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Clinical Trials/NCT02245607
NCT02245607
Unknown
Not Applicable

Compensatory Cognitive Training in Clinical High Risk Latino Youth

University of California, San Diego2 sites in 2 countries120 target enrollmentOctober 2014

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Clinical High Risk
Sponsor
University of California, San Diego
Enrollment
120
Locations
2
Primary Endpoint
Neurocognition (Global Cognitive Index z score)
Last Updated
5 years ago

Overview

Brief Summary

This is a randomized study to compare Compensatory Cognitive Training (CCT) versus Recreational Therapy (RT) in Latino clinical high risk individuals in the US and Mexico.

Study hypotheses: Compared to those who receive RT, study participants receiving CCT will show significant improvement in neurocognition, functional capacity, self-rated functioning and clinical measures.

Detailed Description

This is a 12 week randomized study to compare Compensatory Cognitive Training (CCT) versus Recreational Therapy (RT) in Latino clinical high risk individuals in the US and Mexico. Study participants will be measured 3 times, at baseline, 12 and 24 weeks on all outcome measures. Study hypothesis: Study participants receiving CCT will show significant improvement at 12 and 24 weeks compared to baseline in 1) Neurocognition using the Global Cognitive Index z score derived from the MATRICS neurocognitive domain scores, 2) Functional Capacity as assessed by the UCSD Performance-based Skills Assessment (UPSA/UPSA-Adolescent), 3) Self-Rated Functioning as measured by the Specific Level of Functioning Scale (SLoF) and 4) Clinical symptom ratings as measured by the Scale of Prodromal Symptoms (SOPS) total score when compared to subjects receiving RT training across study time.

Registry
clinicaltrials.gov
Start Date
October 2014
End Date
February 1, 2021
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Kristin Cadenhead, M.D.

Professor

University of California, San Diego

Eligibility Criteria

Inclusion Criteria

  • Meet Clinical High Risk criteria
  • Be of Latino descent
  • Speak Spanish as their preferred language

Exclusion Criteria

  • Concomitant medical or neurological illness
  • Brain injury with loss of consciousness \> 30 minutes
  • Current substance abuse (excluding nicotine)
  • High suicidal risk

Outcomes

Primary Outcomes

Neurocognition (Global Cognitive Index z score)

Time Frame: 3 and 6 months post-baseline

The CGI is derived based on Z scores across multiple neurocognitive domains and is a representation of global cognition

Secondary Outcomes

  • Functional capacity (UPSA/UPSA-A)(3 and 6 month post-baseline)

Study Sites (2)

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