School- and Home-Based Early Intervention for Toddlers With Autism

Study Overview
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Brief Summary
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This study will determine the impact of early intervention on the communication and social development of toddlers with autism.

Detailed Description
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Autism is a condition that affects brain development, often leading to difficulties in social, emotional, and educational functioning. This study will determine whether early intervention can improve such functioning in toddlers with autism. Each treatment session will last 6 months. Children with an autism spectrum disorder will be enrolled in one of two parallel classes and will receive one of two treatments 4 days a week for the duration of the session. Children in each class will receive the same amount and level of intervention, but with a different goal focus. Treatments will be school- and home-based; parents will receive instruction on administering the at-home part of the treatment. The intervention will include environmental engineering, developmental approaches, adaptations of traditional behavioral approaches, and contemporary behavioral approaches that apply principles of applied behavior analysis in more naturalistic teaching frameworks. A series of measures including scales, interviews, and observations will be used to assess the children at baseline, study completion, and 6 months after study completion. The children will be videotaped during the school-based intervention.

Official Title
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Early Detection, Intervention, and Neurobiology in Autism: Early Intervention Portion

Conditions
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Autistic Disorder, Autism

Intervention / Treatment
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* Behavioral: Early intervention blending several tx approaches, w/ focus
* Behavioral: Early intervention blending several treatment approaches


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of autism spectrum disorder Parent or guardian willing to give informed consent for child's participation Developmental level above 9 months on the Visual Reception Scale of the Mullen Scales of Early Learning and on the Adaptive Behavior Composite of the Vineland Adaptive Behavior Scales English is primary language for child and family Exclusion Criteria: Evidence of vision or hearing impairment Diagnosis of fragile X syndrome, Rett syndrome, tuberous sclerosis, neurofibromatosis, phenylketonuria, or congenital rubella History of severe birth trauma or traumatic brain injury Siblings with autism spectrum disorder

Ages Eligible for Study
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Minimum Age: 18 Months
Maximum Age: 33 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: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Behavioral Intervention (experimental) | Behavioral: Early intervention blending several tx approaches, w/ focus<br>* Early intervention blending several different treatment approaches, with a focus on certain skills<br>|
| Active Comparator: 2<br>Behavioral Intervention 2 | Behavioral: Early intervention blending several treatment approaches<br>* Early intervention blending several different treatment approaches<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Receptive language skills |  | Pre-tx, Post-tx, and 6 month follow up | 
| Expressive language skills |  | Pre-tx, Post-tx, and 6 month follow up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Social cognitive skills |  | Pre-tx, Post-tx, and 6 month follow up | 
| Social emotional functioning |  | Pre-tx, Post-tx, and 6 month follow up | 
| Play skills |  | Pre-tx, Post-tx, and 6 month follow up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Child