Responsive ParentingNCT05157906
Effects of the Happy Grow Program on Parental Self-confidence: A Randomized, Controlled Open-label Study
A study testing Education based in people with Responsive Parenting, run by Société des Produits Nestlé (SPN) at 1 site in Indonesia.
Trial 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. Read more about this study
- Who is it for?
- Ages 24 to 28 monthsHealthy volunteers can take part
- Conditions the study is for
- Responsive Parenting
- What is being tested?
- Education based
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteIndonesia
- Study dates
- 15 Jan 2022to 29 Nov 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 24 to 28 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
University Gadjah Mada, Center for Health and Human Nutrition
Sleman
About this 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.
Read the 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.
- Conditions
- Responsive Parenting
- Being tested
- Education based, Control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Education basedBehavioural
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.
ControlBehavioural
At enrollment, subject will be provided with the Mother and Child booklet, which is the Indonesian standard of care for parenting guidance.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | 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. Receives: Behavioral: Education based |
| Control Group | Active comparator | No additional education materials will be proactively provided during trial duration. Subjects will only be provided with the Indonesian standard of care only. Receives: Behavioral: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
To increase self-confidence of mothers (vs. control group) to adopt responsive parenting behaviors that promote optimal child development.
Mothers' self-confidence based on composite scores from the Toddler Care Questionnaire.
Measured: Change from baseline (V1) to 12 weeks of intervention (V2).
Secondary outcomes (8)
Parenting experience
Parenting Experience Questionnaire based on composite scores from a self-administered Questionnaire.
Measured: Change from baseline to 12 weeks
Child's health-related quality of life
Child's health related quality of life scores from the Infant and Toddler Quality of Life Questionnaire Short Form (ITQOL-SF47).
Measured: Change from baseline to 12 weeks
Maternal health-related quality of life
Maternal health related quality of life scores from the Oxford Happiness Inventory (OHI).
Measured: Change from baseline to 12 weeks
Toddler gut comfort
GI symptoms, behaviors and overall GI burden assessed using the Toddler Gut Comfort Questionnaire.
Measured: Change from baseline to 12 weeks
Child eating behavior
Child eating behaviors and patterns assessed using the Child-Parent Mealtime Behavior Questionnaire.
Measured: Change from baseline to 12 weeks
Child temperament
Child temperament as assessed by Children's Behavior Questionnaire (CBQ) Short Form.
Measured: Change from baseline to 12 weeks
Child playfulness
Child playfulness as measured by the Playfulness Questionnaire.
Measured: Change from baseline to 12 weeks
Parenting responsiveness behaviors
Parenting responsiveness using the parenting scale derived from the Parenting Young Children Scale.
Measured: Change from baseline to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2021
- Study start15 Jan 2022
- Primary completion29 Nov 2022
- Study completion29 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Responsive ParentingStudies of the same condition, open and under way.
- More trials run by Société des Produits Nestlé (SPN)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Société des Produits Nestlé (SPN)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Juffrie Mohammad, Ph.D., SpAK, Principal investigator, Faculty of Medicine, Public Health and Medicine, Universitas Gadjah Mada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05157906
- Sponsor's protocol ID
- 20.29.INF
- Status last verified
- Mar 2023
- First submitted
- 7 Oct 2021
- Last updated
- 24 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of the Happy Grow Program on Parental Self-confidence: A Randomized, Controlled Open-label Study
- ClinicalTrials.gov ID
- NCT05157906
- Acronym / sponsor ID
- 20.29.INF
- Conditions
- Responsive Parenting
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Société des Produits Nestlé (SPN)Industry (pharma, biotech, devices)
- Study start
- 15 Jan 2022 (actual)
- Primary completion
- 29 Nov 2022 (actual)
- Study completion
- 29 Nov 2022 (actual)
- First posted
- 15 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Behavioral: Education basedSubjects 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. |
| Control Group | Active comparator | Behavioral: ControlNo additional education materials will be proactively provided during trial duration. Subjects will only be provided with the Indonesian standard of care only. |
Who may qualify
- Ages
- 24 to 28 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Education basedThe 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. | Behavioural | Experimental Group |
| ControlAt enrollment, subject will be provided with the Mother and Child booklet, which is the Indonesian standard of care for parenting guidance. | Behavioural | Control Group |
Primary outcome
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.
8 secondary outcomes
Parenting experience
Time frame: Change from baseline to 12 weeks
Child's health-related quality of life
Time frame: Change from baseline to 12 weeks
Maternal health-related quality of life
Time frame: Change from baseline to 12 weeks
Toddler gut comfort
Time frame: Change from baseline to 12 weeks
Child eating behavior
Time frame: Change from baseline to 12 weeks
Child temperament
Time frame: Change from baseline to 12 weeks
Child playfulness
Time frame: Change from baseline to 12 weeks
Parenting responsiveness behaviors
Time frame: Change from baseline to 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Juffrie Mohammad, Ph.D., SpAK principal investigator
Faculty of Medicine, Public Health and Medicine, Universitas Gadjah Mada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Education based in people with Responsive Parenting, run by Société des Produits Nestlé (SPN) at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2023.