Social Cognitive Development in Young Children With Autism

Study Overview
=================
Brief Summary
-----------------
Through the development of a novel treatment targeting core Autism Spectrum Disorder (ASD) social deficits and studying the efficacy of this intervention, the investigators hope to provide a means for children with ASD to more effectively and efficiently process social information and enable them to more successfully engage in social interactions. Children between the ages of 24 and 36 months and their families may join.

Official Title
-----------------
Effects of Self-Generated Experiences on Social Cognitive Development in Young Children With Autism

Conditions
-----------------
Autism Spectrum Disorder

Intervention / Treatment
-----------------
* Behavioral: Social Enhancement Intervention
* Behavioral: Parent Education


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participants must be 24 to 42 months old Children must meet criteria for ASD or autism on the ADOS (Lord et al., 2000) plus receive a clinical judgment of PDD-NOS or autism by the study team Score ≥ 16 months on the Visual Receptive subtest and ≥ 9 months on the Receptive Language subtest on the Mullen Scales of Early Learning and/or the Vineland Adaptive Behavior Scales at the time of eligibility testing. The parent (or other primary caregiver, such as grandparent) in the PE condition must agree to attend the training sessions each week for the 5-month period. The parent must agree to bring their child in for testing at all testing points (pre-testing, post-testing, follow-up testing). Parents must be between the ages of 18 and 65 years old It is not required that English be their primary language, but they must be fluent in English (or if the child is nonverbal he/she must hear English most of the time at home) Exclusion Criteria: <34 weeks or >42 weeks gestational age <2500 grams birth weight, severe birth trauma Head or serious bodily injury sustained before or during the study Illicit drug or excessive alcohol exposure (defined in our telephone screening interview) Major hearing or visual impairment Non-febrile seizures Any known genetic syndrome Mitochondrial disorders Severe birth defects No foster children may participate The child must not be adopted The child must not be participating in another intervention study simultaneously or be simultaneously enrolled in the CARD clinic's Achievements, Early Achievements, TIPS, Jump Start, or Play with Me programs. Unable to provide baseline data on the eye tracking measure at time of pretesting (e.g., tracker unable to read eye movements) Has a sibling participating in this study

Ages Eligible for Study
-----------------
Minimum Age: 24 Months
Maximum Age: 42 Months

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Social Enhancement Intervention<br>For 5 months children will come in 4 days a week for 2-2.5 hours a session to participate in a classroom in an attempt to increase social communication and understanding. Parent education sessions once a week for 2 hours each session over the 5-month period. | Behavioral: Social Enhancement Intervention<br>* The intervention will be conducted at our center and focuses on providing an invigorating learning environment in which emerging social skills/knowledge are the focus of intervention with the aim of bringing them to a higher level of maturity, integrated with existing abilities, and used functionally. Learning with and through peers, provides the opportunity to address abnormal peer relationships for developmental level. Providing an enriched environment with toys, structured learning, and opportunities for ongoing engagement we offer the children robust learning experiences. Parent training sessions will focus on strategies aimed at improving child social engagement and communication.<br>Behavioral: Parent Education<br>* Parent education sessions will focus on topics related to autism, learning styles, interventions, and resources. The curriculum provides parents with information about child development and autism as well as instructional strategies (e.g., responsive teaching strategies, principles of applied behavior analysis) for use at home to enhance their children's communication, engagement, and play development. Concrete examples for home-based implementation are presented. Each week, homework will be given and parents will be encouraged to practice the strategies daily at home. No direct coaching to parents during interaction with their children or direct intervention with the child will be provided.<br>|
| Active Comparator: Parent Education<br>o Parent education sessions once a week for 2 hours each session over the 5-month period. | Behavioral: Parent Education<br>* Parent education sessions will focus on topics related to autism, learning styles, interventions, and resources. The curriculum provides parents with information about child development and autism as well as instructional strategies (e.g., responsive teaching strategies, principles of applied behavior analysis) for use at home to enhance their children's communication, engagement, and play development. Concrete examples for home-based implementation are presented. Each week, homework will be given and parents will be encouraged to practice the strategies daily at home. No direct coaching to parents during interaction with their children or direct intervention with the child will be provided.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Baseline Eye Tracking Tasks |  | 5 months into treatment and 5 months after the treatment ends | 
| Change in Baseline Communication and Symbolic Behavior Scale Developmental Profile |  | 5 months into treatment and 5 months after the treatment ends | 
| Change in Baseline Spontaneous Imitation Task |  | 5 months into treatment and 5 months after the treatment ends | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Baseline Autism Diagnostic Observation Schedule |  | 5 months into treatment and 5 months after the treatment ends | 
| Change in Baseline Mullen Scales of Early Learning |  | 5 months into treatment and 5 months after the treatment ends | 
| Change in Baseline Action/intention understanding taks |  | 5 months into treatment and 5 months after the treatment ends | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Autism Spectrum Disorder, language, social, toddlers