Compensatory Cognitive Training in Clinical High Risk Latino Youth

February 3, 2021 updated by: Kristin Cadenhead, M.D., University of California, San Diego

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
      • Mexico City, Mexico
        • Instituto Nacional de Neurologia y Neurocirugia
  • United States
    • California
      • La Jolla, California, United States, 92093
        • University of California San Diego

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 30 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)
  • IQ < 80
  • High suicidal risk

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Compensatory Cognitive Training
Behavioral: Compensatory Cognitive Training
Active Comparator: Recreational Therapy
Behavioral: Recreational Therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
3 and 6 months post-baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Functional capacity (UPSA/UPSA-A)
Time Frame: 3 and 6 month post-baseline
The UPSA total Functional Capacity score is the total of all subscale scores on the UPSA (Finances, Communication, Transportation, Household)
3 and 6 month post-baseline

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Self-reported functioning (SLoF)
Time Frame: 3 and 6 month post-baseline
The specific level of functioning (SLOF) assessment scale measures observable behavioral functioning and daily living skills.
3 and 6 month post-baseline
Clinical symptom severity (SOPS total)
Time Frame: 3 and 6 month post-baseline
The Scale of Prodromal Symptoms (SOPS) measures positive, negative, disorganized and general symptoms seen in psychotic illness. The total score is used for outcome.
3 and 6 month post-baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Diego

Collaborators

National Institute of Mental Health (NIMH)

Investigators

  • Principal Investigator: Kristin Cadenhead, MD, University of California, San Diego

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2014

Primary Completion (Actual)

June 30, 2020

Study Completion (Anticipated)

February 1, 2021

Study Registration Dates

First Submitted

September 16, 2014

First Submitted That Met QC Criteria

September 17, 2014

First Posted (Estimate)

September 19, 2014

Study Record Updates

Last Update Posted (Actual)

February 8, 2021

Last Update Submitted That Met QC Criteria

February 3, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MH105247
  • 5R34MH105247-03 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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