- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04656990
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
Status
Completed
Intervention / Treatment
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.
Sponsor
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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