Compensatory Cognitive Training in Clinical High Risk Latino Youth

• ClinicalTrials.gov Identifier: NCT02245607
• Recruitment Status: Unknown
• First Posted: September 19, 2014
• Last Update Posted: February 8, 2021
• Sponsor: University of California, San Diego
• Collaborator: National Institute of Mental Health (NIMH)
• Information provided by (Responsible Party): Kristin Cadenhead, M.D., University of California, San Diego

Tracking Information

• First Submitted Date: September 16, 2014
• First Posted Date: September 19, 2014
• Last Update Posted Date: February 8, 2021
• Study Start Date: October 2014
• Actual Primary Completion Date: June 30, 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: February 3, 2021)

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

• Original Primary Outcome Measures (submitted: September 17, 2014): Neurocognition (Global Cognitive Index z score) [ Time Frame: 3 and 6 months post-baseline ]

Current Secondary Outcome Measures (submitted: February 3, 2021)

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)

• Original Secondary Outcome Measures (submitted: September 17, 2014): Functional capacity (UPSA/UPSA-A) [ Time Frame: 3 and 6 month post-baseline ]

Current Other Pre-specified Outcome Measures (submitted: February 3, 2021)

• 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.

Original Other Pre-specified Outcome Measures (submitted: September 17, 2014)

• 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 ]

Descriptive Information

• Brief Title: Compensatory Cognitive Training in Clinical High Risk Latino Youth
• Official Title: Compensatory Cognitive Training in Clinical High Risk Latino Youth

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.

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
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Outcomes Assessor); Primary Purpose: Treatment

Condition

• Clinical High Risk
• Psychosis
• Prodromal
• Schizophrenia

Intervention

• Behavioral: Compensatory Cognitive Training
• Behavioral: Recreational Therapy

Study Arms

• Experimental: Compensatory Cognitive Training
  Compensatory Cognitive Training
  Intervention: Behavioral: Compensatory Cognitive Training
• Active Comparator: Recreational Therapy
  Recreational Therapy
  Intervention: Behavioral: Recreational Therapy

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: September 17, 2014): 120
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: February 1, 2021
• Actual Primary Completion Date: June 30, 2020 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 12 Years to 30 Years (Child, Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Mexico, United States

Administrative Information

• NCT Number: NCT02245607
• Other Study ID Numbers: MH105247; 5R34MH105247-03 ( U.S. NIH Grant/Contract )
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Kristin Cadenhead, M.D., University of California, San Diego
• Original Responsible Party: Same as current
• Current Study Sponsor: University of California, San Diego
• Original Study Sponsor: Same as current
• Collaborators: National Institute of Mental Health (NIMH)

Investigators

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

• PRS Account: University of California, San Diego
• Verification Date: February 2021