NCT05185635

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2022

Shorter than P25 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 29, 2021

Completed
3 months until next milestone

Study Start

First participant enrolled

January 1, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 11, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2022

Completed
Last Updated

January 11, 2022

Status Verified

December 1, 2021

Enrollment Period

5 months

First QC Date

September 29, 2021

Last Update Submit

December 22, 2021

Conditions

Keywords

Spanish-speakers

Outcome Measures

Primary Outcomes (19)

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

Study Arms (1)

Healthy Spanish-speakers

EXPERIMENTAL
Diagnostic Test: Neuropsychological testing

Interventions

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.

Healthy Spanish-speakers

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Central Study Contacts

Cori Conner, MA

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Neuropsychologist

Study Record Dates

First Submitted

September 29, 2021

First Posted

January 11, 2022

Study Start

January 1, 2022

Primary Completion

May 30, 2022

Study Completion

August 1, 2022

Last Updated

January 11, 2022

Record last verified: 2021-12

Data Sharing

IPD Sharing
Will not share