Early Childhood Development (ECD)
Conditions
Keywords
cluster randomized trial, responsive caregiving, nutrition, early childhood development, animal source food
Brief summary
This study aims to evaluate whether early childhood development is improved by a bundled set of interventions that promote responsive stimulation and improved nutrition by the provision of eggs and dried fish (nutrient-dense animal source foods), and whether, in combination, these stimulation and nutrition interventions are more effective than responsive stimulation or food provision alone.
Detailed description
The BUNDLE study will examine the effects of a 7-month nutrition and caregiving intervention for female and male caregivers delivered by trained adult community facilitators in rural communities across Liberia. The study will use a four-arm 2x2 factorial cluster randomized design to test the effectiveness of the interventions on primary outcomes of child cognitive, language, motor, and socio-emotional development. In this study, 2240 children aged 6 to 30 months will be recruited from 160 rural communities randomized to a comparison arm or one of the three intervention arms. The comparison arm will receive the local standard of care. Three intervention arms will also receive either a responsive stimulation intervention with female and male caregivers, provision of eggs and dried fish accompanied by nutrition education, or responsive stimulation + provision of eggs and dried fish. We hypothesize that child development will be improved in all intervention arms compared to the comparison arm and in the combined intervention arm compared to the single intervention arms.
Interventions
BEHAVIORALResponsive stimulation, female and male caregivers
Caregiving-related social and behavior change (SBC) messages and activities for primary female and secondary (male or female) caregivers focused on responsive stimulation, encompassing responsive caregiver-child interactions and the provision of early learning opportunities.
OTHERFood provision and nutrition education
Provision of eggs and dried Bonny fish. Nutrition-related social and behavior change (SBC) messages focused on infant and young child feeding (IYCF), the importance of feeding the child eggs and dried fish, and ways to feed these foods to the child.
Sponsors
University of South Carolina
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Plan International
Research Institute of the McGill University Health Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Intervention model description
In Bomi, Lofa, Nimba, and Margibi counties in Liberia, 40 rural communities in each county will be randomly selected with equal probability per county, for a total of 160 communities. Each community will be randomized to a comparison arm or one of three intervention arms; randomization will be stratified by county. Using household listings in each community, 14 households fitting the study's eligibility criteria will be randomly selected and invited to participate in the study. Random selection of households will continue until 14 households have provided informed consent. If fewer than 14 eligible households are found, additional households will be selected using the same procedure from a neighboring rural community.
Eligibility
Sex/Gender
ALL
Age
6 Months to 30 Months
Healthy volunteers
Yes
Inclusion criteria
* Resides in selected community in Liberia * Household has a child aged 6-30 months at study enrollment * Child has a primary female caregiver and second (male or female) caregiver ≥ 18 years of age * Caregivers and child intend to continue residing in the study area for the follow-up duration * Both primary and second caregiver provide informed consent
Exclusion criteria
* Children with known allergies to eggs or fish * Caregivers with cognitive and severe physical disabilities who are unable to implement intervention activities * Children with developmental disabilities
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cognitive Development | 7 months | Change from baseline to end-line in cognitive composite score on Bayley Scale of Infant and Toddler Development, 4th Edition. Raw scores range from 0 to 162 with higher scores representing higher cognitive development. |
| Language Development | 7 months | Change from baseline to end-line in language composite score on the Bayley Scale of Infant and Toddler Development, 4th Edition. Raw scores range from 0 to 158 with higher scores representing higher language development. |
| Motor Development | 7 months | Change from baseline to end-line in motor composite score on the Bayley Scale of Infant and Toddler Development, 4th Edition. Raw scores range from 0 to 208 with higher scores representing higher motor development. |
| Socio-emotional Development | 7 months | Change from baseline to end-line in socio-emotional score on the Wolke Behavior Rating scale. Scores range from 9 to 81 with higher scores representing higher socio-emotional development. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Child height or length-for-age z-score | 7 months | Change from baseline to end-line in child height or length-for-age z-score. |
| Child weight-for-age z-score | 7 months | Change from baseline to end-line in child weight-for-age z-score. |
| Child weight-for-height (or length) z-score | 7 months | Change from baseline to end-line in child weight-for-height (or length) z-score. |
| Child egg consumption | 7 months | Change from baseline to end-line in percent children consuming at least 3 eggs in the past week |
| Child fish consumption | 7 months | Change from baseline to end-line in percent children consuming at least 1 piece of fish in the past week |
| Child dietary diversity | 7 months | Change from baseline to end-line in child dietary diversity score defined as number of food groups out of a total of eight food groups consumed in the previous 7 days based on World Health Organization guidelines and is assessed in children aged six months or older. |
| Responsive feeding | 7 months | Change from baseline to end-line in responsive feeding score assessed using the responsive feeding assessment. Scores range from 8 to 32 with higher scores representing higher responsive feeding behaviors. |
| Early learning opportunities | 7 months | Change from baseline to end-line in early learning opportunities score assessed using the Tool for Early learning. Scores range from 0 to 14 with higher scores representing more opportunities for early learning. |
| Primary female caregiver social support | 7 months | Change from baseline to end-line in primary female caregiver perceived social support assessed using the Multidimensional Scale of Perceived Social Support. Scores range from 12 to 84 with higher scores representing higher social support. |
| Primary female caregiver responsive caregiver-child interactions | 7 months | Change from baseline to end-line in proportion of responsive interactions between the primary female caregiver and child assessed using the Tool for Responsive Care. |
| Male caregiver responsive caregiver-child interactions | 7 months | Change from baseline to end-line in proportion of responsive interactions between the male caregiver and child assessed using the Tool for Responsive Care. |
| Secondary female caregiver responsive caregiver-child interactions | 7 months | Change from baseline to end-line in proportion of responsive interactions between the secondary female caregiver and child assessed using the Tool for Responsive Care. |
| Primary female caregiver depression | 7 months | Change from baseline to end-line in the primary female caregiver depression score assessed using the Patient Health Questionnaire-9. Scores range from 0 to 27 with higher scores representing higher depressive symptoms. |
| Male caregiver depression | 7 months | Change from baseline to end-line in the male caregiver depression score assessed using the Patient Health Questionnaire-9. Scores range from 0 to 27 with higher scores representing higher depressive symptoms. |
| Secondary female caregiver depression | 7 months | Change from baseline to end-line in the secondary female caregiver depression score assessed using the Patient Health Questionnaire-9. Scores range from 0 to 27 with higher scores representing higher depressive symptoms. |
| Primary female caregiver anxiety | 7 months | Change from baseline to end-line in the primary female caregiver anxiety score assessed using the General Anxiety Disorder-7 Questionnaire. Scores range from 0 to 21 with higher scores representing higher anxiety. |
| Male caregiver anxiety | 7 months | Change from baseline to end-line in the male caregiver anxiety score assessed using the General Anxiety Disorder-7 Questionnaire. Scores range from 0 to 21 with higher scores representing higher anxiety. |
| Secondary female caregiver anxiety | 7 months | Change from baseline to end-line in the secondary female caregiver anxiety score assessed using the General Anxiety Disorder-7 Questionnaire. Scores range from 0 to 21 with higher scores representing higher anxiety. |
| Primary female caregiver positive mental health | 7 months | Change from baseline to end-line in the primary caregiver positive mental health score assessed using the Mental Health Continuum-Short Form. Scores range from 14 to 84 with higher scores representing poorer mental health. |
| Male caregiver positive mental health | 7 months | Change from baseline to end-line in the male caregiver positive mental health score assessed using the Mental Health Continuum-Short Form. Scores range from 14 to 84 with higher scores representing poorer mental health. |
| Secondary female caregiver positive mental health | 7 months | Change from baseline to end-line in the secondary female caregiver positive mental health score assessed using the Mental Health Continuum-Short Form. Scores range from 14 to 84 with higher scores representing poorer mental health. |
| Primary female caregiver stress | 7 months | Change from baseline to end-line in the primary female caregiver perceived stress score assessed using the Parenting Stress Index. Scores range from 36 to 147 with higher scores representing higher stress. |
| Male caregiver stress | 7 months | Change from baseline to end-line in the male caregiver perceived stress score assessed using the Parenting Stress Index. Scores range from 36 to 147 with higher scores representing higher stress. |
| Secondary female caregiver stress | 7 months | Change from baseline to end-line in the secondary female caregiver perceived stress score assessed using the Parenting Stress Index. Scores range from 36 to 147 with higher scores representing higher stress. |
| Primary female caregiver Co-parenting | 7 months | Change from baseline to end-line in the primary female co-parenting score assessed using the brief Coparenting Relationship Scale. Scores range from 0 to 84 with higher scores representing more positive coparenting. |
| Male caregiver Co-parenting | 7 months | Change from baseline to end-line in the male caregiver co-parenting score assessed using the brief Coparenting Relationship Scale. Scores range from 0 to 84 with higher scores representing more positive coparenting. |
| Secondary female caregiver Co-parenting | 7 months | Change from baseline to end-line in the secondary female caregiver co-parenting score assessed using the brief Coparenting Relationship Scale. Scores range from 0 to 84 with higher scores representing more positive coparenting. |
Countries
Liberia
Contacts
CONTACTLeila Larson, PhD MPH
CONTACTEdward Frongillo, PhD
PRINCIPAL_INVESTIGATORLeila Larson, PhD MPH
University of South Carolina
Outcome results
None listed