Clinical High Risk, Prodromal, Psychosis, Schizophrenia
Conditions
Keywords
Psychotic Disorders, Cognitive Training, Mental Disorders, Schizophrenia and Disorders with Psychotic Features
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.
Interventions
BEHAVIORALCompensatory Cognitive Training
BEHAVIORALRecreational Therapy
Sponsors
National Institute of Mental Health (NIMH)
University of California, San Diego
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
12 Years to 30 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Neurocognition (Global Cognitive Index z score) | 3 and 6 months post-baseline | The CGI is derived based on Z scores across multiple neurocognitive domains and is a representation of global cognition |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Functional capacity (UPSA/UPSA-A) | 3 and 6 month post-baseline | The UPSA total Functional Capacity score is the total of all subscale scores on the UPSA (Finances, Communication, Transportation, Household) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Self-reported functioning (SLoF) | 3 and 6 month post-baseline | The specific level of functioning (SLOF) assessment scale measures observable behavioral functioning and daily living skills. |
| Clinical symptom severity (SOPS total) | 3 and 6 month post-baseline | The Scale of Prodromal Symptoms (SOPS) measures positive, negative, disorganized and general symptoms seen in psychotic illness. The total score is used for outcome. |
Countries
Mexico, United States
Outcome results
None listed