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临床试验/NCT02704221
NCT02704221已完成不适用

Enhancing the Outcomes of a Behavioral Parent Training Intervention

Christina Studts2 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2016年3月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
24
试验地点
2
主要终点
Proportion of participants who complete study procedures within study timeframe

研究概览

简要总结

This study is a feasibility trial, testing the hypothesis that among sedentary mothers of behaviorally at-risk preschool-aged children, those who receive behavioral parent training (BPT) programs and concurrently increase their physical activity levels will demonstrate improved parenting and child behavior outcomes compared to those who receive BPT but remain sedentary.

详细描述

The investigators will randomly assign 20 participants to two groups: behavioral parent training plus contingency management to increase steps (BPT+CM) or behavioral parent training alone (BPT). Contingency management procedures will involve monetary rewards for meeting weekly step-count goals.

The specific aims of the proposed project are to: 1) assess the feasibility of the study design and procedures, 2) assess the acceptability of the BPT+CM condition to participants, and 3) determine whether a signal of an effect of increased physical activity exists (via preliminary comparisons of measures of fatigue, perceived energy, parenting behaviors, parenting sense of competence, parenting stress, and child behavior ratings between participants in the two conditions).

This innovative pilot study will prepare us for a fully powered trial to test the efficacy of this approach.

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
Single (Investigator)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Age 18 years or older
  • Custodial caregiver of a child aged 2-5 years who lives full-time in the caregiver's home
  • Reports that her child has behavioral problems
  • Never or rarely engages in regular physical activity
  • Able to understand, speak, and read English

排除标准

  • The child has been diagnosed with a severe developmental condition (e.g., extreme developmental delay, severe autism, debilitating neurological conditions)
  • Participant reports a condition that may contraindicate physical activity (e.g., asthma)

研究组 & 干预措施

Behavioral Parent Training (BPT)

Active Comparator

The control group will include 10 participants who will 1) wear Fitbit activity trackers daily for 12 weeks and 2) attend 12 weekly BPT training sessions.

干预措施: Fitbit activity tracker (Behavioral)

Behavioral Parent Training (BPT)

Active Comparator

The control group will include 10 participants who will 1) wear Fitbit activity trackers daily for 12 weeks and 2) attend 12 weekly BPT training sessions.

干预措施: BPT training sessions (Behavioral)

BPT + Contingency Management (BPT+CM)

Experimental

The experimental group will include 10 participants who will 1) wear Fitbit activity trackers daily for 12 weeks, 2) attend 12 weekly BPT training sessions, and 3) receive monetary rewards for achieving weekly step-count goals.

干预措施: Fitbit activity tracker (Behavioral)

BPT + Contingency Management (BPT+CM)

Experimental

The experimental group will include 10 participants who will 1) wear Fitbit activity trackers daily for 12 weeks, 2) attend 12 weekly BPT training sessions, and 3) receive monetary rewards for achieving weekly step-count goals.

干预措施: Monetary rewards (Behavioral)

BPT + Contingency Management (BPT+CM)

Experimental

The experimental group will include 10 participants who will 1) wear Fitbit activity trackers daily for 12 weeks, 2) attend 12 weekly BPT training sessions, and 3) receive monetary rewards for achieving weekly step-count goals.

干预措施: BPT training sessions (Behavioral)

结局指标

主要结局

Proportion of participants who complete study procedures within study timeframe

时间窗: 14 months

次要结局

  • Participant satisfaction of both control and experimental arms(1 week after completion of final BPT session)
  • Step counts(end of 2-week screening period, and once per week for 12 weeks)
  • Parenting behaviors(baseline and 1 week after completion of final BPT session)
  • Child behaviors(baseline and 1 week after completion of final BPT session)
  • Time required per participant to complete all instruments(14 months)
  • 2-minute step test(baseline and 1 week after completion of final BPT session)
  • Parenting stress(baseline and 1 week after completion of final BPT session)
  • Parenting sense of competence(baseline and 1 week after completion of final BPT session)
  • Parent depression(baseline and 1 week after completion of final BPT session)
  • Self-reported physical activity level(baseline and 1 week after completion of final BPT session)
  • Visual Analog Scale-Fatigue(baseline and 1 week after completion of final BPT session)

研究者

发起方
Christina Studts
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Christina Studts

Assistant Professor

University of Kentucky

研究点 (2)

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