Pilot Factorial Trial in Malaysia

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:

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

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 Overview

• Status: Completed
• 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
• Intervention / Treatment: Behavioral: Naungan Kasih Text (NKText) + onboarding session; Behavioral: WhatsApp support groups; Behavioral: Closing session

• Study Type: Interventional
• Enrollment (Actual): 208
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Malaysia
  • Kuala Lumpur, Malaysia
    • Universiti Putra Malaysia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion criteria for participating parents or caregivers:

• 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

Exclusion criteria for participating parents or caregivers:

- 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.

Inclusion criteria for child respondents:

• Is enrolled in a KEMAS preschool
• 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

Inclusion criteria for teachers:

• 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

Inclusion criteria for supervisors:

• 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.

Inclusion criteria for KEMAS leadership:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1. ParentText + 1 in-person session	Behavioral: Naungan Kasih Text (NKText) + onboarding session; Naungan Kasih Text (NKText): A self-guided chatbot providing parenting support Onboarding session: an in-person session at the beginning of the intervention
Experimental: 2. ParentText + 1 in-person session + WhatsApp support	Behavioral: Naungan Kasih Text (NKText) + onboarding session; Naungan Kasih Text (NKText): A self-guided chatbot providing parenting support Onboarding session: an in-person session at the beginning of the intervention; Behavioral: WhatsApp support groups; WhatsApp groups facilitated by children's teachers, with other participating parents from the children's preschool classes
Experimental: 3. ParentText + 2 in-person sessions	Behavioral: Naungan Kasih Text (NKText) + onboarding session; Naungan Kasih Text (NKText): A self-guided chatbot providing parenting support Onboarding session: an in-person session at the beginning of the intervention; Behavioral: Closing session; An in-person closing session at the end of the intervention
Experimental: 4. ParentText + 2 in-person sessions + WhatsApp support	Behavioral: Naungan Kasih Text (NKText) + onboarding session; Naungan Kasih Text (NKText): A self-guided chatbot providing parenting support Onboarding session: an in-person session at the beginning of the intervention; Behavioral: WhatsApp support groups; WhatsApp groups facilitated by children's teachers, with other participating parents from the children's preschool classes; Behavioral: Closing session; An in-person closing session at the end of the intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	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)	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)	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.	3 weeks post-intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Parenting	Parenting Young Children Scale (supporting positive behavior, and setting limits; 14 items); (0-6); higher score indicates better outcome.	3 weeks post-intervention
Parent Mental Health	Patient Health Questionnaire-4 (4 items); 0-3; higher score indicates worse outcome	3 weeks post-intervention
Parenting Stress	Parenting Stress Scale (6 items); (0-5); higher score indicates worse outcome	3 weeks post-intervention
Child Behavior	Externalizing problems: Child and Adolescent Behavior Inventory, externalizing subscale (12 items); (0-2); higher score indicates worse outcome	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	3 weeks post-intervention
Marital health/quality	Marital Health Scale (5 items); (1-5); higher score indicates better outcome	3 weeks post-intervention
Financial Stress	Financial Self-Efficacy Scale (5 items); (0-3); higher score indicates worse outcome	3 weeks post-intervention
Quality of Life	Assessment of Quality of Life-4D (12 items); (1-4); higher score indicates worse outcome	3 weeks post-intervention

Collaborators and Investigators

• Sponsor: University of Oxford
• Collaborators: Universiti Putra Malaysia

Publications and helpful links

Helpful Links

• OSF Pre-Registration
• Protocol

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2023
• Primary Completion (Actual): March 31, 2024
• Study Completion (Actual): March 31, 2024

Study Registration Dates

• First Submitted: May 5, 2026
• First Submitted That Met QC Criteria: May 13, 2026
• First Posted (Actual): May 18, 2026

Study Record Updates

• Last Update Posted (Actual): May 18, 2026
• Last Update Submitted That Met QC Criteria: May 13, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: parenting; optimization; child development; engagement; factorial trial
• Other Study ID Numbers: R88954/RE001; 10.17605/OSF.IO/F32KY (Registry Identifier: Prospectively registered on Open Science Framework on 05/12/23; ClinicalTrials.gov entry retrospective and consistent.)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified individual participant data underlying the results reported in publications, including demographic variables, caregiver-reported outcomes, and child assessment outcomes.
• IPD Sharing Time Frame: Deidentified participant data will be available beginning 12 months after publication of the planned article publication to allow completion of planned secondary analyses by the study team; no end date for availability.
• IPD Sharing Access Criteria: Requests for access will require submission of a brief description of the intended use. Requests will be reviewed by the study team. Access will be granted following approval of the request and completion of appropriate data access procedures.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No