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临床试验/NCT04383340
NCT04383340已完成不适用

Sensitivity Training for Mothers With Premature Infants: A Randomized Controlled Trial

The University of Hong Kong1 个研究点 分布在 1 个国家目标入组 68 人开始时间: 2018年2月1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
68
试验地点
1
主要终点
Infant's weight gain

研究概览

简要总结

This study evaluated the effectiveness of a culturally adapted version of the Mother-Infant Transaction Program (MITP) among Chinese mothers with premature infants in public hospitals in Hong Kong.

详细描述

Potential participants at two public hospitals in Hong Kong were identified by ward nurses. Mother-infant dyads with infants born at 36 weeks or earlier were assessed for eligibility. Data collection was conducted after obtaining written consent from the mothers. Mother-infant dyads who met the inclusion criteria were randomly allocated to either the intervention or the treatment-as-usual control group. Each dyad was assessed at six time points, i.e., baseline, immediately after intervention/TAU, and when the infants were at the gestation-corrected ages of 3, 6, 9, and 12 months.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Outcomes Assessor)

盲法说明

All individual assessments were conducted by a clinical psychologist at the hospital who was blinded to the experimental condition of the participants.

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

  • Mothers with premature infants born at 36 weeks or earlier

排除标准

  • insufficient spoken and written Chinese ability of the mother
  • mother under 18 years of age
  • triplets or higher multiples
  • infants with congenital abnormalities (e.g., metabolic disorder, chromosomal disorder)

结局指标

主要结局

Infant's weight gain

时间窗: At infant's corrected age of 12 months

Infant's weight gain from birth

Maternal postnatal depression

时间窗: At infant's corrected age of 6 months

Maternal depression measured by the Edinburgh Postnatal Depression Scale. Possible scores range from 0 to 30. Higher scores indicate higher levels of depression.

Parenting stress

时间窗: At infant's corrected age of 6 months

Parenting stress measured by the Parenting Stress Index-Short Form. Possible scores range from 36 to 180. Higher scores indicate higher levels of parenting stress.

Infant's temperament

时间窗: At infant's corrected age of 6 months

Infant's soothability based on the Infant Behavior Questionnaire. A higher average score denotes higher soothability of the infant, and the highest possible score is 7.

Behavioral observation of mother-infant interactions

时间窗: At infant's corrected age of 6 months

Maternal sensitivity and quality of mother-infant interaction measured by coding a 5-min video of mother-infant interaction. The coded variables are rated on a 5-point scale, and higher scores indicate higher maternal sensitivity and better interaction quality.

Infant's developmental outcomes

时间窗: At infant's corrected age of 12 months

Measured by the Cognitive Battery of the Merrill-Palmer-Revised Scales of Development, which includes assessments in the cognitive, receptive language, and fine motor domains. Higher scores denote better performance in the assessments

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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