Clinical trial NCT05098392: 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
Overall status: RECRUITING
Phase: NA
Conditions: Autism Spectrum Disorder
Lead sponsor: Arizona State University
Sponsor class: OTHER
First posted: 2021-10-28
Enrollment: 40
Sex: ALL
Minimum age (years): 5
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Children in the US and China will be randomized into the two groups at each location.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change in oral reading accuracy
timeFrame: 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
measure: Change in social engagement
timeFrame: 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
measure: Change in sibling relationship
timeFrame: 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
measure: Change in sibling self-efficacy.
timeFrame: 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
measure: Change in reciprocal conversation
timeFrame: 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:
measure: Change in oral retell
timeFrame: 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
measure: Social validity
timeFrame: Immediately after the intervention
Other outcomes:
Locations:
city: Round Rock
country: United States
facility: Children's Autism Center
state: Texas
city: Kunming
country: China
facility: Best Love Child Development Center
state: Yunnan
city: Shanghai
country: China
facility: Clover Children Rehabilitation Kindergarten
Study officials:
affiliation: Arizona State University
name: Chengan Yuan, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Arizona State University
name: Erin Rotheram-Fuller, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Arizona State University
name: Juliet Hart Bartnett, PhD
role: PRINCIPAL_INVESTIGATOR
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