Building Opportunities for Nurturing Care to Enhance Child Development in Eastern and Southern Africa

Official title

Building Opportunities for Nurturing Care to Enhance Development in Eastern and Southern Africa

Overview

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.

Detailed description

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.

Interventions

• Behavioral Friendship Bench
  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.
• Behavioral Infant and Young Child Feeding (IYCF) Curriculum
  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.
• Behavioral Play-Based Curriculum
  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.

Primary outcome measures

• Total Score on the Malawi Developmental Assessment Tool (MDAT) at 24 months [Time frame: Study endline (child age: 24 months)]

Secondary outcome measures (11)

• Total Score on the Malawi Developmental Assessment Tool (MDAT) at 12 months [Time frame: Study midline (child age: 12 months)]
• Gross Motor Domain Score on the Malawi Developmental Assessment Tool (MDAT) at 24 months [Time frame: Study endline (child age: 24 months)]
• Fine Motor Domain Score on the Malawi Developmental Assessment Tool (MDAT) at 24 months [Time frame: Study endline (child age: 24 months)]
• Social Domain Score on the Malawi Developmental Assessment Tool (MDAT) at 24 months [Time frame: Study endline (child age: 24 months)]
• Language Domain Score on the Malawi Developmental Assessment Tool (MDAT) at 24 months [Time frame: Study endline (child age: 24 months)]
• Composite Scores of the MacArthur Bates Communicative Development Inventories (CDI) Vocabulary Checklist [Time frame: Study endline (child age: 24 months)]
• Presence of Functional Difficulties as Assessed by the Washington Group/UNICEF Child Functioning Module (CFM) [Time frame: Study endline (child age: 24 months)]
• Weight-for-age z-score (WAZ) at 24 months [Time frame: Study endline (child age: 24 months)]
• Length-for-age z-score (LAZ) at 24 months [Time frame: Study endline (child age: 24 months)]
• Weight-for-length z-score (WLZ) at 24 months [Time frame: Study endline (child age: 24 months)]
• Head circumference-for-age z-score (HCAZ) at 24 months [Time frame: Study endline (child age: 24 months)]

Eligibility criteria

Inclusion criteria

• 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
• Resides inside of the study catchment area and does not plan to move within the next 2 years

Exclusion criteria

• 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Supportive care

Study locations

Center list to be confirmed — check the primary protocol.

Publications

• 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
• 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. PMID 31732866
• 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. PMID 27717632
• 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. PMID 31974572
• 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. PMID 33970913
• 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. PMID 28027368

Identifiers

NCT: NCT07430826 · STUDY00022343 · 1U19HD118601-01

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗