Trial Outcomes & Findings for SKIPping With PAX: An Integrated Gross Motor and Social-Emotional Skill Intervention (NCT NCT04656990)
NCT ID: NCT04656990
Last Updated: 2025-04-20
Results Overview
Gross motor development assessment ranges from 0-100 with higher scores reflecting better performance.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
277 participants
Primary outcome timeframe
Baseline
Results posted on
2025-04-20
Participant Flow
Unit of analysis: classrooms
Participant milestones
| Measure |
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
|
Control
Participants will receive the center's everyday business as usual curriculum.
|
|---|---|---|
|
Baseline
STARTED
|
129 7
|
148 7
|
|
Baseline
COMPLETED
|
109 7
|
124 7
|
|
Baseline
NOT COMPLETED
|
20 0
|
24 0
|
|
Intervention
STARTED
|
109 7
|
124 7
|
|
Intervention
COMPLETED
|
109 7
|
124 7
|
|
Intervention
NOT COMPLETED
|
0 0
|
0 0
|
|
Follow Up Period
STARTED
|
109 7
|
124 7
|
|
Follow Up Period
COMPLETED
|
48 7
|
51 7
|
|
Follow Up Period
NOT COMPLETED
|
61 0
|
73 0
|
Reasons for withdrawal
| Measure |
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
|
Control
Participants will receive the center's everyday business as usual curriculum.
|
|---|---|---|
|
Baseline
pandemic
|
20
|
24
|
|
Follow Up Period
Lost to Follow-up
|
61
|
73
|
Baseline Characteristics
SKIPping With PAX: An Integrated Gross Motor and Social-Emotional Skill Intervention
Baseline characteristics by cohort
| Measure |
Gross Motor and Social-emotional Integrated Intervention Group
n=109 Participants
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
|
Control
n=124 Participants
Participants will receive the center's everyday business as usual curriculum.
|
Total
n=233 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
60.88 Months
STANDARD_DEVIATION 6.67 • n=93 Participants
|
61.15 Months
STANDARD_DEVIATION 7.14 • n=4 Participants
|
61.03 Months
STANDARD_DEVIATION 6.91 • n=27 Participants
|
|
Sex: Female, Male
Female
|
54 Participants
n=93 Participants
|
64 Participants
n=4 Participants
|
118 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
55 Participants
n=93 Participants
|
60 Participants
n=4 Participants
|
115 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Black
|
15 Participants
n=93 Participants
|
16 Participants
n=4 Participants
|
31 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
White
|
71 Participants
n=93 Participants
|
83 Participants
n=4 Participants
|
154 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
20 Participants
n=93 Participants
|
20 Participants
n=4 Participants
|
40 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
More than one race
|
3 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
8 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: BaselineGross motor development assessment ranges from 0-100 with higher scores reflecting better performance.
Outcome measures
| Measure |
Gross Motor and Social-emotional Integrated Intervention Group
n=109 Participants
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
|
Control
n=124 Participants
Participants will receive the center's everyday business as usual curriculum.
|
|---|---|---|
|
Test of Gross Motor Development, Third Edition
|
41.99 score on a scale
Standard Deviation 14.40
|
43.36 score on a scale
Standard Deviation 13.26
|
PRIMARY outcome
Timeframe: six-month posttestGross motor development assessment ranges from 0-100 with higher scores reflecting better performance.
Outcome measures
| Measure |
Gross Motor and Social-emotional Integrated Intervention Group
n=109 Participants
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
|
Control
n=124 Participants
Participants will receive the center's everyday business as usual curriculum.
|
|---|---|---|
|
Test of Gross Motor Development, Third Edition
|
62.36 score on a scale
Standard Deviation 12.35
|
49.75 score on a scale
Standard Deviation 11.70
|
PRIMARY outcome
Timeframe: three-month follow-upGross motor development assessment ranges from 0-100 with higher scores reflecting better performance.
Outcome measures
| Measure |
Gross Motor and Social-emotional Integrated Intervention Group
n=48 Participants
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
|
Control
n=51 Participants
Participants will receive the center's everyday business as usual curriculum.
|
|---|---|---|
|
Test of Gross Motor Development, Third Edition
|
51.02 score on a scale
Standard Deviation 10.97
|
46.39 score on a scale
Standard Deviation 12.05
|
PRIMARY outcome
Timeframe: BaselineSocial-Emotional scores range from 0-160 with higher scores reflecting better performance.
Outcome measures
| Measure |
Gross Motor and Social-emotional Integrated Intervention Group
n=109 Participants
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
|
Control
n=124 Participants
Participants will receive the center's everyday business as usual curriculum.
|
|---|---|---|
|
Social Skills Improvement System Rating Scales
|
85.63 score on a scale
Standard Deviation 21.65
|
96.38 score on a scale
Standard Deviation 20.33
|
PRIMARY outcome
Timeframe: six-month posttestSocial-Emotional scores range from 0-160 with higher scores reflecting better performance.
Outcome measures
| Measure |
Gross Motor and Social-emotional Integrated Intervention Group
n=109 Participants
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
|
Control
n=124 Participants
Participants will receive the center's everyday business as usual curriculum.
|
|---|---|---|
|
Social Skills Improvement System Rating Scales
|
89.24 score on a scale
Standard Deviation 20.30
|
93.03 score on a scale
Standard Deviation 21.29
|
PRIMARY outcome
Timeframe: three-month follow-upSocial-Emotional scores range from 0-160 with higher scores reflecting better performance.
Outcome measures
| Measure |
Gross Motor and Social-emotional Integrated Intervention Group
n=48 Participants
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
|
Control
n=51 Participants
Participants will receive the center's everyday business as usual curriculum.
|
|---|---|---|
|
Social Skills Improvement System Rating Scales
|
86.27 score on a scale
Standard Deviation 16.77
|
93.00 score on a scale
Standard Deviation 22.82
|
SECONDARY outcome
Timeframe: BaselinePopulation: 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.
The accelerometer, which children wear throughout the day, records step counts which are then converted into numerical representation of levels of physical activity.
Outcome measures
Outcome data not reported
Adverse Events
Gross Motor and Social-emotional Integrated Intervention Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Director, USC Office of Research Compliance
University of South Carolina
Phone: 803 777-6670
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place