Effects of the Happy Grow Program on Parental Self-confidence: A Randomized, Controlled Open-label Study

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effects of the Happy Grow Program on Parental Self-confidence: A Randomized, Controlled Open-label Study

Conditions
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Responsive Parenting

Intervention / Treatment
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* Behavioral: Education based
* Behavioral: Control


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: 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. Toddlers (full-term) between ages of 24 and 28 months at time of enrolment. Normally developing toddlers without any diagnosed behavioral, neurological or eating issues. Exclusion criteria: Primary caregivers with more than one child. Primary caregivers with diagnosed behavioral or eating issues. Toddlers with weight-for-age value < -2 SD from the National Indonesian Growth Chart or per WHO Standards at enrollment. Toddlers with height-for-age < -2 SD from the National Indonesian Growth Chart or per WHO Standards at enrollment.

Ages Eligible for Study
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Minimum Age: 24 Months
Maximum Age: 28 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental Group<br>Subjects will have access to the Grow Happy program materials, including the Grow Happy Book, 99+ Ways to Grow Happy Tips and Engagement Videos, which are provided digitally during the trial duration of 12 weeks. | Behavioral: Education based<br>* 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.<br>|
| Active Comparator: Control Group<br>No additional education materials will be proactively provided during trial duration. Subjects will only be provided with the Indonesian standard of care only. | Behavioral: Control<br>* At enrollment, subject will be provided with the Mother and Child booklet, which is the Indonesian standard of care for parenting guidance.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To increase self-confidence of mothers (vs. control group) to adopt responsive parenting behaviors that promote optimal child development. | Mothers' self-confidence based on composite scores from the Toddler Care Questionnaire. | Change from baseline (V1) to 12 weeks of intervention (V2). | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Parenting experience | Parenting Experience Questionnaire based on composite scores from a self-administered Questionnaire. | Change from baseline to 12 weeks | 
| Child's health-related quality of life | Child's health related quality of life scores from the Infant and Toddler Quality of Life Questionnaire Short Form (ITQOL-SF47). | Change from baseline to 12 weeks | 
| Maternal health-related quality of life | Maternal health related quality of life scores from the Oxford Happiness Inventory (OHI). | Change from baseline to 12 weeks | 
| Toddler gut comfort | GI symptoms, behaviors and overall GI burden assessed using the Toddler Gut Comfort Questionnaire. | Change from baseline to 12 weeks | 
| Child eating behavior | Child eating behaviors and patterns assessed using the Child-Parent Mealtime Behavior Questionnaire. | Change from baseline to 12 weeks | 
| Child temperament | Child temperament as assessed by Children's Behavior Questionnaire (CBQ) Short Form. | Change from baseline to 12 weeks | 
| Child playfulness | Child playfulness as measured by the Playfulness Questionnaire. | Change from baseline to 12 weeks | 
| Parenting responsiveness behaviors | Parenting responsiveness using the parenting scale derived from the Parenting Young Children Scale. | Change from baseline to 12 weeks |