PsychosisSCORESNCT05131035
Targeting Processing Speed Deficits to Improve Social Functioning and Lower Psychosis Risk
A study testing SCORES (Specific COgnitive Remediation with Support) in people with Psychosis and Prodromal Schizophrenia, run by Northwell Health at 1 site in United States.
Trial summary
This 10 week intervention, Specific Cognitive Remediation with Surround (or SCORES), is designed to target processing speed, a cognitive domain related directly to social functioning, which in turn, represents a vulnerability factor for psychosis. Read more about this study
- Who is it for?
- Ages 14 to 20 years
- Conditions the study is for
- Psychosis, Prodromal Schizophrenia, Prodromal Symptoms
- What is being tested?
- SCORES (Specific COgnitive Remediation with Support)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Oct 2021to 31 May 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 14 to 20 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Meet Clinical High Risk (CHR) criteria on the Structured Interview for Psychosis Risk Syndromes, defined by the presence of at least one attenuated positive symptom at a moderate to severe level
- A score representing 0.5 SD below the mean on Animal Naming, Trails A or BACS: Symbol Coding from the MATRICS Consensus Cognitive Battery (MCCB).
Who cannot join
- Any DSM 5 Schizophrenia-Spectrum diagnosis
- Non-English speaking
- Past or current history of a clinically significant central nervous system disorder (e.g., seizure disorder)
- Estimated IQ<70
- Significant head injury
- Significant substance abuse
- Significant visual or auditory impairment.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Northwell Health- The Zucker Hillside Hospital
Glen Oaks, New York, 11042
Andrea M Auther, Ph.D., 718-470-8147, aauther@northwell.edu
Danielle McLaughlin, M.A., 718-470-8375, dmclaugh@northwell.edu
About this study
Official title: Targeting Processing Speed Deficits to Improve Social Functioning and Lower Psychosis Risk in Adolescents at Clinical High Risk for Psychosis
This 10 week intervention, Specific Cognitive Remediation with Surround (or SCORES), is designed to target processing speed, a cognitive domain related directly to social functioning, which in turn, represents a vulnerability factor for psychosis. This remotely-delivered intervention combining targeted cognitive training exercises and group support was developed to directly impact processing speed, and at the same time, boost motivation and engagement in adolescents at risk for schizophrenia and other psychotic disorders.
Read the detailed description
This study evaluates the effectiveness of a cognitive remediation (CR) program plus group coaching and support designed to improve processing speed and, in turn, social functioning and attenuated positive symptoms in individual considered Clinical High Risk for psychosis. The SCORES (Specific COgnitive REmediation with Support) intervention is a novel Cognitive Remediation program combined with group coaching, performance-based rewards, game-like tasks, and educational elements to increase engagement and retention. The study is funded by a R61/R33 award. In the R61 phase, all participants were asked to complete 40 hours of Cognitive Remediation or brain training (4 hours per week/10 weeks) with a mid-point assessment (at 5 weeks) to determine the training dose needed to impact processing speed as measured by the Matrics Cognitive Consensus Battery. The current R33 (Phase 2) will look to replicate the results of the R61 and assess the specificity of the targeted intervention with the addition of a non-speeded cognitive training group..
- Conditions
- Psychosis, Prodromal Schizophrenia, Prodromal Symptoms
- Being tested
- SCORES (Specific COgnitive Remediation with Support)
- Keywords
- Clinical High Risk (CHR), Processing Speed, Social Functioning, Social Impairment, Social Skills, Adolescents, Cognitive Remediation
- Medical subject headings
- Psychotic Disorders, Schizotypal Personality Disorder, Prodromal Symptoms, Social Adjustment, Social Skills
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SCORES (Specific COgnitive Remediation with Support)Behavioural
This study evaluates the effectiveness of a 10-week cognitive remediation program plus group coaching and therapy to improve processing speed and, in turn, social functioning and attenuated positive symptoms in CHR subjects. The SCORES (Specific COgnitive Remediation with Support) intervention is a novel CR program combined with group coaching, performance-based rewards, game-like tasks, and therapy elements to increase engagement and retention.
In the 2 year, R61 phase, all participants will complete 40 hours of CR (4 hrs per week) with a mid-point assessment (20 hours of CR at 5 weeks) to determine the impact of CR on processing speed as measured by the MCCB.
The second phase of the study (R33) will compare the 40 hours of speeded brain training to 40 hours of non-speeded brain training. This three year study will allow for a replication and assessment of specificity of the targeted intervention.
| Study group | Role | What they receive |
|---|---|---|
| Speeded Cognitive Training | Experimental | Participants in this condition will complete 40 hours of Cognitive Remediation with a mid-point assessment (20 hours/5 weeks) to determine the impact of speeded cognitive training tasks on cognition and social function. Receives: Behavioral: SCORES (Specific COgnitive Remediation with Support) |
| Non-Speeded Cognitive Training | Active comparator | Participants in this condition will complete 40 hours of Cognitive Remediation with a mid-point assessment (20 hours/5 weeks) to determine the impact of non-speeded cognitive training tasks on cognition and social function. Receives: Behavioral: SCORES (Specific COgnitive Remediation with Support) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Processing Speed domain score from the MATRICS Consensus Cognitive Battery (MCCB)
Change in processing speed domain score and individual measures within the domain.
Measured: Baseline, Mid-Treatment (5 weeks), Post Treatment (10 weeks)
Secondary outcomes (2)
Global Functioning: Social (GF:Social) scale (Phase 2/R33 only)
Change in GF:Social score from baseline to follow up timepoints. The GF:Social scale scores range from 1 to 10 with higher scores representing better social functioning.
Measured: Baseline, Mid-Treatment (5 weeks), Post Treatment (10 weeks)
SIPS/SOPS: Positive Symptoms (Phase 2/R33 only)
Change in Total Positive Symptom score from baseline to follow up timepoints. Each of the 5 positive symptoms on the SOPS range from 0-6 (6 indicating a psychotic symptom).
Measured: Baseline, Mid-Treatment (5 weeks), Post Treatment (10 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2021
- Study start28 Oct 2021
- Primary completion31 May 2026 (estimated)
- Study completion31 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsychosisStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- The R33 study design will utilize a randomized intervention model. All participants will participate in cognitive training with small group support.One group will complete speeded cognitive training tasks and the other group will complete non-speeded cognitive training tasks.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northwell Health
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Ricardo E Carrion, Ph.D., Principal investigator, Northwell Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05131035
- Sponsor's protocol ID
- 21-0832, 23-0500
- Other IDs
- R61MH123574, R33MH123574
- Acronym
- SCORES
- Status last verified
- Nov 2025
- First submitted
- 11 Nov 2021
- Last updated
- 24 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be uploaded to the NIH Data Archive (NDA).
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Targeting Processing Speed Deficits to Improve Social Functioning and Lower Psychosis Risk in Adolescents at Clinical High Risk for Psychosis
- ClinicalTrials.gov ID
- NCT05131035
- Acronym / sponsor ID
- SCORES / 21-0832, 23-0500
- Conditions
- Psychosis, Prodromal Schizophrenia, Prodromal Symptoms
- Keywords
- Clinical High Risk (CHR), Processing Speed, Social Functioning, Social Impairment, Social Skills, Adolescents, Cognitive Remediation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Northwell HealthUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 28 Oct 2021 (actual)
- Primary completion
- 31 May 2026 (estimated)
- Study completion
- 31 May 2026 (estimated)
- First posted
- 23 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This 10 week intervention, Specific Cognitive Remediation with Surround (or SCORES), is designed to target processing speed, a cognitive domain related directly to social functioning, which in turn, represents a vulnerability factor for psychosis. This remotely-delivered intervention combining targeted cognitive training exercises and group support was developed to directly impact processing speed, and at the same time, boost motivation and engagement in adolescents at risk for schizophrenia and other psychotic disorders.
Detailed description
This study evaluates the effectiveness of a cognitive remediation (CR) program plus group coaching and support designed to improve processing speed and, in turn, social functioning and attenuated positive symptoms in individual considered Clinical High Risk for psychosis. The SCORES (Specific COgnitive REmediation with Support) intervention is a novel Cognitive Remediation program combined with group coaching, performance-based rewards, game-like tasks, and educational elements to increase engagement and retention. The study is funded by a R61/R33 award. In the R61 phase, all participants were asked to complete 40 hours of Cognitive Remediation or brain training (4 hours per week/10 weeks) with a mid-point assessment (at 5 weeks) to determine the training dose needed to impact processing speed as measured by the Matrics Cognitive Consensus Battery. The current R33 (Phase 2) will look to replicate the results of the R61 and assess the specificity of the targeted intervention with the addition of a non-speeded cognitive training group..
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- The R33 study design will utilize a randomized intervention model. All participants will participate in cognitive training with small group support.One group will complete speeded cognitive training tasks and the other group will complete non-speeded cognitive training tasks.
| Arm | Type | Receives |
|---|---|---|
| Speeded Cognitive Training | Experimental | Behavioral: SCORES (Specific COgnitive Remediation with Support)Participants in this condition will complete 40 hours of Cognitive Remediation with a mid-point assessment (20 hours/5 weeks) to determine the impact of speeded cognitive training tasks on cognition and social function. |
| Non-Speeded Cognitive Training | Active comparator | Behavioral: SCORES (Specific COgnitive Remediation with Support)Participants in this condition will complete 40 hours of Cognitive Remediation with a mid-point assessment (20 hours/5 weeks) to determine the impact of non-speeded cognitive training tasks on cognition and social function. |
Who may qualify
- Ages
- 14 to 20 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Meet Clinical High Risk (CHR) criteria on the Structured Interview for Psychosis Risk Syndromes, defined by the presence of at least one attenuated positive symptom at a moderate to severe level
- A score representing 0.5 SD below the mean on Animal Naming, Trails A or BACS: Symbol Coding from the MATRICS Consensus Cognitive Battery (MCCB).
Key exclusion criteria (7 listed)
- Any DSM 5 Schizophrenia-Spectrum diagnosis
- Non-English speaking
- Past or current history of a clinically significant central nervous system disorder (e.g., seizure disorder)
- Estimated IQ<70
- Significant head injury
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 |
|---|---|---|
| SCORES (Specific COgnitive Remediation with Support)This study evaluates the effectiveness of a 10-week cognitive remediation program plus group coaching and therapy to improve processing speed and, in turn, social functioning and attenuated positive symptoms in CHR subjects. The SCORES (Specific COgnitive Remediation with Support) intervention is a novel CR program combined with group coaching, performance-based rewards, game-like tasks, and therapy elements to increase engagement and retention. In the 2 year, R61 phase, all participants will complete 40 hours of CR (4 hrs per week) with a mid-point assessment (20 hours of CR at 5 weeks) to determine the impact of CR on processing speed as measured by the MCCB. The second phase of the study (R33) will compare the 40 hours of speeded brain training to 40 hours of non-speeded brain training. This three year study will allow for a replication and assessment of specificity of the targeted intervention. | Behavioural | Non-Speeded Cognitive Training, Speeded Cognitive Training |
Primary outcome
Processing Speed domain score from the MATRICS Consensus Cognitive Battery (MCCB)
Time frame: Baseline, Mid-Treatment (5 weeks), Post Treatment (10 weeks)
Change in processing speed domain score and individual measures within the domain.
2 secondary outcomes
Global Functioning: Social (GF:Social) scale (Phase 2/R33 only)
Time frame: Baseline, Mid-Treatment (5 weeks), Post Treatment (10 weeks)
SIPS/SOPS: Positive Symptoms (Phase 2/R33 only)
Time frame: Baseline, Mid-Treatment (5 weeks), Post Treatment (10 weeks)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2025.
- Individual participant dataSharing planned: Yes. Data will be uploaded to the NIH Data Archive (NDA).
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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.
Ricardo E Carrion, Ph.D. principal investigator
Northwell Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SCORES (Specific COgnitive Remediation with Support) in people with Psychosis and Prodromal Schizophrenia, run by Northwell Health at 1 site 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 2 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 24 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ricardo E Carrion, Ph.D. (718-470-8788, rcarrion@northwell.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Processing Speed domain score from the MATRICS Consensus Cognitive Battery (MCCB) (time frame: Baseline, Mid-Treatment (5 weeks), Post Treatment (10 weeks)). 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 24 Nov 2025.