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
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:
- ParentText + 1 in-person session
- ParentText + 1 in-person session + WhatsApp support
- ParentText + 2 in-person sessions
- 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).
Descripción general del estudio
Estado
Condiciones
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Kuala Lumpur, Malasia
- Universiti Putra Malaysia
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Otro
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación factorial
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: 1. ParentText + 1 in-person session
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Naungan Kasih Text (NKText): A self-guided chatbot providing parenting support Onboarding session: an in-person session at the beginning of the intervention
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Experimental: 2. ParentText + 1 in-person session + WhatsApp support
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Naungan Kasih Text (NKText): A self-guided chatbot providing parenting support Onboarding session: an in-person session at the beginning of the intervention
WhatsApp groups facilitated by children's teachers, with other participating parents from the children's preschool classes
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Experimental: 3. ParentText + 2 in-person sessions
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Naungan Kasih Text (NKText): A self-guided chatbot providing parenting support Onboarding session: an in-person session at the beginning of the intervention
An in-person closing session at the end of the intervention
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Experimental: 4. ParentText + 2 in-person sessions + WhatsApp support
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Naungan Kasih Text (NKText): A self-guided chatbot providing parenting support Onboarding session: an in-person session at the beginning of the intervention
WhatsApp groups facilitated by children's teachers, with other participating parents from the children's preschool classes
An in-person closing session at the end of the intervention
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Child Physical Abuse
Periodo de tiempo: 3 weeks post-intervention
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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)
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3 weeks post-intervention
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Child Emotional Abuse
Periodo de tiempo: 3 weeks post-intervention
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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)
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3 weeks post-intervention
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Playful Learning
Periodo de tiempo: 3 weeks post-intervention
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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)
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3 weeks post-intervention
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Child Learning and Development
Periodo de tiempo: 3 weeks post-intervention
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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
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Parenting
Periodo de tiempo: 3 weeks post-intervention
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Parenting Young Children Scale (supporting positive behavior, and setting limits; 14 items); (0-6); higher score indicates better outcome.
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3 weeks post-intervention
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Parent Mental Health
Periodo de tiempo: 3 weeks post-intervention
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Patient Health Questionnaire-4 (4 items); 0-3; higher score indicates worse outcome
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3 weeks post-intervention
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Parenting Stress
Periodo de tiempo: 3 weeks post-intervention
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Parenting Stress Scale (6 items); (0-5); higher score indicates worse outcome
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3 weeks post-intervention
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Child Behavior
Periodo de tiempo: 3 weeks post-intervention
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Externalizing problems: Child and Adolescent Behavior Inventory, externalizing subscale (12 items); (0-2); higher score indicates worse outcome
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3 weeks post-intervention
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Gender equitable behaviors
Periodo de tiempo: 3 weeks post-intervention
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Adapted from questionnaires used in previous violence prevention studies (4 items); (1-5); higher score indicates better outcome
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3 weeks post-intervention
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Marital health/quality
Periodo de tiempo: 3 weeks post-intervention
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Marital Health Scale (5 items); (1-5); higher score indicates better outcome
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3 weeks post-intervention
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Financial Stress
Periodo de tiempo: 3 weeks post-intervention
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Financial Self-Efficacy Scale (5 items); (0-3); higher score indicates worse outcome
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3 weeks post-intervention
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Quality of Life
Periodo de tiempo: 3 weeks post-intervention
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Assessment of Quality of Life-4D (12 items); (1-4); higher score indicates worse outcome
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3 weeks post-intervention
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Publicaciones y enlaces útiles
Enlaces Útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- R88954/RE001
- 10.17605/OSF.IO/F32KY (Identificador de registro: Prospectively registered on Open Science Framework on 05/12/23; ClinicalTrials.gov entry retrospective and consistent.)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Marco de tiempo para compartir IPD
Criterios de acceso compartido de IPD
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- SAVIA
- CIF
- CÓDIGO_ANALÍTICO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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