Positive ParentingNCT07599566
Parenting in the Preschool System in Malaysia
A study testing Naungan Kasih Positive Parenting Programme in people with Positive Parenting and Child Maltreatment, run by University of Oxford at 1 site in Malaysia.
Trial summary
This study aims to evaluate the effectiveness of a hybrid human-digital playful parenting programme, "Naungan Kasih-Hybrid (NK-Hybrid)", in Malaysia. The programme is facilitated by teachers from Malaysian preschools for low-income families, consisting of a) one in-person session to introduce caregivers to the… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Positive Parenting, Child Maltreatment, Child Development
- What is being tested?
- Naungan Kasih Positive Parenting Programme
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 772 participants
- Where
- 1 siteMalaysia
- Study dates
- 10 Jul 2024to 17 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Preschools (clusters):
- Registered Ministry of Rural Development (KEMAS) preschool
- Has a class of 20 or more children aged 4-6 years
- Selected by KEMAS leadership as available to participate
- Class teacher is willing to deliver the programme and participates in programme training
- Parents/Caregivers:
Show all 22Show fewer
- Responsible for a child aged 4-6 years enrolled in a participating KEMAS preschool
- Aged 18 years or older
- Has access to a mobile phone compatible with WhatsApp
- Provides informed consent
- Children:
- Enrolled in a participating KEMAS preschool
- Aged 4-6 years
- Parent provides consent
- Provides verbal assent
- Teachers (Facilitators):
- Registered employee with a KEMAS preschool
- Aged 18 years or older
- Diploma/certificate in Early Childhood Education (ECE) or equivalent
- Provides consent
- Completed training
- Available to deliver intervention
Who cannot join
- Parents/caregivers who do not meet inclusion criteria
- Children who do not meet inclusion criteria
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cluster Randomised Trial of a Hybrid Human-digital Playful Parenting Programme in the Malaysian Preschool System
This study aims to evaluate the effectiveness of a hybrid human-digital playful parenting programme, "Naungan Kasih-Hybrid (NK-Hybrid)", in Malaysia. The programme is facilitated by teachers from Malaysian preschools for low-income families, consisting of a) one in-person session to introduce caregivers to the programme, b) teacher-facilitated WhatsApp support groups, and c) an interactive chatbot-led parenting programme featured on WhatsApp, called "Naungan Kasih-Text (NKText)". It tests the effectiveness of this package in a cluster-randomised trial, with 50 preschools as clusters, randomly assigned to either the treatment group or a waitlist control group. Findings from this study will provide evidence for the effectiveness of a low-cost and scalable intervention integrating digital modalities with a "light-touch" in-person component to improve educational outcomes in children attending preschools for low-income families, and thereby address social inequalities in Malaysia.
N = 50 Clusters, 772 Primary Caregivers, 304 Secondary Caregivers, and 754 Children. Enrolment reflects participating primary caregivers.
Read the detailed description
The primary aims of the study are to:
Evaluate the effectiveness of NK-Hybrid on positive parenting at three months post-baseline in comparison to wait-list controls Evaluate the effectiveness of NK-Hybrid on child learning and development, as measured by parent and teacher reports of language and communication, literacy, socioemotional, and numeracy skills, and by direct assessments of literacy and numeracy skills, at approximately 12 months post-baseline in comparison to wait-list controls
Secondary aims of the study include:
Evaluate the sustained effectiveness of NK-Hybrid on positive parenting at approximately 12 months post-baseline.
Evaluate the effectiveness of NK-Hybrid on children's learning, namely their literacy and numeracy skills, in comparison to the control group, at three months post-baseline Evaluate the effectiveness of NK-Hybrid on secondary outcomes - parent involvement in playful learning, child maltreatment (physical and emotional abuse), caregiver anxiety and depression, parenting stress, child externalising symptoms, child learning and development, caregiver financial stress, intimate partner violence, marital health, co-parenting support, father involvement, and gender equitable behaviours - at approximately three months post-baseline and 12 months post-baseline.
Evaluate the intervention costs and cost-effectiveness of NK-Hybrid on primary outcomes of positive parenting and child literacy and numeracy skills.
Evaluate the association between engagement in the NK-Hybrid intervention and primary and secondary outcomes.
Explore potential mediators of positive parenting, child literacy and numeracy skills, child maltreatment, child externalising symptoms, and caregiver depression and anxiety at 12 months post-baseline.
Explore potential moderators of positive parenting, child literacy and numeracy skills, child maltreatment, child externalising symptoms, and caregiver depression and anxiety based on socio-demographics and psychosocial assessments at baseline
In line with the study's primary and secondary objectives, the following hypotheses have been defined a priori and will be evaluated using the methods outlined in this statistical analysis plan.
Hypothesis 1a: Caregivers in the treatment group will show higher levels of positive parenting, in comparison to the control group, at 3 months post-baseline.
Hypothesis 1b: Children in the treatment group will show greater improvements in early learning and development, namely their literacy and numeracy skills, in comparison to the control group, at 12 months post-baseline.
Hypothesis 2a: Caregivers in the treatment group will show higher levels of positive parenting, in comparison to the control group, at 12 months post-baseline.
Hypothesis 2b: Children in the treatment group will show greater improvements in learning, namely their literacy and numeracy skills, in comparison to the control group, at three months post-baseline.
Hypothesis 2c: Caregivers in the treatment group will show lower levels of child maltreatment (physical and emotional abuse), anxiety and depression, parenting stress, child externalising symptoms, financial stress, and intimate partner violence, in comparison to the control group, at 3 months and 12 months post-baseline.
Hypothesis 2d: Caregivers in the treatment group will show higher levels of parent involvement in playful learning, marital health, co-parenting support, father involvement, and gender equitable behaviours in comparison to the control group, at 3 months and 12 months post-baseline.
Hypothesis 3a: The intervention will be more cost-effective than the control condition for the primary outcomes, yielding a cost per unit of effect that supports decision-making by relevant stakeholders.
Hypothesis 3b: Higher engagement with intervention components (i.e., in-person onboarding, NKText, and WhatsApp support groups) will be associated with greater improvements in the aforementioned primary and secondary outcomes.
- Conditions
- Positive Parenting, Child Maltreatment, Child Development, Child Behavior, Parenting Stress, Parent Mental Health
- Being tested
- Naungan Kasih Positive Parenting Programme
- Keywords
- parenting intervention, child development, parenting
- Medical subject headings
- Child Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Naungan Kasih Positive Parenting ProgrammeBehavioural
The programme is facilitated by teachers from Malaysian preschools for low-income families, consisting of a) one in-person session to introduce caregivers to the programme, b) teacher-facilitated WhatsApp support groups, and c) an interactive chatbot-led parenting programme featured on WhatsApp, called "Naungan Kasih-Text".
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Intervention group participants will receive one in-person onboarding session, NKText - a self-guided chatbot providing parenting support, and facilitated WhatsApp support groups. Receives: Behavioral: Naungan Kasih Positive Parenting Programme |
| Control Group | No intervention | The control group will not receive the intervention until after the completion of the intervention period and the final follow-up data collection. Throughout the study period, participants in all groups may access any other interventions, programs, or services that are not part of the study intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Child early learning and development
Children's early learning and development (caregiver- and teacher-report) will be measured using 23 items from the National Preschool Standards-Based Curriculum Assessment (Malaysia); scale = 0-2; higher score indicates better outcome.
Measured: Baseline, 3-5 months post-baseline, 12-15 months post-baseline
Positive Parenting
Positive parenting will be measured using 14 items from the Parenting Young Children Scale (PARYC) (McEachern et al., 2012). (Caregiver Report); (0-6); higher score indicates better outcome.
Measured: Baseline, 3-5 months post-baseline, 12-15 months post-baseline
Child Literacy and Numeracy
Direct child assessments of child learning and development will be conducted by trained research assistants and assessed using an adapted version of the Remote Assessment of Learning (ReAL) High-Access version (Save the Children International, 2021), specifically the Literacy and Numeracy subscales. 12 domains, total score = mean of % correct for each domain; higher score indicates better outcome.
Measured: Baseline, 3-5 months post-baseline, 12-15 months post-baseline
Secondary outcomes (11)
Parent involvement in playful learning
Parent involvement in playful learning will be measured using four items from the UNICEF Multiple Indicator Cluster Surveys (MICS) Child Development Module/Family Care Indicators (Kariger et al., 2012). (4 items) (0-8 times in last two weeks) - higher indicates more playful learning activities (better outcome)
Measured: Baseline, 3-5 months post-baseline, 12-15 months post-baseline
Child Maltreatment
Child maltreatment will be measured using six items from the International Society for the Prevention of Child Abuse and Neglect Child Abuse Screening Tool (Meinck et al., 2018), covering physical violence (two items) and psychological violence (four items). (Parent Report); (0-8 times in last two weeks) - higher indicates more incidence of abuse (worse outcome)
Measured: Baseline, 3-5 months post-baseline, 12-15 months post-baseline
Child externalising symptoms
Child externalising symptoms will be assessed using 12 items from the externalising subscale of the Child and Adolescent Behavior Inventory (CABI) (Cianchetti et al., 2013); (0-2); higher score indicates worse outcome
Measured: Baseline, 3-5 months post-baseline, 12-15 months post-baseline
Parenting Stress
Parenting stress will be assessed using six items from the Parenting Stress Scale (Berry \& Jones, 2016); (0-5); higher score indicates worse outcome
Measured: Baseline, 3-5 months post-baseline, 12-15 months post-baseline
Anxiety and depression
Anxiety and depression will be assessed using four items from the Patient Health Questionnaire (PHQ-4) Scale (Kroenke et al., 2009); (0-3); higher score indicates worse outcome
Measured: Baseline, 3-5 months post-baseline, 12-15 months post-baseline
Father involvement with the child
Father involvement with the child will be assessed using seven items from an adapted version of the Alabama Parenting Questionnaire Involvement Subscale (Frick, 1991); (0-4); higher score indicates better outcome.
Measured: Baseline, 3-5 months post-baseline, 12-15 months post-baseline
Gender equitable behaviours
Gender equitable behaviours will be assessed using four items informed by measures commonly used in violence prevention research (Abramsky et al., 2020; Doyle et al., 2018); (1-5); higher score indicates better outcome
Measured: Baseline, 3-5 months post-baseline, 12-15 months post-baseline
Co-parenting support
Co-parenting support will be assessed using six items from the Co-parenting Relationship Scale (Feinberg et al., 2012); (0-3); higher score indicates better outcome.
Measured: Baseline, 3-5 months post-baseline, 12-15 months post-baseline
Marital health/quality
Marital health/quality will be assessed using five items developed by the research team; (1-5); higher score indicates better outcome
Measured: Baseline, 3-5 months post-baseline, 12-15 months post-baseline
Intimate partner violence
Intimate partner violence will be assessed using four items adapted from the World Health Organisation study on women's health and domestic violence against women (World Health Organization, 2005); (0-3); higher score indicates worse outcome.
Measured: Baseline, 3-5 months post-baseline, 12-15 months post-baseline
Financial Stress
Financial stress will be assessed using six items adapted from the Financial Self-Efficacy Scale (Lown, 2012); (0-3); higher score indicates worse outcome.
Measured: Baseline, 3-5 months post-baseline, 12-15 months post-baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2026
- Study start10 Jul 2024
- Primary completion17 Oct 2025
- Study completion17 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Positive ParentingStudies of the same condition, open and under way.
- More trials run by University of OxfordThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study is a cluster randomised control trial with 50 preschools (clusters) randomly allocated, in a 1:1 ratio, to either a treatment or a control group. Those assigned to the intervention arm will receive the hybrid in-person digital intervention. Those assigned to the control group will be waitlisted to receive the intervention after completion of the research (i.e., 12 months post-baseline).
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 772 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Collaborators
- Universiti Putra Malaysia
- Responsible party
- Principal investigator, DrJamieLachman, University of Oxford
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07599566
- Sponsor's protocol ID
- R94406/RE001
- Other IDs
- 10.17605/OSF.IO/AZ3NY
- Status last verified
- May 2026
- First submitted
- 14 May 2026
- Last updated
- 27 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data underlying the results reported in publications, including demographic variables, caregiver-reported outcomes, and child assessment outcomes.
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cluster Randomised Trial of a Hybrid Human-digital Playful Parenting Programme in the Malaysian Preschool System
- ClinicalTrials.gov ID
- NCT07599566
- Acronym / sponsor ID
- R94406/RE001
- Conditions
- Positive Parenting, Child Maltreatment, Child Development, Child Behavior, Parenting Stress, Parent Mental Health
- Keywords
- parenting intervention, child development, parenting
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 772 participants (actual)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Collaborators
- Universiti Putra Malaysia
- Study start
- 10 Jul 2024 (actual)
- Primary completion
- 17 Oct 2025 (actual)
- Study completion
- 17 Oct 2025 (actual)
- First posted
- 20 May 2026 (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 study aims to evaluate the effectiveness of a hybrid human-digital playful parenting programme, "Naungan Kasih-Hybrid (NK-Hybrid)", in Malaysia. The programme is facilitated by teachers from Malaysian preschools for low-income families, consisting of a) one in-person session to introduce caregivers to the programme, b) teacher-facilitated WhatsApp support groups, and c) an interactive chatbot-led parenting programme featured on WhatsApp, called "Naungan Kasih-Text (NKText)". It tests the effectiveness of this package in a cluster-randomised trial, with 50 preschools as clusters, randomly assigned to either the treatment group or a waitlist control group. Findings from this study will provide evidence for the effectiveness of a low-cost and scalable intervention integrating digital modalities with a "light-touch" in-person component to improve educational outcomes in children attending preschools for low-income families, and thereby address social inequalities in Malaysia.
N = 50 Clusters, 772 Primary Caregivers, 304 Secondary Caregivers, and 754 Children. Enrolment reflects participating primary caregivers.
Detailed description
The primary aims of the study are to:
Evaluate the effectiveness of NK-Hybrid on positive parenting at three months post-baseline in comparison to wait-list controls Evaluate the effectiveness of NK-Hybrid on child learning and development, as measured by parent and teacher reports of language and communication, literacy, socioemotional, and numeracy skills, and by direct assessments of literacy and numeracy skills, at approximately 12 months post-baseline in comparison to wait-list controls
Secondary aims of the study include:
Evaluate the sustained effectiveness of NK-Hybrid on positive parenting at approximately 12 months post-baseline.
Evaluate the effectiveness of NK-Hybrid on children's learning, namely their literacy and numeracy skills, in comparison to the control group, at three months post-baseline Evaluate the effectiveness of NK-Hybrid on secondary outcomes - parent involvement in playful learning, child maltreatment (physical and emotional abuse), caregiver anxiety and depression, parenting stress, child externalising symptoms, child learning and development, caregiver financial stress, intimate partner violence, marital health, co-parenting support, father involvement, and gender equitable behaviours - at approximately three months post-baseline and 12 months post-baseline.
Evaluate the intervention costs and cost-effectiveness of NK-Hybrid on primary outcomes of positive parenting and child literacy and numeracy skills.
Evaluate the association between engagement in the NK-Hybrid intervention and primary and secondary outcomes.
Explore potential mediators of positive parenting, child literacy and numeracy skills, child maltreatment, child externalising symptoms, and caregiver depression and anxiety at 12 months post-baseline.
Explore potential moderators of positive parenting, child literacy and numeracy skills, child maltreatment, child externalising symptoms, and caregiver depression and anxiety based on socio-demographics and psychosocial assessments at baseline
In line with the study's primary and secondary objectives, the following hypotheses have been defined a priori and will be evaluated using the methods outlined in this statistical analysis plan.
Hypothesis 1a: Caregivers in the treatment group will show higher levels of positive parenting, in comparison to the control group, at 3 months post-baseline.
Hypothesis 1b: Children in the treatment group will show greater improvements in early learning and development, namely their literacy and numeracy skills, in comparison to the control group, at 12 months post-baseline.
Hypothesis 2a: Caregivers in the treatment group will show higher levels of positive parenting, in comparison to the control group, at 12 months post-baseline.
Hypothesis 2b: Children in the treatment group will show greater improvements in learning, namely their literacy and numeracy skills, in comparison to the control group, at three months post-baseline.
Hypothesis 2c: Caregivers in the treatment group will show lower levels of child maltreatment (physical and emotional abuse), anxiety and depression, parenting stress, child externalising symptoms, financial stress, and intimate partner violence, in comparison to the control group, at 3 months and 12 months post-baseline.
Hypothesis 2d: Caregivers in the treatment group will show higher levels of parent involvement in playful learning, marital health, co-parenting support, father involvement, and gender equitable behaviours in comparison to the control group, at 3 months and 12 months post-baseline.
Hypothesis 3a: The intervention will be more cost-effective than the control condition for the primary outcomes, yielding a cost per unit of effect that supports decision-making by relevant stakeholders.
Hypothesis 3b: Higher engagement with intervention components (i.e., in-person onboarding, NKText, and WhatsApp support groups) will be associated with greater improvements in the aforementioned primary and secondary outcomes.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This study is a cluster randomised control trial with 50 preschools (clusters) randomly allocated, in a 1:1 ratio, to either a treatment or a control group. Those assigned to the intervention arm will receive the hybrid in-person digital intervention. Those assigned to the control group will be waitlisted to receive the intervention after completion of the research (i.e., 12 months post-baseline).
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: Naungan Kasih Positive Parenting ProgrammeIntervention group participants will receive one in-person onboarding session, NKText - a self-guided chatbot providing parenting support, and facilitated WhatsApp support groups. |
| Control Group | No intervention | –The control group will not receive the intervention until after the completion of the intervention period and the final follow-up data collection. Throughout the study period, participants in all groups may access any other interventions, programs, or services that are not part of the study intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- Registered Ministry of Rural Development (KEMAS) preschool
- Has a class of 20 or more children aged 4-6 years
- Selected by KEMAS leadership as available to participate
- Class teacher is willing to deliver the programme and participates in programme training
- Responsible for a child aged 4-6 years enrolled in a participating KEMAS preschool
Key exclusion criteria (2 listed)
- Parents/caregivers who do not meet inclusion criteria
- Children who do not meet inclusion criteria
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 |
|---|---|---|
| Naungan Kasih Positive Parenting ProgrammeThe programme is facilitated by teachers from Malaysian preschools for low-income families, consisting of a) one in-person session to introduce caregivers to the programme, b) teacher-facilitated WhatsApp support groups, and c) an interactive chatbot-led parenting programme featured on WhatsApp, called "Naungan Kasih-Text". | Behavioural | Intervention Group |
Primary outcome
Child early learning and development
Time frame: Baseline, 3-5 months post-baseline, 12-15 months post-baseline
Children's early learning and development (caregiver- and teacher-report) will be measured using 23 items from the National Preschool Standards-Based Curriculum Assessment (Malaysia); scale = 0-2; higher score indicates better outcome.
Positive Parenting
Time frame: Baseline, 3-5 months post-baseline, 12-15 months post-baseline
Positive parenting will be measured using 14 items from the Parenting Young Children Scale (PARYC) (McEachern et al., 2012). (Caregiver Report); (0-6); higher score indicates better outcome.
Child Literacy and Numeracy
Time frame: Baseline, 3-5 months post-baseline, 12-15 months post-baseline
Direct child assessments of child learning and development will be conducted by trained research assistants and assessed using an adapted version of the Remote Assessment of Learning (ReAL) High-Access version (Save the Children International, 2021), specifically the Literacy and Numeracy subscales. 12 domains, total score = mean of % correct for each domain; higher score indicates better outcome.
11 secondary outcomes
Parent involvement in playful learning
Time frame: Baseline, 3-5 months post-baseline, 12-15 months post-baseline
Child Maltreatment
Time frame: Baseline, 3-5 months post-baseline, 12-15 months post-baseline
Child externalising symptoms
Time frame: Baseline, 3-5 months post-baseline, 12-15 months post-baseline
Parenting Stress
Time frame: Baseline, 3-5 months post-baseline, 12-15 months post-baseline
Anxiety and depression
Time frame: Baseline, 3-5 months post-baseline, 12-15 months post-baseline
Father involvement with the child
Time frame: Baseline, 3-5 months post-baseline, 12-15 months post-baseline
Gender equitable behaviours
Time frame: Baseline, 3-5 months post-baseline, 12-15 months post-baseline
Co-parenting support
Time frame: Baseline, 3-5 months post-baseline, 12-15 months post-baseline
Marital health/quality
Time frame: Baseline, 3-5 months post-baseline, 12-15 months post-baseline
Intimate partner violence
Time frame: Baseline, 3-5 months post-baseline, 12-15 months post-baseline
Financial Stress
Time frame: Baseline, 3-5 months post-baseline, 12-15 months post-baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2026.
- OSF Pre-RegistrationLink provided by the sponsor.
- Statistical Analysis Plan (SAP)Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. De-identified individual participant data underlying the results reported in publications, including demographic variables, caregiver-reported outcomes, and child assessment outcomes.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Naungan Kasih Positive Parenting Programme in people with Positive Parenting and Child Maltreatment, run by University of Oxford at 1 site in Malaysia.
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 22 inclusion and 2 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: finished, as of the sponsor's last update on 27 May 2026. 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 Malaysia. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Child early learning and development (time frame: Baseline, 3-5 months post-baseline, 12-15 months post-baseline). The study lists 3 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 27 May 2026.