Compensatory Cognitive Training in Clinical High Risk Latino Youth
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|ClinicalTrials.gov Identifier: NCT02245607|
Recruitment Status : Unknown
Verified February 2021 by Kristin Cadenhead, M.D., University of California, San Diego.
Recruitment status was: Active, not recruiting
First Posted : September 19, 2014
Last Update Posted : February 8, 2021
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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|
|Actual Primary Completion Date :||June 30, 2020|
|Estimated Study Completion Date :||February 1, 2021|
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 ]The CGI is derived based on Z scores across multiple neurocognitive domains and is a representation of global cognition
- 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)
- 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.
- 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.
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|Ages Eligible for Study:||12 Years to 30 Years (Child, Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Meet Clinical High Risk criteria
- Be of Latino descent
- Speak Spanish as their preferred language
- Concomitant medical or neurological illness
- Brain injury with loss of consciousness > 30 minutes
- Current substance abuse (excluding nicotine)
- IQ < 80
- High suicidal risk
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
|United States, California|
|University of California San Diego|
|La Jolla, California, United States, 92093|
|Instituto Nacional de Neurología y Neurocirugía|
|Mexico City, Mexico|
|Principal Investigator:||Kristin Cadenhead, MD||University of California, San Diego|
|Responsible Party:||Kristin Cadenhead, M.D., Professor, University of California, San Diego|
|Other Study ID Numbers:||
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|
Schizophrenia and Disorders with Psychotic Features
Schizophrenia Spectrum and Other Psychotic Disorders