among clinic participants; (ii) outcomes among individuals participating in this clinical service; and (iii) predictors and mediators of longitudinal outcomes among individuals participating in this clinical service.
- Conditions
- Prodromal Schizophrenia
- Being tested
- Step-Based Care Model
- Keywords
- psychosis, treatment, clinical high-risk
- Medical subject headings
- Schizotypal Personality Disorder, Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Step-Based Care ModelBehavioural
Care model comprised of psychosocial and pharmacological interventions in which individuals start with low-intensity interventions and progress onto progressively higher-intensity interventions until their reach remission criteria.
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to remission of clinical-high risk status for psychosis
Using criteria inspired by Nelson et al. (2018), remission of clinical high risk status for psychosis is defined as simultaneous remission of both (i) symptoms and (ii) functional deficits associated with prodromal psychosis.
Remission of symptoms is defined as all positive symptom items scored less than 3 on the Structured Clinical Interview for Prodromal States (SIPS). Each item is rated from 0-6 with higher scores indicating greater severity of symptoms.
Remission of functional deficits is defined as a 5-point increase on the Personal and Social Performance scale (PSP: Morosini et al., 2000) as compared to baseline assessment or the PSP score ≥ 70. Scores range from 0-100 with higher scores indicative of better personal and social functioning.
Measured: Remission status assessed at all treatment visits which will occur approximately once every week for up to 104 weeks
Secondary outcomes (13)
Change from baseline in quality of life assessed every six months for up to 24 months
Change in scores on WHO Quality of Life Scale Brief (WHOQOL-BREF) as compared to baseline assessment
The WHOQOL-BREF provides scores for four subscales of quality of life: physical health, psychological health, social relationships, and environment. Scores range from 0-100 with higher scores indicative of greater quality of life
Measured: Assessed at baseline and every six months throughout the completion of the study for up to 24 months
Change in from baseline in cognitive functioning assessed every six months for up to 24 months
Change in scores on the MATRICS Consensus Cognitive Battery (MCCB) as compared to baseline assessment. The MCCB provides an overall cognitive composite score as well as subscale scores for processing speed, attention/vigilance, working memory, verbal learning, visual learning, reasoning and problem-solving, and social cognition. Scores range from 0-100 with higher scores indicative of greater cognitive functioning
Measured: Assessed at baseline and every six months throughout the completion of the study for up to 24 months
Change from baseline in suicidality assessed every six months for up to 24 months
Change in scores on the Columbia Suicide Severity Rating Scale (C-SSRS)as compared to baseline assessment. The C-SSRS provide two subscales: suicidal ideation and suicidal behavior. The former is an ordinal rating scale ranging from 0-6 with higher scores indicative of greater suicidal ideation. The latter is a nominal scale identifying the absence/presence of different suicidal behaviors.
Measured: Assessed at baseline and every six months throughout the completion of the study for up to 24 months
Change from baseline in substance use severity assessed every six months for up to 24 months
Change in scores on the HABITS scale as compare to baseline as compared to baseline assessment. The HABITS assesses the frequency/amount of use of different illicit substances with higher scores indicative of greater frequency/amount. There is no predetermined possible range of scores as scores are raw values with regard to frequency/amount of use (e.g., number of cigarettes smoked per day)
Measured: Assessed at baseline and every six months throughout the completion of the study for up to 24 months
Change from baseline in anxiety assessed every six months for up to 24 months
Change in scores on the Hamilton Anxiety Scale scale as compared to baseline assessment.. The total score on this measure ranges from 0-56 with higher scores indicative of worse anxiety
Measured: Assessed at baseline and every six months throughout the completion of the study for up to 24 months
Change from baseline in depressed mood assessed every six months for up to 24 months
Change in scores on the Calgary Depression Scale for Schizophrenia as compared to baseline assessment. Total scores range from 0-3 with higher scores indicative of worse depression
Measured: Assessed at baseline and every six months throughout the completion of the study for up to 24 months
Change from baseline in symptomatology assessed every six months for up to 24 months
Change in scores on the Structured Interview for Psychosis Risk Syndromes as compared to baseline assessment. Item scores range from 0-6 with higher scores indicative of worse symptomatology
Measured: Assessed at baseline and every six months throughout the completion of the study for up to 24 months
Change from baseline in social functioning assessed every six months for up to 24 months
Change in scores on the Global Functioning: Social as compared to baseline assessment. Scores range from 1-10 with higher scores indicative of better social functioning
Measured: Assessed at baseline and every six months throughout the completion of the study for up to 24 months
Change from baseline in role functioning assessed every six months for up to 24 months
Change in scores on the Global Functioning: Role as compared to baseline assessment. Scores range from 1-10 with higher scores indicative of better role functioning
Measured: Assessed at baseline and every six months throughout the completion of the study for up to 24 months
Change from baseline in service utilization assessed every six months for up to 24 months
Change in utilization of health care and related social services as tracked using the Service Utilization and Resources Form as compared to baseline assessment.
Measured: Assessed at baseline and every six months throughout the completion of the study for up to 24 months
Change from baseline in medication adherence assessed every six months for up to 24 months
Change in medication adherence as tracked using the Medication Adherence rating Scale as compared to baseline assessment. Scores range from 0-10 with higher scores indicative of greater adherence to prescribed medication.
Measured: Assessed at baseline and every six months throughout the completion of the study for up to 24 months
Change from baseline in experience of trauma assessed every six months for up to 24 months
Change in experience of trauma as tracked using the Brief Trauma Questionnaire as compared to baseline assessment.
Measured: Assessed at baseline and every six months throughout the completion of the study for up to 24 months
Change from baseline in health-related quality of life assessed every six months for up to 24 months
Change in health-related quality of life as assessed using the RAND 36-Item Health Survey as compared to baseline assessment. Scores on this measure range from 0-100 with higher scores indicative of greater health-related quality of life.
Measured: Assessed at baseline and every six months throughout the completion of the study for up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2019
- Study start19 Apr 2019
- Primary completionSep 2030 (estimated)
- Study completionSep 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prodromal SchizophreniaStudies of the same condition, open and under way.
- More trials run by Ohio State 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 24 Months
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Collaborators
- Substance Abuse and Mental Health Services Administration (SAMHSA)
- Responsible party
- Principal investigator, Nicholas Breitborde, Ohio State University
- Investigators
- Nicholas Breitborde, PhD, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03970005
- Sponsor's protocol ID
- 2018H0503
- Status last verified
- Oct 2026
- First submitted
- 22 May 2019
- Last updated
- 14 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Breitborde NJK, Guirgis H, Stearns W, Carpenter KM, Lteif G, Pine JG, Storey N, Wastler H, Moe AM. The Ohio State University Early Psychosis Intervention Center (EPICENTER) step-based care programme for individuals at clinical high risk for psychosis: study protocol for an observational study. BMJ Open. 2020 Jan 27;10(1):e034031. doi: 10.1136/bmjopen-2019-034031.
PubMed 31992606