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临床试验/NCT04622969
NCT04622969已完成不适用

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

University of South Carolina2 个研究点 分布在 1 个国家目标入组 63 人开始时间: 2021年4月12日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
63
试验地点
2
主要终点
Child Behavior Problems

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
3 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

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

结局指标

主要结局

Child Behavior Problems

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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.

次要结局

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

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ron Prinz, PhD

Professor

University of South Carolina

研究点 (2)

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