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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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07592351
Enrollment
208
Registered
2026-05-18
Start date
2023-07-01
Completion date
2024-03-31
Last updated
2026-05-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

Brief 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. 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).

Interventions

BEHAVIORALNaungan 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

BEHAVIORALWhatsApp support groups

WhatsApp groups facilitated by children's teachers, with other participating parents from the children's preschool classes

BEHAVIORALClosing session

An in-person closing session at the end of the intervention

Sponsors

University of Oxford
Lead SponsorOTHER
Universiti Putra Malaysia
CollaboratorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)

Intervention 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).

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Child Physical Abuse3 weeks post-interventionInternational 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 Abuse3 weeks post-interventionChild 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 Learning3 weeks post-interventionUnited 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 Development3 weeks post-interventionMELQO 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.

Secondary

MeasureTime frameDescription
Parenting3 weeks post-interventionParenting Young Children Scale (supporting positive behavior, and setting limits; 14 items); (0-6); higher score indicates better outcome.
Parent Mental Health3 weeks post-interventionPatient Health Questionnaire-4 (4 items); 0-3; higher score indicates worse outcome
Parenting Stress3 weeks post-interventionParenting Stress Scale (6 items); (0-5); higher score indicates worse outcome
Child Behavior3 weeks post-interventionExternalizing problems: Child and Adolescent Behavior Inventory, externalizing subscale (12 items); (0-2); higher score indicates worse outcome
Gender equitable behaviors3 weeks post-interventionAdapted from questionnaires used in previous violence prevention studies (4 items); (1-5); higher score indicates better outcome
Marital health/quality3 weeks post-interventionMarital Health Scale (5 items); (1-5); higher score indicates better outcome
Financial Stress3 weeks post-interventionFinancial Self-Efficacy Scale (5 items); (0-3); higher score indicates worse outcome
Quality of Life3 weeks post-interventionAssessment of Quality of Life-4D (12 items); (1-4); higher score indicates worse outcome

Countries

Malaysia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 19, 2026