The Effects of Playful Pathways

Gross Motor Development Delay Clinical Trial

Official title:

The Effects of Playful Pathways, a Play-Based Developmentally Focused Group Program, and How it Affects Caregivers' Health Literacy and Self-Efficacy and Influences Outcomes for Infants

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06139549
• Other study ID #: ACHEFALL2023PP
• Status: Recruiting
• Start date: September 20, 2023
• Est. completion date: February 20, 2024

Study information

• Verified date: November 2023
• Source: Arkansas Colleges of Health Education
• Contact: LaVona Traywick, PHD
• Phone: 4794016023
• Email: lavona.traywick[@]achehealth.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: February 20, 2024
• Est. primary completion date: November 8, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

All babies typically developing or any diagnosis ages 0 - 6 months; parents/caregivers of babies typically developing or any diagnosis ages 0 - 6 months participating in the intervention. Sample size will be 12 babies ages 0-6 months and their caregivers (1-2 caregivers per baby). Total population 12 infants with up to 30 caregivers.

Inclusion criteria:

1. All babies typically developing or any diagnosis ages 0 - 6 months

Inclusion criteria for parents/caregivers:

1. At least 18 years of age

2. Able to communicate in and read English

3. Parent/caregiver of baby ages 0 - 6 months who is participating in the program

4. Ability to provide transportation to/from research site(s)

Related Conditions & MeSH terms

• Gross Motor Development Delay

Intervention

Other:
• Gross motor development group session
Group session for gross motor development

Locations

Country	Name	City	State
United States	Arkansas Colleges of Health Education	Fort Smith	Arkansas

Sponsors (1)

Lead Sponsor	Collaborator
Arkansas Colleges of Health Education

Country where clinical trial is conducted

United States, 

References & 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.

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; — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	DAYC-2	measure of gross motor development	9/20/23 - 2/20/24
Primary	PHLAT-8	measure of health literacy	9/20/23 - 2/20/24