SKIPping With PAX: An Integrated Gross Motor and Social-Emotional Skill Intervention

April 18, 2025 updated by: Ali Brian, University of South Carolina
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.

Study Overview

Study Type

Interventional

Enrollment (Actual)

277

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • South Carolina
      • Swansea, South Carolina, United States, 29160
        • Lexington 4 Early Childhood Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years to 5 years (Child)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Enrolled in special education classroom

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Gross motor and social-emotional integrated intervention group
Participants will receive a nine-month intervention which focuses on gross motor skills, physical activity, and social-emotional skills.
Gross motor and social-emotional integrated intervention
No Intervention: Control
Participants will receive the center's everyday business as usual curriculum.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Test of Gross Motor Development, Third Edition
Time Frame: six-month posttest
Gross motor development assessment ranges from 0-100 with higher scores reflecting better performance.
six-month posttest
Test of Gross Motor Development, Third Edition
Time Frame: three-month follow-up
Gross motor development assessment ranges from 0-100 with higher scores reflecting better performance.
three-month follow-up
Social Skills Improvement System Rating Scales
Time Frame: six-month posttest
Social-Emotional scores range from 0-160 with higher scores reflecting better performance.
six-month posttest
Social Skills Improvement System Rating Scales
Time Frame: three-month follow-up
Social-Emotional scores range from 0-160 with higher scores reflecting better performance.
three-month follow-up
Test of Gross Motor Development, Third Edition
Time Frame: Baseline
Gross motor development assessment ranges from 0-100 with higher scores reflecting better performance.
Baseline
Social Skills Improvement System Rating Scales
Time Frame: Baseline
Social-Emotional scores range from 0-160 with higher scores reflecting better performance.
Baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Physical Activity From Accelerometer
Time Frame: Baseline
The accelerometer, which children wear throughout the day, records step counts which are then converted into numerical representation of levels of physical activity.
Baseline

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
NIH Toolbox Flanker Inhibitory Control & Attention Test Ages 3-7
Time Frame: Baseline
Attention & Executive Function - The allocation of one's limited capacities to deal with an abundance of environmental stimulation. Children ages 3-17: Normative scores are provided separately for each year of age to take into account expected developmental changes A score of 100 indicates performance that was at the national average for the test-taking participant's age. A score of 115 or 85, for example, would indicate that the participant's performance is 1 SD above or below the national average, respectively, when compared with like-aged participants
Baseline
NIH Toolbox Picture Sequence Memory Test Ages 3-4;
Time Frame: Baseline
Episodic Memory - Cognitive processes involved in the acquisition, storage, and retrieval of new information: Normative scores are provided separately for each year of age to take into account expected developmental changes A score of 100 indicates performance that was at the national average for the test-taking participant's age. A score of 115 or 85, for example, would indicate that the participant's performance is 1 SD above or below the national average, respectively, when compared with like-aged participants
Baseline
NIH Toolbox Dimensional Change Card Sort Age 3-7
Time Frame: Baseline
Executive Function & Attention - The capacity to plan, organize, and monitor the execution of behaviors that are strategically directed in a goal-oriented manner: Normative scores are provided separately for each year of age to take into account expected developmental changes A score of 100 indicates performance that was at the national average for the test-taking participant's age. A score of 115 or 85, for example, would indicate that the participant's performance is 1 SD above or below the national average, respectively, when compared with like-aged participants
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2020

Primary Completion (Actual)

October 31, 2022

Study Completion (Actual)

February 18, 2023

Study Registration Dates

First Submitted

November 16, 2020

First Submitted That Met QC Criteria

December 3, 2020

First Posted (Actual)

December 7, 2020

Study Record Updates

Last Update Posted (Actual)

April 20, 2025

Last Update Submitted That Met QC Criteria

April 18, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • Pro00091603

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

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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