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OpenTrials
Completed

NCT Number: NCT05157906

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

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.

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Key information

Conditions

Responsive Parenting

Age range

24 month–28 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Gadjah Mada, Center for Health and Human Nutrition

Sleman, Indonesia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Education based

Behavioral

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.

Control

Behavioral

At enrollment, subject will be provided with the Mother and Child booklet, which is the Indonesian standard of care for parenting guidance.

Primary outcomes

  1. To increase self-confidence of mothers (vs. control group) to adopt responsive parenting behaviors that promote optimal child development.

    Time frame: Change from baseline (V1) to 12 weeks of intervention (V2).

    Mothers' self-confidence based on composite scores from the Toddler Care Questionnaire.

Secondary outcomes

  1. Parenting experience

    Time frame: Change from baseline to 12 weeks

    Parenting Experience Questionnaire based on composite scores from a self-administered Questionnaire.

  2. Child's health-related quality of life

    Time frame: 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).

  3. Maternal health-related quality of life

    Time frame: Change from baseline to 12 weeks

    Maternal health related quality of life scores from the Oxford Happiness Inventory (OHI).

  4. Toddler gut comfort

    Time frame: Change from baseline to 12 weeks

    GI symptoms, behaviors and overall GI burden assessed using the Toddler Gut Comfort Questionnaire.

  5. Child eating behavior

    Time frame: Change from baseline to 12 weeks

    Child eating behaviors and patterns assessed using the Child-Parent Mealtime Behavior Questionnaire.

  6. Child temperament

    Time frame: Change from baseline to 12 weeks

    Child temperament as assessed by Children's Behavior Questionnaire (CBQ) Short Form.

  7. Child playfulness

    Time frame: Change from baseline to 12 weeks

    Child playfulness as measured by the Playfulness Questionnaire.

  8. Parenting responsiveness behaviors

    Time frame: Change from baseline to 12 weeks

    Parenting responsiveness using the parenting scale derived from the Parenting Young Children Scale.

Sponsors and collaborators

Lead sponsor

Société des Produits Nestlé (SPN)

Industry

Registry information

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Dec 15, 2021
Registry last updated
Mar 24, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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