The Effects of Playful Pathways

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

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.

Study Overview

• Status: Recruiting
• Conditions: Gross Motor Development Delay
• Intervention / Treatment: Other: Gross motor development group session

• Study Type: Observational
• Enrollment (Estimated): 10

Contacts and Locations

• Study Contact: Name: LaVona Traywick, PHD; Phone Number: 4794016023; Email: lavona.traywick@achehealth.edu
• Study Contact Backup: Name: Allison N Young, DPT; Phone Number: 4794143238; Email: allison.young@achehealth.edu

Study Locations

• United States
  • Arkansas
    • Fort Smith, Arkansas, United States, 72916
      • Recruiting
      • Arkansas Colleges of Health Education
      • Contact: Allison N Young, DPT; Phone Number: 479-401-6029; Email: allison.young@achehealth.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Infants ages 0-6 months Caregivers age 18 and older

Description

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)

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Arkansas Colleges of Health Education
• Investigators: Principal Investigator: Allison N Young, DPT, Arkansas Colleges of Health Education

Publications and helpful links

General Publications

• 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;26(2):415-423. doi: 10.1007/s10995-021-03238-9. Epub 2021 Oct 16.

Study record dates

Study Major Dates

• Study Start (Actual): September 20, 2023
• Primary Completion (Estimated): November 8, 2023
• Study Completion (Estimated): February 20, 2024

Study Registration Dates

• First Submitted: September 17, 2023
• First Submitted That Met QC Criteria: November 14, 2023
• First Posted (Estimated): November 20, 2023

Study Record Updates

• Last Update Posted (Estimated): November 20, 2023
• Last Update Submitted That Met QC Criteria: November 14, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: INFANT; GROSS MOTOR DEVELOPMENT; GROUP SESSION
• Other Study ID Numbers: ACHEFALL2023PP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No