跳至主要内容
临床试验/NCT05277103
NCT05277103已完成不适用

Exploring Predictors of Response to a Peer-mediated Communication Intervention for Minimally Verbal Preschoolers With ASD

University of Kansas Medical Center1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2021年9月21日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
24
试验地点
1
主要终点
Rates of focal child communication

研究概览

简要总结

This study will examine what child variables (i.e., social attention and peer interest) predict communication gains in response to a peer-mediated intervention for 40 minimally-verbal preschool children with ASD and 80 peers. The Stay-Play-Talk with iPad intervention will be implemented for 8 weeks. Gains in communication and reciprocity with peers will be measured at post-treatment and in non-treatment settings. Another goal is to determine if variance in communication gains accounted for by the two social variables differs based on the pre-treatment measurement context.

详细描述

Overview. This project will use a single group pre-post treatment design across four independent cohorts of children (n=8, 10, 11, and 11 per cohort). This design is appropriate because the purpose of this study is to examine predictors of treatment response and the intervention's efficacy has been documented in an RCT.

Research Team. Dr. Bourque (PI) was the lead investigator on a NIH funded R01, examining a peer-mediated SGD intervention for preschoolers with ASD, Co-PI of a RCT peer network intervention for elementary-age students with ASD (IES), and Co-PI of two NIH grants (R01, P01) to assess communication development of preschoolers with ASD/IDD using AAC. She has almost 20 years of established relationships with local districts recruiting participants, Dr. Boyd is PI of a NIH funded R01 grant focused on outcome measure development for children with ASD, and Co-I of an R01 focused on predictors of treatment response for children with ASD. Dr. Salley has extensive experience developing eye-tracking (ET) and bio-behavioral attention measures with infants/toddlers and is PI of a longitudinal study examining the development of early social/nonsocial attention (NIH). Dr. Fleming is Director of the Research Design and Analysis Unit in the Life Span Institute. She has participated as a quantitative methodologist on 38 NIH and USDE-supported grants. Consultants to the team bring specialized expertise: (1) Dr. Shic has contributed to the design of 50 ET paradigms and 6000 recorded eye tracking datasets, the majority at-risk for or diagnosed with ASD, and is thus well-prepared to provide guidance in ET methodology and analysis; (2) Dr. McPartland is PI of the NIH-funded Autism Biomarker Consortium for Clinical Trials, a large scale effort to evaluate the utility of ET and EEG biomarkers in ASD. He will assist in administration of ET paradigms and in data acquisition.

Sample and Recruitment. A total of N=40 children between the ages of 3-6 years will participate, with n=18 recruited in Year 1 (Cohort 1=8; Cohort 2=10) and n=22 in Year 2 (Cohort 3=11; Cohort 4=11). Participants will attend preschool with access to typically developing peers. ASD diagnosis will be confirmed by the Autism Diagnostic Observation Scale-2 and DSM-V criteria, with minimal verbal skills defined as less than 20 spontaneous words or symbols. Each child will demonstrate symbol discrimination skills by intentionally selecting preferred items in 80% of trials in two 1:1 adult sessions using a matching-to-sample procedure; children who do not meet this criteria will be excluded due to insufficient skills to benefit from SGD intervention. Recruitment will occur in local preschools and the Kansas Center for Autism Research and Training registry, which contains 3000+ families, with approximately 65% individuals with ASD. The investigators are confident they can recruit 40 children given the gradual recruitment plan in Year 1 and the teams established relationships with administrators. Two peers without disabilities from the same classroom (or school building) will be recruited for each child with ASD (n=36 peers Year 1; 44 Year 2; N=80 total). Teachers will recommend peers who meet a minimum 6 of 8 behavioral characteristics related to peer social responsiveness and fidelity in the prior RCT.

Pre-Treatment Standardized Measures. Three standardized measures will be administered at enrollment: (1) the Preschool-Language Scale-5 to describe children's expressive language and auditory comprehension skills, (2) the Early Years Battery of the Differential Ability Scales-II to assess cognitive abilities across verbal, nonverbal reasoning, and spatial clusters, and (3) the Vineland Adaptive Behavior Scales III-Parent Interview to describe communication and adaptive skills. Child language and cognitive scores will be used as indicators of global child characteristics and added as covariates to analytic models. All standardized tests and social variable measures will be administered by research staff naive to study hypotheses.

Measurement Contexts. Social attention and peer interest will be measured in three contexts at one time point, prior to the start of treatment: (1) semi-structured peer communication sample, (2) naturalistic observations, and (3) eye-tracking (ET) paradigms. The SGD will be available during contexts (1) and (2), and during breaks in context (3). The first context was used in the PIs R01 to measure communication and joint attention between children with ASD and peers; thus, the administration manual and reliability procedures already exist. In this study, codes will be modified to collect social attention and peer interest data. The PI has extensive experience developing direct observation coding systems and training staff to be reliable in collecting multifaceted communication and social behavior data for this population. Along with Dr. Salley's ET experience, our team is confident that collecting reliable data across the three planned contexts is feasible.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
3 Years 至 6 Years(Child)
性别
All
接受健康志愿者
是

入选标准

  • •Children with ASD (N=40) between 3 to 6 years of age; diagnosis confirmed based on DSM-V criteria (APA, 2013) and administration of the Autism Diagnostic Observational Schedule-2 (ADOS-2; Lord et al., 2012).
  • •minimally verbal defined as less than 20 functional, spontaneous words, signs, or symbols
  • •currently using or a candidate for a SGD to augment communication
  • •symbol discrimination skills based on pre-treatment assessment with an adult partner using a matching-to-sample procedure and a minimum choice of one preferred item and one foil
  • •English as the primary language spoken at home.

排除标准

  • •co-morbid or previously identified genetic conditions associated with ASD (e.g., Fragile X)
  • •visual impairment, deafness, or other sensory disabilities
  • •a lack of symbol discrimination skills
  • •Peer Partners:
  • •ages of 3 and 6 years (N=80 total over 2 years).
  • •recommended by school staff based on meeting six of the eight following criteria: 1) follows simple 2-step directions, (2) responds positively to adult requests to modify or change undesirable behaviors, (3) appropriately approaches and invites other children to play, (4) is comfortable talking to and interacting with other children while playing, (5) takes turns and shares toys with other children, (6) offers to help other children set up play routines or complete tasks, (7) is well-liked by many children in the classroom, and (8) will stay and play with other children for an appropriate length of time.

研究组 & 干预措施

Stay-Play-Talk with iPad Intervention

Experimental

Peers without disabilities will be taught to be active communication partners using an iPad with voice output app as a speech-generating device, then paired up to play with one child with ASD for 16 sessions over 8 weeks. Focal child behaviors are assessed in different pre-treatment contexts (i.e., eye tracking, structured play, and naturalistic classroom settings), and rate of communication will be collected to predict gains children make in social communication with peers after treatment.

干预措施: Exploring predictors of response to a peer-mediated communication intervention for minimally verbal preschoolers with ASD (Behavioral)

结局指标

主要结局

Rates of focal child communication

时间窗: Baseline, 16 weeks Post-Treatment, and generalization probes (two 10-min sns) collected at baseline and 16 weeks post-treatment

Total frequency of child communication acts will be coded during three 10-min sessions prior to the start of treatment in (1) activities that will be the same as in treatment (30 min total), and (2) activities in two generalization settings (snack and free play) (30 min total). Intentional, spontaneous child communication acts that are clearly directed to the peer using eye contact or body orientation including gestures, speech, SGD use, or speech+SGD (e.g., to request objects/actions, comment, or to protest) will be coded. Communication to adults will not be coded. Data will be averaged across the three observations (or 30 min) and converted to a rate per minute to be used in the analyses.

Peer interest

时间窗: Pre-Test

For semi-structured and naturalistic assessments, peer interest will be total rates of (a) child joint attention to peer actions/activities, by looking at the object being acted on then to peer's face within 5 sec, and (b) child imitation of peer actions/activities within 5 sec. For eye tracking assessments, peer interest will be total % time child visually attends to peer faces and activities during the Interactive Visual Exploration Task.

Social Attention

时间窗: Pre-Test

For the semi-structured (12 min total) and naturalistic assessments (30 min total), social attention will be: (a) total % time child visually attends to peer's face, and (b) total % time child visually attends to the adult's face. For eye tracking assessments, social attention will be total % time child visually attends to adult and peer faces in the Static and Dynamic Visual Exploration Tasks.

Rates of reciprocal child-peer exchanges

时间窗: Baseline, at 16 weeks Post-Treatment, and generalization probes collected at baseline and 16 weeks post-treatment

Total rates of reciprocal communication exchanges between the focal child and peer will be coded during three 10-min sessions in baseline, three 10-min sessions at 8 week post-treatment, and two 10-min non-treatment/generalization sessions. Data will be averaged across each set of observations (or 30 min per baseline and treatment phase; 20 min in generalization phase) and converted to a rate per minute to be used in the analyses. Each intentional communication act will be coded as an initiation or a response, with responses coded if observed within 5 seconds of another child's communication act. A reciprocal exchange requires a minimum of one initiation and one response sequence between the focal child and peer (either partner can begin the exchange).

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Kathy Thiemann-Bourque

Associate Research Professor

University of Kansas

研究点 (1)

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