NCT06139549

Brief Summary

The purpose of this study is to evaluate infants ages 0-6 months of age before and after an 8 week developmental and educational "caregiver and baby" interactive program as well as 3 month following the conclusion of the program. The researchers aim to screen and identify developmental delays and the effects of the 8 week program on gross motor development as well as explore parent perceptions of the program. The aim of this study is to assess the physical, social, and emotional outcomes of an interactive group program for infants 0-6 months and their families/caregiver.

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
10

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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 17, 2023

Completed
3 days until next milestone

Study Start

First participant enrolled

September 20, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 8, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

November 18, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 20, 2024

Completed
Last Updated

November 18, 2023

Status Verified

November 1, 2023

Enrollment Period

2 months

First QC Date

September 17, 2023

Last Update Submit

November 14, 2023

Conditions

Gross Motor Development Delay

Keywords

INFANTGROSS MOTOR DEVELOPMENTGROUP SESSION

Outcome Measures

Primary Outcomes (2)

  • DAYC-2

    measure of gross motor development

    9/20/23 - 2/20/24

  • PHLAT-8

    measure of health literacy

    9/20/23 - 2/20/24

Interventions

Gross motor development group sessionOTHER

Group session for gross motor development

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Infants ages 0-6 months Caregivers age 18 and older

You may qualify if:

  • \. All babies typically developing or any diagnosis ages 0 - 6 months
  • At least 18 years of age
  • Able to communicate in and read English
  • Parent/caregiver of baby ages 0 - 6 months who is participating in the program
  • Ability to provide transportation to/from research site(s)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Arkansas Colleges of Health Education

Fort Smith, Arkansas, 72916, United States

RECRUITING

Related Publications (2)

  • Alkhazrajy, L. A., & Aldeen, E. R. S. (2017). Assessment of mothers knowledge regarding the developmental milestone among children under two years in Iraq. American Journal of Applied Sciences, 14(9), 869-877.

    RESULT

  • Aoyama T, Hikihara Y, Watanabe M, Wakabayashi H, Hanawa S, Omi N, Takimoto H, Tanaka S. Association Between Age of Achieving Gross Motor Development Milestones During Infancy and Body Fat Percentage at 6 to 7 Years of Age. Matern Child Health J. 2022 Feb;26(2):415-423. doi: 10.1007/s10995-021-03238-9. Epub 2021 Oct 16.

    PMID: 34655425RESULT

Study Officials

  • Allison N Young, DPT

    Arkansas Colleges of Health Education

    PRINCIPAL INVESTIGATOR

Central Study Contacts

LaVona Traywick, PHD

CONTACT

4794016023lavona.traywick@achehealth.edu

Allison N Young, DPT

CONTACT

4794143238allison.young@achehealth.edu

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

September 17, 2023

First Posted

November 18, 2023

Study Start

September 20, 2023

Primary Completion

November 8, 2023

Study Completion

February 20, 2024

Last Updated

November 18, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations

US(1)