Evaluating Parent Delivered Interventions for Children With Autism
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Developmentally Based Intervention
|
Behavioral: PACE Therapy
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.
Behavioral: PACE and PRT Hybrid
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).
|
| Experimental: Behaviorally Based Intervention
|
Behavioral: Pivotal Response Training (PRT)
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.
Behavioral: PACE and PRT Hybrid
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).
|
Outcome Measures
Primary Outcome Measures
- 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
- 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]
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Stanford University School of Medicine | Stanford | California | United States | 94305 |
Sponsors and Collaborators
- Stanford University
Investigators
- Principal Investigator: Antonio Y Hardan, M.D., Stanford University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- SU-11232011-8727