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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

250 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-15

Study Completion Date

2022-11-29

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.

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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.

Conditions

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Responsive Parenting

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Education based

Intervention Type 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 Group

No additional education materials will be proactively provided during trial duration. Subjects will only be provided with the Indonesian standard of care only.

Group Type ACTIVE_COMPARATOR

Control

Intervention Type BEHAVIORAL

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

Interventions

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Education 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.

Intervention Type BEHAVIORAL

Control

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.

Minimum Eligible Age

24 Months

Maximum Eligible Age

28 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes