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临床试验/NCT06163560
NCT06163560尚未招募不适用

Effectiveness of a Technology-based Developmental Guidance Program for Enhancing Infant Mental Well-being: a Randomized Controlled Trial

The University of Hong Kong1 个研究点 分布在 1 个国家目标入组 586 人开始时间: 2025年4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
尚未招募
入组人数
586
试验地点
1
主要终点
At 6 postpartum

研究概览

简要总结

This RCT aims to design and develop a developmental guidance program delivered by a smartphone app "Happy Baby HK" and evaluate its effectiveness for enhancing the mental well-being of recently born infants in Hong Kong. This study will evaluate the effectiveness of the improvement in the effect of infants and decrease of risk of developmental delay in very young children.

The smartphone app "Happy Baby HK" will be designed and developed by different professionals. Then, participants will be invited to use this app or the MCHC parenting booklet. They will also be invited to fill in some questionnaires at 6, 12 and 18 months postpartum to screen the developmental stages. Researchers will compare the intervention group and the control group to evaluate the effectiveness of this app for enhancing the mental well-being of infants.

详细描述

Infant mental health refers to "the developing capacity of the child from birth to age three to experience, regulate, and express emotions; form close and secure interpersonal relationships; and explore the environment and learn - all in the context of family, community, and cultural expectations for young children". Despite the stability of temperamental characteristics across context and over time, environmental factors such as good mother-infant relationship can protect against the development of psychiatric morbidities in children with difficult temperament. Research studies also show that anticipatory guidance interventions can promote optimal child development, increase maternal knowledge of their infants, positive parent-infant interactions and reduce injury rates.

To enhance infant mental well-being, the proposed project team designs a smartphone app "Happy Baby HK" that provides development guidance to mothers of recently born infants in Hong Kong. Compared to traditional approaches (e.g. parenting pamphlets or clinical consultation on developmental issues), smartphone apps devoted to parenting guidance could feature video demonstrations, quizzes, interactive games, and written information with vivid images and cartoons which are more likely to engage parents and reinforce their learning anytime and anywhere.

However, currently there is no technology-based intervention with provision of anticipatory guidance information on child development in Hong Kong.

Therefore, the objective of this study is to design and develop a developmental guidance program delivered by a smartphone app "Hapy Baby HK" and evaluate its effectiveness for enhancing the mental well-being of recently born infants in Hong Kong. The improvement on parental stress will also be evaluated.

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 (Care Provider)

入排标准

年龄范围
1 Day 至 18 Months(Child)
性别
All
接受健康志愿者
是

入选标准

  • •mothers aged 18 years or above who attend the antenatal clinics or stay in the postnatal wards at Kwong Wah Hospital or Queen Mary Hospital at the time of recruitment and can give consent

排除标准

  • •mothers who have inability to read Chinese, no Internet access, high risk pregnancy, history of psychiatric illness,
  • •infants with congenital/genetic/structural abnormalities,
  • •infants required admission to neonatal intensive care unit

研究组 & 干预措施

Babyapp group

Experimental

This group will be provided access to the app and be asked for their feedback on the performance of the app.

干预措施: Smartphone app "Happy Baby HK" (Device)

Control group

Active Comparator

This group will be given an information pack consisting of a parenting booklet from the Maternal and Child Health Centres (MCHC).

干预措施: Family Health Service parenting booklet (Device)

结局指标

主要结局

At 6 postpartum

时间窗: 6 months postpatrum

Mothers will be asked to answer the 6 months version of Ages \& Stages Questionnaires.

12 months postpartum

时间窗: 12 months postpatrum

Mothers will be asked to answer the 12 months version of Ages \& Stages Questionnaires.

次要结局

  • At 18 months postpartum (screen time)(18 months postpartum)
  • At 18 months postpartum (KIDI)(18 months postpartum)
  • At 18 months postpartum (PSS)(18 months postpartum)
  • At 18 months postpartum (child development)(18 months postpartum)
  • At 18 months postpartum (DASS-21)(18 months postpartum)

研究者

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

Winnie Wan Yee Tso (Dr)

Clinical Assistant Professor

The University of Hong Kong

研究点 (1)

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