School-Age Children With Autism With Limited Expressive Language Skills

Study Overview
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Brief Summary
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This project will address a major challenge to the field of autism research: improving expressive communication in children with autism who have reached school age but have not acquired functional spoken language (non-verbal school aged children with autism; NVSACA). Fifteen children who completed the RO1 ICAN intervention (NCT01018407) at the Kennedy Krieger site and follow-up testing but continue to have minimal functional spoken language will be participants in this study. After eligibility is established, participants will be randomly assigned to a baseline duration of one week, two weeks or three weeks before the start of active treatment. Once the baseline duration is completed, participants begin active treatment one hour of intervention three days per week in the participants' school setting. In month 2, weekly teacher trainings begin. In month 5, weekly parent trainings begin to improve the child's generalization of skills and teach parents the strategies implemented in their child's treatment. Post-baseline and post-treatment assessments will be completed in the lab at a time that is convenient for the participants' families.

Official Title
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School-Age Children With Autism With Limited Expressive Language Skills: An Intervention Study

Conditions
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Autism Spectrum Disorder

Intervention / Treatment
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* Behavioral: Non-Verbal School Aged Children with Autism (NVSACA) Intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of autism by a licensed psychologist or board certified developmental pediatrician, or child and adolescent psychiatrist, confirmed by the Autism Diagnostic Observation Schedule (ADOS; Lord, Rutter, DiLavore, & Risi, 1999) Chronological age between 4.0 years and 7 years, 11 months Reynell developmental score ≤ 24 months, ADOS A1 score of 2, 3 or 8 Nonverbal IQ of ≥ 40 (Leiter International Performance Scale-Revised (Leiter-R), Roid & Miller, 2007) Children have participated in and completed follow-up testing for the ICAN study. Exclusion Criteria: Major medical conditions other than autism (e.g., genetic disorders [e.g., Fragile X, Down syndrome, tuberous sclerosis], blindness or deafness, and motor disabilities such as cerebral palsy; Uncontrolled seizures; Self-injurious behavior or moderate to severe aggression. Children in foster care. Children who are exposed to < 50% English throughout their typical day. Children currently participating in another intervention/treatment study.

Ages Eligible for Study
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Minimum Age: 48 Months
Maximum Age: 95 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1 Week Basline Prior to Intervention<br>If eligible, you will be randomly assigned- as if by flipping a coin- to one of three baseline durations, during which your child will engage in daily interactions with their interventionist to determine if skills targeted by this intervention are improving naturally as your child matures, without active treatment from the study's interventionist. In this case, the duration is 1 week before your child begins active treatment with their interventionist. | Behavioral: Non-Verbal School Aged Children with Autism (NVSACA) Intervention<br>* The intervention has 3 components: One-on-one play based intervention: administered by the interventionist at the school for 1 hour, three times a week, each week for the 5 month duration of the intervention. Parent training: at the beginning of the 5th month of intervention, parents will receive training once a week for an hour during the remaining four weeks of intervention. Teacher training: in month 2 of the intervention, the teacher will receive 2 1.5 hour training sessions along with a weekly in-class coaching given as needed following completion of the second session of training.<br>|
| Experimental: 2 Week Basline Prior to Intervention<br>If eligible, you will be randomly assigned- as if by flipping a coin- to one of three baseline durations, during which your child will engage in daily interactions with their interventionist to determine if skills targeted by this intervention are improving naturally as your child matures, without active treatment from the study's interventionist. In this case, the duration is 2 weeks before your child begins active treatment with their interventionist. | Behavioral: Non-Verbal School Aged Children with Autism (NVSACA) Intervention<br>* The intervention has 3 components: One-on-one play based intervention: administered by the interventionist at the school for 1 hour, three times a week, each week for the 5 month duration of the intervention. Parent training: at the beginning of the 5th month of intervention, parents will receive training once a week for an hour during the remaining four weeks of intervention. Teacher training: in month 2 of the intervention, the teacher will receive 2 1.5 hour training sessions along with a weekly in-class coaching given as needed following completion of the second session of training.<br>|
| Experimental: 3 Week Basline Prior to Intervention<br>If eligible, you will be randomly assigned- as if by flipping a coin- to one of three baseline durations, during which your child will engage in daily interactions with their interventionist to determine if skills targeted by this intervention are improving naturally as your child matures, without active treatment from the study's interventionist. In this case, the duration is 3 weeks before your child begins active treatment with their interventionist. | Behavioral: Non-Verbal School Aged Children with Autism (NVSACA) Intervention<br>* The intervention has 3 components: One-on-one play based intervention: administered by the interventionist at the school for 1 hour, three times a week, each week for the 5 month duration of the intervention. Parent training: at the beginning of the 5th month of intervention, parents will receive training once a week for an hour during the remaining four weeks of intervention. Teacher training: in month 2 of the intervention, the teacher will receive 2 1.5 hour training sessions along with a weekly in-class coaching given as needed following completion of the second session of training.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Baseline Spontaneous Language | The number of unprompted spontaneous language during a 15min play sample. | Weekly throughout the 5 month intervention (baseline and 5 months) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Baseline Autism Diagnostic Observation Schedule |  | 5 months into treatment (at completion of intervention) | 
| Change in Baseline Reynell |  | 5 months into treatment (at completion of intervention) | 
| Changes in Baseline Early Social Communication Scales (ESCS) |  | 5 months into treatment (at completion of intervention) and 6 months following the completion of the intervention | 
| Changes in Baseline Structured Play Assessment |  | 5 months into treatment (at completion of intervention) and 6 months following the completion of the intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Autism Spectrum Disorder, language, intervention, school-age