Building Opportunities for Nurturing Care to Enhance Child Development in Eastern and Southern Africa
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age15+
SponsorUniversity of Washington
About this trial
The goal of this randomized controlled trial is to adapt and test a package of interventions to provide nurturing care for children aged 0-2 years in three countries (Botswana, Kenya, Zimbabwe). Mothers living with and without HIV will be enrolled in pregnancy, and their children will be followed for two years. The main objectives of this study are to:
* Determine whether the adapted package of interventions improves neurodevelopment among children with and without in utero HIV exposure * Identify why the intervention does or does not impact children's neurodevelopment.
Researchers will compare children who receive the intervention package and those who do not to see if the interventions improve child neurodevelopment and growth. Researchers will also compare children with and without HIV exposure to see if there are improvements in neurodevelopment and growth for children who were exposed to HIV.
All participants will attend regular prenatal and postnatal care appointments. Participants who are randomized to receive the package of interventions will attend regularly scheduled visits where they will discuss problem-solving strategies, receive information on healthy foods for children, and learn about how to play with their children. Mothers receiving the intervention package will also have the opportunity to meet with other mothers and babies in small groups where their children can play together.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Pregnant woman attending participating clinics
≥15 years of age
Willing to disclose a known positive HIV status or undergo HIV testing if serostatus is unknown or negative
Willing to attend follow up visits
Disqualifiers
Incarcerated individuals
Pregnant women and mothers who participated in the Aim 1 pilot of the BONDS interventions or has previously participated in the BONDS interventions during the trial
Any pregnant women and mothers who live in a home in which a BONDS participant has already been enrolled
Pregnant women, mothers, and babies who have any acute or chronic condition which, in the opinion of the study team, means enrollment in the trial would not be advisable
Trial design
Design model
Parallel
Treatments tested in this trial
Friendship Bench
BehavioralAfter enrollment, participants randomized to BONDS will be linked to a community health worker (CHW) who will arrange Friendship Bench (FB) sessions. During the sessions, participants identify their current stressors, and work with CHWs to consider solutions and select and implement practical solutions.
Infant and Young Child Feeding (IYCF) Curriculum
BehavioralCommunity health workers will deliver the infant and young child feeding (IYCF) curriculum between pregnancy and 2 years. Modules in pregnancy will focus on early breastfeeding initiation, exclusive breastfeeding (EBF), how to breastfeed and challenges with breastfeeding. Following birth, modules will reinforce education and support EBF through 6 months and then transition to the introduction of other foods and food preparation demonstrations with continued breastfeeding.
Play-Based Curriculum
BehavioralThis parent-focused, play-based intervention addresses responsive caregiving and opportunities for early learning. The intervention will emphasize the importance of early learning experiences and adopting a growth mindset, with common themes including the use of scaffolding and "serve and return" activities.
Treatment groups
1,260 Participants
are divided into 2 treatment groupsGroup A: BONDS InterventionExperimental treatment 3 interventions
Group B: Standard of CareNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Total Score on the Malawi Developmental Assessment Tool (MDAT) at 24 months
MDAT measures social, language, fine motor and gross motor development using 138 direct observations of children's ability in each domain (gross motor: 36 items; fine motor: 36 items; language: 36 items; social: 30 items). A continuous standardized z-score will be derived based on the total number of items passed by the child across all four domains. Mean differences in total MDAT z-score at 24 months will be compared between the intervention and control arms.
Time frame
Study endline (child age: 24 months)Secondary outcomes
1
Total Score on the Malawi Developmental Assessment Tool (MDAT) at 12 months
MDAT measures social, language, fine motor and gross motor development using 138 direct observations of children's ability in each domain (gross motor: 36 items; fine motor: 36 items; language: 36 items; social: 30 items). A continuous standardized z-score will be derived based on the total number of items passed by the child across all four domains. Mean differences in total MDAT z-score at 12 months will be compared between the intervention and control arms.
Time frame
Study midline (child age: 12 months)2
Gross Motor Domain Score on the Malawi Developmental Assessment Tool (MDAT) at 24 months
MDAT measures gross motor development using 36 direct observations. A continuous standardized z-score will be will be derived based on the total number of items passed by the child across these 36 items. Mean differences in MDAT gross motor domain z-score at 24 months will be compared between the intervention and control arms.
Time frame
Study endline (child age: 24 months)3
Fine Motor Domain Score on the Malawi Developmental Assessment Tool (MDAT) at 24 months
MDAT measures fine motor development using 36 direct observations. A continuous standardized z-score will be will be derived based on the total number of items passed by the child across these 36 items. Mean differences in MDAT fine motor domain z-score at 24 months will be compared between the intervention and control arms.
Time frame
Study endline (child age: 24 months)4
Social Domain Score on the Malawi Developmental Assessment Tool (MDAT) at 24 months
MDAT measures social development using 30 direct observations. A continuous standardized z-score will be will be derived based on the total number of items passed by the child across these 30 items. Mean differences in MDAT social domain z-score at 24 months will be compared between the intervention and control arms.
Time frame
Study endline (child age: 24 months)Other outcomes
1
Gross Motor Domain Score on the Malawi Developmental Assessment Tool (MDAT) at 12 months
MDAT measures gross motor development using 36 direct observations. A continuous standardized z-score will be will be derived based on the total number of items passed by the child across these 36 items. Mean differences in MDAT gross motor domain z-score at 12 months will be compared between the intervention and control arms.
Time frame
Study midline (child age: 12 months)2
Fine Motor Domain Score on the Malawi Developmental Assessment Tool (MDAT) at 12 months
MDAT measures fine motor development using 36 direct observations. A continuous standardized z-score will be will be derived based on the total number of items passed by the child across these 36 items. Mean differences in MDAT fine motor domain z-score at 12 months will be compared between the intervention and control arms.
Time frame
Study midline (child age: 12 months)3
Social Domain Score on the Malawi Developmental Assessment Tool (MDAT) at 12 months
MDAT measures social development using 30 direct observations. A continuous standardized z-score will be will be derived based on the total number of items passed by the child across these 30 items. Mean differences in MDAT social domain z-score at 12 months will be compared between the intervention and control arms.
Time frame
Study midline (child age: 12 months)4
Language Domain Score on the Malawi Developmental Assessment Tool (MDAT) at 12 months
MDAT measures language development using 36 direct observations. A continuous standardized z-score will be will be derived based on the total number of items passed by the child across these 36 items. Mean differences in MDAT language domain z-score at 12 months will be compared between the intervention and control arms.
Time frame
Study midline (child age: 12 months)Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Washington
Lead sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator
Source ClinicalTrials.gov
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