Evaluation of Family Networks (FaNs) for Children With Developmental Disorders and Delays Program: A Cluster Randomized Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 540
- 试验地点
- 1
- 主要终点
- Developmental Disorders- Children Disability Assessment Schedule (DD-CDAS)
研究概览
简要总结
Over 6% of children in Pakistan suffer from a developmental disorder (intellectual disability or Autistic spectrum disorder) and most receive no intervention.In an earlier proof of concept study, the investigators integrated social, technological and business innovations to develop and successfully pilot a sustainable service for such children in one rural population of 30,000. Affected families were identified through a mobile phone-based interactive voice response system, and organised into family networks. 'Champion' family volunteers were trained in evidence-based interventions. A Tablet-based android application was developed for training, monitoring and supervision of the champions, based on the World Health Organization's guidelines. The champions delivered the intervention to other families in the network. The project was sustainable and demonstrated significant improvements in the lives of children and their families in the first 6 months of its operation. The investigators are scaling-up this intervention to a population of 1 million. The investigators aim to evaluate the effectiveness and cost effectiveness of the scaled-up programme using cluster randomized control trial nested within the scale-up study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 2 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children aged between 2-12 years,
- •Screen positive on any of the Ten Questions screen questionnaire items # 1,4,5,7,8,9,10 for developmental disorders and delays.
- •Developmental disorder and delay present according to clinical assessment (History & clinical examination for developmental delay in motor, communication, social, cognitive, daily living skills domains according to mhGAP developmental disorders guidelines for clinical assessment
排除标准
- •Co-morbid physical or mental conditions in the child requiring inpatient hospitalization
- •Deafness or blindness in the child
- •Primary caregiver not available or unwilling to participate in the intervention program for 6 months
- •Physical or mental conditions in the primary caregiver needing inpatient hospitalization or frequent outpatient visits (more than two times a month)
- •Written consent not obtained for participation in the trial by the primary caregiver
结局指标
主要结局
Developmental Disorders- Children Disability Assessment Schedule (DD-CDAS)
时间窗: Change in DD-CDAS score at 6 months post-intervention
The DD-CDAS is a 36-item questionnaire measuring functioning and disability. The 36 items are rated on a five-point Likert scale (1=none to 5=extreme/cannot do). The items represent cognition, mobility, self-care, getting along with others, life activities, and participation in the society. The raw scores are sum across all the items of each domain and all 36 items for a tool. Domain and total raw scores are transformed into a range from 0 to 100. The tool has been validated for children with developmental disorders in Pakistan (DD-CDAS) by our group (Hamdani et al, 2020).
次要结局
- Clinical Global Impression (CGI)(Baseline (Pre treatment) and follow up (6 months post-intervention))
- Caregiver-Child Interaction(Baseline (Pre treatment) and follow-up (6 months post-intervention))
- Strengths and Difficulties Questionnaire (SDQ)(Baseline (Pre treatment) and follow up (6 months post-intervention))
- Family Empowerment Scale (FES)(Baseline (Pre treatment) and follow up (6 months post-intervention))
- Inventory of Stigmatizing Experiences (Family version)(Baseline (Pre treatment) and follow up (6 months post-intervention))
- Pediatric Quality of Life (PedsQL) family impact module(Baseline (Pre treatment) and follow up (6 months post-intervention))
- Client Services Receipt Inventory (CSRI)(Baseline (Pre treatment) and follow up (6 months post-intervention))
研究者
Syed Usman Hamdani
Director
Human Development Research Foundation, Pakistan