NCT Number: NCT07430826
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.
Trial opening soon.
Get Notified15 year and older
Female
Interventional
Not applicable
Prior to enrollment for the clinical trial, the three interventions will be culturally adapted and refined in Botswana and Kenya using a user-centered co-design approach. A 3-day participatory workshop will be held to select appropriate adaptations to the three interventions while maintaining core components. Following these adaptations, ~80 pregnant women/mother-infant pairs will be recruited for a formative pilot to further refine the three interventions. The workshop and pilot activities have already been completed in Zimbabwe under a different protocol.
Following the clinical trial, we will determine how the package of interventions works (or if it does not work, why) to improve child development. Hypothesized causal biological and behavioral pathways include maternal health, including mental health; infant health and nutrition; caregiving quality; and maternal-child interactions. Throughout the clinical trial, both quantitative and qualitative data will be collected to identify determinants of implementation, acceptability, feasibility, appropriateness, and cost of incorporating the intervention package and neurodevelopmental evaluations into regular maternal and child health services across the three countries. Costing data will also be collected from time and motion cards and study budget records to determine the incremental costs of incorporating the intervention package and neurodevelopmental evaluations in the three participating countries.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
After 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.
Community 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.
This 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.
Time frame: Study endline (child age: 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 midline (child age: 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 endline (child age: 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)
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)
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)
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 24 months will be compared between the intervention and control arms.
Time frame: Study endline (child age: 24 months)
The MacArthur Bates CDI uses caregiver-reported assessments of a child's language acquisition. Caregivers are provided a checklist of the ~100 most commonly spoken words in each language that their child speaks. Mean differences in the number of words spoken will be compared between the intervention and control arms.
Time frame: Study endline (child age: 24 months)
The CFM assess functional difficulties across eight domains (vision, hearing, mobility, dexterity, communication, learning, playing, and controlling behavior), each assessed using 1-3 four-point Likert scales. The proportion of children with at least one functional difficulty across the eight domains will be compared between the intervention and control arms.
Time frame: Study endline (child age: 24 months)
WAZ will be calculated for each child at 24 months. Mean differences in WAZ will be compared between the intervention and control arms.
Time frame: Study endline (child age: 24 months)
LAZ will be calculated for each child at 24 months. Mean differences in LAZ will be compared between the intervention and control arms.
Time frame: Study endline (child age: 24 months)
WLZ will be calculated for each child at 24 months. Mean differences in WLZ will be compared between the intervention and control arms.
Time frame: Study endline (child age: 24 months)
HCAZ will be calculated for each child at 24 months. Mean differences in HCAZ will be compared between the intervention and control arms.
Time frame: Study midline (child age: 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)
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)
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)
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 endline (child age: 24 months)
The proportion of children who are stunted will be compared between the intervention and control arms.
Time frame: Study endline (child age: 24 months)
The proportion of children who are wasted will be compared between the intervention and control arms.
Time frame: Study endline (child age: 24 months)
The proportion of children who are underweight will be compared between the intervention and control arms.
Time frame: Study midline (child age: 12 months)
Mothers are considered to have mental distress if they have a positive screening for depression and/or anxiety. The proportion of mothers with mental distress will be compared between the intervention and control arms.
Time frame: Study endline (child age: 24 months)
Mothers are considered to have mental distress if they have a positive screening for depression and/or anxiety. The proportion of mothers with mental distress will be compared between the intervention and control arms.
Time frame: First postnatal visit (0-2 weeks after delivery)
Early initiation of breastfeeding (defined as mothers who put the baby to the breast within the first hour of birth) will be obtained via maternal self-report. The proportion of women who initiated breastfeeding within one hour of birth will be compared between the intervention and control arms.
Time frame: First postnatal visit (0-2 weeks after delivery) through child age 6 months
Exclusive breastfeeding will be obtained via maternal self-report of breastfeeding through 6-months of age with no introduction of formula or complementary foods. The proportion of children who were exclusively breastfed for six months will be compared between the intervention and control arms.
Time frame: First postnatal visit (0-2 weeks after delivery) through study endline (child age: 24 months)
Overall breastfeeding duration will be measured continuously for each child as the number of months they were breastfed. This will be obtained from maternal self-report. Mean differences in the overall duration of breastfeeding will be compared between the intervention and control arms.
Contact information is provided by the study sponsor or research team.
Christine McGrath
CONTACT
Irene Nyambura Njuguna
CONTACT
University of Washington
Other
Building Opportunities for Nurturing Care to Enhance Development in Eastern and Southern Africa
Acronym: BONDS
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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