Gross Motor Development DelayNCT04656990
SKIPping With PAX: An Integrated Gross Motor and Social-Emotional Skill Intervention
A study testing Integrated Intervention in people with Gross Motor Development Delay and Social Skills, run by University of South Carolina at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 4 to 5 yearsHealthy volunteers can take part
- Conditions the study is for
- Gross Motor Development Delay, Social Skills, Social Behavior
- What is being tested?
- Integrated Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 277 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2020to 18 Feb 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 5 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Enrolled in the early childhood center, aged 4-5 years
Who cannot join
- Enrolled in special education classroom
Trial locations and contacts
1 site in 1 country.
United States1 site
Lexington 4 Early Childhood Center
Swansea, South Carolina, 29160
About this study
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.
- Being tested
- Integrated Intervention
- Medical subject headings
- Social Skills, Social Behavior, Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Integrated InterventionBehavioural
Gross motor and social-emotional integrated intervention
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Integrated Intervention |
| Control | No intervention | Participants will receive the center's everyday business as usual curriculum. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Test of Gross Motor Development, Third Edition
Gross motor development assessment ranges from 0-100 with higher scores reflecting better performance.
Measured: Baseline
Test of Gross Motor Development, Third Edition
Gross motor development assessment ranges from 0-100 with higher scores reflecting better performance.
Measured: six-month posttest
Test of Gross Motor Development, Third Edition
Gross motor development assessment ranges from 0-100 with higher scores reflecting better performance.
Measured: three-month follow-up
Social Skills Improvement System Rating Scales
Social-Emotional scores range from 0-160 with higher scores reflecting better performance.
Measured: Baseline
Social Skills Improvement System Rating Scales
Social-Emotional scores range from 0-160 with higher scores reflecting better performance.
Measured: six-month posttest
Social Skills Improvement System Rating Scales
Social-Emotional scores range from 0-160 with higher scores reflecting better performance.
Measured: three-month follow-up
Secondary outcomes (1)
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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2020
- Study start1 Sep 2020
- Primary completion31 Oct 2022
- Study completion18 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Gross Motor Development DelayStudies of the same condition, open and under way.
- More trials run by University of South CarolinaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 277 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of South Carolina
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ali Brian, University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04656990
- Sponsor's protocol ID
- Pro00091603
- Status last verified
- Apr 2025
- First submitted
- 16 Nov 2020
- Last updated
- 20 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SKIPping With PAX: An Integrated Gross Motor and Social-Emotional Skill Intervention
- ClinicalTrials.gov ID
- NCT04656990
- Acronym / sponsor ID
- Pro00091603
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 277 participants (actual)
- Lead sponsor
- University of South CarolinaUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 31 Oct 2022 (actual)
- Study completion
- 18 Feb 2023 (actual)
- First posted
- 7 Dec 2020 (actual)
- Results
- Posted 20 Apr 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gross motor and social-emotional integrated intervention group | Experimental | Behavioral: Integrated InterventionParticipants 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. |
Who may qualify
- Ages
- 4 to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Enrolled in the early childhood center, aged 4-5 years
Key exclusion criteria (1 listed)
- Enrolled in special education classroom
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Integrated InterventionGross motor and social-emotional integrated intervention | Behavioural | Gross motor and social-emotional integrated intervention group |
Primary outcome
Test of Gross Motor Development, Third Edition
Time frame: Baseline
Gross motor development assessment ranges from 0-100 with higher scores reflecting better performance.
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.
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.
Social Skills Improvement System Rating Scales
Time frame: Baseline
Social-Emotional scores range from 0-160 with higher scores reflecting better performance.
Social Skills Improvement System Rating Scales
Time frame: six-month posttest
Social-Emotional scores range from 0-160 with higher scores reflecting better performance.
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.
1 secondary outcome
Physical Activity From Accelerometer
Time frame: Baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Integrated Intervention in people with Gross Motor Development Delay and Social Skills, run by University of South Carolina at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Test of Gross Motor Development, Third Edition (time frame: Baseline). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2025.