StuntingNCT07769723
Simulation-Based Education and Caregiving Ability Among Families of Stunted Children
A study testing Simulation-Based Education and Standardized Growth and Development Education Module in people with Stunting, run by Universitas Muhammadiyah Tasikmalaya at 1 site in Indonesia.
Trial summary
Stunting can affect children's growth and development and requires not only nutritional management but also appropriate stimulation and responsive caregiving. This study evaluated whether adding simulation-based growth and development education to a standard educational module could improve the caregiving ability of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stunting
- What is being tested?
- Simulation-Based Education and Standardized Growth and Development Education Module
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteIndonesia
- Study dates
- 10 Apr 2026to 26 May 2026
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Family caregivers of children aged 1-3 years diagnosed with stunting.
- The caregiver is the primary person responsible for daily child care.
- The caregiver lives with the child during the study period.
- The caregiver is willing to participate and provide written informed consent.
- The caregiver is able to communicate and complete the study questionnaire.
Who cannot join
- Caregivers who cannot participate in the educational sessions.
- Caregivers who have communication barriers that prevent completion of the assessment.
- Participants who withdraw consent during the study period.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Simulation-Based Education and Caregiving Ability Among Families of Stunted Children: A Nonrandomized Quasi-Experimental Study
Stunting can affect children's growth and development and requires not only nutritional management but also appropriate stimulation and responsive caregiving. This study evaluated whether adding simulation-based growth and development education to a standard educational module could improve the caregiving ability of families with stunted children. Caregivers received either a standardized take-home module alone or the same module combined with simulation-based education. The study assessed changes in caregivers' knowledge and self-reported ability to perform developmental stimulation activities.
Read the detailed description
This study was a nonrandomized quasi-experimental study using a pretest-posttest control group design. The study was conducted among family caregivers of children with stunting aged 1-3 years in the working area of Tamansari Public Health Center, Tasikmalaya, Indonesia.
Participants were allocated based on geographical areas. The control group received a standardized growth and development education module to use at home. The intervention group received the same module plus simulation-based education. The simulation session included explanation of child growth and development concepts, demonstration of developmental stimulation activities, guided caregiver practice, and corrective feedback from the facilitator.
The study included 55 caregivers in the final analysis, consisting of 31 caregivers in the intervention group and 24 caregivers in the control group. Caregiving ability was assessed in two domains: cognitive ability measured using a 32-item instrument and self-reported psychomotor ability measured using a 20-item questionnaire.
The primary purpose of this study was to determine whether simulation-based education provides additional benefits compared with module-only education in improving caregiver knowledge and perceived ability to perform developmental stimulation activities for children with stunting.
The study received ethical approval from the Health Research Ethics Committee, Faculty of Nursing and Health Sciences, Universitas Muhammadiyah Semarang (Ethical Clearance No. 001/KE/05/2026). Participation was voluntary, and all participants provided written informed consent before joining the study.
- Conditions
- Stunting
- Being tested
- Simulation-Based Education, Standardized Growth and Development Education Module
- Keywords
- Stunting, simulation, caregiver education, developmental stimulation, caregiving ability
- Medical subject headings
- Growth Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Simulation-Based EducationBehavioural
A simulation-based educational intervention consisting of growth and development education, demonstration of developmental stimulation activities, guided caregiver practice, and corrective feedback.
Standardized Growth and Development Education ModuleBehavioural
A standardized educational module about child growth, development, and caregiving practices provided to caregivers as take-home educational material.
| Study group | Role | What they receive |
|---|---|---|
| Simulation-Based Education Group | Experimental | Participants received a standardized growth and development education module combined with simulation-based education. The simulation included explanation, demonstration, caregiver practice, and corrective feedback regarding developmental stimulation activities for children with stunting. Receives: Behavioral: Simulation-Based Education; Behavioral: Standardized Growth and Development Education Module |
| Module-Only Group | Active comparator | Participants received the standardized growth and development education module only without simulation-based education. Receives: Behavioral: Standardized Growth and Development Education Module |
What is being measured
The primary outcome is the main question the study is designed to answer.
Caregiver Ability in Providing Care for Children with Stunting
The primary outcome was caregiver ability in caring for children with stunting, consisting of cognitive ability and self-reported psychomotor ability related to child growth and development stimulation practices.
Measured: Immediately after the intervention (posttest)
Secondary outcomes (2)
Caregiver Cognitive Ability
Caregiver cognitive ability was assessed using a 32-item instrument measuring knowledge related to child growth, development, and stimulation practices.
Measured: Immediately after the intervention (posttest)
Caregiver Self-Reported Psychomotor Ability
Caregiver self-reported psychomotor ability was assessed using a 20-item questionnaire evaluating the ability to perform developmental stimulation activities.
Measured: Immediately after the intervention (posttest)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2026
- Study start10 Apr 2026
- Primary completion26 May 2026
- Study completion26 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StuntingStudies of the same condition, open and under way.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Participants were assigned to two parallel groups based on geographical areas. The intervention group received a standardized growth and development education module plus simulation-based education, while the control group received the standardized module only.
- Masking
- None (open label)
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Muhammadiyah Tasikmalaya
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- NIA RESTIANA, M.Kep, Principal investigator, Universitas Muhammadiyah TasikmalayaNeni Solihat, M.Psi, Study director, Universitas Muhammadiyah TasikmalayaRosy Rosnawanty, M.Kep, Study director, Universitas Muhammadiyah Tasikmalaya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07769723
- Sponsor's protocol ID
- UMTAS-FPH-SIM-STUNT-2026-01
- Other IDs
- 0259.828/I.3/D/2025
- Status last verified
- Aug 2026
- First submitted
- 6 Aug 2026
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared with other researchers because the dataset contains confidential information from participants. Data access is restricted to the research team and will only be used for the purposes described in the approved study protocol. Any dissemination of findings will be conducted using aggregated results without identifying individual participants.
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Simulation-Based Education and Caregiving Ability Among Families of Stunted Children: A Nonrandomized Quasi-Experimental Study
- ClinicalTrials.gov ID
- NCT07769723
- Acronym / sponsor ID
- UMTAS-FPH-SIM-STUNT-2026-01
- Conditions
- Stunting
- Keywords
- Stunting, simulation, caregiver education, developmental stimulation, caregiving ability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Universitas Muhammadiyah TasikmalayaUniversity, hospital or other
- Study start
- 10 Apr 2026 (actual)
- Primary completion
- 26 May 2026 (actual)
- Study completion
- 26 May 2026 (actual)
- First posted
- 18 Aug 2026 (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.
Stunting can affect children's growth and development and requires not only nutritional management but also appropriate stimulation and responsive caregiving. This study evaluated whether adding simulation-based growth and development education to a standard educational module could improve the caregiving ability of families with stunted children. Caregivers received either a standardized take-home module alone or the same module combined with simulation-based education. The study assessed changes in caregivers' knowledge and self-reported ability to perform developmental stimulation activities.
Detailed description
This study was a nonrandomized quasi-experimental study using a pretest-posttest control group design. The study was conducted among family caregivers of children with stunting aged 1-3 years in the working area of Tamansari Public Health Center, Tasikmalaya, Indonesia.
Participants were allocated based on geographical areas. The control group received a standardized growth and development education module to use at home. The intervention group received the same module plus simulation-based education. The simulation session included explanation of child growth and development concepts, demonstration of developmental stimulation activities, guided caregiver practice, and corrective feedback from the facilitator.
The study included 55 caregivers in the final analysis, consisting of 31 caregivers in the intervention group and 24 caregivers in the control group. Caregiving ability was assessed in two domains: cognitive ability measured using a 32-item instrument and self-reported psychomotor ability measured using a 20-item questionnaire.
The primary purpose of this study was to determine whether simulation-based education provides additional benefits compared with module-only education in improving caregiver knowledge and perceived ability to perform developmental stimulation activities for children with stunting.
The study received ethical approval from the Health Research Ethics Committee, Faculty of Nursing and Health Sciences, Universitas Muhammadiyah Semarang (Ethical Clearance No. 001/KE/05/2026). Participation was voluntary, and all participants provided written informed consent before joining the study.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants were assigned to two parallel groups based on geographical areas. The intervention group received a standardized growth and development education module plus simulation-based education, while the control group received the standardized module only.
| Arm | Type | Receives |
|---|---|---|
| Simulation-Based Education Group | Experimental | Behavioral: Simulation-Based Education, Behavioral: Standardized Growth and Development Education ModuleParticipants received a standardized growth and development education module combined with simulation-based education. The simulation included explanation, demonstration, caregiver practice, and corrective feedback regarding developmental stimulation activities for children with stunting. |
| Module-Only Group | Active comparator | Behavioral: Standardized Growth and Development Education ModuleParticipants received the standardized growth and development education module only without simulation-based education. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Family caregivers of children aged 1-3 years diagnosed with stunting.
- The caregiver is the primary person responsible for daily child care.
- The caregiver lives with the child during the study period.
- The caregiver is willing to participate and provide written informed consent.
- The caregiver is able to communicate and complete the study questionnaire.
Key exclusion criteria (3 listed)
- Caregivers who cannot participate in the educational sessions.
- Caregivers who have communication barriers that prevent completion of the assessment.
- Participants who withdraw consent during the study period.
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 |
|---|---|---|
| Simulation-Based EducationA simulation-based educational intervention consisting of growth and development education, demonstration of developmental stimulation activities, guided caregiver practice, and corrective feedback. | Behavioural | Simulation-Based Education Group |
| Standardized Growth and Development Education ModuleA standardized educational module about child growth, development, and caregiving practices provided to caregivers as take-home educational material. | Behavioural | Module-Only Group, Simulation-Based Education Group |
Primary outcome
Caregiver Ability in Providing Care for Children with Stunting
Time frame: Immediately after the intervention (posttest)
The primary outcome was caregiver ability in caring for children with stunting, consisting of cognitive ability and self-reported psychomotor ability related to child growth and development stimulation practices.
2 secondary outcomes
Caregiver Cognitive Ability
Time frame: Immediately after the intervention (posttest)
Caregiver Self-Reported Psychomotor Ability
Time frame: Immediately after the intervention (posttest)
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 19 Aug 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared with other researchers because the dataset contains confidential information from participants. Data access is restricted to the research team and will only be used for the purposes described in the approved study protocol. Any dissemination of findings will be conducted using aggregated results without identifying individual participants.
Related trials for Stunting
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Maternal Probiotic Intervention to Improve Gut Health-Trial II-Pakistan
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Statin Intervention for Severe Early-Onset Placental Insufficiency. (STATIN-PRE Trial)
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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.
NIA RESTIANA, M.Kep principal investigator
Universitas Muhammadiyah Tasikmalaya
Neni Solihat, M.Psi study director
Universitas Muhammadiyah Tasikmalaya
Rosy Rosnawanty, M.Kep study director
Universitas Muhammadiyah Tasikmalaya
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Simulation-Based Education and Standardized Growth and Development Education Module in people with Stunting, run by Universitas Muhammadiyah Tasikmalaya 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 5 inclusion and 3 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 19 Aug 2026. 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?
Caregiver Ability in Providing Care for Children with Stunting (time frame: Immediately after the intervention (posttest)). 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 19 Aug 2026.