NCT07769723

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
55

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 10, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 26, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 26, 2026

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 6, 2026

Completed
12 days until next milestone

First Posted

Study publicly available on registry

August 18, 2026

Completed
Last Updated

August 19, 2026

Status Verified

August 1, 2026

Enrollment Period

2 months

First QC Date

August 6, 2026

Last Update Submit

August 17, 2026

Conditions

Keywords

Stuntingsimulationcaregiver educationdevelopmental stimulationcaregiving ability

Outcome Measures

Primary Outcomes (1)

  • 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.

    Immediately after the intervention (posttest)

Secondary Outcomes (2)

  • Caregiver Cognitive Ability

    Immediately after the intervention (posttest)

  • Caregiver Self-Reported Psychomotor Ability

    Immediately after the intervention (posttest)

Study Arms (2)

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.

Behavioral: Simulation-Based EducationBehavioral: 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.

Behavioral: Standardized Growth and Development Education Module

Interventions

A simulation-based educational intervention consisting of growth and development education, demonstration of developmental stimulation activities, guided caregiver practice, and corrective feedback.

Simulation-Based Education Group

A standardized educational module about child growth, development, and caregiving practices provided to caregivers as take-home educational material.

Module-Only GroupSimulation-Based Education Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Puskesmas Tamansari

Tasikmalaya, West Java, 46196, Indonesia

Location

MeSH Terms

Conditions

Growth Disorders

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • NIA RESTIANA, M.Kep

    Universitas Muhammadiyah Tasikmalaya

    PRINCIPAL INVESTIGATOR
  • Neni Solihat, M.Psi

    Universitas Muhammadiyah Tasikmalaya

    STUDY DIRECTOR
  • Rosy Rosnawanty, M.Kep

    Universitas Muhammadiyah Tasikmalaya

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Masking Details
No masking was applied because the intervention involved direct educational simulation activities.
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 6, 2026

First Posted

August 18, 2026

Study Start

April 10, 2026

Primary Completion

May 26, 2026

Study Completion

May 26, 2026

Last Updated

August 19, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will not share

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.

Locations