- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05157906
Effects of the Happy Grow Program on Parental Self-confidence: A Randomized, Controlled Open-label Study (Parentopia)
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Sleman, Indonesia
- University Gadjah Mada, Center for Health and Human Nutrition
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Experimental Group
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.
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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.
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Active Comparator: Control Group
No additional education materials will be proactively provided during trial duration.
Subjects will only be provided with the Indonesian standard of care only.
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At enrollment, subject will be provided with the Mother and Child booklet, which is the Indonesian standard of care for parenting guidance.
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What is the study measuring?
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.
Time Frame: Change from baseline (V1) to 12 weeks of intervention (V2).
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Mothers' self-confidence based on composite scores from the Toddler Care Questionnaire.
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Change from baseline (V1) to 12 weeks of intervention (V2).
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Parenting experience
Time Frame: Change from baseline to 12 weeks
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Parenting Experience Questionnaire based on composite scores from a self-administered Questionnaire.
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Change from baseline to 12 weeks
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Child's health-related quality of life
Time Frame: Change from baseline to 12 weeks
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Child's health related quality of life scores from the Infant and Toddler Quality of Life Questionnaire Short Form (ITQOL-SF47).
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Change from baseline to 12 weeks
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Maternal health-related quality of life
Time Frame: Change from baseline to 12 weeks
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Maternal health related quality of life scores from the Oxford Happiness Inventory (OHI).
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Change from baseline to 12 weeks
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Toddler gut comfort
Time Frame: Change from baseline to 12 weeks
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GI symptoms, behaviors and overall GI burden assessed using the Toddler Gut Comfort Questionnaire.
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Change from baseline to 12 weeks
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Child eating behavior
Time Frame: Change from baseline to 12 weeks
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Child eating behaviors and patterns assessed using the Child-Parent Mealtime Behavior Questionnaire.
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Change from baseline to 12 weeks
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Child temperament
Time Frame: Change from baseline to 12 weeks
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Child temperament as assessed by Children's Behavior Questionnaire (CBQ) Short Form.
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Change from baseline to 12 weeks
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Child playfulness
Time Frame: Change from baseline to 12 weeks
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Child playfulness as measured by the Playfulness Questionnaire.
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Change from baseline to 12 weeks
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Parenting responsiveness behaviors
Time Frame: Change from baseline to 12 weeks
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Parenting responsiveness using the parenting scale derived from the Parenting Young Children Scale.
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Change from baseline to 12 weeks
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Collaborators and Investigators
Investigators
- Principal Investigator: Juffrie Mohammad, Ph.D., SpAK, Faculty of Medicine, Public Health and Medicine, Universitas Gadjah Mada
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 20.29.INF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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