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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gross motor and social-emotional integrated intervention group | Experimental | Participants will receive a nine-month intervention which focuses on gross motor skills, physical activity, and social-emotional skills. |
|
| Control | No Intervention | Participants will receive the center's everyday business as usual curriculum. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Integrated Intervention | Behavioral | Gross motor and social-emotional integrated intervention |
|
| Measure | Description | Time Frame |
|---|---|---|
| Test of Gross Motor Development, Third Edition | Gross motor development assessment ranges from 0-100 with higher scores reflecting better performance. | Baseline |
| Test of Gross Motor Development, Third Edition | Gross motor development assessment ranges from 0-100 with higher scores reflecting better performance. | six-month posttest |
| 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 |
| Social Skills Improvement System Rating Scales | Social-Emotional scores range from 0-160 with higher scores reflecting better performance. | Baseline |
| Social Skills Improvement System Rating Scales | Social-Emotional scores range from 0-160 with higher scores reflecting better performance. | six-month posttest |
| Social Skills Improvement System Rating Scales | Social-Emotional scores range from 0-160 with higher scores reflecting better performance. | three-month follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lexington 4 Early Childhood Center | Swansea | South Carolina | 29160 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | Control | Participants will receive the center's everyday business as usual curriculum. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline |
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| Intervention |
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| Follow Up Period |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Test of Gross Motor Development, Third Edition | Gross motor development assessment ranges from 0-100 with higher scores reflecting better performance. | Posted | Mean | Standard Deviation | score on a scale | Baseline |
|
Baseline, during intervention, posttest, follow up for a total of 12 months
Participants did not partake in any activities that would stray or differ from what could potentially be offered in a school setting.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director, USC Office of Research Compliance | University of South Carolina | 803 777-6670 | lisaj@mailbox.sc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 30, 2019 | Mar 20, 2025 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jul 30, 2019 | Jun 12, 2024 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D066107 | Social Skills |
| D012919 | Social Behavior |
| D057185 | Sedentary Behavior |
| ID | Term |
|---|---|
| D001519 | Behavior |
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| NOT COMPLETED |
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| NOT COMPLETED |
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| Control |
Participants will receive the center's everyday business as usual curriculum. |
| BG002 | Total | Total of all reporting groups |
| Months |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Units | Counts |
|---|---|
| Participants |
|
|
| Primary | Test of Gross Motor Development, Third Edition | Gross motor development assessment ranges from 0-100 with higher scores reflecting better performance. | Posted | Mean | Standard Deviation | score on a scale | six-month posttest |
|
|
|
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| Primary | Test of Gross Motor Development, Third Edition | Gross motor development assessment ranges from 0-100 with higher scores reflecting better performance. | Posted | Mean | Standard Deviation | score on a scale | three-month follow-up |
|
|
|
| Primary | Social Skills Improvement System Rating Scales | Social-Emotional scores range from 0-160 with higher scores reflecting better performance. | Posted | Mean | Standard Deviation | score on a scale | Baseline |
|
|
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| Primary | Social Skills Improvement System Rating Scales | Social-Emotional scores range from 0-160 with higher scores reflecting better performance. | Posted | Mean | Standard Deviation | score on a scale | six-month posttest |
|
|
|
|
| Primary | Social Skills Improvement System Rating Scales | Social-Emotional scores range from 0-160 with higher scores reflecting better performance. | Posted | Mean | Standard Deviation | score on a scale | three-month follow-up |
|
|
|
| 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. | 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. | Posted | Baseline |
|
|
| 0 |
| 129 |
| 0 |
| 129 |
| 0 |
| 129 |
| EG001 | Control | Participants will receive the center's everyday business as usual curriculum. | 0 | 148 | 0 | 148 | 0 | 148 |
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