Predicting & Optimizing Language Outcomes in Minimally Verbal Children With Autism Spectrum Disorder: Boosting Language Outcomes of Minimally Verbal Children With ASD
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 56
- 试验地点
- 2
- 主要终点
- Change in spontaneous socially communicative utterances (SCU) using the Elicitation of Language Samples for Analysis (ELSA).
研究概览
简要总结
In this project, the investigator will test the effect of augmenting an evidence based joint attention intervention (JASPER) with a motor-sound system intervention (PROMPT) compared to JASPER only on speech and language outcomes. The investigator will model change over a year to determine the percentage of children who cross the hurdle from single words to word combinations by Kindergarten. The proposed research will foster the understanding of the mechanisms underlying speech heterogeneity in ASD, thereby ultimately contributing to the development of more personalized, efficacious interventions.
Upon qualification to the study (after entry assessments), the child will be randomized to receive JASPER alone (play-based intervention) or JASPER plus PROMPT (both play-based and speech-based interventions). The active intervention will last for 12 weeks, 60 minute sessions twice a week. There are assessments scheduled at entry (6.5 hours), end of study (exit-2.5 hours), 3 month follow up (2 hours), and when the child turns 6 years of age (2 hours). The total time commitment per participant is 37 hours.
详细描述
Children will be recruited through local school districts and early intervention service providers, approximately 20 children per year for a total of 80 children. Parents interested in the study will call the lab and be screened. If children pass the screen, they will be invited to go to UCLA for a series of assessments. The process will take 2-3 days. The following assessments and data will be collected: ADOS-2, ADI-R, Mullen Scales of Early Learning (MSEL), Demographic & Medical Questionnaires, Vineland-III Interview, ELSA Language Sample, PLS-5,SPA, Repetitive Behaviors RBS-R, SSP, ABC-2, ESCS, BOSCC, KSPT, EEG, and saliva sample. Eligibility for the study will then evaluated. Each child's clinical diagnosis of ASD will be validated by administration of the Autism Diagnostic Observation Schedule-2 (ADOS-2) and the Autism Diagnostic Interview-Revised (ADI-R) by a research-reliable lab staff. Children will participate in a language sample (eligible if < 20 words), and the Mullen Scales of Early Learning (MSEL) to evaluate nonverbal mental age (eligible if > 12 months).
After qualifying to the study, the screening data will be entered into Biostatistics and Epidemiology Data Analytics Center (BEDAC), secured website. Randomization will then occur. Children will be randomly assigned to one of two intervention options: JASPER + PROMPT versus JASPER only.
JASPER is a naturalistic, developmental, behavioral intervention (NDBI) that focuses on developing social communication and language skills in the context of a play based intervention.
Intervening on oral motor skills may improve speech. In Los Angeles, a fairly common community intervention delivered by certified speech language pathologists (SLP) is Prompts for Restructuring Oral Muscular Phonetic Targets (PROMPT). PROMPT has a growing evidence base among a number of clinical populations with language delays related to oral motor deficits (although not ASD).
- JASPER only: Child will receive 2, 60 minute sessions per week at UCLA. or
- JASPER + PROMPT: Child will receive 2, 60 minute sessions per week at Santa Monica's SSLP, Inc.
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
- 42 Months 至 66 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children meeting ADOS-2 and ADI-R criteria for ASD
- •age 42-66 months
- •have had > 3 months of early intervention/preschool (to ensure that children already have been exposed to some community interventions)
- •walked prior to 24 months
- •use < 20 functional words (i.e., non-echoed, non-scripted). Number of functional spoken words will be totaled in a language sample assessment. The functional word criterion is based on a 2010 NIH workgroup definition of 'minimally verbal' in school-aged children. The same definition may also apply to younger children with limited language.
- •stable medication over the past 6 months
- •nonverbal mental age of >12 months on the Mullen Scales of Early Learning (visual reception and fine motor subscales).
排除标准
- •We will exclude children who are deaf, blind or with cerebral palsy.
- •We will not exclude on the basis of known genetic disorder associated with ASD (ex: TSC), but expect few will actually participate, in part due to rarity of these disorders, and because for some there are other trials available at UCLA (ex: TSC).
- •We will exclude children in other intervention trials; in other words, we will not double enroll children into intervention trials.
研究组 & 干预措施
JASPER only
This group will consist of the child and therapist having one-on-one, JASPER sessions, twice a week.
干预措施: JASPER (Behavioral)
JASPER + PROMPT
This group will consist of the child and therapist having one-on-one, JASPER sessions plus Prompts for Restructuring Oral Muscular Phonetic Targets (PROMPT), twice a week.
干预措施: JASPER (Behavioral)
JASPER + PROMPT
This group will consist of the child and therapist having one-on-one, JASPER sessions plus Prompts for Restructuring Oral Muscular Phonetic Targets (PROMPT), twice a week.
干预措施: PROMPT (Behavioral)
结局指标
主要结局
Change in spontaneous socially communicative utterances (SCU) using the Elicitation of Language Samples for Analysis (ELSA).
时间窗: T1 entry (1st month of study), T2 exit (3 months after entry), T3 3-month Follow Up (6 months after entry), T4 when child turns 6 years of age
The ELSA is comprised of a series of semi-structured activities including: play-based interactive activities centered around a nature walk (falling leaves; planting an acorn, finding animals; making and eating S'mores); conversational chat and clean up; crafts (art project); games (bean bag toss); and an optional video narration (Pixar short movies, presented to the participant on a tablet). The activities are appropriate for the age range of this study (4 to 7 years). The more words the child has, the better the outcome.
次要结局
- Presence of word combinations at age six based on the Preschool Language Scales-5 (PLS-5)(T1 entry (1st month of study), T2 exit (3 months after entry), T3 3-month Follow Up (6 months after entry), T4 when child turns 6 years of age)
- Change in number of novel and distinct word root (NDWR), and presence of word combinations at age six based on the ELSA language sample.(T1 entry (1st month of study), T2 exit (3 months after entry), T3 3-month Follow Up (6 months after entry), T4 when child turns 6 years of age)
- Change in number of novel and distinct word root (NDWR) based on the Preschool Language Scales-5 (PLS-5).(T1 entry (1st month of study), T2 exit (3 months after entry), T3 3-month Follow Up (6 months after entry), T4 when child turns 6 years of age)
研究者
Connie Kasari, Ph.D.
Professor/PhD
University of California, Los Angeles