Child DevelopmentNCT06163560
Effectiveness of a Baby App for Enhancing Infant Mental Well-being (RCT)
A study testing Smartphone app "Happy Baby HK" and Family Health Service parenting booklet in people with Child Development, run by The University of Hong Kong at 1 site in Hong Kong.
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. Read more about this study
- Who is it for?
- Ages 1 day to 18 monthsHealthy volunteers can take part
- Conditions the study is for
- Child Development
- What is being tested?
- Smartphone app "Happy Baby HK" and Family Health Service parenting booklet
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 586 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Apr 2025to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 18 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read the 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.
- Conditions
- Child Development
- Being tested
- Smartphone app "Happy Baby HK", Family Health Service parenting booklet
- Keywords
- Infant mental health, Parenting skills, Smartphone app
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 bookletDevice
The parenting booklet is publicly available and provides brief caretaking tips for mothers with children under 3 years of age.
| Study group | Role | What they receive |
|---|---|---|
| Babyapp group | Experimental | This group will be provided access to the app and be asked for their feedback on the performance of the app. Receives: 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). Receives: Device: Family Health Service parenting booklet |
What is being measured
The primary outcome is the main question the study is designed to answer.
At 6 postpartum
Mothers will be asked to answer the 6 months version of Ages \& Stages Questionnaires.
Measured: 6 months postpatrum
12 months postpartum
Mothers will be asked to answer the 12 months version of Ages \& Stages Questionnaires.
Measured: 12 months postpatrum
Secondary outcomes (5)
At 18 months postpartum (child development)
Mothers will be asked to answer the 18 months version of Ages \& Stages Questionnaires.
Measured: 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.
Measured: 18 months postpartum
At 18 months postpartum (DASS-21)
Mothers will be asked to complete Depression Anxiety Stress Scale - 21.
Measured: 18 months postpartum
At 18 months postpartum (KIDI)
Mothers will be asked to complete the Knowledge of Infant Development Inventory Accuracy Score.
Measured: 18 months postpartum
At 18 months postpartum (PSS)
Mothers will be asked to complete the Parental stress scale (PSS).
Measured: 18 months postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2023
- Study start1 Apr 2025 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Child DevelopmentStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 586 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Winnie Wan Yee Tso (Dr), The University of Hong Kong
- Investigators
- Winnie Wan Yee Tso, MBBS, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06163560
- Sponsor's protocol ID
- Babyapp_rct
- Status last verified
- Mar 2025
- First submitted
- 20 Nov 2023
- Last updated
- 28 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Technology-based Developmental Guidance Program for Enhancing Infant Mental Well-being: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06163560
- Acronym / sponsor ID
- Babyapp_rct
- Conditions
- Child Development
- Keywords
- Infant mental health, Parenting skills, Smartphone app
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 586 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 1 Apr 2025 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 11 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Babyapp group | Experimental | Device: Smartphone app "Happy Baby HK"This group will be provided access to the app and be asked for their feedback on the performance of the app. |
| Control group | Active comparator | Device: Family Health Service parenting bookletThis group will be given an information pack consisting of a parenting booklet from the Maternal and Child Health Centres (MCHC). |
Who may qualify
- Ages
- 1 day to 18 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Smartphone app "Happy Baby HK""Happy Baby HK" will provide developmental stage, developmental aspects, parenting videos and cartoon images created for new mothers. | Device | Babyapp group |
| Family Health Service parenting bookletThe parenting booklet is publicly available and provides brief caretaking tips for mothers with children under 3 years of age. | Device | Control group |
Primary outcome
At 6 postpartum
Time frame: 6 months postpatrum
Mothers will be asked to answer the 6 months version of Ages \& Stages Questionnaires.
12 months postpartum
Time frame: 12 months postpatrum
Mothers will be asked to answer the 12 months version of Ages \& Stages Questionnaires.
5 secondary outcomes
At 18 months postpartum (child development)
Time frame: 18 months postpartum
At 18 months postpartum (screen time)
Time frame: 18 months postpartum
At 18 months postpartum (DASS-21)
Time frame: 18 months postpartum
At 18 months postpartum (KIDI)
Time frame: 18 months postpartum
At 18 months postpartum (PSS)
Time frame: 18 months postpartum
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Winnie Wan Yee Tso, MBBS principal investigator
The University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Smartphone app "Happy Baby HK" and Family Health Service parenting booklet in people with Child Development, run by The University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 28 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tracy LI, MPH (22554375, tracyli8@hku.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
At 6 postpartum (time frame: 6 months postpatrum). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2025.