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

Not Applicable

Completed

• Conditions: Responsive Parenting

• Registration Number: NCT05157906
• Lead Sponsor: Société des Produits Nestlé (SPN)

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.

Study Timeline

• Study First Submitted: 2021-10-07
• Study First Submitted QC: 2021-12-14
• Study First Posted: 2021-12-15
• Study Start: 2022-01-15
• Primary Completion: 2022-11-29
• Study Completion: 2022-11-29
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-22
• Last Update Posted: 2023-03-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 250

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Toddler gut comfort	Change from baseline to 12 weeks	GI symptoms, behaviors and overall GI burden assessed using the Toddler Gut Comfort Questionnaire.
Child eating behavior	Change from baseline to 12 weeks	Child eating behaviors and patterns assessed using the Child-Parent Mealtime Behavior Questionnaire.
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.
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.
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).
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).

Trial Locations

Locations (1)

University Gadjah Mada, Center for Health and Human Nutrition; 🇮🇩 Sleman, Indonesia