Clinical trial NCT06163560: Effectiveness of a Baby App for Enhancing Infant Mental Well-being (RCT)
Official title: Effectiveness of a Technology-based Developmental Guidance Program for Enhancing Infant Mental Well-being: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Child Development
Keywords: Infant mental health
Parenting skills
Smartphone app
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2023-12-11
Enrollment: 586
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: At 6 postpartum
timeFrame: 6 months postpatrum
measure: 12 months postpartum
timeFrame: 12 months postpatrum
Secondary outcomes:
measure: At 18 months postpartum (child development)
timeFrame: 18 months postpartum
measure: At 18 months postpartum (screen time)
timeFrame: 18 months postpartum
measure: At 18 months postpartum (DASS-21)
timeFrame: 18 months postpartum
measure: At 18 months postpartum (KIDI)
timeFrame: 18 months postpartum
measure: At 18 months postpartum (PSS)
timeFrame: 18 months postpartum
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Li Ka Shing Faculty of Medicine
Study officials:
affiliation: The University of Hong Kong
name: Winnie Wan Yee Tso, MBBS
role: PRINCIPAL_INVESTIGATOR
References: