Responsive Parenting
Conditions
Brief summary
This is a randomized, controlled education-based interventional study without any investigational product. Study subjects are randomized to the intervention or control groups with a follow-up period of 12 weeks. 250 toddlers between ages 24 and 28 months with first-time primary caregiver (mother or father) from low to mid-income families in Indonesia will be enrolled.
Detailed description
Extensive scientific literature demonstrates that childhood happiness can be nurtured through positive and responsive parenting strategies, and is associated with optimal child development and is a predictor of future happiness. The Grow Happy program is a translation of scientific literature into parent-friendly educational materials and actionable tips and advice aimed at improving parental knowledge and child happiness through parenting techniques and play. Although the Grow Happy Program is scientifically validated, it has yet to be clinically tested. It is hypothesized that the Grow Happy program will improve mothers' knowledge and self-confidence related to parenting behaviors that promote happiness and optimal child development.
Interventions
BEHAVIORALEducation based
The interventional materials will be provided digitally for 12 weeks, with the monthly theme featured from the educational Grow Happy book and related tips and videos that will be released weekly.
BEHAVIORALControl
At enrollment, subject will be provided with the Mother and Child booklet, which is the Indonesian standard of care for parenting guidance.
Sponsors
Société des Produits Nestlé (SPN)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Intervention model description
This is a randomized, controlled education-based interventional study without any investigational product. Study subjects are randomized to the intervention or control groups with a follow-up period of 12 weeks.
Eligibility
Sex/Gender
ALL
Age
24 Months to 28 Months
Healthy volunteers
Yes
Inclusion criteria
1. Caregiver-toddler dyad pair is from low to mid-income households, as defined by a cut-off annual income level of IDR \<4,800,000 according to National Socioeconomic Survey. 2. Toddlers (full-term) between ages of 24 and 28 months at time of enrolment. 3. Normally developing toddlers without any diagnosed behavioral, neurological or eating issues.
Exclusion criteria
1. Primary caregivers with more than one child. 2. Primary caregivers with diagnosed behavioral or eating issues. 3. Toddlers with weight-for-age value \< -2 SD from the National Indonesian Growth Chart or per WHO Standards at enrollment. 4. Toddlers with height-for-age \< -2 SD from the National Indonesian Growth Chart or per WHO Standards at enrollment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To increase self-confidence of mothers (vs. control group) to adopt responsive parenting behaviors that promote optimal child development. | Change from baseline (V1) to 12 weeks of intervention (V2). | Mothers' self-confidence based on composite scores from the Toddler Care Questionnaire. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Child's health-related quality of life | Change from baseline to 12 weeks | Child's health related quality of life scores from the Infant and Toddler Quality of Life Questionnaire Short Form (ITQOL-SF47). |
| Maternal health-related quality of life | Change from baseline to 12 weeks | Maternal health related quality of life scores from the Oxford Happiness Inventory (OHI). |
| Toddler gut comfort | Change from baseline to 12 weeks | GI symptoms, behaviors and overall GI burden assessed using the Toddler Gut Comfort Questionnaire. |
| Parenting experience | Change from baseline to 12 weeks | Parenting Experience Questionnaire based on composite scores from a self-administered Questionnaire. |
| Child temperament | Change from baseline to 12 weeks | Child temperament as assessed by Children's Behavior Questionnaire (CBQ) Short Form. |
| Child playfulness | Change from baseline to 12 weeks | Child playfulness as measured by the Playfulness Questionnaire. |
| Parenting responsiveness behaviors | Change from baseline to 12 weeks | Parenting responsiveness using the parenting scale derived from the Parenting Young Children Scale. |
| Child eating behavior | Change from baseline to 12 weeks | Child eating behaviors and patterns assessed using the Child-Parent Mealtime Behavior Questionnaire. |
Countries
Indonesia
Outcome results
None listed