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| ID | Type | Description | Link |
|---|---|---|---|
| 1U19HD118601-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
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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:
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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BONDS Intervention | Experimental | The intervention arm will combine three evidence-based interventions (Friendship Bench, infant and young child feeding curriculum, play-based learning curriculum) in a country-adapted package delivered by CHWs to participants starting in pregnancy and continuing through a child's second year of life. The intervention will be delivered at home, in the community, in a government clinic, or study clinic in the context of ongoing antenatal care and maternal and child health services for pregnant women, mothers, and children. |
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| Standard of Care | No Intervention | The standard of care arm includes regular antenatal care and maternal and child health services. These services across the three countries include recommended antenatal care visits during which maternal/fetal health is assessed, antenatal tests are conducted, nutrition supplements and disease prophylaxis are provided, and basic education on danger signs, breastfeeding and nutrition are provided. Postnatal and infant care include family planning, growth monitoring, immunization, and assessment of child development. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Friendship Bench | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Study endline (child age: 24 months) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Irene Nyambura Njuguna | Contact | +1-206-519-1275 | injugun@emory.edu | |
| Christine McGrath | Contact | +1 206 619 8700 | mcgrathc@uw.edu |
| Name | Affiliation | Role |
|---|---|---|
| Grace John-Stewart, Md, PhD | University of Washington | Principal Investigator |
| Andrew Prendergast | Queen Mary University of London | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | World Health Organization. Nurturing care for early childhood development: a framework for helping children survive and thrive to transform health and human potential [Internet]. Geneva: World Health Organization; 2018. 55 p. Available from: iris.who.int/handle/10665/272603 | ||
| 31732866 | Background | Wedderburn CJ, Evans C, Yeung S, Gibb DM, Donald KA, Prendergast AJ. Growth and Neurodevelopment of HIV-Exposed Uninfected Children: a Conceptual Framework. Curr HIV/AIDS Rep. 2019 Dec;16(6):501-513. doi: 10.1007/s11904-019-00459-0. | |
| 27717632 |
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All IPD that is not directly identifiable will be shared.
IPD will be available on NICHD DASH 12 months after the end of participant follow-up, which is anticipated to be December 2029. Supporting information (protocol, ICFs, SAPs) is anticipated to be available on ct.gov by May 2027.
IPD will be available open access on NICHD DASH. Supporting information will be available open access on ct.gov.
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| ID | Term |
|---|---|
| D006130 | Growth Disorders |
| D002100 | Cachexia |
| D013851 | Thinness |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D015431 | Weight Loss |
| D001836 | Body Weight Changes |
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Data analysts will also be blinded to arm allocation.
|
| Infant and Young Child Feeding (IYCF) Curriculum | Behavioral | 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. |
|
| Play-Based Curriculum | Behavioral | 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. |
|
| Study midline (child age: 12 months) |
| 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. | Study endline (child age: 24 months) |
| 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. | Study endline (child age: 24 months) |
| 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. | Study endline (child age: 24 months) |
| Language Domain Score on the Malawi Developmental Assessment Tool (MDAT) at 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. | Study endline (child age: 24 months) |
| Composite Scores of the MacArthur Bates Communicative Development Inventories (CDI) Vocabulary Checklist | 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. | Study endline (child age: 24 months) |
| Presence of Functional Difficulties as Assessed by the Washington Group/UNICEF Child Functioning Module (CFM) | 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. | Study endline (child age: 24 months) |
| Weight-for-age z-score (WAZ) at 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. | Study endline (child age: 24 months) |
| Length-for-age z-score (LAZ) at 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. | Study endline (child age: 24 months) |
| Weight-for-length z-score (WLZ) at 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. | Study endline (child age: 24 months) |
| Head circumference-for-age z-score (HCAZ) at 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. | Study endline (child age: 24 months) |
| Study midline (child age: 12 months) |
| 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. | Study midline (child age: 12 months) |
| 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. | Study midline (child age: 12 months) |
| 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. | Study midline (child age: 12 months) |
| Proportion of children who are stunted | The proportion of children who are stunted will be compared between the intervention and control arms. | Study endline (child age: 24 months) |
| Proportion of children who are wasted | The proportion of children who are wasted will be compared between the intervention and control arms. | Study endline (child age: 24 months) |
| Proportion of children who are underweight | The proportion of children who are underweight will be compared between the intervention and control arms. | Study endline (child age: 24 months) |
| Proportion of mothers with mental distress at 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. | Study midline (child age: 12 months) |
| Proportion of mothers with mental distress at 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. | Study endline (child age: 24 months) |
| Proportion of mothers who did early initiation of breastfeeding | 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. | First postnatal visit (0-2 weeks after delivery) |
| Proportion of infants who were exclusively breastfed through six months of age | 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. | First postnatal visit (0-2 weeks after delivery) through child age 6 months |
| Overall breastfeeding duration | 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. | First postnatal visit (0-2 weeks after delivery) through study endline (child age: 24 months) |
| Kathleen Powis |
| Massachusetts General Hospital |
| Principal Investigator |
| Dalton Wamalwa | University of Nairobi / Kenyatta National Hospital | Principal Investigator |
| Irene Njuguna | Emory University | Study Director |
| Christine McGrath | University of Washington | Study Director |
| Andrew Prendergast | Queen Mary University of London | Study Director |
| Adam Cassidy | Mayo Clinic | Study Director |
| Background |
| Lu C, Black MM, Richter LM. Risk of poor development in young children in low-income and middle-income countries: an estimation and analysis at the global, regional, and country level. Lancet Glob Health. 2016 Dec;4(12):e916-e922. doi: 10.1016/S2214-109X(16)30266-2. Epub 2016 Oct 4. |
| 31974572 | Background | Evans C, Chasekwa B, Ntozini R, Majo FD, Mutasa K, Tavengwa N, Mutasa B, Mbuya MNN, Smith LE, Stoltzfus RJ, Moulton LH, Humphrey JH, Prendergast AJ; Sanitation Hygiene Infant Nutrition Efficacy (SHINE) Trial Team. Mortality, Human Immunodeficiency Virus (HIV) Transmission, and Growth in Children Exposed to HIV in Rural Zimbabwe. Clin Infect Dis. 2021 Feb 16;72(4):586-594. doi: 10.1093/cid/ciaa076. |
| 33970913 | Background | Jeong J, Franchett EE, Ramos de Oliveira CV, Rehmani K, Yousafzai AK. Parenting interventions to promote early child development in the first three years of life: A global systematic review and meta-analysis. PLoS Med. 2021 May 10;18(5):e1003602. doi: 10.1371/journal.pmed.1003602. eCollection 2021 May. |
| 28027368 | Background | Chibanda D, Weiss HA, Verhey R, Simms V, Munjoma R, Rusakaniko S, Chingono A, Munetsi E, Bere T, Manda E, Abas M, Araya R. Effect of a Primary Care-Based Psychological Intervention on Symptoms of Common Mental Disorders in Zimbabwe: A Randomized Clinical Trial. JAMA. 2016 Dec 27;316(24):2618-2626. doi: 10.1001/jama.2016.19102. |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |