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NCT Number: NCT06163560

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

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.

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Key information

Conditions

Age range

1 day–18 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Li Ka Shing Faculty of Medicine

Hong Kong, 0000

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Smartphone app "Happy Baby HK"

Device

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

Family Health Service parenting booklet

Device

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

Primary outcomes

  1. At 6 postpartum

    Time frame: 6 months postpatrum

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

  2. 12 months postpartum

    Time frame: 12 months postpatrum

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

Secondary outcomes

  1. At 18 months postpartum (child development)

    Time frame: 18 months postpartum

    Mothers will be asked to answer the 18 months version of Ages & Stages Questionnaires.

  2. At 18 months postpartum (screen time)

    Time frame: 18 months postpartum

    Mothers will be asked to answer the family questionnaire items related to child screen time use.

  3. At 18 months postpartum (DASS-21)

    Time frame: 18 months postpartum

    Mothers will be asked to complete Depression Anxiety Stress Scale - 21.

  4. At 18 months postpartum (KIDI)

    Time frame: 18 months postpartum

    Mothers will be asked to complete the Knowledge of Infant Development Inventory Accuracy Score.

  5. At 18 months postpartum (PSS)

    Time frame: 18 months postpartum

    Mothers will be asked to complete the Parental stress scale (PSS).

Study contacts

Contact information is provided by the study sponsor or research team.

Oscar Leung, MSocSc

CONTACT

[email protected]

22554375

Tracy LI, MPH

CONTACT

[email protected]

22554375

Sponsors and collaborators

Lead sponsor

The University of Hong Kong

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Dec 11, 2023
Registry last updated
Mar 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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