ParentText + 1 In-person SessionNCT07592351
Pilot Factorial Trial in Malaysia
A study testing Naungan Kasih Text (NKText) + onboarding session, WhatsApp support groups and Closing session in people with ParentText + 1 In-person Session and ParentText + 1 In-person Session + WhatsApp Support, run by University of Oxford at 1 site in Malaysia.
Trial summary
This pilot study aims to determine the feasibility, acceptability, and engagement for different combinations of three components of a human-digital hybrid playful parenting programme, "Naungan Kasih (NK) Parenting Programme", in Malaysia. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- ParentText + 1 In-person Session, ParentText + 1 In-person Session + WhatsApp Support, ParentText + 2 In-person Sessions
- What is being tested?
- Naungan Kasih Text (NKText) + onboarding session, WhatsApp support groups and Closing session
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 208 participants
- Where
- 1 siteMalaysia
- Study dates
- 1 Jul 2023to 31 Mar 2024
- 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
- Responsible for the child aged 4-6 years who is registered with KEMAS preschool
- Aged 18 years or more
- Lives in the same household with the child for at least four nights a month
- Have access to a mobile phone compatible with WhatsApp
- Gives consent to participate in the study
- Is enrolled in a KEMAS preschool
Show all 25Show fewer
- Is between the ages of 4 and 6
- Parent gives consent for the child to participate in the study
- Child gives verbal assent to participate in the study
- Registered employee with KEMAS preschool
- 18 years old and above
- Diploma/certificate in Early Childhood Education (ECE) or equivalent
- Give consent to participate in the study
- Participated in training of intervention package
- Available to deliver intervention package
- Registered supervisor with KEMAS
- 18 years old and above
- Have a diploma/certificate in Early Childhood Education (ECE) or equivalent
- Agree to participate in the study
- Participated in the training of the programme:
- Facilitator Training workshop: for new facilitators to deliver the programme
- Training of Trainers workshop: supervisors (who completed the facilitator training working) were trained to deliver future training to new facilitators.
- Federal or state administrative staff of the Division of Early Childhood Education within KEMAS
- 18 years old and above
- Agree to participate in the study
Who cannot join
- Adult parents/caregivers with a severely limited mental capacity (either due to learning disability or acute mental health disorder), which will be assessed by research assistants by way of a four-item checklist.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Cluster Randomised Trial of a Hybrid Human-digital Playful Parenting Programme to Improve Positive Parenting, Learning Through Play, and Child Educational Outcomes Among Preschool Children in Malaysia
This pilot study aims to determine the feasibility, acceptability, and engagement for different combinations of three components of a human-digital hybrid playful parenting programme, "Naungan Kasih (NK) Parenting Programme", in Malaysia. The first component is ParentText, a chatbot-led parenting programme, which will be delivered to all participants. The second component is in-person sessions facilitated by trained teachers, and the third component consists of remote online WhatsApp support groups. The research aims to investigate the differential feasibility, acceptability, and engagement for NK when ParentText is delivered with a) 1 or 2 in-person sessions, and b) with remote online WhatsApp support groups (Yes/No). The combinations of Parent Text (which will be delivered to all participants) with the in-person sessions and WhatsApp support groups yields four treatment conditions:
- ParentText + 1 in-person session
- ParentText + 1 in-person session + WhatsApp support
- ParentText + 2 in-person sessions
- ParentText + 2 in-person sessions + WhatsApp support
This pilot aims to examine the feasibility of the delivery of the different combinations of intervention components, and the user-engagement for each condition, in preparation for a full factorial trial in 2024. Data from this pilot will be used to inform modifications to the programme and study methods prior to the larger factorial trial. The pilot study also aims to provide preliminary exploratory data regarding the relative effectiveness of the different versions of the programme. To answer the research questions, the investigators will track engagement data digitally, conduct pre- and post-intervention surveys and observational assessments, and carry out a series of interviews and focus group discussions with key stakeholders: parents, teacher-facilitators, teacher-facilitators' supervisors, and leadership members of the Ministry of Rural Development (KEMAS) in Malaysia (the government department that are responsible for 33% of preschools in Malaysia, and those which this study focuses on).
- Conditions
- ParentText + 1 In-person Session, ParentText + 1 In-person Session + WhatsApp Support, ParentText + 2 In-person Sessions, ParentText + 2 In-person Sessions + WhatsApp Support
- Being tested
- Naungan Kasih Text (NKText) + onboarding session, WhatsApp support groups, Closing session
- Keywords
- factorial trial, optimization, engagement, parenting, child development
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Naungan Kasih Text (NKText) + onboarding sessionBehavioural
Naungan Kasih Text (NKText): A self-guided chatbot providing parenting support Onboarding session: an in-person session at the beginning of the intervention
WhatsApp support groupsBehavioural
WhatsApp groups facilitated by children's teachers, with other participating parents from the children's preschool classes
Closing sessionBehavioural
An in-person closing session at the end of the intervention
| Study group | Role | What they receive |
|---|---|---|
| 1. ParentText + 1 in-person session | Experimental | Not described Receives: Behavioral: Naungan Kasih Text (NKText) + onboarding session |
| 2. ParentText + 1 in-person session + WhatsApp support | Experimental | Not described Receives: Behavioral: Naungan Kasih Text (NKText) + onboarding session; Behavioral: WhatsApp support groups |
| 3. ParentText + 2 in-person sessions | Experimental | Not described Receives: Behavioral: Naungan Kasih Text (NKText) + onboarding session; Behavioral: Closing session |
| 4. ParentText + 2 in-person sessions + WhatsApp support | Experimental | Not described Receives: Behavioral: Naungan Kasih Text (NKText) + onboarding session; Behavioral: WhatsApp support groups; Behavioral: Closing session |
What is being measured
The primary outcome is the main question the study is designed to answer.
Child Physical Abuse
International Society for the Prevention of Child Abuse and Neglect (ISPCAN) Child Abuse Screening Tool-Trial, physical abuse subscale (4 items) (0-8 times in last two weeks) - higher indicates more incidence of abuse (worse outcome)
Measured: 3 weeks post-intervention
Child Emotional Abuse
Child emotional abuse: ISPCAN Child Abuse Screening Tool-Parent version, emotional abuse subscale (5 items) (0-8 times in last two weeks) - higher indicates more incidence of abuse (worse outcome)
Measured: 3 weeks post-intervention
Playful Learning
United Nations Children's Fund Multiple Indicator Cluster Surveys child development module and family care indicators (4 items) (0-8 times in last two weeks) - higher indicates more playful learning activities (better outcome)
Measured: 3 weeks post-intervention
Child Learning and Development
MELQO framework's Measure of Development and Early Learning module teacher or caregiver report item: Literacy and Numeracy subscales (0 = No, 1 = Yes) higher score indicates better outcome. Socio-emotional development and executive function 0-4 scale, mixture of higher score indicating better outcome and reverse coded items where higher score indicates worse outcome - needs recoding for analysis.
IDELA (8 overarching items, total 21 subitems), direct child assessment (0 = No, 1 = Yes) - higher score indicates better outcome.
Measured: 3 weeks post-intervention
Secondary outcomes (8)
Parenting
Parenting Young Children Scale (supporting positive behavior, and setting limits; 14 items); (0-6); higher score indicates better outcome.
Measured: 3 weeks post-intervention
Parent Mental Health
Patient Health Questionnaire-4 (4 items); 0-3; higher score indicates worse outcome
Measured: 3 weeks post-intervention
Parenting Stress
Parenting Stress Scale (6 items); (0-5); higher score indicates worse outcome
Measured: 3 weeks post-intervention
Child Behavior
Externalizing problems: Child and Adolescent Behavior Inventory, externalizing subscale (12 items); (0-2); higher score indicates worse outcome
Measured: 3 weeks post-intervention
Gender equitable behaviors
Adapted from questionnaires used in previous violence prevention studies (4 items); (1-5); higher score indicates better outcome
Measured: 3 weeks post-intervention
Marital health/quality
Marital Health Scale (5 items); (1-5); higher score indicates better outcome
Measured: 3 weeks post-intervention
Financial Stress
Financial Self-Efficacy Scale (5 items); (0-3); higher score indicates worse outcome
Measured: 3 weeks post-intervention
Quality of Life
Assessment of Quality of Life-4D (12 items); (1-4); higher score indicates worse outcome
Measured: 3 weeks post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2026
- Study start1 Jul 2023
- Primary completion31 Mar 2024
- Study completion31 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ParentText + 1 In-person SessionStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- This feasibility pilot is a 2 x 2 factorial cluster randomised trial that compares ParentText (chatbot-led parenting programme) delivered to all participants, with different combinations of two engagement components: i) a remote online WhatsApp support group (Yes or No); and ii) either one or two in-person sessions (Table 1). This study will adopt a parallel design employing a 1:1:1:1 allocation ratio (each cluster in each study site exposed to one experimental condition).
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 208 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
- NCT07592351
- Sponsor's protocol ID
- R88954/RE001
- Other IDs
- 10.17605/OSF.IO/F32KY
- Status last verified
- May 2026
- First submitted
- 5 May 2026
- Last updated
- 18 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 18 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Cluster Randomised Trial of a Hybrid Human-digital Playful Parenting Programme to Improve Positive Parenting, Learning Through Play, and Child Educational Outcomes Among Preschool Children in Malaysia
- ClinicalTrials.gov ID
- NCT07592351
- Acronym / sponsor ID
- R88954/RE001
- Conditions
- ParentText + 1 In-person Session, ParentText + 1 In-person Session + WhatsApp Support, ParentText + 2 In-person Sessions, ParentText + 2 In-person Sessions + WhatsApp Support
- Keywords
- factorial trial, optimization, engagement, parenting, child development
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 208 participants (actual)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Collaborators
- Universiti Putra Malaysia
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 31 Mar 2024 (actual)
- Study completion
- 31 Mar 2024 (actual)
- First posted
- 18 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 pilot study aims to determine the feasibility, acceptability, and engagement for different combinations of three components of a human-digital hybrid playful parenting programme, "Naungan Kasih (NK) Parenting Programme", in Malaysia. The first component is ParentText, a chatbot-led parenting programme, which will be delivered to all participants. The second component is in-person sessions facilitated by trained teachers, and the third component consists of remote online WhatsApp support groups. The research aims to investigate the differential feasibility, acceptability, and engagement for NK when ParentText is delivered with a) 1 or 2 in-person sessions, and b) with remote online WhatsApp support groups (Yes/No). The combinations of Parent Text (which will be delivered to all participants) with the in-person sessions and WhatsApp support groups yields four treatment conditions:
- ParentText + 1 in-person session
- ParentText + 1 in-person session + WhatsApp support
- ParentText + 2 in-person sessions
- ParentText + 2 in-person sessions + WhatsApp support
This pilot aims to examine the feasibility of the delivery of the different combinations of intervention components, and the user-engagement for each condition, in preparation for a full factorial trial in 2024. Data from this pilot will be used to inform modifications to the programme and study methods prior to the larger factorial trial. The pilot study also aims to provide preliminary exploratory data regarding the relative effectiveness of the different versions of the programme. To answer the research questions, the investigators will track engagement data digitally, conduct pre- and post-intervention surveys and observational assessments, and carry out a series of interviews and focus group discussions with key stakeholders: parents, teacher-facilitators, teacher-facilitators' supervisors, and leadership members of the Ministry of Rural Development (KEMAS) in Malaysia (the government department that are responsible for 33% of preschools in Malaysia, and those which this study focuses on).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
- Model description
- This feasibility pilot is a 2 x 2 factorial cluster randomised trial that compares ParentText (chatbot-led parenting programme) delivered to all participants, with different combinations of two engagement components: i) a remote online WhatsApp support group (Yes or No); and ii) either one or two in-person sessions (Table 1). This study will adopt a parallel design employing a 1:1:1:1 allocation ratio (each cluster in each study site exposed to one experimental condition).
| Arm | Type | Receives |
|---|---|---|
| 1. ParentText + 1 in-person session | Experimental | Behavioral: Naungan Kasih Text (NKText) + onboarding session |
| 2. ParentText + 1 in-person session + WhatsApp support | Experimental | Behavioral: Naungan Kasih Text (NKText) + onboarding session, Behavioral: WhatsApp support groups |
| 3. ParentText + 2 in-person sessions | Experimental | Behavioral: Naungan Kasih Text (NKText) + onboarding session, Behavioral: Closing session |
| 4. ParentText + 2 in-person sessions + WhatsApp support | Experimental | Behavioral: Naungan Kasih Text (NKText) + onboarding session, Behavioral: WhatsApp support groups, Behavioral: Closing session |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (25 listed)
- Responsible for the child aged 4-6 years who is registered with KEMAS preschool
- Aged 18 years or more
- Lives in the same household with the child for at least four nights a month
- Have access to a mobile phone compatible with WhatsApp
- Gives consent to participate in the study
Key exclusion criteria (1 listed)
- Adult parents/caregivers with a severely limited mental capacity (either due to learning disability or acute mental health disorder), which will be assessed by research assistants by way of a four-item checklist.
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 Text (NKText) + onboarding sessionNaungan Kasih Text (NKText): A self-guided chatbot providing parenting support Onboarding session: an in-person session at the beginning of the intervention | Behavioural | 1. ParentText + 1 in-person session, 2. ParentText + 1 in-person session + WhatsApp support, 3. ParentText + 2 in-person sessions, 4. ParentText + 2 in-person sessions + WhatsApp support |
| WhatsApp support groupsWhatsApp groups facilitated by children's teachers, with other participating parents from the children's preschool classes | Behavioural | 2. ParentText + 1 in-person session + WhatsApp support, 4. ParentText + 2 in-person sessions + WhatsApp support |
| Closing sessionAn in-person closing session at the end of the intervention | Behavioural | 3. ParentText + 2 in-person sessions, 4. ParentText + 2 in-person sessions + WhatsApp support |
Primary outcome
Child Physical Abuse
Time frame: 3 weeks post-intervention
International Society for the Prevention of Child Abuse and Neglect (ISPCAN) Child Abuse Screening Tool-Trial, physical abuse subscale (4 items) (0-8 times in last two weeks) - higher indicates more incidence of abuse (worse outcome)
Child Emotional Abuse
Time frame: 3 weeks post-intervention
Child emotional abuse: ISPCAN Child Abuse Screening Tool-Parent version, emotional abuse subscale (5 items) (0-8 times in last two weeks) - higher indicates more incidence of abuse (worse outcome)
Playful Learning
Time frame: 3 weeks post-intervention
United Nations Children's Fund Multiple Indicator Cluster Surveys child development module and family care indicators (4 items) (0-8 times in last two weeks) - higher indicates more playful learning activities (better outcome)
Child Learning and Development
Time frame: 3 weeks post-intervention
MELQO framework's Measure of Development and Early Learning module teacher or caregiver report item: Literacy and Numeracy subscales (0 = No, 1 = Yes) higher score indicates better outcome. Socio-emotional development and executive function 0-4 scale, mixture of higher score indicating better outcome and reverse coded items where higher score indicates worse outcome - needs recoding for analysis. IDELA (8 overarching items, total 21 subitems), direct child assessment (0 = No, 1 = Yes) - higher score indicates better outcome.
8 secondary outcomes
Parenting
Time frame: 3 weeks post-intervention
Parent Mental Health
Time frame: 3 weeks post-intervention
Parenting Stress
Time frame: 3 weeks post-intervention
Child Behavior
Time frame: 3 weeks post-intervention
Gender equitable behaviors
Time frame: 3 weeks post-intervention
Marital health/quality
Time frame: 3 weeks post-intervention
Financial Stress
Time frame: 3 weeks post-intervention
Quality of Life
Time frame: 3 weeks post-intervention
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 18 May 2026.
- OSF Pre-RegistrationLink provided by the sponsor.
- ProtocolLink 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.
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 Text (NKText) + onboarding session, WhatsApp support groups and Closing session in people with ParentText + 1 In-person Session and ParentText + 1 In-person Session + WhatsApp Support, 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 25 inclusion and 1 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 18 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 Physical Abuse (time frame: 3 weeks post-intervention). The study lists 4 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 18 May 2026.