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Clinical Trials/NCT04622969
NCT04622969
Completed
N/A

Targeting Behavioral Adjustment and Healthy Lifestyle in Preschool-age Children Using an Integrated Family-Based Intervention

University of South Carolina1 site in 1 country63 target enrollmentApril 12, 2021

Overview

Phase
N/A
Intervention
Not specified
Conditions
Child Behavior
Sponsor
University of South Carolina
Enrollment
63
Locations
1
Primary Endpoint
Child Behavior Problems
Status
Completed
Last Updated
12 months ago

Overview

Brief Summary

This study conducts a preliminary test of an intervention program delivered in the home to assist families of preschool-age children with social, emotional, and behavioral development, and the acquisition of healthy lifestyle behaviors.

Detailed Description

Utilizing referrals from community-based organizations serving high-risk families, this study addresses both health and behavioral domains through a family-based intervention. The home-delivered prevention intervention includes content on strengthening positive behaviors in children, managing misbehavior, and addressing healthy lifestyle choices. Families engage in practical skill building and have the opportunity to practice these skills and receive feedback.

Registry
clinicaltrials.gov
Start Date
April 12, 2021
End Date
January 26, 2024
Last Updated
12 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Ron Prinz, PhD

Professor

University of South Carolina

Eligibility Criteria

Inclusion Criteria

  • parent has primary custody of the child
  • one or more children in the home is in the 3 to 4 year old age range
  • English-speaking parent
  • parent stated an interest to participate in the program
  • parent completes informed consent process
  • family experiencing economic disadvantage
  • parenting challenges due to child behavior

Exclusion Criteria

  • an open Child Protective Services maltreatment case on the family
  • parent receiving inpatient treatment or enrolled in an institutional-residential treatment program

Outcomes

Primary Outcomes

Child Behavior Problems

Time Frame: six months after baseline assessment

Child behavior problems refers to the Eyberg Child Behavior Inventory Intensity Scale, which is the sum of parental report responses on 36 items. The minimum and maximum values on this measure are 36 and 252 respectively, with higher scores meaning a worse outcome.

Child Physical Activity

Time Frame: six months after baseline assessment

Child physical activity will be measured using an ActiGraph Link accelerometer to assess the number of minutes each day for each level of activity, to arrive at the average number of minutes per day the child spends engaging in moderate and vigorous physical activity.

Child Screen Time

Time Frame: six months after baseline assessment

Multi-day estimate of child screen time will be derived from parental log for the daily amount of child screen time at home.

Child Sleep Duration

Time Frame: six months after baseline assessment

Multi-day estimate of child sleep duration will be derived from parental log for the daily amount of child sleep duration at home.

Secondary Outcomes

  • Parenting Difficulties(six months after baseline assessment)
  • Parental Stress(six months after baseline assessment)
  • Parental Confidence(six months after baseline assessment)

Study Sites (1)

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