NCT06619691

Brief Summary

The aim of this study is to determine if an 8 week fine motor intervention program will lead to improve fine motor skills as measured by a standardized assessment (PDMS-3) in pre- and post-test.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 27, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 1, 2024

Completed
Same day until next milestone

Study Start

First participant enrolled

October 1, 2024

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2025

Completed
Last Updated

October 3, 2024

Status Verified

September 1, 2024

Enrollment Period

5 months

First QC Date

September 27, 2024

Last Update Submit

October 1, 2024

Conditions

Fine Motor Skills

Keywords

Preschoolfine motor programfine motor skillsearly childhood development

Outcome Measures

Primary Outcomes (1)

  • Peabody Developmental Motor Scale, 3rd Edition

    Peabody Developmental Motor Scales, 3rd edition - Norm referenced and standardized assessment of fine motor skills for children ages birth-5.11

    8 weeks

Study Arms (1)

FIne Motor Program participants

EXPERIMENTAL

All enrolled participants will completed a fine motor intervention program over 8 weeks

Other: Fine motor skills

Interventions

Fine motor skillsOTHER

Only intervention

FIne Motor Program participants

Eligibility Criteria

Age3 Years - 5 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • preschooler aged 3-5 years old enrolled in local preschool

You may not qualify if:

  • None other than denial of parent consent or lack of child assent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mercy University

Dobbs Ferry, New York, 10950, United States

Location

Central Study Contacts

Elizabeth Berliner, MS

CONTACT

914-674-7688eberliner@mercy.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 27, 2024

First Posted

October 1, 2024

Study Start

October 1, 2024

Primary Completion

March 1, 2025

Study Completion

June 1, 2025

Last Updated

October 3, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)