Promoting health and wellbeing among children (3-12 years) through establishing safe, stable, nurturing relationships: A hybrid implementation trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 3,600
- 试验地点
- 1
- 主要终点
- Identification of child cognitive and behavioral disorder through Child Behavior Checklist and Strength and difficulties questionnaire, and referred to the health centers for management.
研究概览
简要总结
This is a three-year hybrid effectiveness–implementation trial designed as a two-arm, parallel-group, cluster-randomized study with a planned crossover. The trial will be conducted in 80 clusters located in suburban and rural areas of Wardha, Maharashtra, India. The objective is to develop and evaluate the effectiveness of a co-designed convergence model to promote safe, stable, and nurturing relationships (SSNR) among children aged 3–12 years. The intervention will be delivered by trained facilitators, including community health workers, teachers, and other stakeholders, with the aim of improving children’s cognitive and behavioral outcomes.
A total of 3,600 parent–child dyads will be enrolled. The intervention arm will receive a structured, co-designed program implemented at the family, school, and community levels, while the control arm will continue with usual care and subsequently cross over to the intervention after 12 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 3.00 Year(s) 至 12.00 Year(s)（—）
- 性别
- All
入选标准
- •·Participants must be willing to comply with study requirements ·Families where both parents are willing to participate in the parenting program (exception – single parent/caregiver) ·Both parents/ single parent/ caregiver must provide consent to participate in the study.
排除标准
- •Severely ill participants Participants who refuse to consent.
结局指标
主要结局
Identification of child cognitive and behavioral disorder through Child Behavior Checklist and Strength and difficulties questionnaire, and referred to the health centers for management.
时间窗: Baseline (0 months) | 12 months | 24 months
次要结局
- Parenting behavior and practices along with their perceived competency in parenting practices and satisfaction in their role as a parent, Assessment of child nutritional status (anthropometric measurements),(Assessment of acceptability, adoption, feasibility, effectiveness of intervention and to delineate the facilitators and barriers for effective implementation)
研究者
Subodh Sharan Gupta
Mahatma Gandhi Institute of Medical Sciences