Clinical Trial

Pilot Factorial Trial in Malaysia

Completed
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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).
Trial Details
NCT Number NCT07592351
Lead Sponsor University of Oxford
Collaborators: Universiti Putra Malaysia
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
Enrollment 208 participants
Start Date 2023-07-01
Primary Completion 2024-03-31 (estimated)
Study Completion 2024-03-31 (estimated)
Updated on ClinicalTrials.gov 2026-05-18