Effectiveness of the selected non-pharmacological intervention on developmental outcomes in children (1–5 years) with developmental delay in selected Child Development Centers of Gorakhpur Uttar Pradesh: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Improvement in developmental outcomes (cognitive motor and communication domains)
研究概览
简要总结
This randomized controlled trial aims to evaluate the effectiveness of a structured non-pharmacological intervention on developmental outcomes in children aged 1 to 5 years with developmental delay. The study will be conducted in selected Child Development Centers of Gorakhpur. Eligible participants will be randomly assigned to intervention and control groups. The intervention group will receive therapy sessions twice weekly for 8 weeks, while the control group will receive standard care. Developmental outcomes will be assessed pre and post intervention using standardized tools. The study aims to generate evidence to support the use of non-pharmacological approaches in early childhood developmental support.
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
- 1.00 Year(s) 至 5.00 Year(s)（—）
- 性别
- All
入选标准
- •Children aged 1–5 years diagnosed with developmental delay Medically stable and attending child development center Parents and caregivers willing to participate and provide informed consent.
排除标准
- •Children with known genetic syndromes (e.g., Down syndrome), cerebral palsy, or neurological disorders.
- •Children with sensory deficits (e.g., severe hearing or visual impairment).
- •Those currently undergoing intensive therapy elsewhere.
- •Parents/caregivers unwilling to comply with follow-up or intervention sessions.
结局指标
主要结局
Improvement in developmental outcomes (cognitive motor and communication domains)
时间窗: Baseline (Day 0) 4 weeks and 8 weeks after initiation of the intervention
次要结局
- 1. Parental/caregiver stress and satisfaction with the intervention.(2. Adherence to and feasibility of the intervention in clinical settings.)
研究者
Vanshika
College of nursing , AIIMS Gorakhpur