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| ID | Type | Description | Link |
|---|---|---|---|
| 10.17605/OSF.IO/AZ3NY | Registry Identifier | Prospectively registered on Open Science Framework on 17/08/24; ClinicalTrials.gov entry retrospective and consistent. |
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| Name | Class |
|---|---|
| Universiti Putra Malaysia | OTHER |
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This study aims to evaluate the effectiveness of a hybrid human-digital playful parenting programme, "Naungan Kasih-Hybrid (NK-Hybrid)", in Malaysia. The programme is facilitated by teachers from Malaysian preschools for low-income families, consisting of a) one in-person session to introduce caregivers to the programme, b) teacher-facilitated WhatsApp support groups, and c) an interactive chatbot-led parenting programme featured on WhatsApp, called "Naungan Kasih-Text (NKText)". It tests the effectiveness of this package in a cluster-randomised trial, with 50 preschools as clusters, randomly assigned to either the treatment group or a waitlist control group. Findings from this study will provide evidence for the effectiveness of a low-cost and scalable intervention integrating digital modalities with a "light-touch" in-person component to improve educational outcomes in children attending preschools for low-income families, and thereby address social inequalities in Malaysia.
N = 50 Clusters, 772 Primary Caregivers, 304 Secondary Caregivers, and 754 Children. Enrolment reflects participating primary caregivers.
The primary aims of the study are to:
Evaluate the effectiveness of NK-Hybrid on positive parenting at three months post-baseline in comparison to wait-list controls Evaluate the effectiveness of NK-Hybrid on child learning and development, as measured by parent and teacher reports of language and communication, literacy, socioemotional, and numeracy skills, and by direct assessments of literacy and numeracy skills, at approximately 12 months post-baseline in comparison to wait-list controls
Secondary aims of the study include:
Evaluate the sustained effectiveness of NK-Hybrid on positive parenting at approximately 12 months post-baseline.
Evaluate the effectiveness of NK-Hybrid on children's learning, namely their literacy and numeracy skills, in comparison to the control group, at three months post-baseline Evaluate the effectiveness of NK-Hybrid on secondary outcomes - parent involvement in playful learning, child maltreatment (physical and emotional abuse), caregiver anxiety and depression, parenting stress, child externalising symptoms, child learning and development, caregiver financial stress, intimate partner violence, marital health, co-parenting support, father involvement, and gender equitable behaviours - at approximately three months post-baseline and 12 months post-baseline.
Evaluate the intervention costs and cost-effectiveness of NK-Hybrid on primary outcomes of positive parenting and child literacy and numeracy skills.
Evaluate the association between engagement in the NK-Hybrid intervention and primary and secondary outcomes.
Explore potential mediators of positive parenting, child literacy and numeracy skills, child maltreatment, child externalising symptoms, and caregiver depression and anxiety at 12 months post-baseline.
Explore potential moderators of positive parenting, child literacy and numeracy skills, child maltreatment, child externalising symptoms, and caregiver depression and anxiety based on socio-demographics and psychosocial assessments at baseline
In line with the study's primary and secondary objectives, the following hypotheses have been defined a priori and will be evaluated using the methods outlined in this statistical analysis plan.
Hypothesis 1a: Caregivers in the treatment group will show higher levels of positive parenting, in comparison to the control group, at 3 months post-baseline.
Hypothesis 1b: Children in the treatment group will show greater improvements in early learning and development, namely their literacy and numeracy skills, in comparison to the control group, at 12 months post-baseline.
Hypothesis 2a: Caregivers in the treatment group will show higher levels of positive parenting, in comparison to the control group, at 12 months post-baseline.
Hypothesis 2b: Children in the treatment group will show greater improvements in learning, namely their literacy and numeracy skills, in comparison to the control group, at three months post-baseline.
Hypothesis 2c: Caregivers in the treatment group will show lower levels of child maltreatment (physical and emotional abuse), anxiety and depression, parenting stress, child externalising symptoms, financial stress, and intimate partner violence, in comparison to the control group, at 3 months and 12 months post-baseline.
Hypothesis 2d: Caregivers in the treatment group will show higher levels of parent involvement in playful learning, marital health, co-parenting support, father involvement, and gender equitable behaviours in comparison to the control group, at 3 months and 12 months post-baseline.
Hypothesis 3a: The intervention will be more cost-effective than the control condition for the primary outcomes, yielding a cost per unit of effect that supports decision-making by relevant stakeholders.
Hypothesis 3b: Higher engagement with intervention components (i.e., in-person onboarding, NKText, and WhatsApp support groups) will be associated with greater improvements in the aforementioned primary and secondary outcomes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Group | Experimental | Intervention group participants will receive one in-person onboarding session, NKText - a self-guided chatbot providing parenting support, and facilitated WhatsApp support groups. |
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| Control Group | No Intervention | The control group will not receive the intervention until after the completion of the intervention period and the final follow-up data collection. Throughout the study period, participants in all groups may access any other interventions, programs, or services that are not part of the study intervention. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Naungan Kasih Positive Parenting Programme | Behavioral | The programme is facilitated by teachers from Malaysian preschools for low-income families, consisting of a) one in-person session to introduce caregivers to the programme, b) teacher-facilitated WhatsApp support groups, and c) an interactive chatbot-led parenting programme featured on WhatsApp, called "Naungan Kasih-Text". |
| Measure | Description | Time Frame |
|---|---|---|
| Child early learning and development | Children's early learning and development (caregiver- and teacher-report) will be measured using 23 items from the National Preschool Standards-Based Curriculum Assessment (Malaysia); scale = 0-2; higher score indicates better outcome. | Baseline, 3-5 months post-baseline, 12-15 months post-baseline |
| Positive Parenting | Positive parenting will be measured using 14 items from the Parenting Young Children Scale (PARYC) (McEachern et al., 2012). (Caregiver Report); (0-6); higher score indicates better outcome. | Baseline, 3-5 months post-baseline, 12-15 months post-baseline |
| Child Literacy and Numeracy | Direct child assessments of child learning and development will be conducted by trained research assistants and assessed using an adapted version of the Remote Assessment of Learning (ReAL) High-Access version (Save the Children International, 2021), specifically the Literacy and Numeracy subscales. 12 domains, total score = mean of % correct for each domain; higher score indicates better outcome. | Baseline, 3-5 months post-baseline, 12-15 months post-baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Parent involvement in playful learning | Parent involvement in playful learning will be measured using four items from the UNICEF Multiple Indicator Cluster Surveys (MICS) Child Development Module/Family Care Indicators (Kariger et al., 2012). (4 items) (0-8 times in last two weeks) - higher indicates more playful learning activities (better outcome) | Baseline, 3-5 months post-baseline, 12-15 months post-baseline |
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Inclusion Criteria:
Preschools (clusters):
Parents/Caregivers:
Children:
Teachers (Facilitators):
Exclusion Criteria:
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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 |
| Statistical Analysis Plan (SAP) | 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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| ID | Term |
|---|---|
| D002652 | Child Behavior |
| ID | Term |
|---|---|
| D001519 | Behavior |
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This study is a cluster randomised control trial with 50 preschools (clusters) randomly allocated, in a 1:1 ratio, to either a treatment or a control group. Those assigned to the intervention arm will receive the hybrid in-person digital intervention. Those assigned to the control group will be waitlisted to receive the intervention after completion of the research (i.e., 12 months post-baseline).
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The trial statisticians (GJMT, SV) conducting randomisation and analyses will be blinded to condition. Blinding of participants is not possible given the nature of the intervention. Enumerators are blinded at baseline assessments (T0) and will remain blinded at the endline (T1) and follow-up (T2) assessments, although it is plausible that they may find out from participants which individuals received the intervention.
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| Child Maltreatment | Child maltreatment will be measured using six items from the International Society for the Prevention of Child Abuse and Neglect Child Abuse Screening Tool (Meinck et al., 2018), covering physical violence (two items) and psychological violence (four items). (Parent Report); (0-8 times in last two weeks) - higher indicates more incidence of abuse (worse outcome) | Baseline, 3-5 months post-baseline, 12-15 months post-baseline |
| Child externalising symptoms | Child externalising symptoms will be assessed using 12 items from the externalising subscale of the Child and Adolescent Behavior Inventory (CABI) (Cianchetti et al., 2013); (0-2); higher score indicates worse outcome | Baseline, 3-5 months post-baseline, 12-15 months post-baseline |
| Parenting Stress | Parenting stress will be assessed using six items from the Parenting Stress Scale (Berry & Jones, 2016); (0-5); higher score indicates worse outcome | Baseline, 3-5 months post-baseline, 12-15 months post-baseline |
| Anxiety and depression | Anxiety and depression will be assessed using four items from the Patient Health Questionnaire (PHQ-4) Scale (Kroenke et al., 2009); (0-3); higher score indicates worse outcome | Baseline, 3-5 months post-baseline, 12-15 months post-baseline |
| Father involvement with the child | Father involvement with the child will be assessed using seven items from an adapted version of the Alabama Parenting Questionnaire Involvement Subscale (Frick, 1991); (0-4); higher score indicates better outcome. | Baseline, 3-5 months post-baseline, 12-15 months post-baseline |
| Gender equitable behaviours | Gender equitable behaviours will be assessed using four items informed by measures commonly used in violence prevention research (Abramsky et al., 2020; Doyle et al., 2018); (1-5); higher score indicates better outcome | Baseline, 3-5 months post-baseline, 12-15 months post-baseline |
| Co-parenting support | Co-parenting support will be assessed using six items from the Co-parenting Relationship Scale (Feinberg et al., 2012); (0-3); higher score indicates better outcome. | Baseline, 3-5 months post-baseline, 12-15 months post-baseline |
| Marital health/quality | Marital health/quality will be assessed using five items developed by the research team; (1-5); higher score indicates better outcome | Baseline, 3-5 months post-baseline, 12-15 months post-baseline |
| Intimate partner violence | Intimate partner violence will be assessed using four items adapted from the World Health Organisation study on women's health and domestic violence against women (World Health Organization, 2005); (0-3); higher score indicates worse outcome. | Baseline, 3-5 months post-baseline, 12-15 months post-baseline |
| Financial Stress | Financial stress will be assessed using six items adapted from the Financial Self-Efficacy Scale (Lown, 2012); (0-3); higher score indicates worse outcome. | Baseline, 3-5 months post-baseline, 12-15 months post-baseline |