Joint Engagement in Infants at Risk for ASD: Integrating Treatment With Biomarkers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 110
- 试验地点
- 2
- 主要终点
- Assessing change in Parent Child Interaction (PCX) throughout the diverse time points.
研究概览
简要总结
The study will evaluate the efficacy of a novel intervention implemented in a classroom setting aimed at improving joint attention and joint engagement skills with infants who are at risk of developing an Autism Spectrum Disorder.
详细描述
The proposed intervention adapts a parent-mediated intervention that successfully improved outcomes in toddlers with autism. The intervention model (a) targets the foundations of social-communication (joint attention, imitation, play), (b) uses naturalistic strategies to increase the rate and complexity of social-communication and (c) includes parents as implementers of the intervention to promote generalization across settings and activities and to ensure maintenance over time.
In addition to testing the primary effects of this early intervention on the developmental outcomes of children with signs of autism, we will examine whether this method is superior to an early intervention focused on global infant development. Because brain development occurs rapidly in infants and toddlers, we will use high density EEG to investigate (1) biomarkers of change in these infants as a result of intervention and (2) biomarkers predicting response to treatment, with focus on the neural correlates of social attention and learning from joint engagement.
Study Aims:
AIM 1: To examine the effects of the experimental intervention (Baby JASPER) on primary (joint attention) and secondary outcomes (receptive language, play, symbol-infused joint engagement and parent use of social communication support strategies).
AIM 2: To examine maintenance and generalization of the effects of the experimental intervention on children and their parents.
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 (Care Provider)
入排标准
- 年龄范围
- 12 Months 至 21 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have elevated scores on the ADOS-Toddler version and clinical concern from professional (Pediatrician, Psychologist, etc). Because of the young age of children, we expect to intervene with children who do not yet have a diagnosis of ASD but may only show some risk by virtue of elevated scores on the ADOS-T.
- •Have a parent available for parent-mediated sessions 2 times per week in the classroom
- •Do not have seizures
- •Do not have associated sensory or physical disorders
- •Are not co-morbid with other syndromes or diseases
排除标准
- •Other co-morbid syndromes or diseases
- •Seizure activity
- •Other sensory or physical disorders
研究组 & 干预措施
Baby JASPER
This classroom will spend the majority of the time focusing on social-communication goals
干预措施: Baby JASPER (Behavioral)
Standard Baby Classroom
This classroom will focus more heavily on developing motor and cognitive skills
干预措施: Standard Baby Classroom (Behavioral)
结局指标
主要结局
Assessing change in Parent Child Interaction (PCX) throughout the diverse time points.
时间窗: Prior to treatment commencing (Study Entry), within treatment (3 and 6 weeks post entry), Exit (8-10 weeks post entry), and three further follow ups (2 months post exit, 4 months post exit and 10 months post exit)
10 minute unstructured free play assessment with caregiver and child measuring change over the duration of the study.
次要结局
- Early Social Communication Scales (ESCS)(Prior to treatment commencing (Study Entry), within treatment (3 and 6 weeks post entry), Exit (8-10 weeks post entry), and three further follow ups (2 months post exit, 4 months post exit and 10 months post exit))
- Autism Diagnostic Observation Schedule Toddler module (ADOS-T)(Prior to treatment commencing (Study Entry) and 10 months post treatment exit)
- Imitation Task(Prior to treatment commencing (Study Entry), within treatment (3 and 6 weeks post entry), Exit (8-10 weeks post entry), and three further follow ups (2 months post exit, 4 months post exit and 10 months post exit))
- EEG/Event Related Potential (ERP)(Prior to treatment commencing (Study Entry), within treatment (3 and 6 weeks post entry), Exit (8-10 weeks post entry), and three further follow ups (2 months post exit, 4 months post exit and 10 months post exit))
- Mullen Scales of Early Learning (MSEL)(Prior to treatment commencing (Study Entry), within treatment (3 and 6 weeks post entry), Exit (8-10 weeks post entry), and three further follow ups (2 months post exit, 4 months post exit and 10 months post exit))
- Vineland Adaptive Behavior Scales (VABS)(Prior to treatment commencing (Study Entry), within treatment (3 and 6 weeks post entry), Exit (8-10 weeks post entry), and three further follow ups (2 months post exit, 4 months post exit and 10 months post exit))
- Structured Play Assessment (SPA)(Prior to treatment commencing (Study Entry), within treatment (3 and 6 weeks post entry), Exit (8-10 weeks post entry), and three further follow ups (2 months post exit, 4 months post exit and 10 months post exit))
研究者
Connie Kasari, Ph.D.
Principal Investigator
University of California, Los Angeles