Compensatory Cognitive Training in Clinical High Risk Latino Youth

Not Applicable

• Conditions: Schizophrenia; Clinical High Risk; Prodromal; Psychosis
• Interventions: Behavioral: Compensatory Cognitive Training; Behavioral: Recreational Therapy

• Registration Number: NCT02245607
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2014-09-16
• Study First Submitted QC: 2014-09-17
• Study First Posted: 2014-09-19
• Study Start: 2014-10
• Primary Completion: 2020-06-30
• Status Verified: 2021-02
• Study Completion: 2021-02-01
• Last Update Submitted: 2021-02-03
• Last Update Posted: 2021-02-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Compensatory Cognitive Training	Compensatory Cognitive Training	Compensatory Cognitive Training
Recreational Therapy	Recreational Therapy	Recreational Therapy

Primary Outcome Measures

Name	Time	Method
Neurocognition (Global Cognitive Index z score)	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

Name	Time	Method
Functional capacity (UPSA/UPSA-A)	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)

Trial Locations

Locations (2)

University of California San Diego; 🇺🇸 La Jolla, California, United States

Instituto Nacional de Neurología y Neurocirugía; 🇲🇽 Mexico City, Mexico