Impact of Graduation on Child Development in Uganda - Wave 2 (Ancillary/Extension)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 2,100
- 试验地点
- 1
- 主要终点
- Height-for-age z-score (HAZ)
研究概览
简要总结
This ancillary/extension study ("Wave 2") measures child development and school readiness outcomes among children residing in households within host communities that participated in the Graduation to Resilience (G2R) randomized controlled trial in Uganda (G2R trial: AEARCTR-0004080 [AEA RCT Registry]; Wave 1 child assessments: NCT05531812). No new randomization or intervention assignment occurs in Wave 2; rather, we assess outcomes in children linked to households in communities previously randomized in the parent study.
Wave 2 expands the eligible child age range (0-9 years) and includes age-appropriate outcomes (e.g., IDELA for school readiness; Raven's Progressive Matrices and executive function tasks for older children). We will compare children in households assigned to receive the Graduation program in the parent RCT (T1) to children in pure ("spillover") control households (C2) in host communities. Primary completion is anticipated in October 2025. Pre-analysis plans for Wave 1 and Wave 2 are posted.
详细描述
Parent RCT & groups: The G2R trial used staged randomization at the community level. In Wave 2 we sample host-community households only, comparing:
T1 (Graduation): households in host communities assigned to receive the Graduation program in the parent trial;
C2 (pure "spillover" control): households in host control communities.
Wave 2 purpose: To measure child development and school readiness outcomes in an expanded age range (0-9 years) using validated, age-appropriate instruments.
Design note: Wave 2 is observational with exposure defined by prior random assignment in the parent RCT; there is no new assignment of interventions in Wave 2.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 6 Months 至 119 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Child aged 0-9 years at time of Wave 2 assessment.
- •Resides in a host-community household within the G2R trial sample
- •Caregiver provides informed consent; child provides assent where applicable.
排除标准
- •Caregiver declines consent or child declines assent.
- •Not resident in the study communities at time of assessment.
结局指标
主要结局
Height-for-age z-score (HAZ)
时间窗: 6 years after the introduction of Graduation
Based on WHO Growth Standards
Anemia
时间窗: 6 years after the introduction of Graduation
Hemoglobin levels captured using HemoCue devices and categorized according to anemia status (\<11.5 g/dL)
Forward Digit Span score
时间窗: 6 years after the introduction of Graduation
Children are asked to repeated a sequence of numbers. Children who are successful are presented with progressively longer sequences.
Head-Toes-Knees-Shoulders-Revised (HTKS-R) score
时间窗: 6 years after the introduction of Graduation
A self-regulation game which taps children's cognitive flexibility, memory, and self-control. Children are presented with instructions and must remember the rules of a game, which require them to: inhibit the more natural response to instructions in favor of the correct, unnatural one; flexibly shift between old and new rules to commands when given, and; regulate their behavior in accordance with all of the above.
Raven's Progressive Matrices Second Edition score
时间窗: 6 years after the introduction of Graduation
A direct assessment of fluid intelligence. Children are presented with 36 items and for each item they are asked to identify the missing piece from a set of options that finishes the matrix/picture that is presented.
IDELA total score
时间窗: 6 years after the introduction of Graduation
International Development and Early Learning Assessment (IDELA) total score. Direct assessment of children with items across four domains: literacy, numeracy, motor, and socio-emotional.
Caregiver-Reported Early Development Index (CREDI) overall z-score
时间窗: 6 years after the introduction of Graduation
Caregivers report on their child's abilities in the domains of cognitive, language, motor, and social-emotional skills.
次要结局
- Diet diversity(6 years after the introduction of Graduation)
- Caregiver-child interactions(6 years after the introduction of Graduation)