NCT05332912

Brief Summary

Based on available literature and our own preliminary research, the researchers have concluded that persons with Down syndrome (DS) exhibit difficulties in utilizing the specific spatial abilities of mental rotation and perspective taking and performing complex spatial tasks such as wayfinding and environmental learning. A weakness in spatial abilities may have many direct applications to daily life, ranging from activities such as tying shoes to using hand tools and navigating the environment. Spatial abilities also serve as a cognitive foundation for many other complex skills such as solving mathematical problems and using spatial language for giving and receiving directions. Moreover, spatial abilities are used in a variety of specialty jobs such as grocery stocking, packaging, and assembling, which are among the most commonly reported jobs for adults with DS. Hence, a new focus on spatial ability and its modifiability in persons with DS is clearly warranted. The primary goal of the research proposed in this application is to evaluate the malleability of mental rotation and perspective taking in people with DS through providing intentional experience with numerous spatial activities. Two groups of participants will be tested over the course of the project: adolescents and young adults with DS and typically developing (TD) children. Following an initial evaluation of performance on the two abilities, participants will receive up to eight sessions of spatial activity experience utilizing puzzle construction, block building, and computer search tasks. Following the experience sessions, spatial abilities of participants will be re-evaluated. These data will be used to investigate two specific aims. First, the researchers investigate whether spatial abilities of persons with DS can be modified by experience with spatial activities. Second, the researchers investigate whether the degree of modification observed for persons with DS can reduce performance differences between them and TD children. The researchers also consider whether performance on the PPVT, Raven's matrices, and Chronological Age are associated with any benefits from spatial ability experience.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
84

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

April 1, 2021

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

April 2, 2022

Completed
16 days until next milestone

First Posted

Study publicly available on registry

April 18, 2022

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 10, 2024

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2025

Completed
7 months until next milestone

Results Posted

Study results publicly available

October 14, 2025

Completed
Last Updated

October 14, 2025

Status Verified

September 1, 2025

Enrollment Period

3.4 years

First QC Date

April 2, 2022

Results QC Date

August 5, 2025

Last Update Submit

September 18, 2025

Conditions

Outcome Measures

Primary Outcomes (4)

  • Change in Mental Rotation Ability at 8 Weeks

    The Mental Rotation Assessment was used to assess ability to match objects rotated at varying degrees from a standard. Number of correct matches out of 18 possible matches over all rotations (excluding 0 degrees) was used as a measure of performance. Minimum score = 0. Maximum score = 18. Higher scores reflect better performance. Change in Mental Rotation Ability was calculated by subtracting Baseline (Time 1) Assessment scores from 8 Week (Time 2) Assessment scores.

    Following 8 weeks of experience training.

  • Change in Mental Rotation Ability at 16 Weeks

    The Mental Rotation Assessment was used to assess ability to match objects rotated at varying degrees from a standard. Number of correct matches out of 18 possible matches over all rotations (excluding 0 degrees) was used as a measure of performance. Minimum score = 0. Maximum score = 18. Higher scores reflect better performance. Change in Mental Rotation Ability was calculated by subtracting Baseline (Time 1) Assessment scores from 8 Week (Time 3) Assessment scores.

    Following 16 weeks of experience training.

  • Change in Perspective Taking Ability at 8 Weeks

    Measure Description: Participants received 8 trials in which they judged another's point of view. Scores could range from 0 to 24. . Change in Perspective Taking Ability was calculated by subtracting Baseline (Time 1) Assessment scores from 8 Week (Time 2) Assessment scores.

    Following 8 weeks of experience training.

  • Change in Perspective Taking Ability at 16 Weeks

    Participants received 8 trials in which they judged another's point of view. Scores could range from 0 to 24. Change in Perspective Taking Ability was calculated by subtracting Baseline (Time 1) Assessment scores from 16 Week (Time 3) Assessment scores.

    Following 16 weeks of experience training.

Study Arms (2)

Immediate

EXPERIMENTAL

Participants will receive 16 weeks of spatial ability experience.

Behavioral: Spatial Ability Experience

Delayed

PLACEBO COMPARATOR

Participants will receive 8 weeks of verbal ability experience prior to receiving 8 weeks of spatial ability experience.

Behavioral: Spatial Ability Experience

Interventions

Participants will engage in puzzle construction, block play, visual search, hide and seek

DelayedImmediate

Eligibility Criteria

Age4 Years - 25 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Typically Developing Children ages 4.0 years to 9.0 years
  • Individuals with Down Syndrome ages 10.0 - 25.0
  • Verbal Comprehension Ability at 4.0 years or above

You may not qualify if:

  • Inability to follow verbal instructions
  • Inability of use tablet computer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Alabama, Tuscaloosa

Tuscaloosa, Alabama, 35405, United States

Location

MeSH Terms

Conditions

Down Syndrome

Condition Hierarchy (Ancestors)

Intellectual DisabilityNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesAbnormalities, MultipleCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesChromosome DisordersGenetic Diseases, Inborn

Limitations and Caveats

Remote training due to CoVid increased duration of the project (16 instead of 8 weeks), made it difficult to recruit participants with Down Syndrome for the Delayed intervention condition. Hence, there is a need to modify the basic Data Analysis Plan, including using covariation procedures to account for difficulties matching groups. Still, the comparisons have yielded important results relevant to using experiential training to improve spatial abilities of individuals with Down Syndrome.

Results Point of Contact

Title
Professor Emeritus
Organization
University of Alabama, Tuscaloosa

Study Officials

  • Edward C Merrill, Phd

    University of Alabama, Tuscaloosa

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: Typically developing children will be compared to adolescents/young adults with Down syndrome (groups matched on non-verbal ability). A delayed start condition (verbal experience instead of spatial ability experience) of eight weeks will be used for 1/2 of participants in each group.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor Emeritus

Study Record Dates

First Submitted

April 2, 2022

First Posted

April 18, 2022

Study Start

April 1, 2021

Primary Completion

August 10, 2024

Study Completion

March 31, 2025

Last Updated

October 14, 2025

Results First Posted

October 14, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will share

Individual Participant Data (IPD) will be available upon request after the study is completed, data has been analyzed, and the primary data has been published or within 5 years of study completion if data has not been published. Requests can be made to the PI.

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
Data will be available following publication of the primary data or within 5 years of study completion if data has not been published. Data will be available for a minimum of 5 years.
Access Criteria
Requests will be accepted from behavioral researchers with a PhD or equivalent who identify a specific purpose and research appropriate justification for accessing the IPD. Requests will be reviewed by the PI and the sub-contract PI.

Locations