Compensatory Cognitive Training in Clinical High Risk Latino Youth

Study Overview
=================
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.

Official Title
-----------------
Compensatory Cognitive Training in Clinical High Risk Latino Youth

Conditions
-----------------
Clinical High Risk, Psychosis, Prodromal, Schizophrenia

Intervention / Treatment
-----------------
* Behavioral: Compensatory Cognitive Training
* Behavioral: Recreational Therapy


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum Age: 30 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Compensatory Cognitive Training<br>Compensatory Cognitive Training | Behavioral: Compensatory Cognitive Training<br> <br> |
| Active Comparator: Recreational Therapy<br>Recreational Therapy | Behavioral: Recreational Therapy<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neurocognition (Global Cognitive Index z score) | The CGI is derived based on Z scores across multiple neurocognitive domains and is a representation of global cognition | 3 and 6 months post-baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional capacity (UPSA/UPSA-A) | The UPSA total Functional Capacity score is the total of all subscale scores on the UPSA (Finances, Communication, Transportation, Household) | 3 and 6 month post-baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Psychotic Disorders, Cognitive Training, Mental Disorders, Schizophrenia and Disorders with Psychotic Features