Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000343606
Ethics application status
Approved
Date submitted
30/01/2023
Date registered
31/03/2023
Date last updated
25/09/2023
Date data sharing statement initially provided
31/03/2023
Type of registration
Retrospectively registered

Titles & IDs
Public title
The Effect of Education about Online Developmental Stimulation in Mothers of Stunted Children Aged 2-5 Years on the Practice of Stimulation and Socio-Emotional Development of Children
Scientific title
The Effect of Education about Online Developmental Stimulation in Mothers of Stunted Children Aged 2-5 Years on the Practice of Stimulation and Socio-Emotional Development of Children
Secondary ID [1] 308797 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
emotional social development 328748 0
Condition category
Condition code
Mental Health 325751 325751 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Online Education Interventions
The study used the Theory of Planned Behavior approach to examine the effect of online developmental stimulation education on mothers of stunted children aged 2-5 who were resistant to the practice of stimulation and children's socio-emotional development.
1. The online educational intervention provided to respondents is an advanced stage of previous research. The first phase of research produced a product in the form of an educational e-module to stimulate children's socio-emotional development, which was designed according to the needs of mothers who have stunted toddlers aged 2-5 years and used as a medium for the educational process. Online educational interventions are provided through WhatsApp Group (WAG) through chat and video according to the module's content and e-module that respondents can access at a mutually agreed time. The number of respondents, 46, was divided into four groups. One group consists of between 10-15 respondents. Education is provided for 1 hour per virtual face-to-face for 12 virtual face-to-face. Online classes are held twice weekly, so it takes six weeks. Researchers provide educational interventions to participants, and researchers are pediatric nurses. To find out the attendance of participants in education, researchers shared an attendance link and asked participants to write down attendance in the chat column at WAG.
2. The study was conducted on a sample not randomly but in the determination of the Center for Public Health as a research area was carried out randomly. Researchers determined four community health centers as intervention groups and four groups as controls.
Intervention code [1] 325248 0
Behaviour
Intervention code [2] 325249 0
Treatment: Other
Comparator / control treatment
The treatment given to the control group is about sex education.
In the control group, health education will be given, namely about sex education for child development and female contraception. Educational interventions are provided online through WhatsApp groups and materials are provided in the form of Power Points. Similar to the intervention group, in the control group education is given for 1 hour each virtual face-to-face. given 1 time per week by nurses who have passed the competency test. Educational media is shared through WAG so that respondents can access materials in the group.
Control group
Active

Outcomes
Primary outcome [1] 333600 0
Behaviors measured before and after the intervention is a practice of stimulating child development.
In a recent study on children's social-emotional development, researchepatternsped a questionnaire to measure the practices of parents in stimulating their children's social-emotional development. The questionnaire assessed various aspects of parenting practices related to social-emotional development, such as the frequency and quality of parent-child interactions, emotional support, and behavior management strategies.
The researchers conducted validity and reliability testing to ensure that the questionnaire accurately measures what it intends to measure. Validity testing involves examining whether the questionnaire measures the construct it is intended to measure. Reliability testing, on the other hand, assessed the consistency and stability of the questionnaire over time and across different raters. After conducting validity and reliability testing, the researchers determined that the questionnaire was an effective tool for measuring the practices of parents in stimulating social-emotional development.
Timepoint [1] 333600 0
After 12 face-to-face times or two months is a Knowledge
This sentence means that respondents' knowledge of child development stimulation practices will be assessed after they have received online education. To measure respondents' knowledge of child development stimulation practices, they will be provided with online education. After online education, respondents' learning will be assessed using a knowledge test. The assessment will occur after 12 face-to-face sessions or two months since the online instruction was provided.
This approach is used to measure the effectiveness of online education in improving respondents' knowledge of child developmental stimulation practices. By waiting for 12 face-to-face sessions or two months, it is possible to ensure enough time has passed for an education that the respondent fully absorbs. In addition, this approach can help determine whether education needs to be customized or improved to better meet the target audience's needs.
Overall, using a knowledge test after some time following online education can provide valuable insights into the effectiveness of the teaching and its impact on respondents' knowledge of child development stimulation practices.
Secondary outcome [1] 417712 0
social-emotional development
Timepoint [1] 417712 0
Age and Stage Questionnaire assess social-emotional development: Social-Emotional – 2 (ASQ: SE2) after intervention during 12 online educational sessions

Eligibility
Key inclusion criteria
Mothers of stunting toddlers aged 2 – 5 years have smartphones
Minimum age
No limit
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Mothers have stunted toddlers aged 2 – 5 years with chronic diseases.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Suspended
Date of first participant enrolment
Anticipated
Actual
2/02/2023
Date of last participant enrolment
Anticipated
4/04/2023
Actual
4/04/2023
Date of last data collection
Anticipated
15/09/2023
Actual
24/05/2023
Sample size
Target
96
Accrual to date
100
Final
Recruitment outside Australia
Country [1] 25219 0
Indonesia
State/province [1] 25219 0
East Java

Funding & Sponsors
Funding source category [1] 313013 0
Self funded/Unfunded
Name [1] 313013 0
Faridah
Country [1] 313013 0
Indonesia
Primary sponsor type
Individual
Name
Faridah
Address
STIKES Hang Tuah Surabaya, Jl. Gadung No.1, Jagir, Kec. Wonokromo Surabaya, East Java
Country
Indonesia
Secondary sponsor category [1] 314979 0
Individual
Name [1] 314979 0
Zainuri
Address [1] 314979 0
PT. Indowire Prima Industrindo, Jl. Margomulyo Indah No.C-1, Buntaran, Kecamatan Tandes, Kota Surabaya, East Java 60185
Country [1] 314979 0
Indonesia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312276 0
Diponegoro University Health Research Ethics Committee
Ethics committee address [1] 312276 0
Ethics committee country [1] 312276 0
Indonesia
Date submitted for ethics approval [1] 312276 0
02/02/2022
Approval date [1] 312276 0
24/02/2022
Ethics approval number [1] 312276 0
No: 57/EA/KEPK-FKM/2022

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 124078 0
Mrs Faridah
Address 124078 0
STIKES Hang Tuah Surabaya, Jl. Gadung No.1, Jagir, Kec. Wonokromo Surabaya East Java
Country 124078 0
Indonesia
Phone 124078 0
+62 8123093148
Fax 124078 0
Email 124078 0
[email protected]
Contact person for public queries
Name 124079 0
Faridah
Address 124079 0
STIKES Hang Tuah Surabaya, Jl. Gadung No.1, Jagir, Kec. Wonokromo Surabaya East Java
Country 124079 0
Indonesia
Phone 124079 0
+62 8123093148
Fax 124079 0
Email 124079 0
[email protected]
Contact person for scientific queries
Name 124080 0
Faridah
Address 124080 0
STIKES Hang Tuah Surabaya, Jl. Gadung No.1, Jagir, Kec. Wonokromo Surabaya East Java
Country 124080 0
Indonesia
Phone 124080 0
+62 8123093148
Fax 124080 0
Email 124080 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Individual participant data is not shared because the researcher must maintain the respondent's confidentiality. Respondents have filled out informed consent before participating in the research, and researchers have promised to preserve the confidentiality of the respondents.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.