Feasibility of Implementing RINEW Through the Government System

Early Childhood Development Clinical Trial

— RINEW  

Official title:

Exploring the Feasibility of Implementing an Integrated Nutrition, Early Childhood Development and WASH (RINEW) Intervention Through the Government Health System: A Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04111016
• Other study ID #: 50733
• Status: Completed
• Start date: April 6, 2019
• Est. completion date: September 16, 2020

Study information

• Verified date: May 2022
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2823
• Est. completion date: September 16, 2020
• Est. primary completion date: September 16, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Early Childhood Development

Intervention

Behavioral:
• Integrated child stimulation, nutrition, lead, arsenic, WASH intervention
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.

Locations

Country	Name	City	State
Bangladesh	International Centre for Diarrhoeal Disease Research, Bangladesh	Dhaka

Sponsors (5)

Lead Sponsor	Collaborator
Stanford University	BRAC University, International Centre for Diarrhoeal Disease Research, Bangladesh, Johns Hopkins University, University of California, Berkeley

Country where clinical trial is conducted

Bangladesh, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in session quality	Semi-structured checklist for one pregnancy session and one mother-baby session in each health facility per assessment time period.	2nd, 6th and 12th month of the intervention; ~60 min per assessment
Primary	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.	Every 2 weeks through study completion; ~10 min
Primary	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.	Monthly through study completion; ~15 min/assessment
Primary	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.	2nd, 6th and 12th month of the intervention; ~20 min per assessment
Primary	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	2nd, 6th and 12th month of the intervention; ~20 min per assessment
Primary	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	2nd, 6th and 12th month of the intervention; ~20 min per assessment
Secondary	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.	Monthly through study completion; ~3 min/assessment
Secondary	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.	Baseline and 12 months after intervention; ~15 min/assessment
Secondary	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.	Baseline and 12 months after intervention; ~15 min/assessment
Secondary	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.	Baseline and 12 months after intervention; ~5 min/assessment
Secondary	Change in maternal depressive symptoms	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.	Baseline and 12 months after intervention; ~5 min/assessment
Secondary	Change in maternal knowledge regarding lead, nutrition, WASH, and arsenic	This will be assessed with self-report questions about knowledge about lead exposure and prevention, nutrition, WASH, and arsenic exposure.	Baseline and 12 months after intervention; ~5 min/assessment
Secondary	Change in self-reported behaviour regarding prevention of lead contamination, disposal of human and chicken feces, water and food storage	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.	Baseline and 12 months after intervention; ~5 min/assessment
Secondary	Change in availability and accessibility of safe water storage containers, hygienic toilet, handwashing station, child potty (for >6 months to 2 year old children), and covers for cooked food.	This will be measured with self-reported behaviors, as well as observations of water storage facilities, latrine quality, handwashing station and child potty.	Baseline and 12 months after intervention; ~5 min/assessment
Secondary	Change in responsive feeding and interactions during mealtime	This will be assessed with self-reported interactions mother/caregiver follow during feeding (complementary foods) to their 6-24 months old children	Baseline and 12 months after intervention; ~5 min/assessment