临床试验/jRCT1040240068

jRCT1040240068招募中不适用

Effects of Parent-Child Interaction Therapy with Toddlers (PCIT-Toddlers) for parent-child relationship among late preterm infants : A randomized controlled trial

Nagoya City University0 个研究点入组 80 人开始时间: 2024年8月30日最近更新: 2024年10月28日

适应症

试验速览

阶段: 不适用
状态: 招募中
发起方: Nagoya City University
入组人数: 80
主要终点: Devereux Early Childhood Assessment-Toddler (DECA)

研究概览研究设计入排标准结局指标研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: 干预性
分配方式: 随机
干预模型: parallel assignment
主要目的: treatment purpose
盲法: open(masking not used)

入排标准

年龄范围: 1age 0month 0week old over 至 3age 0month 0week old under（—）
性别: All

入选标准

Child aged between 1 and 2.5 years old at the time of recruitment and discharged NICU when they are newborn babies
Child born between 34 weeks 0 days and 36 weeks six days gestation.
Primary caregiver lives with the participating child and can be involved with them daily.

排除标准

Primary caregivers refuse to participate in the trial
Child with multiple births (two or more children)
Child with chromosomal abnormalities or obvious visual, auditory, or motor impairments
Caregiver who lives separately from the child
Caregiver who uses a language other than Japanese
Candidate who assessed difficulty in participating in the study by the principal investigator
Child receiving individual parent-child based treatment

结局指标

主要结局

Devereux Early Childhood Assessment-Toddler (DECA)

Change score between baseline and post-intervention

次要结局

Brief Infant Toddler Social Emotional Assessment (BITSEA)
Parenting Stress Index Short Form (PSI-SF)
Dyadic Parent-Child Interaction Coding System-IV (DIPICS-IV)

研究者

发起方

Nagoya City University

标识符

jRCT 编号: jRCT1040240068

日期

首次提交: 2024年8月8日 (2年前)
最近更新: 2024年10月28日 (去年)

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