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
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|
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 (Clinical Trial)|
|Estimated Enrollment :||120 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|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|
Experimental: Compensatory Cognitive Training
Compensatory Cognitive Training
Behavioral: Compensatory Cognitive Training
Active Comparator: Recreational Therapy
Behavioral: Recreational Therapy
- Neurocognition (Global Cognitive Index z score) [ Time Frame: 3 and 6 months post-baseline ]
- Functional capacity (UPSA/UPSA-A) [ Time Frame: 3 and 6 month post-baseline ]
- Self-reported functioning (SLoF) [ Time Frame: 3 and 6 month post-baseline ]
- Clinical symptom severity (SOPS total) [ Time Frame: 3 and 6 month post-baseline ]
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
|Contact: Kristin Cadenhead, MDemail@example.com|
|United States, California|
|University of California San Diego||Recruiting|
|La Jolla, California, United States, 92093|
|Principal Investigator: Kristin Cadenhead, MD|
|Instituto Nacional de Neurología y Neurocirugía||Recruiting|
|Mexico City, Mexico|
|Principal Investigator: Francisco Camilo de la Fuente, MD, PhD|
|Principal Investigator:||Kristin Cadenhead, MD||University of California, San Diego|