Effectiveness of nurse delivered WHO Caregiver Skill Training Program compared to Treatment as Usual in Autism Spectrum Disorder children: A randomized controlled trial
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 130
- 试验地点
- 1
- 主要终点
- To determine whether treatment with WHO-CSTP as compared to TAU improved total ASD symptoms in children at risk/diagnosed with ASD.
研究概览
简要总结
Autism Spectrum Disorders (ASD) have a prevalence of 1-1.5% in 2-6 years-old children. Untreated ASD causes a considerable
burden. The limited availability of diagnostic and therapeutic services impacts the long-term outcome of children with ASD. Evidence-based caregiver-delivered
interventions are known to improve both child and parent outcomes. Novelty: Implementation research on the World Health Organisation Caregiver Skill Training
Program (WHO-CSTP) to caregivers of children diagnosed with ASD in routine clinical services. Objectives: Primary objective: To evaluate the effectiveness of WHOCSTP
compared to Treatment as Usual for ASD symptoms. Secondary Objective: To evaluate the effectiveness of WHO-CSTP compared to Treatment as Usual on
adaptive functioning, global functioning, caregiver empowerment, and caregiver stress in children diagnosed with ASD. Methods: Study site: Children 2-6 years of
age diagnosed with ASD in Psychiatry OPD of a tertiary medical institute. WHO-CST group: Nine weekly group sessions of WHO CSTP for caregivers by trained
nurses and three weekly at-home sessions. Treatment as Usual: Twelve sessions of Parent Education in groups using the Parent Autism Information booklet (Child
Neurology Unit, AlIMS New Delhi). Study instruments. 1. AlIMS modified INDT tool for Autism Spectrum Disorder. 2. Modified CHecklist for Autism in Toddlers-R 3.
Indian Scale for Assessment of Autism. 4. Developmental Disability- Childhood Global Assessment of Functioning scale. 5. Family Empowerment Scale 6. Parent
Stress Scale Randomisation: Block randomisation using software to allocate 1:1 children to the WHO-CSTP or Treatment As Usual. Expected outcome: Effectiveness
of WHO-CSTP in children with ASD.
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
- 2.00 Year(s) 至 6.00 Year(s)（—）
- 性别
- All
入选标准
- •Meeting the DSM 5 diagnostic criteria for Autism Spectrum Disorder as per
- •AIIMS modified INCLEN diagnostic tool for Autism.
- •Indian Scale for Assessment of Autism.
排除标准
- •i) Psychosis ii) Unstable medical conditions iii) Children not staying with at-least one parent.
结局指标
主要结局
To determine whether treatment with WHO-CSTP as compared to TAU improved total ASD symptoms in children at risk/diagnosed with ASD.
时间窗: One month | two months | three months | six months
次要结局
- To determine whether treatment with WHO-CSTP as compared to TAU:(Improves adaptive functioning of children.)
研究者
Suravi Patra
All India Institute of Medical Sciences Bhubaneswar, Odisha, India