NCT07599566

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
772

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 10, 2024

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 17, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 17, 2025

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

May 14, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 20, 2026

Completed
Last Updated

May 20, 2026

Status Verified

April 1, 2026

Enrollment Period

1.3 years

First QC Date

May 14, 2026

Last Update Submit

May 14, 2026

Conditions

Keywords

parenting interventionchild developmentparenting

Outcome Measures

Primary Outcomes (3)

  • 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.

    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.

    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.

    Baseline, 3-5 months post-baseline, 12-15 months post-baseline

Secondary Outcomes (11)

  • Parent involvement in playful learning

    Baseline, 3-5 months post-baseline, 12-15 months post-baseline

  • Child Maltreatment

    Baseline, 3-5 months post-baseline, 12-15 months post-baseline

  • Child externalising symptoms

    Baseline, 3-5 months post-baseline, 12-15 months post-baseline

  • Parenting Stress

    Baseline, 3-5 months post-baseline, 12-15 months post-baseline

  • Anxiety and depression

    Baseline, 3-5 months post-baseline, 12-15 months post-baseline

  • +6 more secondary outcomes

Study Arms (2)

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.

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.

Interventions

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".

Intervention Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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:
  • 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
  • +7 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universiti Putra Malaysia

Kuala Lumpur, Malaysia

Location

Related Links

MeSH Terms

Conditions

Child Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The trial statisticians (GJMT, SV) conducting randomisation and analyses will be blinded to condition. Blinding of participants is not possible given the nature of the intervention. Enumerators are blinded at baseline assessments (T0) and will remain blinded at the endline (T1) and follow-up (T2) assessments, although it is plausible that they may find out from participants which individuals received the intervention.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 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).
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 14, 2026

First Posted

May 20, 2026

Study Start

July 10, 2024

Primary Completion

October 17, 2025

Study Completion

October 17, 2025

Last Updated

May 20, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will share

De-identified individual participant data underlying the results reported in publications, including demographic variables, caregiver-reported outcomes, and child assessment outcomes.

Shared Documents
STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
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.
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.

Locations