Recruiting

Observational Study

Sponsor:

Arkansas Colleges of Health Education

Code:

NCT06139549

Conditions

Gross Motor Development Delay

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Accepted

Interventions

Gross motor development group session

Study Details

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.

Conditions

Gross Motor Development Delay

Study ID

NCT06139549

Start date

Sep 20, 2023

Status verified date

Nov, 2023

Completion date

Feb 20, 2024

Anticipated

Primary completion date

Nov 8, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Accepted

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 Design

Enrollment

10 participants

Anticipated

Interventions and Outcome Measures

Interventions

Gross motor development group session

Group session for gross motor development

Primary outcome measure

  • DAYC-2 [ Time Frame: 9/20/23 - 2/20/24 ]
  • PHLAT-8 [ Time Frame: 9/20/23 - 2/20/24 ]

Central Contacts and Locations

Central contacts

LaVona Traywick, PHD

4794016023lavona.traywick@achehealth.edu

Allison N Young, DPT

4794143238allison.young@achehealth.edu

Locations

Arkansas Colleges of Health Education

Recruiting

Fort Smith, Arkansas, United States, 72916

Contacts

Allison N Young, DPT

479-401-6029allison.young@achehealth.edu

More Information

Sponsor

Arkansas Colleges of Health Education

Last update posted

Nov 18, 2023

Last verified

Nov, 2023

Keywords

  • INFANT
  • GROSS MOTOR DEVELOPMENT
  • GROUP SESSION

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Arkansas Colleges of Health Education on 2023-11-18.