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| ID | Type | Description | Link |
|---|---|---|---|
| 10.17605/OSF.IO/F32KY | Registry Identifier | Prospectively registered on Open Science Framework on 05/12/23; ClinicalTrials.gov entry retrospective and consistent. |
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| Name | Class |
|---|---|
| Universiti Putra Malaysia | OTHER |
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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:
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1. ParentText + 1 in-person session | Experimental |
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| 2. ParentText + 1 in-person session + WhatsApp support | Experimental |
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| 3. ParentText + 2 in-person sessions | Experimental |
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| 4. ParentText + 2 in-person sessions + WhatsApp support | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Child Physical Abuse | 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 | 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 | 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 | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Parenting | 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 |
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Inclusion criteria for participating parents or caregivers:
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:
Inclusion criteria for teachers:
Inclusion criteria for supervisors:
Inclusion criteria for KEMAS leadership:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universiti Putra Malaysia | Kuala Lumpur | Malaysia |
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| Label | URL |
|---|---|
| OSF Pre-Registration | View source |
| Protocol | View source |
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De-identified individual participant data underlying the results reported in publications, including demographic variables, caregiver-reported outcomes, and child assessment outcomes.
Deidentified participant data will be available beginning 12 months after publication of the planned article publication to allow completion of planned secondary analyses by the study team; no end date for availability.
Requests for access will require submission of a brief description of the intended use. Requests will be reviewed by the study team. Access will be granted following approval of the request and completion of appropriate data access procedures.
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This feasibility pilot is a 2 x 2 factorial cluster randomised trial that compares ParentText (chatbot-led parenting programme) delivered to all participants, with different combinations of two engagement components: i) a remote online WhatsApp support group (Yes or No); and ii) either one or two in-person sessions (Table 1). This study will adopt a parallel design employing a 1:1:1:1 allocation ratio (each cluster in each study site exposed to one experimental condition).
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| WhatsApp support groups | Behavioral | WhatsApp groups facilitated by children's teachers, with other participating parents from the children's preschool classes |
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| Closing session | Behavioral | An in-person closing session at the end of the intervention |
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Patient Health Questionnaire-4 (4 items); 0-3; higher score indicates worse outcome
| 3 weeks post-intervention |
| Parenting Stress | Parenting Stress Scale (6 items); (0-5); higher score indicates worse outcome | 3 weeks post-intervention |
| Child Behavior | 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 | 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 | Marital Health Scale (5 items); (1-5); higher score indicates better outcome | 3 weeks post-intervention |
| Financial Stress | Financial Self-Efficacy Scale (5 items); (0-3); higher score indicates worse outcome | 3 weeks post-intervention |
| Quality of Life | Assessment of Quality of Life-4D (12 items); (1-4); higher score indicates worse outcome | 3 weeks post-intervention |