Validating Neuropsych Tests in Spanish-speakers

Neuropsychology Clinical Trial

Official title:

Validating Neuropsychological Tests Among Healthy Spanish-Speaking Adults: A Pilot Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05185635
• Other study ID #: 11390
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 1, 2022
• Est. completion date: August 1, 2022

Study information

• Verified date: December 2021
• Source: Rehabilitation Hospital of Indiana
• Contact: Cori Conner, MA
• Phone: 3173292224
• Email: cori.conner[@]rhin.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: August 1, 2022
• Est. primary completion date: May 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Neuropsychology
• Testing

Intervention

Diagnostic Test:
• Neuropsychological testing
potential participants will complete the following: Mini-Mental State Examination (MMSE), Patient Health Questionnaire-9 (PHQ-9) and Generalized Anxiety Disorder 7- item (GAD-7) as part of the screening process. Additionally to the pre-screening instruments, participants will complete the following neuropsychological tests: Bi-dimensional Acculturation Scale, Bilingual Dominance Scale, Verbal Fluency Tests, Boston Naming Test, Symbol Digit Modalities Test, Brief Test of Attention, Who-UCLA Auditory Verbal Learning Test, Rey-Osterrieth Complex Figure, Modified Wisconsin Card Sorting Test, Stroop Color and Word Test, Trail Making Test, Word Accentuation Test, Clock Drawing Task, Bells Test, Test of Memory Malingering, and the Five Point Test.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Rehabilitation Hospital of Indiana

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mini-Mental State Examination (MMSE)	The Mini-Mental State Examination (MMSE) is well known cognitive screening tool that is widely used in neuropsychological clinical practice. Several reports have used this rapid test as a baseline measure to obtain reliable diagnoses when cognitive impairment is suspected. The MMSE has many benefits, particularly its rapid application and high sensitivity and specificity in relation to cognitive dysfunction.	Up to 5 months
Primary	Patient Health Questionnaire (PHQ-9)	The Patient Health Questionnaire is a self-administered assessment tool used to screen specifically for the presence depression.	Up to 5 months
Primary	Generalized Anxiety Disorder(GAD-7)	The Generalized Anxiety Disorder 7-item test is a useful self-report measure with strong criterion validity for identifying probable cases of GAD.	Up to 5 months
Primary	Bidimensional Acculturation Scale (BAS)	The Bidimensional Acculturation Scale is a 24-item measure that assesses an individual's level of acculturation to Hispanic culture and to non-Hispanic culture.	Up to 5 months
Primary	Gradient Bilingual Dominance Scale	The Bilingual Dominance Scale (BDS; Dunn & Tree, 2009) is a 12 item self-report measure that can be used to quantify the language dominance of bilingual participants.	Up to 5 months
Primary	Verbal Fluency Tests	Verbal fluency tests (VFT) are commonly used measures both in clinical practice and research due to their sensitivity to brain damage. There are multiple variations of the VFT, but the two more commonly used paradigms measure letter and semantic fluency. In the letter VFT, participants are asked to produce as many words as possible that begin with a certain letter within a 60 second time limit. In the semantic VFT, participants are required to produce as many words as s/he can that belong to a category within the same 60 second timeframe.	Up to 5 months
Primary	Standard Form of the Boston Naming Test	The Boston Naming Test requires examinees to denominate 60 pictures, which are presented in order of increasing difficulty. If the participant does not spontaneously provide the correct response, the examiner provides a prompt in the form of a semantic cue or phonological cue	Up to 5 months
Primary	The Symbol Digit Modalities Test	The Symbol Digit Modalities Test is a timed measure that requires participants to convert symbols (shaped geometric figures) into numbers, as quickly as possible.	Up to 5 months
Primary	Brief Test of Attention	The Brief Test of Attention test consists of two equivalent forms that are administered consecutively (Forms N and L). In the N form, the subject hears a list of 10 series of letters and numbers that are intercalated, after which the subject must indicate how many numbers were mentioned. Subsequently, in the form L, the subjects are presented the same list series, but this time the subject must indicate how many letters were mentioned.	Up to 5 months
Primary	WHO-UCLA Auditory Verbal Learning Test (WHO-UCLA AVLT)	The WHO-UCLA Auditory Verbal Learning Test (AVLT) is a measure of verbal learning and memory that consists of 15 words selected from a standardized lexicon of 250 universally familiar concepts . The 15-item word list is repeated across five learning trials, and patients are to complete immediate recall, do an interference task, a short-delay free-recall, a 20-min delay, and then another free recall, followed by forced choice.	Up to 5 months
Primary	Rey-Osterrieth Complex Figure	The Rey-Osterrieth Complex Figure Test is a measure of visual perception, visual-spatial constructional ability, and visual memory that was developed by Swiss psychologist Andre Rey in 1941. For the purpose of the present study, the Spanish-language ROCF manual scoring guidelines will be followed (Rey, 2009).	Up to 5 months
Primary	Modified Wisconsin Card Sorting Test (M-WCST)	The Modified Wisconsin Card Sorting Test consists of four stimulus cards and 48 response cards. Each card varies in shape (cross, circle, triangle or star), color (red, blue, yellow or green), and number (one to four). The first participant's response is always considered right, and during the administration, the examiner informs him/her whether their response is correct or incorrect until the participant accurately classifies six consecutive cards in each category. Then, the examiner indicates that the rules have changed and to try to "find another rule." If the second category chosen differs from what was chosen in the first, it is considered correct. The test continues until all six categories are classified or until having used the whole card deck	Up to 5 months
Primary	Stroop Color-Word Interference Test	The Stroop Color and Word test consists of three pages, each with 100 components randomly organized into five columns. The subject has 45 seconds to read aloud, as quickly as possible, the columns from left to right. The sheet on words is formed by the words "Red," "Green," and "Blue" in black ink, and the score is the number of words read correctly. For the sheet containing only colors, there are groups of four X's ("XXXX") printed in blue, green, and red. The score is the number of elements properly named. Finally, the last list consists of the three words of the first printed page in the colors of the second, with words being incongruent with the color of the ink. The task is to name the ink color, inhibiting the reading of the word, and the score is the number of correctly named elements.	Up to 5 months
Primary	Trail Making Test	The Trail Making Test is a times measure consists of two parts: TMT-A and B. In the TMT-A the participant must draw a line, as quickly as they can, connecting 25 numbers in ascending order, which are circled and randomly distributed on a sheet of paper. The task requirements are similar for the TMT-B, except that the person alternates between numbers and letters the latter being significantly more difficult	Up to 5 months
Primary	Word Accentuation Test-Chicago (WAT-C)	The Word Accentuation Test is a reading test utilized to estimate premorbid cognitive ability among Spanish-speaking individual's ages 29-73 years.	Up to 5 months
Primary	Clock Drawing Test	The Clock Drawing Test is a measure that screens for dementia as well as for visuospatial, constructional, and visual planning difficulties. T	Up to 5 months
Primary	Bells Test	The Bells Test is used to detect visual inattention in children and adults and it consists of a 21.5 × 28 cm sheet of paper on which seven lines of 35 distractor figures (e.g., bird, key, apple, mushroom, car) and five target figures (bells) are presented.	Up to 5 months
Primary	Test of Memory Malingering (TOMM II)	The Test of Memory Malingering is a visual recognition test designed to help distinguish between bona fide and malingered memory impairments.	Up to 5 months
Primary	Five Point Test	The Five Point Test is a measure that requires production of novel designs under time constraints. Patients are asked to produce as many different figures as possible by connecting the dots within each rectangle.	Up to 5 months