NCT05098392

Brief Summary

Given the increasing prevalence of autism spectrum disorder (ASD), estimated to be 1 in 68 in the United States alone, ASD has become one of the fastest-growing pediatric concerns. The deficits of children with ASD range across social communication and academic skills. One of the effective interventions that have been used commonly for ASD is the model-lead-test, which includes modeling, prompting children to practice target skills together, and providing children with affirmative feedback or error correction. Previous research has demonstrated that the model-lead-test is successful in teaching different skills for individuals with ASD, including functional, social, and academic skills. The vast majority of the studies had researchers, therapists, or teachers implement the intervention. However, there is clear empirical support and implications for interventions mediated by more familiar persons, such as parents and siblings, which may lead to better effects, maintenance, and generalization due to more practice opportunities in the natural environments. Research has supported the effectiveness of using parents or peers as agents to deliver interventions for individuals with ASD, whereas fewer studies explored the use of siblings to deliver or mediate intervention. As typically developing siblings are an essential part of the daily life of children with ASD, it makes logical extensions to have siblings as mediators to deliver interventions. In the initial findings, the investigators found the typically developing siblings can accurately implement the model-lead-test procedure that improved various skills of their siblings with ASD. This project will extend these findings by examining the efficacy of the sibling-implemented intervention on early literacy (reading) and social reciprocity (conversation and play) of children with ASD as well as the sibling relationship before, during, and after the intervention.

Trial Health

60
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2021

Longer than P75 for not_applicable

Geographic Reach
2 countries

3 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 13, 2021

Completed
15 days until next milestone

First Posted

Study publicly available on registry

October 28, 2021

Completed
5 days until next milestone

Study Start

First participant enrolled

November 2, 2021

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 7, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 7, 2025

Completed
Last Updated

September 12, 2025

Status Verified

September 1, 2025

Enrollment Period

3.8 years

First QC Date

October 13, 2021

Last Update Submit

September 8, 2025

Conditions

Outcome Measures

Primary Outcomes (5)

  • Change in oral reading accuracy

    Participants in the US will complete DIBELS Grades K-1 Benchmark. Participants in China read pinyin's using a pinyin matrix

    Assessment will begin from the date of randomization, during and after the intervention, and up to 9 months after the intervention for a total of approximately 12 months

  • Change in social engagement

    Children will play with their siblings for 15 minutes. The interaction will be coded using the Playground Observation of Peer Engagement (POPE).

    Assessment will begin from the date of randomization, during and after the intervention, and up to 9 months after the intervention for a total of approximately 12 months

  • Change in sibling relationship

    Parents will complete the "Sibling Inventory of Behavior" scale. The minimum value of the scale is 32, and the maximum value is 160. The scale measures multiple dimensions of the sibling relationship, including companionship, empathy, teaching, rivalry, conflict, avoidance. Higher values obtained in each of the dimensions mean a higher level of companionship, empathy, teaching, rivalry, conflict, or avoidance from the sibling.

    Assessment will begin from the date of randomization, during and after the intervention, and up to 9 months after the intervention for a total of approximately 12 months

  • Change in sibling self-efficacy.

    Typically developing siblings will complete the investigator-created "Children's Self-Efficacy Scale for TD Siblings". The scale is broken down into four sections of four to ten items. Each item is rated from 0 indicating a lack of self-efficacy to 100 indicating confidence. Thus, the minimum score that can be obtained is 0 and the maximum score is 2,700.

    Assessment will begin from the date of randomization, during and after the intervention, and up to 9 months after the intervention for a total of approximately 12 months

  • Change in reciprocal conversation

    Children will play with their siblings for 15 minutes. Components in reciprocal conversation, such as answering questions, expansion, and reciprocal question-asking will be coded.

    Assessment will begin from the date of randomization, during and after the intervention, and up to 9 months after the intervention for a total of approximately 12 months

Secondary Outcomes (2)

  • Change in oral retell

    Assessment may begin from the date of randomization, after the intervention, and up to 9 months after the intervention for a total of approximately 12 months

  • Social validity

    Immediately after the intervention

Study Arms (2)

Treatment as usual/Sibling interaction

NO INTERVENTION

Children with autism will spend time with their typically developing siblings for 20-30 mins at least three times a week

Sibling-mediated intervention

EXPERIMENTAL

Children with autism will receive explicit instruction from their typically developing siblings

Behavioral: Sibling-mediated intervention

Interventions

Typically developing siblings will be trained to use an explicit instruction strategy (model-lead-test) and a checklist to self-monitor their teaching when working with their siblings with ASD on reading and social skills.

Sibling-mediated intervention

Eligibility Criteria

Age5 Years - 11 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Both siblings can demonstrate compliance during instruction.
  • Children with ASD can imitate physical actions and repeat vocalizations, answering common questions, label common objects and actions with adjectives.
  • Typically developing children can sound out and blend letters during reading.

You may not qualify if:

  • Children with aggression towards their siblings and noncompliance during instruction
  • Children with ASD who can sound out and blend letters.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Children's Autism Center

Round Rock, Texas, 78664, United States

Location

Best Love Child Development Center

Kunming, Yunnan, China

Location

Clover Children Rehabilitation Kindergarten

Shanghai, China

Location

Related Publications (7)

  • Christensen DL, Baio J, Van Naarden Braun K, Bilder D, Charles J, Constantino JN, Daniels J, Durkin MS, Fitzgerald RT, Kurzius-Spencer M, Lee LC, Pettygrove S, Robinson C, Schulz E, Wells C, Wingate MS, Zahorodny W, Yeargin-Allsopp M; Centers for Disease Control and Prevention (CDC). Prevalence and Characteristics of Autism Spectrum Disorder Among Children Aged 8 Years--Autism and Developmental Disabilities Monitoring Network, 11 Sites, United States, 2012. MMWR Surveill Summ. 2016 Apr 1;65(3):1-23. doi: 10.15585/mmwr.ss6503a1.

    PMID: 27031587BACKGROUND
  • Johnny L. Matson, Jonathan Wilkins & Jennifer Macken (2008) The Relationship of Challenging Behaviors to Severity and Symptoms of Autism Spectrum Disorders, Journal of Mental Health Research in Intellectual Disabilities, 2:1, 29-44, DOI: 10.1080/19315860802611415

    BACKGROUND
  • Chang YC, Locke J. A systematic review of peer-mediated interventions for children with autism spectrum disorder. Res Autism Spectr Disord. 2016 Jul;27:1-10. doi: 10.1016/j.rasd.2016.03.010. Epub 2016 Mar 26.

  • Stadnick NA, Stahmer A, Brookman-Frazee L. Preliminary Effectiveness of Project ImPACT: A Parent-Mediated Intervention for Children with Autism Spectrum Disorder Delivered in a Community Program. J Autism Dev Disord. 2015 Jul;45(7):2092-104. doi: 10.1007/s10803-015-2376-y.

  • Kryzak LA, Jones EA. Sibling self-management: Programming for generalization to improve interactions between typically developing siblings and children with autism spectrum disorders. Dev Neurorehabil. 2017 Nov;20(8):525-537. doi: 10.1080/17518423.2017.1289270. Epub 2017 Mar 9.

  • Shivers CM, Plavnick JB. Sibling involvement in interventions for individuals with autism spectrum disorders: a systematic review. J Autism Dev Disord. 2015 Mar;45(3):685-96. doi: 10.1007/s10803-014-2222-7.

  • Archer AL, Hughes CA. Explicit instruction: Effective and efficient teaching. 2011. Guilford Press,

    RESULT

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Study Officials

  • Chengan Yuan, PhD

    Arizona State University

    PRINCIPAL INVESTIGATOR
  • Erin Rotheram-Fuller, PhD

    Arizona State University

    PRINCIPAL INVESTIGATOR
  • Juliet Hart Bartnett, PhD

    Arizona State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The outcome assessor will not be informed of the group status of the children.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Children in the US and China will be randomized into the two groups at each location.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 13, 2021

First Posted

October 28, 2021

Study Start

November 2, 2021

Primary Completion

September 7, 2025

Study Completion

September 7, 2025

Last Updated

September 12, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations