Compensatory Cognitive Training in Clinical High Risk Latino Youth

Schizophrenia Clinical Trial

Official title:

Compensatory Cognitive Training in Clinical High Risk Latino Youth

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02245607
• Other study ID #: MH105247
• Secondary ID: 5R34MH105247-03
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 2014
• Est. completion date: February 1, 2021

Study information

• Verified date: February 2021
• Source: University of California, San Diego
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 120
• Est. completion date: February 1, 2021
• Est. primary completion date: June 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 30 Years

Eligibility

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

Related Conditions & MeSH terms

• Clinical High Risk
• Prodromal
• Psychosis
• Schizophrenia

Intervention

Behavioral:
• Compensatory Cognitive Training

• Recreational Therapy

Locations

Country	Name	City	State
Mexico	Instituto Nacional de Neurología y Neurocirugía	Mexico City
United States	University of California San Diego	La Jolla	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Diego	National Institute of Mental Health (NIMH)

Countries where clinical trial is conducted

United States,  Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Self-reported functioning (SLoF)	The specific level of functioning (SLOF) assessment scale measures observable behavioral functioning and daily living skills.	3 and 6 month post-baseline
Other	Clinical symptom severity (SOPS total)	The Scale of Prodromal Symptoms (SOPS) measures positive, negative, disorganized and general symptoms seen in psychotic illness. The total score is used for outcome.	3 and 6 month post-baseline
Primary	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	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