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Compensatory Cognitive Training in Clinical High Risk Latino Youth

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ClinicalTrials.gov Identifier: NCT02245607
Recruitment Status : Unknown
Verified November 2015 by Kristin Cadenhead, M.D., University of California, San Diego.
Recruitment status was:  Recruiting
First Posted : September 19, 2014
Last Update Posted : December 2, 2015
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
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.


Condition or disease Intervention/treatment
Clinical High Risk Psychosis Prodromal Schizophrenia Behavioral: Compensatory Cognitive Training Behavioral: Recreational Therapy

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 Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Compensatory Cognitive Training in Clinical High Risk Latino Youth
Study Start Date : October 2014
Estimated Primary Completion Date : September 2017
Estimated Study Completion Date : September 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Compensatory Cognitive Training
Compensatory Cognitive Training
Behavioral: Compensatory Cognitive Training
Active Comparator: Recreational Therapy
Recreational Therapy
Behavioral: Recreational Therapy


Outcome Measures

Primary Outcome Measures :
  1. Neurocognition (Global Cognitive Index z score) [ Time Frame: 3 and 6 months post-baseline ]

Secondary Outcome Measures :
  1. Functional capacity (UPSA/UPSA-A) [ Time Frame: 3 and 6 month post-baseline ]

Other Outcome Measures:
  1. Self-reported functioning (SLoF) [ Time Frame: 3 and 6 month post-baseline ]
  2. Clinical symptom severity (SOPS total) [ Time Frame: 3 and 6 month post-baseline ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 30 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
  • IQ < 80
  • High suicidal risk
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02245607


Contacts
Contact: Kristin Cadenhead, MD 619-543-6445 kcadenhead@ucsd.edu

Locations
United States, California
University of California San Diego Recruiting
La Jolla, California, United States, 92093
Principal Investigator: Kristin Cadenhead, MD         
Mexico
Instituto Nacional de Neurología y Neurocirugía Recruiting
Mexico City, Mexico
Principal Investigator: Francisco Camilo de la Fuente, MD, PhD         
Sponsors and Collaborators
University of California, San Diego
National Institute of Mental Health (NIMH)
Investigators
Principal Investigator: Kristin Cadenhead, MD University of California, San Diego
More Information

Responsible Party: Kristin Cadenhead, M.D., Professor, University of California, San Diego
ClinicalTrials.gov Identifier: NCT02245607     History of Changes
Other Study ID Numbers: MH105247
First Posted: September 19, 2014    Key Record Dates
Last Update Posted: December 2, 2015
Last Verified: November 2015

Keywords provided by Kristin Cadenhead, M.D., University of California, San Diego:
Psychotic Disorders
Cognitive Training
Mental Disorders
Schizophrenia and Disorders with Psychotic Features

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders