Evaluating Parent Delivered Interventions for Children With Autism
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Stanford University
- Enrollment
- 104
- Locations
- 1
- Primary Endpoint
- Change in CGI-S (Clinical Global Impression - Severity)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Months to 17 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Developmentally Based Intervention
Intervention: PACE Therapy (Behavioral)
Developmentally Based Intervention
Intervention: PACE and PRT Hybrid (Behavioral)
Behaviorally Based Intervention
Intervention: Pivotal Response Training (PRT) (Behavioral)
Behaviorally Based Intervention
Intervention: PACE and PRT Hybrid (Behavioral)
Outcomes
Primary Outcomes
Change in CGI-S (Clinical Global Impression - Severity)
Time Frame: Difference from Baseline to Week 12
Change in SRS (Social Responsiveness Scale)
Time Frame: Difference from Baseline to Week 12
Change in CDI (Communicative Development Survey) Score
Time Frame: Difference from Baseline to Week 12
Change in social and communication behaviors as assessed by standardized laboratory observations
Time Frame: Difference from Baseline to Week 12
Secondary Outcomes
- 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 frequency and duration of investigation therapy(Difference from Baseline to Week 12)
- Change in demographics data(Difference from Baseline to Week 12)
- Change in FES (Family Empowerment Scale) Score(Difference from Baseline to Week 12)
Investigators
Antonio Hardan
Associate Professor
Stanford University