Evaluating The Efficacy of Pathways Parent-Mediated Intervention's Mutual Gaze Protocol on Social Skills in Young Children Suspected of Having Autism: A Randomized Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Improved Social skills
研究概览
简要总结
Purpose of the Study: The goal of this clinical trial is to find out if a technique called the "mutual gaze procedure," used in Pathways Early Intervention (Pathways), is the key to helping improve social communication, language, and everyday skills in young children (16-30 months old) who are at high risk for autism, particularly those from diverse cultural and language backgrounds.
What Will Happen: Researchers will compare two versions of the Pathways Intervention:
- Version 1: Includes mutual gaze strategies.
- Version 2: Does not include mutual gaze strategies.
What to Expect: Participants will:
- Attend 12 sessions of Pathways Intervention, each lasting 1.5 hours (or 15 weeks if there are cancellations).
- Come to the clinic for a developmental check-up three times: before starting Pathways, right after completing Pathways, and three months after finishing Pathways.
详细描述
Purpose of the Study: The primary goal of this clinical trial is to evaluate whether a parent-mediated treatment can improve social communication, language, and adaptive functioning in 16-30-month-old children from diverse cultural and language backgrounds who are at high risk for autism (referred to as children with social challenges).
Study Design:
- Study Phase: N/A
- Intervention Model: Participants are assigned to one of two groups in parallel.
Study Description:
- Participants: 80 children aged 16-30 months who show social communication challenges and are at high risk for autism will be randomly assigned to one of two groups:
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 16 Months 至 30 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children must be between 16-30 months old at the start of the study;
- •Children must receive social disability index of 7 or lower if child is 16-20 months old, or 8.1 or lower if child is 21-30 months old on the EarliPointTM assessment with a researcher (i.e., human) confirming social challenges are present;
- •Parents must report no other known neurological or genetic concerns or disorders
- •Parents must be fluent in English or Spanish
- •Parents must live within a 30-mile radius of the Callier Center Dallas or Callier Center Richardson.
排除标准
- •Children younger than 16 months or older than 30 months at the start of the study
- •Children who are not at high risk for autism based on an EarliPointTM assessment (with researcher confirmation of social challenges)
- •Children whose parents report they have any other known neurological or genetic concerns or disorders;
- •Children whose parents are not fluent in English or Spanish
研究组 & 干预措施
Pathways without Mutual Gaze Protocol
12 90-minute sessions (or 15 weeks, whichever comes first) of Pathways manualized Naturalistic Developmental Behavioral Intervention (NDBI) parent-mediated intervention (research version) without the Mutual Gaze protocol. Pathways uses a coaching model.
干预措施: Pathways Parent Mediated Intervention without Mutual Gaze (Behavioral)
Pathways with a Mutal Gaze Protocol
12 90-minute sessions (or 15 weeks, whichever comes first) of Pathways manualized Naturalistic Developmental Behavioral Intervention (NDBI) parent-mediated intervention (research version). Pathways uses a coaching model.
干预措施: Pathways Parent Mediated Intervention (Behavioral)
结局指标
主要结局
Improved Social skills
时间窗: At baseline (i.e., within two weeks prior to the start of intervention); Post-intervention (i.e., within two weeks after completing the intervention); At three-month follow-up
Assessors blind to group assignment will evaluate each child for social skills using the EarliPointTM The EarliPointTM is an FDA-authorized eye-tracking tool that uses artificial intelligence (AI) eye-tracking technology to assess social disability in children between 16 and 30 months by measuring the number of social interactions a child observes on the portable eye-tracking screen. EarliTech will be used to measure improved social skills. There are 2 different EarliTech Scores: social disability and Verbal and nonverbal. Social disability scores range from -15 to +25, higher scores indicate better ability. Verbal and nonverbal scores range from 0-90, high scores indicate better ability.
Improved Social Communication Skills
时间窗: At baseline (i.e., within two weeks prior to the start of intervention); Post-intervention (i.e., within two weeks after completing the intervention); At three-month follow-up
Change in the raw scores obtained on the social, speech and symbolic composite of The Communication and Symbolic Behavior Scales- Developmental Profile (CSBS-DP) will be measured. Raw scores for the social, speech and symbolic composite range from 0-64, 0-54 and 0-53 respectively, 0 being the worst score. The CSBS-DP is a direct assessment of early social communication.
Change in Adaptive Functioning
时间窗: At baseline (i.e., within two weeks prior to the start of intervention); Post-intervention (i.e., within two weeks after completing the intervention); At three-month follow-up
The Vineland II is a standardized parent interview to assess adaptive functioning. Change in raw scores obtained on Vineland Adaptive Behavior Scales, Second Edition (Vineland II) will be measured. The Vineland II has 4 domains - Communication, Daily Living, Social Skills and Relationships, Physical Activity. The raw scores for these domains range from 0-252, 0-286, 0-224, 0-154 respectively (lower scores being worse outcomes).
次要结局
未报告次要终点
研究者
Pamela Rollins
Professor
The University of Texas at Dallas