NCT04656990

Brief Summary

The purpose of this study was to test the effects of an integrated intervention on the gross motor and social-emotional development of rural preschool boys and girls. A secondary purpose was to examine intervention effects on physical activity and sedentary behavior. An exploratory aim was to examine the role of executive functioning skills on intervention outcomes. This study featured a repeated measures (baseline, six-month posttest, three month retention \[nine-month follow-up\]), control group, experimental design. Classrooms were randomly assigned to either the experimental or control groups. Experimental participants received intervention while control participants received business as usual curricula.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
277

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

September 1, 2020

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 16, 2020

Completed
21 days until next milestone

First Posted

Study publicly available on registry

December 7, 2020

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2022

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 18, 2023

Completed
2.2 years until next milestone

Results Posted

Study results publicly available

April 20, 2025

Completed
Last Updated

April 20, 2025

Status Verified

April 1, 2025

Enrollment Period

2.2 years

First QC Date

November 16, 2020

Results QC Date

August 17, 2023

Last Update Submit

April 18, 2025

Conditions

Outcome Measures

Primary Outcomes (6)

  • Test of Gross Motor Development, Third Edition

    Gross motor development assessment ranges from 0-100 with higher scores reflecting better performance.

    Baseline

  • Test of Gross Motor Development, Third Edition

    Gross motor development assessment ranges from 0-100 with higher scores reflecting better performance.

    six-month posttest

  • Test of Gross Motor Development, Third Edition

    Gross motor development assessment ranges from 0-100 with higher scores reflecting better performance.

    three-month follow-up

  • Social Skills Improvement System Rating Scales

    Social-Emotional scores range from 0-160 with higher scores reflecting better performance.

    Baseline

  • Social Skills Improvement System Rating Scales

    Social-Emotional scores range from 0-160 with higher scores reflecting better performance.

    six-month posttest

  • Social Skills Improvement System Rating Scales

    Social-Emotional scores range from 0-160 with higher scores reflecting better performance.

    three-month follow-up

Secondary Outcomes (1)

  • Physical Activity From Accelerometer

    Baseline

Study Arms (2)

Gross motor and social-emotional integrated intervention group

EXPERIMENTAL

Participants will receive a nine-month intervention which focuses on gross motor skills, physical activity, and social-emotional skills.

Behavioral: Integrated Intervention

Control

NO INTERVENTION

Participants will receive the center's everyday business as usual curriculum.

Interventions

Gross motor and social-emotional integrated intervention

Gross motor and social-emotional integrated intervention group

Eligibility Criteria

Age4 Years - 5 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Enrolled in the early childhood center, aged 4-5 years

You may not qualify if:

  • Enrolled in special education classroom

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lexington 4 Early Childhood Center

Swansea, South Carolina, 29160, United States

Location

MeSH Terms

Conditions

Social SkillsSocial BehaviorSedentary Behavior

Condition Hierarchy (Ancestors)

Behavior

Results Point of Contact

Title
Director, USC Office of Research Compliance
Organization
University of South Carolina

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

November 16, 2020

First Posted

December 7, 2020

Study Start

September 1, 2020

Primary Completion

October 31, 2022

Study Completion

February 18, 2023

Last Updated

April 20, 2025

Results First Posted

April 20, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations