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Trial registered on ANZCTR
Registration number
ACTRN12626000957392
Ethics application status
Approved
Date submitted
9/07/2026
Date registered
4/08/2026
Date last updated
4/08/2026
Date data sharing statement initially provided
4/08/2026
Date results provided
4/08/2026
Type of registration
Prospectively registered
Titles & IDs
Public title
Parenting program for early development of children from ethnic minority groups in Lai Chau: a cluster randomised controlled trial of effectiveness
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Scientific title
Evaluation of the effectiveness of the Early Journey of Life Program adapted for ethnic minority groups for child development in Lai Chau: a cluster randomised controlled trial
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Additional trial identifiers [1]
317516
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Nil
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Universal Trial Number (UTN)
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Trial acronym
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Related trial records
ACTRN12617000442303 - original trial
The Early Journey of Life (EJoL) intervention that is to be investigated in this current trial is based on the community-based multicomponent parenting intervention, Learning Clubs, which was tested in the original cluster Randomised Controlled Trial.
ACTRN12625001113448 - follow-up study of original trial.
This study is following-up the parents and child that participated in the original trial.
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Health condition
Health condition(s) studied:
Child cognitive development
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Maternal mental health
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Maternal experience of intimate partner violence
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Perinatal common mental disorders among women
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Condition category
Condition code
Public Health
338370
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0
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Health promotion/education
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Mental Health
338371
338371
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0
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Studies of normal psychology, cognitive function and behaviour
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Reproductive Health and Childbirth
338372
338372
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0
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Antenatal care
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Reproductive Health and Childbirth
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0
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Childbirth and postnatal care
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Intervention/exposure
Study type
Interventional
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Description of the intervention or exposure
The Early Journey of Life (EJoL) intervention is based on the community-based multicomponent parenting intervention, Learning Clubs, which was tested in rural Ha Nam (ACTRN12617000442303). To scale EJoL and promote feasible and sustainable implementation it was integrated into the National Expanded Program on Immunization (NEPI). The parenting group sessions are now delivered following routine immunizations in selected provinces.
To ensure the intervention was accessible and culturally appropriate, EJoL underwent a period of community consultation to develop a version that was culturally adapted and accessible in local languages in partnership with national and provincial governments. The EJoL intervention includes twelve practice-based sessions of approximately 30 - 45 minutes delivered over the course of 18 months, covering prenatal care during pregnancy, early learning to support child cognitive development, responsive caregiving, adequate nutrition, health, safety, and hygiene. Two of these twelve sessions are delivered during pregnancy and the remaining ten are delivered to both mother and child post birth. Sessions will take place at commune health centres (CHCs), satellite CHCs, or mobile immunization spots. Participant attendance, adherence, and program coverage will be monitored through standardized checklists.
Commune or village health workers will serve as facilitators, delivering these sessions to small groups of up to 20 caregivers. Facilitators will receive training in two phases, Phase 1 consists of the self-paced e-learning course, 'Early Childhood Care and Development in the First 2,000 Days', which comprises nine modules and requires approximately six hours to complete. Upon completion of Phase 1, facilitators will attend a two day, face to face Phase 2 training workshop. Phase 2 will cover integrating EJoL into immunization services through role playing, communication skills, participant engagement techniques, and quality assurance.
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Intervention code [1]
334305
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Prevention
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Intervention code [2]
334308
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Behaviour
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Description of the comparator or control
The control group will receive the usual standard of pregnancy and postpartum health care. This includes free antenatal checks, birth in a medical facility and access to the National Growth Monitoring and Expanded Immunisation Programmes.
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Control group
Active
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Outcomes
Primary outcome [1]
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Child cognitive development at 12 months old
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Assessment method [1]
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Assessed using the Bayley Scales of Infant and Toddler Development
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Timepoint [1]
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When child is 12 months old
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Secondary outcome [1]
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Child social-emotional development
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Assessment method [1]
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Assessed using the Bayley Scales of Infant and Toddler Development
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Timepoint [1]
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When child is 12 months old
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Secondary outcome [2]
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Child language development
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Assessment method [2]
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Assessed using the Bayley Scales of Infant and Toddler Development
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Timepoint [2]
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When child is 12 months old
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Secondary outcome [3]
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Child motor development
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Assessment method [3]
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Assessed using the Bayley Scales of Infant and Toddler Development
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Timepoint [3]
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When child is 12 months old
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Secondary outcome [4]
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Child height
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Assessment method [4]
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This will be determined by a stadiometer.
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Timepoint [4]
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When child is 12 months old
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Secondary outcome [5]
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Child weight
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Assessment method [5]
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This will be determined using balance scales.
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Timepoint [5]
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When child is 12 months old
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Secondary outcome [6]
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Child BMI
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Assessment method [6]
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This will be assessed by a composite outcome using height (stadiometer) and weight (balance) measurements.
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Timepoint [6]
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When child is 12 months old
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Secondary outcome [7]
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Breastfeeding practice
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Assessment method [7]
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Using study-specific structured questions delivered through a questionnaire.
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Timepoint [7]
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When child is 12 months old
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Secondary outcome [8]
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Child Healthcare expenditure
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Assessment method [8]
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Using study-specific structured questions delivered through a questionnaire.
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Timepoint [8]
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When child is 12 months old
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Secondary outcome [9]
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Maternal height
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Assessment method [9]
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This will be determined by a stadiometer.
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Timepoint [9]
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During pregnancy; 12-months postpartum
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Secondary outcome [10]
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Maternal weight
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Assessment method [10]
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This will be determined using balance scales.
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Timepoint [10]
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During pregnancy; 12-months postpartum
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Secondary outcome [11]
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Pregnancy characteristics
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Assessment method [11]
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Using study-specific structured questions delivered through a questionnaire.
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Timepoint [11]
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During pregnancy; 12-months postpartum
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Secondary outcome [12]
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Maternal emotional wellbeing
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Assessment method [12]
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Using the Edinburg Postnatal Depression Scale (EPDS)
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Timepoint [12]
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During pregnancy; 12-months postpartum
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Secondary outcome [13]
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Parenting practices
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Assessment method [13]
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Using study-specific structured questions delivered through a questionnaire and the UNICEF Multiple Cluster Index Surveys 7 (MICS7) questions on child discipline.
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Timepoint [13]
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12-months postpartum
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Secondary outcome [14]
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Intimate partner violence
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Assessment method [14]
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Using items from the WHO Multi-country Study on Women’s Health and Life Events Questionnaire Version 9.9.
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Timepoint [14]
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During pregnancy; 12-months postpartum
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Secondary outcome [15]
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Relationship with partner
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Assessment method [15]
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Using Vietnam validation of the Intimate Bond Measure (IBM-V)
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Timepoint [15]
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During pregnancy; 12-months postpartum
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Secondary outcome [16]
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Hygiene practices
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Assessment method [16]
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study-specific structured questions delivered through a questionnaire.
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Timepoint [16]
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During pregnancy; 12-months postpartum
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Secondary outcome [17]
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Male engagement
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Assessment method [17]
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study-specific structured questions delivered through a questionnaire.
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Timepoint [17]
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During pregnancy; 12-months postpartum
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Eligibility
Key inclusion criteria
All pregnant women less than 35 weeks gestation living in the selected communes will be eligible to participate. All newborns of pregnant women that completed the pregnancy sessions will be eligible to participate.
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Minimum age
No limit
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Maximum age
No limit
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Sex
Females
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Healthy volunteers
No
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Key exclusion criteria
Women that are not pregnant or who do not live in the province of Lai Chau will be excluded.
Women with cognitive or physical disabilities that would limit their ability to attend sessions will be excluded, as determined by commune health workers.
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
All 38 communes in Lai Chau are eligible and willing to participate. An independent statistician will randomly allocate 19 communes to the intervention and 19 communes to the control group using Stata V.19.0. People analysing outcomes will analyse the data on the basis of there being two groups, but will not know which group is the intervention and which is the control group.
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
In 2025, across the 38 communes in Lai Chau the number of pregnant women from the H’mong ethnic group was estimated to be approximately 3,000, which is expected to meet the required sample size. A sample size of 494 pregnant women from 38 communes (cluster units) is needed to detect a standard mean difference of 0.35 in the primary outcome (child cognitive score at 1 year old) between control and intervention groups with 80% statistical power, a significance level of 0.05, an intracluster correlation coefficient of 0.025 and an average cluster size of 10 women. The sample size allows 10% of cluster drop-out and 20% of participants missing data/loss to follow-up or drop-out. These assumptions are based on our previous study and consultations with local authorities. Additionally, a cost-effectiveness analysis will be conducted to assess the economic value of the intervention.
All analyses will follow the intention-to-treat principles. Analyses will be conducted at the individual level using Stata, V.19.0. and SAS 9.4.
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
10/08/2026
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Actual
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Date of last participant enrolment
Anticipated
31/08/2026
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Actual
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Date of last data collection
Anticipated
31/01/2028
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Actual
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Sample size
Target
800
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Accrual to date
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Final
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Recruitment outside Australia
Country [1]
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Viet Nam
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State/province [1]
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Lai Chau Province
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Funding & Sponsors
Funding source category [1]
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Charities/Societies/Foundations
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Name [1]
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The LEGO Foundation
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Address [1]
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Country [1]
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Denmark
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Funding source category [2]
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Charities/Societies/Foundations
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Name [2]
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The Human Safety Net
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Address [2]
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Country [2]
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Italy
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Primary sponsor type
University
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Name
Monash Universty
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Address
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Country
Australia
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Secondary sponsor category [1]
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Other Collaborative groups
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Name [1]
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Research and Training Centre for Community Development
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Address [1]
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Country [1]
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Viet Nam
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Monash University Human Research Ethics Committee
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Ethics committee address [1]
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https://www.monash.edu/researchoffice/ethics
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
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08/06/2026
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Approval date [1]
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07/07/2026
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Ethics approval number [1]
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52509
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Summary
Brief summary
Experiences in the early years of life can have long lasting impacts on an individual's health, productivity and well-being, which are also relevant to communities, economies and societies. To improve child health and development, parenting interventions especially from conception to age two are crucial to support children in reaching their full potential. Scientific evidence shows that well-designed multicomponent interventions can improve child development outcomes. Our team developed an evidence-based parenting intervention to improve infant health and development in Vietnam. In a previous cluster randomized controlled trial conducted by the team the original version of the parenting intervention, now known as ‘The Early Journey of Life’, was found to be both effective and cost-effective (ACTRN12617000442303). However, evidence on effectiveness and cost-effectiveness in ethnically diverse and geographically remote populations remains limited. Vietnam is a multi-ethnic country comprising 54 ethnic groups and diverse geographical settings, including mountainous and highland areas, lowland deltas, and coastal regions, requiring careful cultural and contextual adaptation of interventions. While Early Journey of Life has recently been adapted for these settings, its effectiveness among ethnic minority populations has not yet been evaluated.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Prof Jane Fisher
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Address
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Monash University Level 4, 553 St Kilda Road, Melbourne VIC 3004
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Country
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Australia
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Phone
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+61 3 9903 0290
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Jane Fisher
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Address
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Monash University Level 4, 553 St Kilda Road, Melbourne VIC 3004
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Country
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Australia
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Phone
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+61 3 9903 0290
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Name
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Yeji Baek
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Address
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Monash University Level 4, 553 St Kilda Road, Melbourne VIC 3004
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Country
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Australia
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Phone
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+61 3 9903 0066
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Fax
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Email
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[email protected]
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Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
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Anyone
Conditions for requesting access:
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Yes, conditions apply:
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Requires review on a case-by-case basis by the trial custodian, sponsor or data sharing committee
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Requires a scientifically sound proposal or protocol
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Requires approval by an ethics committee
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Requires a data sharing agreement between data requester and trial custodian or sponsor
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Consideration will be given to proposals to use data from the trial for scientifically sound proposals. Formal data sharing agreement will be required and data will be made available through Monash University’s Secure eResearch Platform.
What individual participant data might be shared?
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All de-identified individual participant data
What types of analyses could be done with individual participant data?
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Any type of analysis (i.e. no restrictions on data re-use)
When can requests for individual participant data be made (start and end dates)?
From:
At the end of the study
To:
Not yet decided
Where can requests to access individual participant data be made, or data be obtained directly?
•
Email of trial custodian, sponsor or committee:
Principal investigator
Professor Jane Fisher
[email protected]
Are there extra considerations when requesting access to individual participant data?
No
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
Type
Is Peer Reviewed?
DOI
Citations or Other Details
Attachment
Other files
No
Approval letter from the Lai Chau Provincial Peopl...
[
More Details
]
CV 2487_UBND Lai Chau approved the cRCT_08042026_VIE.pdf
Documents added automatically
No additional documents have been identified.
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