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临床试验/NCT04114305
NCT04114305已完成不适用

Evaluating Integration of Early Childhood Development Interventions Into the m2m Program in Swaziland

Johns Hopkins Bloomberg School of Public Health0 个研究点目标入组 431 人开始时间: 2016年1月18日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
431
主要终点
Maternal Psychosocial Well-being

研究概览

简要总结

With increased use of effective strategies to prevent HIV transmission from women to their infants, the number of HIV infected children has dramatically decreased. This has led to an increased number of children who have been exposed to HIV, but who are not themselves infected. There is concern that exposure to HIV can lead to poorer health outcomes, including less optimal neurodevelopment. Because of this possibility in a growing population of HIV-exposed, but uninfected (HEU) children, there is a need to identify interventions to optimize their growth and development. This study was undertaken to evaluate the impact of a two-generation intervention, jointly targeting child neurodevelopment and maternal psychosocial wellbeing, integrated into antenatal care/prevention of maternal to child transmission (ANC/PMTCT) clinics.

The intervention was implemented by mothers2mothers (m2m), an organization based in South Africa with a long-standing program using peer mentors (Mentor Mothers) to support HIV-infected women and their families. The m2m ECD intervention provided by specially trained Mentor Mothers included home- and community based activities meant to assist mothers and other caregivers in building resilience and gaining skills to support their children's development. The primary intervention was an intensive program of home visits beginning during pregnancy and continuing until the child reached two years of age, with up to 46 home visits. At each visit, the ECD Mentor Mothers helped parents/caregivers to learn about ages and stages of growth (including pre-birth), and to facilitate responsive parenting and early learning opportunities for their children. Mentor Mothers also conducted parenting information play groups (PIPs) in each community for ECD clients and ECD information was integrated into the existing facility support groups provided at each health clinic. The intervention covered general areas of maternal and child health, nutrition, social services, support for primary caregivers and stimulation for early learning.

Since the intervention was targeted at two generations, the primary aims were two-fold: to assess the impact on pediatric neurodevelopment and on maternal psychosocial function. Secondary aims included assessment of maternal and child retention in care, maternal HIV outcomes and child mortality, health, growth and nutrition. Children were enrolled into one of two study arms: 1) the intervention arm included children from clinics where the m2m ECD program was being implemented, and 2) the comparison arm included children from government clinics that offered standard of care services but no m2m or ECD program.

Mothers were enrolled during antenatal care, in the third trimester of pregnancy. Children and their mothers were followed though 18 months of age and their evaluation included an assessment of development (Mullen Scale of Early Learning) at 9 and 18 months, as well as assessments of child growth, maternal psychosocial well-being, parenting practices and retention in care.

详细描述

Intervention Methods

ECD Intervention. Mothers2mothers (m2m) was selected to pilot-test a parenting intervention integrated within the Eswatini standard integrated antenatal care and PMTCT program developed according to the World Health Organization (WHO) Option B+ recommendations. Each clinic selected for the pilot test had already implemented a m2m mentor mother (MM) peer support program at the facility, as well as defaulter follow-up in the community.

The parenting intervention strategy, known as "uMntfwana Wami, uMntfwana Wetfu"( "My Child, Our Child") was focused on peer support for pregnant women and parents/caregivers of young children to assist them in building resilience and gaining skills to support their children's development.

M2m's facility-based Mentor Mothers (MMs) recruited pregnant women at the ANC/PMTCT clinics. Both HIV-positive and HIV-negative women were eligible to participate in the m2m intervention. Community-based ECD MMs, who received five weeks of program-specific training, provided the parental training intervention.

Evaluation Methods

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Age 18 years and over
  • HIV+ woman with confirmed HIV status recorded on a clinic chart or register
  • Visiting the PMTCT clinic in the 3rd trimester of pregnancy
  • Verified resident within the clinic-defined catchment area

排除标准

  • Age less than 18 years
  • Reported specific plan to move outside catchment area or switch HIV care to another site
  • Did not provide written consent to participate in the study or did not complete the enrollment questionnaire.
  • Please note that the infants born to these pregnant women were also enrolled. The following inclusion criterion applied to the infants:
  • Born to enrolled woman as a result of the pregnancy during which she was enrolled.

结局指标

主要结局

Maternal Psychosocial Well-being

时间窗: Assessed at 9 and 18 months postpartum

The primary maternal outcome of psychosocial well-being was assessed using the Edinburgh Postnatal Depression Scale (EPDS), categorized dichotomously as depressive symptoms present (EPDS score \>13) or absent (EPDS score ≤13). Parenting self-confidence was also assessed, using the Maternal Self-Report Inventory (Short Form) (MSRI). These instruments were administered to women at enrollment and at nine and 18 months postpartum.

Child development

时间窗: Through 18 months of age

The primary outcome of childhood development was assessed when the children were 9 and 18 months of age using the Mullen Scales of Early Learning. Scores from each domain (Visual Reception, Fine Motor skills, Receptive Language, Expressive Language and Gross Motor skills) were analyzed separately.

次要结局

  • Maternal Retention in HIV care(3, 6, 9 and 18 months postpartum)
  • Child retention in well-child care(3, 6, 9, 12-15 and 18 months after birth)
  • Maternal CD4 count(Through study completion, an average of 18 months postpartum)
  • Maternal HIV viral load(Through study completion, an average of 18 months postpartum)
  • Child mortality(2 weeks, 3, 6, 9 12-15 and 18 months postpartum)
  • Pediatric hospitalizations(3, 6, 9, 12-15 and 18 months after birth)

研究者

申办方类型
Other
责任方
Sponsor

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