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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04656990
Enrollment
277
Registered
2020-12-07
Start date
2020-09-01
Completion date
2023-02-18
Last updated
2025-04-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gross Motor Development Delay, Sedentary Behavior, Social Behavior, Social Skills

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.

Interventions

Gross motor and social-emotional integrated intervention

Sponsors

University of South Carolina
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
4 Years to 5 Years
Healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

* Enrolled in special education classroom

Design outcomes

Primary

MeasureTime frameDescription
Test of Gross Motor Development, Third EditionBaselineGross motor development assessment ranges from 0-100 with higher scores reflecting better performance.
Social Skills Improvement System Rating ScalesBaselineSocial-Emotional scores range from 0-160 with higher scores reflecting better performance.

Secondary

MeasureTime frameDescription
Physical Activity From AccelerometerBaselineThe accelerometer, which children wear throughout the day, records step counts which are then converted into numerical representation of levels of physical activity.

Countries

United States

Participant flow

Participants by arm

ArmCount
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. Integrated Intervention: Gross motor and social-emotional integrated intervention
109
Control
Participants will receive the center's everyday business as usual curriculum.
124
Total233

Withdrawals & dropouts

PeriodReasonFG000FG001
Baselinepandemic2024
Follow Up PeriodLost to Follow-up6173

Baseline characteristics

CharacteristicTotalGross Motor and Social-emotional Integrated Intervention GroupControl
Age, Continuous61.03 Months
STANDARD_DEVIATION 6.91
60.88 Months
STANDARD_DEVIATION 6.67
61.15 Months
STANDARD_DEVIATION 7.14
Race/Ethnicity, Customized
Black
31 Participants15 Participants16 Participants
Race/Ethnicity, Customized
Hispanic
40 Participants20 Participants20 Participants
Race/Ethnicity, Customized
More than one race
8 Participants3 Participants5 Participants
Race/Ethnicity, Customized
White
154 Participants71 Participants83 Participants
Sex: Female, Male
Female
118 Participants54 Participants64 Participants
Sex: Female, Male
Male
115 Participants55 Participants60 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 1290 / 148
other
Total, other adverse events
0 / 1290 / 148
serious
Total, serious adverse events
0 / 1290 / 148

Outcome results

Primary

Social Skills Improvement System Rating Scales

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

Time frame: three-month follow-up

ArmMeasureValue (MEAN)Dispersion
Gross Motor and Social-emotional Integrated Intervention GroupSocial Skills Improvement System Rating Scales86.27 score on a scaleStandard Deviation 16.77
ControlSocial Skills Improvement System Rating Scales93.00 score on a scaleStandard Deviation 22.82
Primary

Social Skills Improvement System Rating Scales

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

Time frame: Baseline

ArmMeasureValue (MEAN)Dispersion
Gross Motor and Social-emotional Integrated Intervention GroupSocial Skills Improvement System Rating Scales85.63 score on a scaleStandard Deviation 21.65
ControlSocial Skills Improvement System Rating Scales96.38 score on a scaleStandard Deviation 20.33
Primary

Social Skills Improvement System Rating Scales

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

Time frame: six-month posttest

ArmMeasureValue (MEAN)Dispersion
Gross Motor and Social-emotional Integrated Intervention GroupSocial Skills Improvement System Rating Scales89.24 score on a scaleStandard Deviation 20.3
ControlSocial Skills Improvement System Rating Scales93.03 score on a scaleStandard Deviation 21.29
p-value: =0.04Mixed Models Analysis
Primary

Test of Gross Motor Development, Third Edition

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

Time frame: three-month follow-up

ArmMeasureValue (MEAN)Dispersion
Gross Motor and Social-emotional Integrated Intervention GroupTest of Gross Motor Development, Third Edition51.02 score on a scaleStandard Deviation 10.97
ControlTest of Gross Motor Development, Third Edition46.39 score on a scaleStandard Deviation 12.05
Primary

Test of Gross Motor Development, Third Edition

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

Time frame: Baseline

ArmMeasureValue (MEAN)Dispersion
Gross Motor and Social-emotional Integrated Intervention GroupTest of Gross Motor Development, Third Edition41.99 score on a scaleStandard Deviation 14.4
ControlTest of Gross Motor Development, Third Edition43.36 score on a scaleStandard Deviation 13.26
Primary

Test of Gross Motor Development, Third Edition

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

Time frame: six-month posttest

ArmMeasureValue (MEAN)Dispersion
Gross Motor and Social-emotional Integrated Intervention GroupTest of Gross Motor Development, Third Edition62.36 score on a scaleStandard Deviation 12.35
ControlTest of Gross Motor Development, Third Edition49.75 score on a scaleStandard Deviation 11.7
p-value: <0.0001Mixed Models Analysis
Secondary

Physical Activity From Accelerometer

The accelerometer, which children wear throughout the day, records step counts which are then converted into numerical representation of levels of physical activity.

Time frame: Baseline

Population: No data were collected on this measure for the following reason. Because of restrictions emanating from the pandemic, school authorities did not permit children to wear the accelerometers. Consequently, it was not possible to implement this measure. Consequently the number of participants with data on this measure was zero, and the number of participants analyzed on this measure was zero.

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026