Building Opportunities for Nurturing Care to Enhance Development in Eastern and Southern Africa
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 1,260
- 主要终点
- Total Score on the Malawi Developmental Assessment Tool (MDAT) at 24 months
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
Data analysts will also be blinded to arm allocation.
入排标准
- 年龄范围
- 15 Years 至 —（Child, Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
BONDS Intervention
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.
干预措施: Friendship Bench (Behavioral)
BONDS Intervention
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.
干预措施: Infant and Young Child Feeding (IYCF) Curriculum (Behavioral)
BONDS Intervention
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.
干预措施: Play-Based Curriculum (Behavioral)
Standard of Care
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.
结局指标
主要结局
Total Score on the Malawi Developmental Assessment Tool (MDAT) at 24 months
时间窗: 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.
次要结局
- Total Score on the Malawi Developmental Assessment Tool (MDAT) at 12 months(Study midline (child age: 12 months))
- Gross Motor Domain Score on the Malawi Developmental Assessment Tool (MDAT) at 24 months(Study endline (child age: 24 months))
- Fine Motor Domain Score on the Malawi Developmental Assessment Tool (MDAT) at 24 months(Study endline (child age: 24 months))
- Social Domain Score on the Malawi Developmental Assessment Tool (MDAT) at 24 months(Study endline (child age: 24 months))
- Language Domain Score on the Malawi Developmental Assessment Tool (MDAT) at 24 months(Study endline (child age: 24 months))
- Composite Scores of the MacArthur Bates Communicative Development Inventories (CDI) Vocabulary Checklist(Study endline (child age: 24 months))
- Presence of Functional Difficulties as Assessed by the Washington Group/UNICEF Child Functioning Module (CFM)(Study endline (child age: 24 months))
- Weight-for-age z-score (WAZ) at 24 months(Study endline (child age: 24 months))
- Length-for-age z-score (LAZ) at 24 months(Study endline (child age: 24 months))
- Weight-for-length z-score (WLZ) at 24 months(Study endline (child age: 24 months))
- Head circumference-for-age z-score (HCAZ) at 24 months(Study endline (child age: 24 months))
研究者
Grace John-Stewart
Professor: School of Medicine, Global Health
University of Washington