Recruiting

Observational Study

Sponsor:

Northwell Health

Code:

NCT05131035

Conditions

Psychosis

Prodromal Schizophrenia

Prodromal Symptoms

Eligibility Criteria

Sex: All

Age: 14 - 20

Healthy Volunteers: Not accepted

Interventions

SCORES (Specific COgnitive Remediation with Support)

Study Details

Brief 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. 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.

Conditions

Psychosis

Prodromal Schizophrenia

Prodromal Symptoms

Study ID

NCT05131035

Start date

Oct 28, 2021

Status verified date

Nov, 2025

Completion date

May 31, 2026

Anticipated

Primary completion date

May 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 14 - 20

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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).

Exclusion Criteria:

  • 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.

Study Design

Enrollment

54 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: Speeded Cognitive Training

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.

active comparator: Non-Speeded Cognitive Training

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.

Interventions

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.

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) ]

Central Contacts and Locations

Central contacts

Ricardo E Carrion, Ph.D.

718-470-8788rcarrion@northwell.edu

Danielle McLaughlin, M.A.

718-470-8375dmclaugh@northwell.edu

Locations

Northwell Health- The Zucker Hillside Hospital

Recruiting

Glen Oaks, New York, United States, 11042

Contacts

Andrea M Auther, Ph.D.

718-470-8147aauther@northwell.edu

Danielle McLaughlin, M.A.

718-470-8375dmclaugh@northwell.edu

Principal Investigator:

Barbara A Cornblatt, Ph.D.

More Information

Sponsor

Northwell Health

Last update posted

Nov 24, 2025

Last verified

Nov, 2025

Keywords

  • Clinical High Risk (CHR)
  • Processing Speed
  • Social Functioning
  • Social Impairment
  • Social Skills
  • Adolescents
  • Cognitive Remediation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Northwell Health on 2025-11-24.