Compensatory Cognitive Training in Clinical High Risk Latino Youth

NCT ID: NCT02245607

Last Updated: 2021-02-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-31

Study Completion Date

2021-02-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Clinical High Risk Psychosis Prodromal Schizophrenia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Compensatory Cognitive Training

Compensatory Cognitive Training

Group Type EXPERIMENTAL

Compensatory Cognitive Training

Intervention Type BEHAVIORAL

Recreational Therapy

Recreational Therapy

Group Type ACTIVE_COMPARATOR

Recreational Therapy

Intervention Type BEHAVIORAL

Interventions

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Compensatory Cognitive Training

Intervention Type BEHAVIORAL

Recreational Therapy

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

12 Years

Maximum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

University of California, San Diego

OTHER

Sponsor Role lead

Responsible Party

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Kristin Cadenhead, M.D.

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kristin Cadenhead, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Diego

Locations

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University of California San Diego

La Jolla, California, United States

Site Status

Instituto Nacional de Neurología y Neurocirugía

Mexico City, , Mexico

Site Status

Countries

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United States Mexico

Other Identifiers

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5R34MH105247-03

Identifier Type: NIH

Identifier Source: secondary_id

View Link

MH105247

Identifier Type: -

Identifier Source: org_study_id

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