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| ID | Type | Description | Link |
|---|---|---|---|
| 5R34MH105247-03 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Compensatory Cognitive Training | Experimental | Compensatory Cognitive Training |
|
| Recreational Therapy | Active Comparator | Recreational Therapy |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Compensatory Cognitive Training | Behavioral |
| ||
| Recreational Therapy |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Clinical symptom severity (SOPS total) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kristin Cadenhead, MD | University of California, San Diego | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California San Diego | La Jolla | California | 92093 | United States | ||
| Instituto Nacional de NeurologÃa y NeurocirugÃa |
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| ID | Term |
|---|---|
| D011618 | Psychotic Disorders |
| D012559 | Schizophrenia |
| D001523 | Mental Disorders |
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
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| ID | Term |
|---|---|
| D057173 | Recreation Therapy |
| ID | Term |
|---|---|
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
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| Behavioral |
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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 |
| Mexico City |
| Mexico |
| D013812 |
| Therapeutics |