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

Child Development Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06163560
• Other study ID #: Babyapp_rct
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 1, 2024
• Est. completion date: December 31, 2025

Study information

• Verified date: May 2024
• Source: The University of Hong Kong
• Contact: Tracy LI, MPH
• Phone: 22554375
• Email: tracyli8[@]hku.hk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 586
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 1 Day to 18 Months

Eligibility

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

Related Conditions & MeSH terms

• Child Development

Intervention

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

Locations

Country	Name	City	State
Hong Kong	Li Ka Shing Faculty of Medicine	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
The University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	At 6 postpartum	Mothers will be asked to answer the 6 months version of Ages & Stages Questionnaires.	6 months postpatrum
Primary	12 months postpartum	Mothers will be asked to answer the 12 months version of Ages & Stages Questionnaires.	12 months postpatrum
Secondary	At 18 months postpartum (child development)	Mothers will be asked to answer the 18 months version of Ages & Stages Questionnaires.	18 months postpartum
Secondary	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
Secondary	At 18 months postpartum (DASS-21)	Mothers will be asked to complete Depression Anxiety Stress Scale - 21.	18 months postpartum
Secondary	At 18 months postpartum (KIDI)	Mothers will be asked to complete the Knowledge of Infant Development Inventory Accuracy Score.	18 months postpartum
Secondary	At 18 months postpartum (PSS)	Mothers will be asked to complete the Parental stress scale (PSS).	18 months postpartum