Evaluating Parent Delivered Interventions for Children With Autism

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Stanford University
Sponsor:
Information provided by (Responsible Party):
Antonio Hardan, Stanford University
ClinicalTrials.gov Identifier:
NCT01882153
First received: June 17, 2013
Last updated: January 13, 2014
Last verified: January 2014
  Purpose

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 Intervention
Autistic Disorder
Developmental Disabilities
Behavioral: Pivotal Response Training (PRT)
Behavioral: PACE Therapy
Behavioral: PACE and PRT Hybrid

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Stanford University:

Primary Outcome Measures:
  • Change in CGI-S (Clinical Global Impression - Severity) [ Time Frame: Difference from Baseline to Week 12 ] [ Designated as safety issue: No ]
  • Change in SRS (Social Responsiveness Scale) [ Time Frame: Difference from Baseline to Week 12 ] [ Designated as safety issue: No ]
  • Change in CDI (Communicative Development Survey) Score [ Time Frame: Difference from Baseline to Week 12 ] [ Designated as safety issue: No ]
  • Change in social and communication behaviors as assessed by standardized laboratory observations [ Time Frame: Difference from Baseline to Week 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in VABS (Vineland Adaptive Behavior Scale) Score [ Time Frame: Difference from Baseline to Week 12 ] [ Designated as safety issue: No ]
  • Change in social and communication behaviors as assessed from home videos [ Time Frame: Difference from Baseline to Week 12 ] [ Designated as safety issue: No ]
  • Change in PSI (Parenting Stress Index) Score [ Time Frame: Difference from Baseline to Week 12 ] [ Designated as safety issue: No ]
  • Change in FES (Family Empowerment Scale) Score [ Time Frame: Difference from Baseline to Week 12 ] [ Designated as safety issue: No ]
  • Change in frequency and duration of investigation therapy [ Time Frame: Difference from Baseline to Week 12 ] [ Designated as safety issue: No ]
  • Change in demographics data [ Time Frame: Difference from Baseline to Week 12 ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: February 2010
Estimated Primary Completion Date: February 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).

  Eligibility

Ages Eligible for Study:   18 Months to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01882153

Contacts
Contact: Christina Ardel 650-736-1235 cmich@stanford.edu
Contact: Robin Libove 650-736-1235 rlibove@stanford.edu

Locations
United States, California
Stanford University School of Medicine Recruiting
Stanford, California, United States, 94305
Contact: Robin Libove, BS    650-736-1235    rlibove@stanford.edu   
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Antonio Y Hardan, M.D. Stanford University
  More Information

No publications provided

Responsible Party: Antonio Hardan, Associate Professor, Stanford University
ClinicalTrials.gov Identifier: NCT01882153     History of Changes
Other Study ID Numbers: SU-11232011-8727
Study First Received: June 17, 2013
Last Updated: January 13, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Autistic Disorder
Developmental Disabilities
Child Development Disorders, Pervasive
Mental Disorders Diagnosed in Childhood
Mental Disorders

ClinicalTrials.gov processed this record on August 18, 2014