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Effectiveness of a Baby App for Enhancing Infant Mental Well-being (RCT)

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

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06163560
Enrollment
586
Registered
2023-12-11
Start date
2025-04-01
Completion date
2027-12-31
Last updated
2025-03-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Child Development

Keywords

Infant mental health, Parenting skills, Smartphone app

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 (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.

Interventions

DEVICESmartphone app Happy Baby HK

Happy Baby HK will provide developmental stage, developmental aspects, parenting videos and cartoon images created for new mothers.

DEVICEFamily Health Service parenting booklet

The parenting booklet is publicly available and provides brief caretaking tips for mothers with children under 3 years of age.

Sponsors

The University of Hong Kong
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Caregiver)

Eligibility

Sex/Gender
ALL
Age
1 Days to 18 Months
Healthy volunteers
Yes

Inclusion criteria

* 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

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
At 6 postpartum6 months postpatrumMothers will be asked to answer the 6 months version of Ages & Stages Questionnaires.
12 months postpartum12 months postpatrumMothers will be asked to answer the 12 months version of Ages & Stages Questionnaires.

Secondary

MeasureTime frameDescription
At 18 months postpartum (DASS-21)18 months postpartumMothers will be asked to complete Depression Anxiety Stress Scale - 21.
At 18 months postpartum (child development)18 months postpartumMothers will be asked to answer the 18 months version of Ages & Stages Questionnaires.
At 18 months postpartum (PSS)18 months postpartumMothers will be asked to complete the Parental stress scale (PSS).
At 18 months postpartum (KIDI)18 months postpartumMothers will be asked to complete the Knowledge of Infant Development Inventory Accuracy Score.
At 18 months postpartum (screen time)18 months postpartumMothers will be asked to answer the family questionnaire items related to child screen time use.

Countries

Hong Kong

Contacts

Primary ContactTracy LI, MPH
tracyli8@hku.hk22554375
Backup ContactOscar Leung, MSocSc
oscarlk@hku.hk22554375

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026