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Compensatory Cognitive Training in Clinical High Risk Latino Youth

Primary Purpose

Clinical High Risk, Psychosis, Prodromal

Status
Unknown status
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Compensatory Cognitive Training
Recreational Therapy
Sponsored by
University of California, San Diego
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Clinical High Risk focused on measuring Psychotic Disorders, Cognitive Training, Mental Disorders, Schizophrenia and Disorders with Psychotic Features

Eligibility Criteria

12 Years - 30 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of California San Diego
  • Instituto Nacional de Neurología y Neurocirugía

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Compensatory Cognitive Training

Recreational Therapy

Arm Description

Compensatory Cognitive Training

Recreational Therapy

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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)

Full Information

First Posted
September 16, 2014
Last Updated
February 3, 2021
Sponsor
University of California, San Diego
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT02245607
Brief Title
Compensatory Cognitive Training in Clinical High Risk Latino Youth
Official Title
Compensatory Cognitive Training in Clinical High Risk Latino Youth
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Unknown status
Study Start Date
October 2014 (undefined)
Primary Completion Date
June 30, 2020 (Actual)
Study Completion Date
February 1, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, San Diego
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Clinical High Risk, Psychosis, Prodromal, Schizophrenia
Keywords
Psychotic Disorders, Cognitive Training, Mental Disorders, Schizophrenia and Disorders with Psychotic Features

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Compensatory Cognitive Training
Arm Type
Experimental
Arm Description
Compensatory Cognitive Training
Arm Title
Recreational Therapy
Arm Type
Active Comparator
Arm Description
Recreational Therapy
Intervention Type
Behavioral
Intervention Name(s)
Compensatory Cognitive Training
Intervention Type
Behavioral
Intervention Name(s)
Recreational Therapy
Primary Outcome Measure Information:
Title
Neurocognition (Global Cognitive Index z score)
Description
The CGI is derived based on Z scores across multiple neurocognitive domains and is a representation of global cognition
Time Frame
3 and 6 months post-baseline
Secondary Outcome Measure Information:
Title
Functional capacity (UPSA/UPSA-A)
Description
The UPSA total Functional Capacity score is the total of all subscale scores on the UPSA (Finances, Communication, Transportation, Household)
Time Frame
3 and 6 month post-baseline
Other Pre-specified Outcome Measures:
Title
Self-reported functioning (SLoF)
Description
The specific level of functioning (SLOF) assessment scale measures observable behavioral functioning and daily living skills.
Time Frame
3 and 6 month post-baseline
Title
Clinical symptom severity (SOPS total)
Description
The Scale of Prodromal Symptoms (SOPS) measures positive, negative, disorganized and general symptoms seen in psychotic illness. The total score is used for outcome.
Time Frame
3 and 6 month post-baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kristin Cadenhead, MD
Organizational Affiliation
University of California, San Diego
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California San Diego
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States
Facility Name
Instituto Nacional de Neurología y Neurocirugía
City
Mexico City
Country
Mexico

12. IPD Sharing Statement

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Compensatory Cognitive Training in Clinical High Risk Latino Youth

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