Clinical trial NCT01882153: Evaluating Parent Delivered Interventions for Children With Autism
Official title: Evaluating Parent Delivered Interventions for Children With Autism
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Autistic Disorder
Developmental Disabilities
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2013-06-20
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Change in CGI-S (Clinical Global Impression - Severity)
timeFrame: Difference from Baseline to Week 12
measure: Change in SRS (Social Responsiveness Scale)
timeFrame: Difference from Baseline to Week 12
measure: Change in CDI (Communicative Development Survey) Score
timeFrame: Difference from Baseline to Week 12
measure: Change in social and communication behaviors as assessed by standardized laboratory observations
timeFrame: Difference from Baseline to Week 12
Secondary outcomes:
measure: Change in VABS (Vineland Adaptive Behavior Scale) Score
timeFrame: Difference from Baseline to Week 12
measure: Change in social and communication behaviors as assessed from home videos
timeFrame: Difference from Baseline to Week 12
measure: Change in PSI (Parenting Stress Index) Score
timeFrame: Difference from Baseline to Week 12
measure: Change in FES (Family Empowerment Scale) Score
timeFrame: Difference from Baseline to Week 12
measure: Change in frequency and duration of investigation therapy
timeFrame: Difference from Baseline to Week 12
measure: Change in demographics data
timeFrame: Difference from Baseline to Week 12
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
Study officials:
affiliation: Stanford University
name: Antonio Y Hardan, M.D.
role: PRINCIPAL_INVESTIGATOR
References: