Randomized Controlled Trial of Center-Based Early Start Denver Model (ESDM) vs. Pivotal Response Treatment (PRT) in Children With Autism
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Week 24 Clinical Global Impressions - Improvement (CGI-I)
研究概览
简要总结
The goal of this study is to compare two well-established early autism interventions, Early Start Denver Model (ESDM) and Pivotal Response Treatment (PRT), to better understand which approach is most effective for improving communication skills in young children with autism and which children may benefit most from each treatment. Additionally, after completing either the ESDM or PRT, some participants who meet specific clinical criteria may be offered home-based Developmental Reciprocity Treatment (DRT). The study will include boys and girls 2 to 4 years 11 months old diagnosed with ASD. The main questions this study aims to answer are whether center-based ESDM and center-based PRT improve communication skills in young children with autism, and whether certain children respond better to one treatment approach than the other. Participants will be randomly assigned to either ESDM or PRT for 24 weeks in a center-based program, attend treatment session 4 days per week (~3 hours/day), complete developmental and autism assessments at baseline, 12 weeks, and 24 weeks, have a parent participate in weekly parent training sessions, and complete follow-up assessments at weeks 36 and 48.
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 4 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children must be between 2 and 4 years, 11 months of age at enrollment
- •Confirmed diagnosis of autism spectrum disorder based on standardized diagnostic assessments and clinical judgment
- •Demonstrated significant language delay as determined by standardized language measures
- •Ability to participate in study assessments and intervention procedures
- •At least one English-speaking parent or caregiver available to participate in parent training and research measures
- •Receiving stable community-based treatments or medications for at least one month prior to baseline, with no anticipated changes during the study period
排除标准
- •Current or lifetime diagnosis of a severe psychiatric disorder (e.g., bipolar disorder)
- •Presence of an active or unstable medical condition (e.g., uncontrolled seizure disorder or significant cardiac disease)
- •Child's primary language is not English
- •Prior adequate trial of PRT or ESDM
- •Receipt of more than 15 hours per week of in-home applied behavior analysis services
- •Inability to complete study assessments or procedures to obtain valid data
研究组 & 干预措施
Developmental Reciprocity Treatment (DRT)
干预措施: Developmental Reciprocity Treatment (DRT) (Behavioral)
Early Start Denver Model (ESDM)
干预措施: Early Start Denver Model (ESDM) (Behavioral)
Pivotal Response Treatment (PRT)
干预措施: Pivotal Response Treatment (PRT) (Behavioral)
结局指标
主要结局
Week 24 Clinical Global Impressions - Improvement (CGI-I)
时间窗: Baseline, Week 12, Week 24, Week 36, Week 48
A clinician rating that measures how much a child's overall symptoms and functioning have improved or worsened compared to the start of treatment. The CGI ratings will be assessed by a psychologist blind to group assignment and treatment phase, and will specifically focus on social and communication skills.
次要结局
- Change from Baseline on Functional utterances during Structured Laboratory Observation (SLO)(Baseline, Week 12, Week 24, Week 36, Week 48)
- Change from Baseline on Early Start Denver Model Curriculum Checklist (ESDM-CC)(Baseline, Week 12, Week 24, Week 36, Week 48)
研究者
Antonio Hardan
Professor of Psychiatry & Behavioral Sciences
Stanford University