Evaluating Parent Delivered Interventions for Children With Autism

Study Overview
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Brief Summary
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The investigators will assess the efficacy of parent delivered interventions in the treatment of social and communication deficits in children with autism. By collecting information about parent and child functioning before and after intervention, the investigators will be able to determine whether the intervention is effective in improving child social communication and reducing parent stress.

Official Title
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Evaluating Parent Delivered Interventions for Children With Autism

Conditions
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Autistic Disorder, Developmental Disabilities

Intervention / Treatment
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* Behavioral: Pivotal Response Training (PRT)
* Behavioral: PACE Therapy
* Behavioral: PACE and PRT Hybrid


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria for autism participants: Children between the ages of 1.6 and 17.11 years of age Males and females Diagnosis of autism based on DSM-IV-TR criteria, an expert clinical evaluation, and ADOS or ADI-R if needed Receiving or will receive a parent delivered intervention to alleviate symptoms related to their diagnosis of autistic disorder Have a care provider that will reliably bring subjects to their chosen intervention and clinic visits, and is trustworthy to provide accurate accounts of services provided to the subject Inclusion Criteria for developmentally delayed participants: Will have an age range between 1.6 and 17.11 years of age Males or females Diagnosis of a developmental delay or disorder based on DSM-IV-TR, ICD-10, and an expert clinical evaluation Have historical evidence of significant abnormal developmental milestones as determined by neurological history Receiving or will receive a parent delivered intervention Have a care provider that will reliably bring subjects to their chosen intervention and clinic visits, and is trustworthy to provide accurate accounts of services provided to the subject Exclusion Criteria for autism participants: Is medically unstable (e.g., more than one seizure a month) Have a medical diagnosis that causes autism like symptomology (e.g., Fragile X, Down syndrome, Angelman's syndrome, tuberous sclerosis, Rett's disorder) Exclusion Criteria for developmentally delayed subjects: Is medically unstable (e.g., more than one seizure a month) Has a diagnosis of ASD

Ages Eligible for Study
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Minimum Age: 18 Months
Maximum Age: 17 Years

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: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Developmentally Based Intervention<br> | Behavioral: PACE Therapy<br>* The developmentally based intervention is grounded in a development theory, that focuses on child-directed interactions with warm and caring individuals that aid in acquiring missed developmental and functional milestones.<br>Behavioral: PACE and PRT Hybrid<br>* The hybrid based treatment has an eclectic approach that incorporates both systematic (behaviorally-based) and affect-based learning (developmentally-based)that focuses on increasing children's skill development (http://www.pacificautism.org).<br>|
| Experimental: Behaviorally Based Intervention<br> | Behavioral: Pivotal Response Training (PRT)<br>* The behaviorally-based intervention is a treatment model that uses the principles of Applied Behavior Analysis (Koegel, Openden, Fredeen, & Koegel, 2006) to increase children's adaptive behaviors and decrease maladaptive behaviors.<br>Behavioral: PACE and PRT Hybrid<br>* The hybrid based treatment has an eclectic approach that incorporates both systematic (behaviorally-based) and affect-based learning (developmentally-based)that focuses on increasing children's skill development (http://www.pacificautism.org).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in CGI-S (Clinical Global Impression - Severity) |  | Difference from Baseline to Week 12 | 
| Change in SRS (Social Responsiveness Scale) |  | Difference from Baseline to Week 12 | 
| Change in CDI (Communicative Development Survey) Score |  | Difference from Baseline to Week 12 | 
| Change in social and communication behaviors as assessed by standardized laboratory observations |  | Difference from Baseline to Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in VABS (Vineland Adaptive Behavior Scale) Score |  | Difference from Baseline to Week 12 | 
| Change in social and communication behaviors as assessed from home videos |  | Difference from Baseline to Week 12 | 
| Change in PSI (Parenting Stress Index) Score |  | Difference from Baseline to Week 12 | 
| Change in FES (Family Empowerment Scale) Score |  | Difference from Baseline to Week 12 | 
| Change in frequency and duration of investigation therapy |  | Difference from Baseline to Week 12 | 
| Change in demographics data |  | Difference from Baseline to Week 12 |