CompletedNot Applicable

Pilot Factorial Trial in Malaysia

Malaysia208 participantsStarted 2023-07-01

Plain-language 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).

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 p…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Child Physical Abuse

Timeframe: 3 weeks post-intervention

Child Emotional Abuse

Timeframe: 3 weeks post-intervention

Playful Learning

Timeframe: 3 weeks post-intervention

Child Learning and Development

Timeframe: 3 weeks post-intervention

Trial details

NCT IDNCT07592351

SponsorUniversity of Oxford

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-03-31

View on ClinicalTrials.gov More ParentText + 1 In-person Session trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.