Viewing Study NCT06163560



Ignite Creation Date: 2024-05-06 @ 7:51 PM
Last Modification Date: 2024-10-26 @ 3:15 PM
Study NCT ID: NCT06163560
Status: NOT_YET_RECRUITING
Last Update Posted: 2024-05-08
First Post: 2023-11-20

Brief Title: Effectiveness of a Baby App for Enhancing Infant Mental Well-being RCT
Sponsor: The University of Hong Kong
Organization: The University of Hong Kong

Study Overview

Official Title: Effectiveness of a Technology-based Developmental Guidance Program for Enhancing Infant Mental Well-being A Randomized Controlled Trial
Status: NOT_YET_RECRUITING
Status Verified Date: 2024-05
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: 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
Detailed Description: 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 eg 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

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: False
Is an FDA AA801 Violation?: None