- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT04622969
Family-Based Healthy Child Development Program for Preschoolers
This clinical trial explores the effectiveness of a family-based intervention program aimed at improving both behavioral adjustment and healthy lifestyle choices in preschool-age children (3-4 years old). The Healthy Child Development Program focuses on strengthening positive behaviors, managing misbehavior, and promoting healthier daily routines through a 15-week home-delivered curriculum.
The study targets families experiencing economic disadvantage and parenting challenges, with participants randomized into either the immediate intervention group or a waitlist control group. Primary outcomes measured include:
- Child behavior problems (using Eyberg Child Behavior Inventory)
- Physical activity levels (measured by accelerometer)
- Screen time habits
- Sleep duration patterns
Secondary outcomes examine parenting factors including:
- Parenting difficulties (Parenting Scale Total Score)
- Parental stress (Parenting Daily Hassles Scale)
- Parental confidence (Parenting Sense of Competence scale)
The intervention involves practical skill-building sessions where families can practice techniques and receive feedback. Researchers will also evaluate program acceptability, measure completion rates, and assess parent understanding of assessment tools through qualitative interviews.
Conducted by the University of South Carolina with Principal Investigator Kristen D. Seay, Ph.D., MSW, this study enrolled 63 English-speaking families with primary custody of their preschool-aged children. Families with open Child Protective Services cases or parents in institutional treatment programs were excluded from participation.
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