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Completed

NCT Number: NCT07592351

Pilot Factorial Trial in Malaysia

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).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universiti Putra Malaysia

Kuala Lumpur, Malaysia

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

WhatsApp support groups

Behavioral

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

Closing session

Behavioral

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

Primary outcomes

  1. Child Physical Abuse

    Time frame: 3 weeks post-intervention

    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)

  2. Child Emotional Abuse

    Time frame: 3 weeks post-intervention

    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. Playful Learning

    Time frame: 3 weeks post-intervention

    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)

  4. Child Learning and Development

    Time frame: 3 weeks post-intervention

    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.

Secondary outcomes

  1. Parenting

    Time frame: 3 weeks post-intervention

    Parenting Young Children Scale (supporting positive behavior, and setting limits; 14 items); (0-6); higher score indicates better outcome.

  2. Parent Mental Health

    Time frame: 3 weeks post-intervention

    Patient Health Questionnaire-4 (4 items); 0-3; higher score indicates worse outcome

  3. Parenting Stress

    Time frame: 3 weeks post-intervention

    Parenting Stress Scale (6 items); (0-5); higher score indicates worse outcome

  4. Child Behavior

    Time frame: 3 weeks post-intervention

    Externalizing problems: Child and Adolescent Behavior Inventory, externalizing subscale (12 items); (0-2); higher score indicates worse outcome

  5. Gender equitable behaviors

    Time frame: 3 weeks post-intervention

    Adapted from questionnaires used in previous violence prevention studies (4 items); (1-5); higher score indicates better outcome

  6. Marital health/quality

    Time frame: 3 weeks post-intervention

    Marital Health Scale (5 items); (1-5); higher score indicates better outcome

  7. Financial Stress

    Time frame: 3 weeks post-intervention

    Financial Self-Efficacy Scale (5 items); (0-3); higher score indicates worse outcome

  8. Quality of Life

    Time frame: 3 weeks post-intervention

    Assessment of Quality of Life-4D (12 items); (1-4); higher score indicates worse outcome

Sponsors and collaborators

Lead sponsor

University of Oxford

Other

Collaborators

  • Universiti Putra Malaysia

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
May 18, 2026
Registry last updated
May 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.