Compensatory Cognitive Training in Clinical High Risk Latino Youth

University of California San Diego

Status: Unknown

Conditions: Schizophrenia; Psychosis; Prodromal; Clinical High Risk

Treatments: Behavioral: Recreational Therapy; Behavioral: Compensatory Cognitive Training

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02245607

5R34MH105247-03 (U.S. NIH Grant/Contract)

MH105247

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 12 to 30 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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120 participants in 2 patient groups

Compensatory Cognitive Training

Experimental group

Description:

Compensatory Cognitive Training

Treatment:

Behavioral: Compensatory Cognitive Training

Recreational Therapy

Active Comparator group

Description:

Recreational Therapy

Treatment:

Behavioral: Recreational Therapy