The Effects of Playful Pathways | NCT06139549

Studies
The Effects of Playful Pathways

NCT06139549

Sponsor

Arkansas Colleges of Health Education

Status

Unknown status

Last Update Posted

Nov 18, 2023Actual

Enrollment

10Estimated

Phase

Not provided

Conditions

Gross Motor Development Delay

Interventions

Gross motor development group session

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 20, 2023Actual

Primary Completion Date

Nov 8, 2023Estimated

Completion Date

Feb 20, 2024Estimated

First Submitted Date

Sep 17, 2023

First Submission Date that Met QC Criteria

Nov 14, 2023

First Posted Date

Nov 18, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 14, 2023

Last Update Posted Date

Nov 18, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Allison Young, Assistant Professor, Arkansas Colleges of Health EducationPrincipal Investigator

Lead Sponsor

Arkansas Colleges of Health EducationOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

10Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Gross motor development group session	Other	Group session for gross motor development

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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:

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)

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Infants ages 0-6 months Caregivers age 18 and older

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
LaVona Traywick, PHD	Contact	4794016023		lavona.traywick@achehealth.edu
Allison N Young, DPT	Contact	4794143238		allison.young@achehealth.edu

Overall Officials

Name	Affiliation	Role
Allison N Young, DPT	Arkansas Colleges of Health Education	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Arkansas Colleges of Health Education	Recruiting	Fort Smith	Arkansas	72916	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
	Result	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.
34655425	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.