Evaluating Parent Delivered Interventions for Children With Autism

Autistic Disorder Clinical Trial

Official title:

Evaluating Parent Delivered Interventions for Children With Autism

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01882153
• Other study ID #: SU-11232011-8727
• Status: Completed
• Phase: N/A
• Start date: February 2010
• Est. completion date: February 18, 2022

Study information

• Verified date: July 2023
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 104
• Est. completion date: February 18, 2022
• Est. primary completion date: February 18, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Months to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Autistic Disorder
• Developmental Disabilities

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.
• 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.
• 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).

Locations

Country	Name	City	State
United States	Stanford University School of Medicine	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in CGI-S (Clinical Global Impression - Severity)		Difference from Baseline to Week 12
Primary	Change in SRS (Social Responsiveness Scale)		Difference from Baseline to Week 12
Primary	Change in CDI (Communicative Development Survey) Score		Difference from Baseline to Week 12
Primary	Change in social and communication behaviors as assessed by standardized laboratory observations		Difference from Baseline to Week 12
Secondary	Change in VABS (Vineland Adaptive Behavior Scale) Score		Difference from Baseline to Week 12
Secondary	Change in social and communication behaviors as assessed from home videos		Difference from Baseline to Week 12
Secondary	Change in PSI (Parenting Stress Index) Score		Difference from Baseline to Week 12
Secondary	Change in FES (Family Empowerment Scale) Score		Difference from Baseline to Week 12
Secondary	Change in frequency and duration of investigation therapy		Difference from Baseline to Week 12
Secondary	Change in demographics data		Difference from Baseline to Week 12