Pilot Factorial Trial in Malaysia

NCT07592351 | Completed

• 2 other identifiers: R88954/RE00110.17605/OSF.IO/F32KY
• Study Type: interventional
• Target: 208
• Locations: 1 country
• Sites: 1

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. 1.ParentText + 1 in-person session
2. 2.ParentText + 1 in-person session + WhatsApp support
3. 3.ParentText + 2 in-person sessions
4. 4.ParentText + 2 in-person sessions + WhatsApp support

Conditions

ParentText + 1 In-person Session; ParentText + 2 In-person Sessions; ParentText + 1 In-person Session + WhatsApp Support; ParentText + 2 In-person Sessions + WhatsApp Support

Keywords

factorial trial; optimization; engagement; parenting; child development

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (8)

• Parenting

  3 weeks post-intervention

• Parent Mental Health

  3 weeks post-intervention

• Parenting Stress

  3 weeks post-intervention

• Child Behavior

  3 weeks post-intervention

• Gender equitable behaviors

  3 weeks post-intervention

Study Arms (4)

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

Interventions

Naungan Kasih Text (NKText) + onboarding session BEHAVIORAL

Naungan Kasih Text (NKText): A self-guided chatbot providing parenting support Onboarding session: an in-person session at the beginning of the intervention

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 groups BEHAVIORAL

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

2. ParentText + 1 in-person session + WhatsApp support; 4. ParentText + 2 in-person sessions + WhatsApp support

Closing session BEHAVIORAL

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

3. ParentText + 2 in-person sessions; 4. ParentText + 2 in-person sessions + WhatsApp support

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• \- 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.
• 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
• Registered employee with KEMAS preschool
• 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
• years old and above
• Have a diploma/certificate in Early Childhood Education (ECE) or equivalent
• Agree to participate in the study

Sponsors & Collaborators

• Universiti Putra Malaysia: collaborator
• University of Oxford: lead

Study Sites (1)

Universiti Putra Malaysia

Kuala Lumpur, Malaysia

Location

Related Links

• OSF Pre-Registration
• Protocol

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Jamie Lachman

Model Details: 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).

Study Record Dates

• First Submitted: May 5, 2026
• First Posted: May 18, 2026
• Study Start: July 1, 2023
• Primary Completion: March 31, 2024
• Study Completion: March 31, 2024
• Last Updated: May 18, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• 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

MY (1)