Feasibility of Implementing RINEW Through the Government System

Stanford University2,823 enrolled

Overview

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.

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: 1. Assess the feasibility (i.e. satisfaction of providers, perceived appropriateness of content and practicability of session delivery, population demand for sessions, quality and frequency of implementation, and preparedness of health system) of implementing the RINEW intervention through the government health system 2. Identify barriers, facilitators/opportunities, and pathway for scale up of the RINEW intervention through government health system 3. Assess the coverage of the intervention in the target population 4. Assess the uptake of recommended behaviors in the target population To reach these objectives the investigators will 1. Train government health workers to deliver the intervention at government health facilities 2. Conduct a clinic-based process evaluation using both quantitative and qualitative methods at multiple time points during the 12-months intervention 3. Conduct population-based quantitative baseline and endline assessments to assess intervention coverage and uptake

Study Type

OBSERVATIONAL

Enrollment

2,823

Conditions

Early Childhood Development

Interventions

Integrated child stimulation, nutrition, lead, arsenic, WASH interventionBEHAVIORAL

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion criteria for household assessment of study participants: 1. mother or primary caregiver of a child 6-24 months old, 2. living in Chatmohar sub-district 3. planning to reside in that area for at least one year (Baseline), or 4. having lived in the area for at least 1 year (Endline). Exclusion criteria for household assessment of study participants: 1\) Child, mother, or primary caregiver with impaired cognitive development, or hearing, vision, speech impaired child or mother. Inclusion criteria for interviews with study facilitators 1\) Government health workers who are participating in the facilitation or supervision of RINEW sessions 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 1\) Child, mother, or primary caregiver with impaired cognitive development, or hearing, vision, speech impaired child or mother

Locations (1)

International Centre for Diarrhoeal Disease Research, Bangladesh

Dhaka, Bangladesh

Outcomes

Primary Outcomes

Change in session quality

Semi-structured checklist for one pregnancy session and one mother-baby session in each health facility per assessment time period.

Time frame: 2nd, 6th and 12th month of the intervention; ~60 min per assessment

Change in proportion of planned session conducted

This data will be reported by the intervention facilitators and collected by the intervention supervisors on a monthly basis.

Time frame: Every 2 weeks through study completion; ~10 min

Change in number and proportion of eligible pregnant women and mother attendees at each session

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: Monthly through study completion; ~15 min/assessment

Change in satisfaction of trained health workers with training and intervention implementation: Semi-structured individual interviews and focus group discussions

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

Change in determinants of session quality

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

Change in determinants of session attendance

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

Data from ClinicalTrials.gov

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Secondary Outcomes

Change in individual-level attendance records and self-reports

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: Monthly through study completion; ~3 min/assessment

Change in caregiver early child development knowledge and practices

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

Change in child dietary diversity, child minimum meal frequency and minimum acceptable diet.

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; ~15 min/assessment

Change in maternal dietary diversity

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.