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Compensatory Cognitive Training in Clinical High Risk Latino Youth

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02245607
Recruitment Status : Active, not recruiting
First Posted : September 19, 2014
Last Update Posted : February 8, 2021
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Kristin Cadenhead, M.D., University of California, San Diego

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 Phase
Clinical High Risk Psychosis Prodromal Schizophrenia Behavioral: Compensatory Cognitive Training Behavioral: Recreational Therapy Not Applicable

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.

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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
Actual Primary Completion Date : June 30, 2020
Estimated Study Completion Date : February 1, 2021

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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)


Other Outcome Measures:
  1. 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.

  2. 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.



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

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


Locations
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United States, California
University of California San Diego
La Jolla, California, United States, 92093
Mexico
Instituto Nacional de Neurología y Neurocirugía
Mexico City, Mexico
Sponsors and Collaborators
University of California, San Diego
National Institute of Mental Health (NIMH)
Investigators
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Principal Investigator: Kristin Cadenhead, MD University of California, San Diego
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Responsible Party: Kristin Cadenhead, M.D., Professor, University of California, San Diego
ClinicalTrials.gov Identifier: NCT02245607    
Other Study ID Numbers: MH105247
5R34MH105247-03 ( U.S. NIH Grant/Contract )
First Posted: September 19, 2014    Key Record Dates
Last Update Posted: February 8, 2021
Last Verified: February 2021
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:
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Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders