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).
Studieoversigt
Status
Betingelser
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
-
Kuala Lumpur, Malaysia
- Universiti Putra Malaysia
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Andet
- Tildeling: Randomiseret
- Interventionel model: Faktoriel opgave
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: 1. ParentText + 1 in-person session
|
Naungan Kasih Text (NKText): A self-guided chatbot providing parenting support Onboarding session: an in-person session at the beginning of the intervention
|
|
Eksperimentel: 2. ParentText + 1 in-person session + WhatsApp support
|
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
|
|
Eksperimentel: 3. ParentText + 2 in-person sessions
|
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
|
|
Eksperimentel: 4. ParentText + 2 in-person sessions + WhatsApp support
|
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
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Child Physical Abuse
Tidsramme: 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)
|
3 weeks post-intervention
|
|
Child Emotional Abuse
Tidsramme: 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 weeks post-intervention
|
|
Playful Learning
Tidsramme: 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)
|
3 weeks post-intervention
|
|
Child Learning and Development
Tidsramme: 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. |
3 weeks post-intervention
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Parenting
Tidsramme: 3 weeks post-intervention
|
Parenting Young Children Scale (supporting positive behavior, and setting limits; 14 items); (0-6); higher score indicates better outcome.
|
3 weeks post-intervention
|
|
Parent Mental Health
Tidsramme: 3 weeks post-intervention
|
Patient Health Questionnaire-4 (4 items); 0-3; higher score indicates worse outcome
|
3 weeks post-intervention
|
|
Parenting Stress
Tidsramme: 3 weeks post-intervention
|
Parenting Stress Scale (6 items); (0-5); higher score indicates worse outcome
|
3 weeks post-intervention
|
|
Child Behavior
Tidsramme: 3 weeks post-intervention
|
Externalizing problems: Child and Adolescent Behavior Inventory, externalizing subscale (12 items); (0-2); higher score indicates worse outcome
|
3 weeks post-intervention
|
|
Gender equitable behaviors
Tidsramme: 3 weeks post-intervention
|
Adapted from questionnaires used in previous violence prevention studies (4 items); (1-5); higher score indicates better outcome
|
3 weeks post-intervention
|
|
Marital health/quality
Tidsramme: 3 weeks post-intervention
|
Marital Health Scale (5 items); (1-5); higher score indicates better outcome
|
3 weeks post-intervention
|
|
Financial Stress
Tidsramme: 3 weeks post-intervention
|
Financial Self-Efficacy Scale (5 items); (0-3); higher score indicates worse outcome
|
3 weeks post-intervention
|
|
Quality of Life
Tidsramme: 3 weeks post-intervention
|
Assessment of Quality of Life-4D (12 items); (1-4); higher score indicates worse outcome
|
3 weeks post-intervention
|
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Publikationer og nyttige links
Hjælpsomme links
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- R88954/RE001
- 10.17605/OSF.IO/F32KY (Registry Identifier: Prospectively registered on Open Science Framework on 05/12/23; ClinicalTrials.gov entry retrospective and consistent.)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
IPD-delingstidsramme
IPD-delingsadgangskriterier
IPD-deling Understøttende informationstype
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .