Multisite Randomized Control Treatment of Early Intervention for Spoken Communication in Autism
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 192
- 试验地点
- 3
- 主要终点
- Reynell Developmental Language Scale
研究概览
简要总结
The goal of this project is to compare the efficacy of two interventions for improving spoken language and reducing symptoms of autism.
详细描述
While significant progress has been made toward identifying effective interventions for preschool-age children with autism (National Research Council, 2001), few scientifically rigorous studies have compared active ingredients of these interventions or examined outcomes focused on core deficits. To address these areas of need, this collaborative, multi-site project combines the expertise of investigators experienced in randomized controlled clinical trials (RCTs), in the study of core deficits in young children with autism, and in data management and analysis of multi-site clinical trials.
The goal of this project is to compare the efficacy of two interventions for improving spoken language and reducing symptoms of autism: (1) Discrete trial training (DTT)--an applied behavior analysis approach emphasizing highly structured teaching of school readiness skills (match-to-sample, imitation, functional play, and receptive and expressive language) and (2) Interpersonal developmental approach (IDA): a visually supported, child-focused, flexible engagement, social communicative engagement approach on joint attention, symbolic play, and the use of conventional symbols within socially valid communicative contexts.
Children will be randomly assigned to DTT or IDA. In each condition, children's ongoing early intervention programs will be augmented with two 30-minute sessions daily of the study intervention (DTT or IDA) conducted by supervised therapists for 4 months, with transition to home therapy for 2 months.
Potential moderators (e.g., initial mental age and language age) and mediators (e.g. parent synchronization of joint attention and changes in parental expectancies) on treatment outcome will also be examined.
The assessment measures will include diagnostic and developmental measures. There are three sets of assessments. The first set of assessments is to determine whether the child is eligible for the study. If the child is eligible, we will complete the next set of assessments, which are completed at three points: (1) prior to entry into the treatment (this is a baseline measurement conducted just before the start of the treatment phase); (2) at exit; and (3) at a 6 month follow-up. Several assessments will also be completed after 2 months, 4 months, and 6 months.
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
- None
入排标准
- 年龄范围
- 33 Months 至 54 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Diagnosis of an autism spectrum disorder (Autistic Disorder or Pervasive Developmental Disorder Not Otherwise Specified) from a licensed doctoral-level clinician, confirmed by the Autism Diagnostic Observation Schedule and clinical judgment.
- •Chronological age between 33 and 54 months
- •Must be receiving at least 12.5 hours per week of early intervention or preschool developmental services, some of which must be provided in a school setting.
- •Cognitive and language requirements (at least two of the following three criteria must be met:
- •>12 months for visual reception (as determined by Mullen Scales of Early Learning) or receptive language (as determined by Mullen or Reynell Developmental Language Scales)
- •a score of 1,2 or 3 on the ADOS Module 1
- •<30 spontaneous communicative words, as determined by behavior assessments (Mother- Child Interaction, Early Social Communication Scales, and Structured Play Assessment)
排除标准
- •Major medical conditions other than autism, specifically (a) genetic disorders such as Fragile X, Down syndrome, or tuberous sclerosis, (b) sensory disabilities such as blindness or deafness, and (c) motor disabilities such as cerebral palsy
- •Nonverbal mental age < 12 months, based on a nonverbal score from the Mullen Scales of Early Learning (Mullen, 1995), as reliability of a diagnosis of autism is questionable at this developmental level.
- •Expressive language level that exceeds the First Words level, as evidenced by an age equivalent of 24 months or greater on the Expressive Language Scale of the Reynell
- •Exposure to English less than 50% of the time
研究组 & 干预措施
Discrete Trial Training
Targets nonverbal imitation, match-to-sample, verbal imitation, imitation of play activities, receptive language, and expressive language. 5 hours per week of individual instruction for 4 months (Two 30-minute sessions per day, five days per week) with reductions in classroom pull out sessions in months 5 and 6 with implementation of 1 hour per week of in-home parent training for the last 2 months.
干预措施: Discrete Trial Training (Behavioral)
Interpersonal Developmental Approach
Targets Joint Attention and Symbolic Play. 5 hours per week of individual instruction for 4 months (Two 30-minute sessions per day, five days per week) with reductions in classroom pull out sessions in months 5 and 6 with implementation of 1 hour per week of in-home parent training for the last 2 months.
干预措施: Interpersonal Developmental Approach (Behavioral)
结局指标
主要结局
Reynell Developmental Language Scale
时间窗: Pre-treatment, post-treatment, and 6 months later
次要结局
- Structured Play Assessment(Pre-treatment, post-treatment, and 6-month follow up)
- McArthur-Bates Communicative Development Inventory (Word and Gestures Inventory and/or Words and Sentences Inventory)(Pre-treatment, post-treatment, and 6-month follow up)
- Caregiver-child Interaction(Pre-treatment, three times during active intervention, post-treatment, and 6-month follow up)
- Early Social Communication Scale(Pre-treatment, post-treatment, and 6-month follow up)
研究者
Connie Kasari, Ph.D.
Professor of Psychological Studies in Education and Psychiatry
University of California, Los Angeles