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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Child Development
• Intervention / Treatment: Device: Smartphone app "Happy Baby HK"; Device: Family Health Service parenting booklet

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.

• Study Type: Interventional
• Enrollment (Estimated): 586
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Tracy LI, MPH; Phone Number: 22554375; Email: tracyli8@hku.hk
• Study Contact Backup: Name: Oscar Leung, MSocSc; Phone Number: 22554375; Email: oscarlk@hku.hk

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong, 0000
    • Li Ka Shing Faculty of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Babyapp group; This group will be provided access to the app and be asked for their feedback on the performance of the app.	Device: Smartphone app "Happy Baby HK"; "Happy Baby HK" will provide developmental stage, developmental aspects, parenting videos and cartoon images created for new mothers.
Active Comparator: Control group; This group will be given an information pack consisting of a parenting booklet from the Maternal and Child Health Centres (MCHC).	Device: Family Health Service parenting booklet; The parenting booklet is publicly available and provides brief caretaking tips for mothers with children under 3 years of age.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
At 6 postpartum	Mothers will be asked to answer the 6 months version of Ages & Stages Questionnaires.	6 months postpatrum
12 months postpartum	Mothers will be asked to answer the 12 months version of Ages & Stages Questionnaires.	12 months postpatrum

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: The University of Hong Kong
• Investigators: Principal Investigator: Winnie Wan Yee Tso, MBBS, The University of Hong Kong

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: November 20, 2023
• First Submitted That Met QC Criteria: November 30, 2023
• First Posted (Actual): December 11, 2023

Study Record Updates

• Last Update Posted (Actual): March 28, 2025
• Last Update Submitted That Met QC Criteria: March 24, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: Infant mental health; Smartphone app; Parenting skills
• Other Study ID Numbers: Babyapp_rct

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No