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).
Panoramica dello studio
Stato
Condizioni
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
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-
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Kuala Lumpur, Malaysia
- Universiti Putra Malaysia
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Altro
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione fattoriale
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Sperimentale: 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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Sperimentale: 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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Sperimentale: 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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Sperimentale: 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
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Child Physical Abuse
Lasso di tempo: 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)
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3 weeks post-intervention
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Child Emotional Abuse
Lasso di tempo: 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
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Playful Learning
Lasso di tempo: 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
Lasso di tempo: 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
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Parenting
Lasso di tempo: 3 weeks post-intervention
|
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
Lasso di tempo: 3 weeks post-intervention
|
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
Lasso di tempo: 3 weeks post-intervention
|
Parenting Stress Scale (6 items); (0-5); higher score indicates worse outcome
|
3 weeks post-intervention
|
|
Child Behavior
Lasso di tempo: 3 weeks post-intervention
|
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
Lasso di tempo: 3 weeks post-intervention
|
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
Lasso di tempo: 3 weeks post-intervention
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Marital Health Scale (5 items); (1-5); higher score indicates better outcome
|
3 weeks post-intervention
|
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Financial Stress
Lasso di tempo: 3 weeks post-intervention
|
Financial Self-Efficacy Scale (5 items); (0-3); higher score indicates worse outcome
|
3 weeks post-intervention
|
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Quality of Life
Lasso di tempo: 3 weeks post-intervention
|
Assessment of Quality of Life-4D (12 items); (1-4); higher score indicates worse outcome
|
3 weeks post-intervention
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Collaboratori e investigatori
Sponsor
Collaboratori
Pubblicazioni e link utili
Collegamenti utili
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Altri numeri di identificazione dello studio
- R88954/RE001
- 10.17605/OSF.IO/F32KY (Identificatore di registro: Prospectively registered on Open Science Framework on 05/12/23; ClinicalTrials.gov entry retrospective and consistent.)
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Descrizione del piano IPD
Periodo di condivisione IPD
Criteri di accesso alla condivisione IPD
Tipo di informazioni di supporto alla condivisione IPD
- STUDIO_PROTOCOLLO
- LINFA
- ICF
- CODICE_ANALITICO
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