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

Nestlé

Status: Completed

Conditions: Responsive Parenting

Treatments: Behavioral: Education based; Behavioral: Control

Study type: Interventional

Funder types: Industry

Identifiers

NCT05157906

20.29.INF

Details and patient eligibility

About

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.

Full 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.

Enrollment: 250 patients

Sex: All

Ages: 24 to 28 months old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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250 participants in 2 patient groups

Experimental Group

Experimental group

Description:

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.

Treatment:

Behavioral: Education based

Control Group

Active Comparator group

Description:

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

Treatment:

Behavioral: Control