Clinical trial NCT05185635: Validating Neuropsych Tests in Spanish-speakers
Official title: Validating Neuropsychological Tests Among Healthy Spanish-Speaking Adults: A Pilot Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Neuropsychology
Testing
Keywords: Spanish-speakers
Lead sponsor: Rehabilitation Hospital of Indiana
Sponsor class: OTHER
First posted: 2022-01-11
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This project is an initial cross-sectional study of 40 Spanish-speaking subjects to generate pilot normative neuropsychological performance data that will be used in the future in grant submissions and as an initial feasibility platform for larger scale research projects.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The proposed pilot further emphasizes the need for collecting language and demographic specific norms for Spanish-speaking Latino individuals in the U.S. by developing new normative test data for this demographic population. The study looks to contribute to minimize healthcare disparities and inaccurate test interpretations, which can have direct implications on diagnosis and treatment. This study will allow us to develop new neuropsychological test norms for predominantly Spanish-speaking adults by establishing expected cognitive performance on a battery of frequently used neuropsychological tests. As such, the current study will help fill a large gap in the literature pertaining to neuropsychological assessment of Spanish-Speakers living in the U.S., as well as produce data of clinical utility for providers working with this population. Finally, this pilot could serve as a model to eventually extend it to other non-English speaking populations in the US.

Detailed description: Hispanics/Latinos are now recognized as the largest and fastest growing ethnic/racial minority group in the United States (U.S.). By 2017, the Hispanic/Latino population reached nearly 60 million comprising 18% of the total U.S. population. Current projections indicate that Hispanic/Latinos will reach almost 111 million, making up 28% of the total U.S. population by 2060.

Clinical neuropsychologists must be equipped with the right tools to accurately serve the rapidly growing Hispanic/Latino population in the US. Findings from normative data studies in foreign countries emphasize the need for developing language and demographic specific norms for Spanish-speaking Hispanics in the US. This is particularly relevant given recent literature indicating that factors such as ethnicity, language, quality of education, degree of acculturation, and bilingualism can have a profound impact on neuropsychological test performance. Within participants that self-identify as primarily Spanish-speaking, language performance has been positively associated with greater Spanish vs. English language dominance and completing education outside the U.S., whereas other cognitive abilities have a negative association with the same variables.

The proposed pilot further emphasizes the need for collecting language and demographic specific norms for Spanish-speaking Latino individuals in the U.S. by developing new normative test data for this demographic population. The study looks to contribute to minimize healthcare disparities and inaccurate test interpretations, which can have direct implications on diagnosis and treatment. This study will allow us to develop new neuropsychological test norms for predominantly Spanish-speaking adults by establishing expected cognitive performance on a battery of frequently used neuropsychological tests. As such, the current study will help fill a large gap in the literature pertaining to neuropsychological assessment of Spanish-Speakers living in the U.S., as well as produce data of clinical utility for providers working with this population. Finally, this pilot could serve as a model to eventually extend it to other non-English speaking populations in the US.

Eligibility criteria: Inclusion Criteria:

* Be between 18 to 80 years of age
* Have been living in the US for at least 1 year (12 continuous months)
* Identify Spanish as their primary and/or dominant language
* Have at least one year of formal education
* Be able to read and write at the time of evaluation in Spanish
* a score of ≥23 on the Mini-Mental State Examination (MMSE)
* score of ≤10 on the Patient Health Questionnaire-9 (PHQ-9)
* score of ≤10 on the generalized anxiety disorder (GAD-7)

Exclusion Criteria:

* History of neurodevelopmental disorder
* History of learning disorder
* Past or present neurologic condition
* Past or present chronic medical condition that may affect cognition (i.e. metabolic syndrome, chronic heart failure, sleep apnea)
* Past or present use of psychotropic medications that may affect cognition
* Past or present history of substance abuse or dependence
* Past or present history of psychiatric disorder
* Presence of severe sensory deficits, such as loss of hearing or vision

Primary outcomes:
measure: Mini-Mental State Examination (MMSE)
timeFrame: Up to 5 months
measure: Patient Health Questionnaire (PHQ-9)
timeFrame: Up to 5 months
measure: Generalized Anxiety Disorder(GAD-7)
timeFrame: Up to 5 months
measure: Bidimensional Acculturation Scale (BAS)
timeFrame: Up to 5 months
measure: Gradient Bilingual Dominance Scale
timeFrame: Up to 5 months
measure: Verbal Fluency Tests
timeFrame: Up to 5 months
measure: Standard Form of the Boston Naming Test
timeFrame: Up to 5 months
measure: The Symbol Digit Modalities Test
timeFrame: Up to 5 months
measure: Brief Test of Attention
timeFrame: Up to 5 months
measure: WHO-UCLA Auditory Verbal Learning Test (WHO-UCLA AVLT)
timeFrame: Up to 5 months
measure: Rey-Osterrieth Complex Figure
timeFrame: Up to 5 months
measure: Modified Wisconsin Card Sorting Test (M-WCST)
timeFrame: Up to 5 months
measure: Stroop Color-Word Interference Test
timeFrame: Up to 5 months
measure: Trail Making Test
timeFrame: Up to 5 months
measure: Word Accentuation Test-Chicago (WAT-C)
timeFrame: Up to 5 months
measure: Clock Drawing Test
timeFrame: Up to 5 months
measure: Bells Test
timeFrame: Up to 5 months
measure: Test of Memory Malingering (TOMM II)
timeFrame: Up to 5 months
measure: Five Point Test
timeFrame: Up to 5 months
Secondary outcomes:
Other outcomes:
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