International Centre for Diarrhoeal Disease Research, Bangladesh
Dhaka, Bangladesh
NCT Number: NCT04111016
The goal of this study is to assess the feasibility of implementing a group-based integrated early child development intervention through the government health system in one sub-district of Bangladesh, and to assess the resulting uptake of the intervention in the target population.
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Notify Me18 year and older
All sexes
Observational
Dhaka, Bangladesh
The RINEW intervention is a group-based integrated nutrition, responsive stimulation, and WASH intervention with a goal to improve child development outcomes. The intervention is delivered in group sessions to pregnant women and mothers or primary caregivers of children under 24 months of age. The RINEW intervention was tested in a pilot cluster-randomized control study in Bangladesh, where the investigators found the intervention group had better self-reported knowledge and behavior related to early child development. The investigators aim to implement this intervention through the government health system in one sub-district of Bangladesh, and assess the feasibility of delivering the intervention in this way, as well as the uptake of the intervention in the target population. The facilitators will be trained by the study team, and the intervention will be implemented in community-level health centers, facilitated by government health workers.
The specific objectives of this work are to:
To reach these objectives the investigators will
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
for household assessment of study participants:
Exclusion criteria
for household assessment of study participants:
Inclusion criteria
for interviews with study facilitators
Inclusion criteria
for qualitative interviews with intervention attendees 1) Mothers or primary caregivers eligible for the intervention sessions
Exclusion criteria
for qualitative interviews with intervention attendees
The content of the intervention curriculum was developed considering the needs of the specific ages of the children attending the group, as well as the feasibility of delivering the package in the community. The pregnancy module encompasses information on significance of prenatal care for child development, physiological symptoms and solutions, maternal diet, education on kangaroo mother care (KMC), breast feeding, thinking healthy, hygiene, and lead and arsenic prevention. The curriculum for lactating mothers focuses on specialized messages for 4 age groups of children: 0-5 months, 6-11 months, 12-18 months and 19-24 months. The overall package includes information regarding WASH, psychosocial stimulation, nutrition, maternal mental health, lead and arsenic. As research evidence showed that psychosocial stimulation provided for 10 or 12 months can significantly improve child development, the psychosocial stimulation component is included in every fortnightly session.
Time frame: 2nd, 6th and 12th month of the intervention; ~60 min per assessment
Semi-structured checklist for one pregnancy session and one mother-baby session in each health facility per assessment time period.
Time frame: Every 2 weeks through study completion; ~10 min
This data will be reported by the intervention facilitators and collected by the intervention supervisors on a monthly basis.
Time frame: Monthly through study completion; ~15 min/assessment
The attendance numbers will be collected at each pregnancy and mother-baby session, and reported to the study team on a monthly basis.
Time frame: 2nd, 6th and 12th month of the intervention; ~20 min per assessment
Semi-structured individual interviews and focus group discussions with intervention implementors and their supervisors.
Time frame: 2nd, 6th and 12th month of the intervention; ~20 min per assessment
Semi-structure individual interviews and focus group discussions with a purposive sample of intervention implementors, their supervisors, and intervention attendees
Time frame: 2nd, 6th and 12th month of the intervention; ~20 min per assessment
Semi-structure individual interviews and focus group discussions with a purposive sample of intervention implementors, their supervisors, and intervention attendees
Time frame: Monthly through study completion; ~3 min/assessment
Attendance to group sessions over the intervention period will be recorded on participant-held attendance records. At the end line assessment participants will also be asked to show their intervention cards and report the number of sessions they have attended over the previous 12 months.
Time frame: Baseline and 12 months after intervention; ~15 min/assessment
A modified version of the Family Care Indicators (FCI), including self-reported behaviors and knowledge and observations during the interview, will be used to measure childhood development knowledge and practices. The FCI has the following sub-scales: 1) household books (number); 2) magazines or newspapers in the household (number), 3) sources of play materials (number of 3 possible categories), 4) varieties of play materials (number of 7 possible categories), 5) play activities (number of 6 possible categories). The scores from each sub-scale are summed to calculate the total score. For all sub-scales and the total score, higher scores are associated with a better child care. Investigators will also assess 11 additional observational items including observations of the home environment, and parental responsiveness and acceptance during the interview. Positive responses are summed to create an observation score.
Time frame: Baseline and 12 months after intervention; ~15 min/assessment
Child dietary diversity will be calculated based on the number of 7 different food groups consumed by the child yesterday. This will be determined based on a maternal-reported 24 hour recall of all foods consumed by the mother and the child. Minimum acceptable diet is determined by the child's dietary diversity and meal frequency.
Time frame: Baseline and 12 months after intervention; ~5 min/assessment
Maternal dietary diversity indicated by the number of 10 different food groups consumed by the mother yesterday. This will be determined based on a maternal-reported 24 hour recall of all foods consumed by the mother and the child.
Time frame: Baseline and 12 months after intervention; ~5 min/assessment
Caregiver mental health will be measured using the Center for Epidemiologic Studies Depression scale (CESD), which includes 20 questions about symptoms experienced in the previous week. Number of days experiencing each symptom in the last week is converted into a score: 0= 0 or less than 1 day; 1= 1-2 days; 2= 3-4 days, 3=5-7 days, and the total score is a sum of negative symptoms experienced (positive items are reverse scored). The score ranges from 0-60, with higher scores indicating more depressive symptoms experienced.
Time frame: Baseline and 12 months after intervention; ~5 min/assessment
This will be assessed with self-report questions about knowledge about lead exposure and prevention, nutrition, WASH, and arsenic exposure.
Time frame: Baseline and 12 months after intervention; ~5 min/assessment
This will be assessed with self-reported questions about behaviours regarding prevention of lead contamination, disposal of human and chicken feces, water and food storage.
Time frame: Baseline and 12 months after intervention; ~5 min/assessment
This will be measured with self-reported behaviors, as well as observations of water storage facilities, latrine quality, handwashing station and child potty.
Time frame: Baseline and 12 months after intervention; ~5 min/assessment
This will be assessed with self-reported interactions mother/caregiver follow during feeding (complementary foods) to their 6-24 months old children
Stanford University
Other
Exploring the Feasibility of Implementing an Integrated Nutrition, Early Childhood Development and WASH (RINEW) Intervention Through the Government Health System: A Pilot Study
Acronym: RINEW
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