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Integrated Intervention for Social Behavior

N/A

Waitlist Available

Research Sponsored by University of South Carolina

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up three-month follow-up

Awards & highlights

Study Summary

This trial found that an intervention focusing on gross motor and social-emotional skills helped improve those skills in young children, with benefits lasting up to nine months after the intervention ended. The intervention also had positive effects on physical activity and sedentary behavior.

Eligible Conditions

Social Behavior
Gross Motor Delay
Social Skills
Sedentary Lifestyle

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ three-month follow-up

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~three-month follow-up

This trial's timeline: 3 weeks for screening, Varies for treatment, and three-month follow-up for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Social Skills Improvement System Rating Scales

Social Skills Improvement System Rating Scales SSIS-RS

Test of Gross Motor Development, Third Edition

+1 more

Secondary outcome measures

Accelerometers

Other outcome measures

NIH Toolbox Dimensional Change Card Sort Age 3-7

NIH Toolbox Flanker Inhibitory Control & Attention Test Ages 3-7

NIH Toolbox Picture Sequence Memory Test Ages 3-4;

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Gross motor and social-emotional integrated intervention groupExperimental Treatment1 Intervention

Participants will receive a nine-month intervention which focuses on gross motor skills, physical activity, and social-emotional skills.

Group II: ControlActive Control1 Intervention

Participants will receive the center's everyday business as usual curriculum.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Integrated Intervention

2015

Completed Phase 3

~2490

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of South CarolinaLead Sponsor

211 Previous Clinical Trials

120,259 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What demographic might be most likely to benefit from participating in this clinical trial?

"This clinical trial requires 200 applicants aged 4 and 5 years old, who are able to demonstrate a basic level of social skills."

Answered by AI

Are adults aged 35 and above eligible for this research?

"This medical trial only allows for children between the ages of 4 and 5 to enrol. There are 12 separate studies designed specifically for minors, while 46 clinical trials are available to individuals over 65 years old."

Answered by AI

Are currently enrolling participants in this trial?

"Clinicaltrials.gov indicates that this research endeavour is not currently open to new participants; the trial was initially posted on September 1st, 2020 and last modified on December 4th 2022. However, there are presently 65 other clinical trials actively seeking patients."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Ali Brian 2020. "SKIPping With PAX: An Integrated Gross Motor and Social-Emotional Skill Intervention". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04656990.