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Sibling-Mediated Intervention on Literacy and Reciprocity for Children With Autism

Primary Purpose

Autism Spectrum Disorder

Status
Recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Sibling-mediated intervention
Sponsored by
Arizona State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Autism Spectrum Disorder

Eligibility Criteria

5 Years - 11 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

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

Sites / Locations

  • Children's Autism CenterRecruiting
  • Best Love Child Development CenterRecruiting
  • Clover Children Rehabilitation KindergartenRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Treatment as usual/Sibling interaction

Sibling-mediated intervention

Arm Description

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

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

Outcomes

Primary Outcome Measures

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
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).
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.
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.
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.

Secondary Outcome Measures

Change in oral retell
Participants will read a narrative passage for 1 minute and answer comprehension questions if they pass the DIBELS benchmark or can read pinyin for more than 70% correct
Social validity
Both children will complete a social validity survey after the intervention - "Social Validity Survey Questionnaire". The survey is broken into two parts, one for each child in the dyad. All items are rated from 1-5. The minimum score is 14 and the maximum score is 70. However, these items contain positive and negative statements. Thus, a higher (or a lower) score does not necessarily mean a better or worse outcome.

Full Information

First Posted
October 13, 2021
Last Updated
November 8, 2021
Sponsor
Arizona State University
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1. Study Identification

Unique Protocol Identification Number
NCT05098392
Brief Title
Sibling-Mediated Intervention on Literacy and Reciprocity for Children With Autism
Official Title
Effects of Sibling-Mediated Intervention on Early Literacy and Social Reciprocity for Children With Autism
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Recruiting
Study Start Date
November 2, 2021 (Actual)
Primary Completion Date
November 1, 2022 (Anticipated)
Study Completion Date
November 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Arizona State University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Prescreening: Before the study, the investigators at each site will review existing assessment information for each participant with autism, which may include age, gender, IQ, autism, and behavioral scales, and verbal language functioning to confirm the children that meet the inclusion criteria. Each dyad's involvement will last over the course of approximately 12 months. The first 3 months will be the intervention and data will be collected throughout. Follow-up data will be collected 3, 6, and 9 months after the intervention is concluded. The study will involve the following components: Pre-Assessments: For children with ASD: After each dyad is enrolled, the research team assessor/evaluator will administer either the Childhood Autism Rating Scale (CARS) or Autism Diagnostic Observation Schedule (ADOS). Children with ASD in China will be assessed using CARS while the children with ASD will be assessed with ADOS. Further, Vineland Adaptive Behavior Scales will be used for children in both countries For typically developing children: The current reading achievement of all typically developing siblings will be assessed by the research team assessor. For siblings in the U.S., DIBELS GK-1 level will be used to assess if the siblings will be able to read words and nonsense words fluently. For siblings in China, different combinations of letters (pinyin) will be assessed. For parents: Parents will complete a demographic survey online using their participant ID. Pretest/Baseline Early literacy: During each session, the research team assessor will ask the children with ASD in the U.S. to read Grade K to Grade 1 letters, words, and nonsense words. If the children could meet the Benchmark goals for core support per DIBELS benchmark goals for Grade K-1, they will then be asked to read a narrative passage for 1 minute and answer questions related to whom, where, and when as well as the actions and internal responses of the characters. For children with ASD in China, the research team assessor will ask them to read pinyins using the pinyin matrix. If the children could read 70% pinyins correctly, they will then be asked to read a narrative passage with pinyin for 1 minute and answer questions related to whom, where, and when as well as the actions and internal responses of the characters. Social reciprocity: Parents will place toys, games, and books in a location at home and ask the siblings to play with each other for 15 minutes. The entire 15-minute session will be video recorded and then coded using the Playground Observation of Peer Engagement (POPE) and Reciprocity datasheets. The assessment for early literacy and social reciprocity skills lasts for a minimum of five days. Sibling Relationship Quality: Parents will complete one Sibling Inventory of Behavior scale. Sibling Self-Efficacy scale: The TD sibling will complete a self-efficacy scale. Sibling and parent interview: The investigators will interview the parents and siblings regarding everyday sibling interaction and relationship and the influence of the sibling with autism on the daily life of the typically developing sibling. The investigators will use some guiding questions to begin the interviews. Questions that elicit additional details or responses for examples and feelings (e.g., Tell me more. How do you feel? Do you have an example?) may be used depending on the answers. The interview will take place online for approximately 1 hour using a teleconference tool (e.g., Zoom), and interviews will be both audio and video recorded. Random assignments: In each country, children will be randomly assigned to a treatment-as-usual group and a sibling-mediated intervention group with 10 in each group. Treatment-as-usual/sibling interaction group: Parents will place toys, games, and books in a location at home and ask the siblings to spend time with each other for 20-30 minutes, at least three times a week for a total of three months. All sessions will be video recorded. The families in the treatment-as-usual group will receive the intervention after the procedure is completed. Sibling-mediated intervention group: The sibling-mediated intervention will start with three 45-minute training sessions for the typically developing sibling via telecommunication (e.g., Zoom) on how to use the model-lead-test strategy (i.e., model the correct response, guided practice of the correct response and test the correct response) and the self-monitoring checklist. During training, parents will be present and may be asked to pretend to be learners. After the training sessions, the first phase, Compliance Training Phase, will begin. At the beginning of each session, parents will give the TD sibling an activity schedule consisting of the tasks (e.g., a series of questions) for the session. The TD sibling will follow the activity schedule to present the tasks (e.g., asking children with ASD a series of common questions) and use the self-monitoring checklist to deliver model-lead-test when needed. In the initial sessions, the instructor will be present to prompt the TD sibling to deliver the intervention and correctly use the self-monitoring checklist. After each session, the instructor will deliver feedback until the typically developing sibling meets the mastery criterion (i.e., at least 85% correct across five sessions). Once mastery is met, the research team instructor will then review videos every 3-5 days and deliver feedback to the TD sibling. The compliance training phase will last for 9-15 sessions. During the intervention phase, the research team interventionist will start by briefly meeting with the TD sibling to introduce the self-monitoring checklists for early literacy and social reciprocity. The TD siblings will then follow the visual activity schedule (e.g., the list of the tasks: reading, social play; the order of the activities may change daily) and use the self-monitoring checklists when teaching reading and social reciprocity. For reading, each week, the investigator will identify 3-5 words in a children's book, the typically developing sibling will read the children's book to the sibling with ASD and pausing upon the target words. The sibling with ASD will be asked to read the target words. If the child with ASD could not read the target words, the typically developing sibling will teach how to read words using model-lead-test. If the child with ASD read the target words correct, the typically developing sibling will provide praise or any other rewards (e.g., high-five, tickle, etc.) as identified by parents. The book will be changed weekly. For social reciprocity, the parents will bring toys and games and ask the typically developing sibling to play with their sibling with ASD. During the play, after a few physical actions and verbalizations from the typically developing sibling, the typically developing sibling will teach the sibling with ASD to respond with a reciprocal physical action and conversation. If the sibling with ASD responds with a physical action along with conversation, the typically developing sibling will provide praise or any other social rewards. Similar to the compliance phase, the instructor will initially monitor and deliver feedback over Zoom to the TD sibling in each session until mastery, followed by a variable schedule (e.g., every 3-5 sessions). Ongoing data collection on the readings and social reciprocity from the children with ASD will be conducted. The compliance training and intervention phases will last 3 months. Posttest/Post-intervention The procedure for the posttest/post-intervention phase is the same as pretest/baseline phase. In addition, both children in each dyad will complete a social validity questionnaire. 3-month, 6-month, and 9-month follow-ups Three follow-ups will be conducted after 3, 6, and 9 months after the completion of the intervention. The procedure is the same as pretest/baseline phase.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism Spectrum Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Children in the US and China will be randomized into the two groups at each location.
Masking
Outcomes Assessor
Masking Description
The outcome assessor will not be informed of the group status of the children.
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment as usual/Sibling interaction
Arm Type
No Intervention
Arm Description
Children with autism will spend time with their typically developing siblings for 20-30 mins at least three times a week
Arm Title
Sibling-mediated intervention
Arm Type
Experimental
Arm Description
Children with autism will receive explicit instruction from their typically developing siblings
Intervention Type
Behavioral
Intervention Name(s)
Sibling-mediated intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in oral reading accuracy
Description
Participants in the US will complete DIBELS Grades K-1 Benchmark. Participants in China read pinyin's using a pinyin matrix
Time Frame
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
Title
Change in social engagement
Description
Children will play with their siblings for 15 minutes. The interaction will be coded using the Playground Observation of Peer Engagement (POPE).
Time Frame
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
Title
Change in sibling relationship
Description
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.
Time Frame
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
Title
Change in sibling self-efficacy.
Description
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.
Time Frame
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
Title
Change in reciprocal conversation
Description
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.
Time Frame
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 Outcome Measure Information:
Title
Change in oral retell
Description
Participants will read a narrative passage for 1 minute and answer comprehension questions if they pass the DIBELS benchmark or can read pinyin for more than 70% correct
Time Frame
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
Title
Social validity
Description
Both children will complete a social validity survey after the intervention - "Social Validity Survey Questionnaire". The survey is broken into two parts, one for each child in the dyad. All items are rated from 1-5. The minimum score is 14 and the maximum score is 70. However, these items contain positive and negative statements. Thus, a higher (or a lower) score does not necessarily mean a better or worse outcome.
Time Frame
Immediately after the intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: Children with aggression towards their siblings and noncompliance during instruction Children with ASD who can sound out and blend letters.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chengan Yuan, PhD
Phone
4807270671
Email
chengan.yuan@asu.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chengan Yuan, PhD
Organizational Affiliation
Arizona State University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Erin Rotheram-Fuller, PhD
Organizational Affiliation
Arizona State University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Juliet Hart Bartnett, PhD
Organizational Affiliation
Arizona State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Autism Center
City
Round Rock
State/Province
Texas
ZIP/Postal Code
78664
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laura Saldana
Phone
512-733-2800
Email
lsaldana@cactexas.com
First Name & Middle Initial & Last Name & Degree
Natalija Milutinovic
First Name & Middle Initial & Last Name & Degree
Katie Castro
Facility Name
Best Love Child Development Center
City
Kunming
State/Province
Yunnan
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Qian Zhang
Phone
+86 180 8711 5491
Email
1156653735@qq.com
First Name & Middle Initial & Last Name & Degree
Qian Zhang
Facility Name
Clover Children Rehabilitation Kindergarten
City
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ruijie Ren
Phone
+86 139 1899 9489
Email
sanyecao101@163.com
First Name & Middle Initial & Last Name & Degree
Qiuyu Min

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
27031587
Citation
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. Erratum In: MMWR Morb Mortal Wkly Rep. 2016;65(15):404. MMWR Morb Mortal Wkly Rep. 2018 Nov 16;67(45):1279.
Results Reference
background
Citation
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
Results Reference
background
PubMed Identifier
27807466
Citation
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.
Results Reference
result
PubMed Identifier
25633920
Citation
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.
Results Reference
result
PubMed Identifier
28277816
Citation
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.
Results Reference
result
PubMed Identifier
25178988
Citation
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.
Results Reference
result
Citation
Archer AL, Hughes CA. Explicit instruction: Effective and efficient teaching. 2011. Guilford Press,
Results Reference
result

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Sibling-Mediated Intervention on Literacy and Reciprocity for Children With Autism

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