NCT06163560

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
586

participants targeted

Target at P75+ for not_applicable

Timeline
17mo left

Started Apr 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress49%
Apr 2025Dec 2027

First Submitted

Initial submission to the registry

November 20, 2023

Completed
21 days until next milestone

First Posted

Study publicly available on registry

December 11, 2023

Completed
1.3 years until next milestone

Study Start

First participant enrolled

April 1, 2025

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

March 28, 2025

Status Verified

March 1, 2025

Enrollment Period

1.8 years

First QC Date

November 20, 2023

Last Update Submit

March 24, 2025

Conditions

Child Development

Keywords

Infant mental healthParenting skillsSmartphone app

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (5)

  • At 18 months postpartum (child development)

    18 months postpartum

  • At 18 months postpartum (screen time)

    18 months postpartum

  • At 18 months postpartum (DASS-21)

    18 months postpartum

  • At 18 months postpartum (KIDI)

    18 months postpartum

  • At 18 months postpartum (PSS)

    18 months postpartum

Study Arms (2)

Babyapp group

EXPERIMENTAL

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"

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).

Device: Family Health Service parenting booklet

Interventions

Smartphone app "Happy Baby HK"DEVICE

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

Babyapp group
Family Health Service parenting bookletDEVICE

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

Control group

Eligibility Criteria

Age1 Day - 18 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Li Ka Shing Faculty of Medicine

Hong Kong, Hong Kong, 0000, Hong Kong

Location

Study Officials

  • Winnie Wan Yee Tso, MBBS

    The University of Hong Kong

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Tracy LI, MPH

CONTACT

22554375tracyli8@hku.hk

Oscar Leung, MSocSc

CONTACT

22554375oscarlk@hku.hk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Assistant Professor

Study Record Dates

First Submitted

November 20, 2023

First Posted

December 11, 2023

Study Start

April 1, 2025

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2027

Last Updated

March 28, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations

HK(1)