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

Sedentary Behavior Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04656990
• Other study ID #: Pro00091603
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 1, 2020
• Est. completion date: February 18, 2023

Study information

• Verified date: December 2022
• Source: University of South Carolina
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 200
• Est. completion date: February 18, 2023
• Est. primary completion date: October 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 4 Years to 5 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Enrolled in special education classroom

Related Conditions & MeSH terms

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

Intervention

Behavioral:
• Integrated Intervention
Gross motor and social-emotional integrated intervention

Locations

Country	Name	City	State
United States	Lexington 4 Early Childhood Center	Swansea	South Carolina

Sponsors (1)

Lead Sponsor	Collaborator
University of South Carolina

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	NIH Toolbox Flanker Inhibitory Control & Attention Test Ages 3-7	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
Other	NIH Toolbox Picture Sequence Memory Test Ages 3-4;	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
Other	NIH Toolbox Dimensional Change Card Sort Age 3-7	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
Primary	Test of Gross Motor Development, Third Edition TGMD-3	Gross motor development assessment ranges from 0-100 with higher scores reflecting better performance.	Baseline
Primary	Test of Gross Motor Development, Third Edition	Gross motor development assessment ranges from 0-100 with higher scores reflecting better performance.	six-month posttest
Primary	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
Primary	Social Skills Improvement System Rating Scales SSIS-RS	Social-Emotional scores range from 0-160 with higher scores reflecting better performance.	Baseline
Primary	Social Skills Improvement System Rating Scales	Social-Emotional scores range from 0-160 with higher scores reflecting better performance.	six-month posttest
Primary	Social Skills Improvement System Rating Scales	Social-Emotional scores range from 0-160 with higher scores reflecting better performance.	three-month follow-up
Secondary	Accelerometers	Physical Activity and Sedentary Behavior	Baseline
Secondary	Accelerometers	Physical Activity and Sedentary Behavior	six-month posttest
Secondary	Accelerometers	Physical Activity and Sedentary Behavior	three-month follow-up