Evaluating Parent Delivered Interventions for Children With Autism

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 Overview

• Status: Completed
• Conditions: Autistic Disorder; Developmental Disabilities
• Intervention / Treatment: Behavioral: PACE Therapy; Behavioral: PACE and PRT Hybrid; Behavioral: Pivotal Response Training (PRT)

• Study Type: Interventional
• Enrollment (Actual): 104
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Stanford, California, United States, 94305
      • Stanford University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 17 years (Child)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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: 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).; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Stanford University
• Investigators: Principal Investigator: Antonio Y Hardan, M.D., Stanford University

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2010
• Primary Completion (Actual): February 18, 2022
• Study Completion (Actual): February 18, 2022

Study Registration Dates

• First Submitted: June 17, 2013
• First Submitted That Met QC Criteria: June 19, 2013
• First Posted (Estimated): June 20, 2013

Study Record Updates

• Last Update Posted (Actual): July 14, 2023
• Last Update Submitted That Met QC Criteria: July 13, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Neurodevelopmental Disorders; Child Development Disorders, Pervasive; Autism Spectrum Disorder; Autistic Disorder; Developmental Disabilities
• Other Study ID Numbers: SU-11232011-8727