An Evaluation of a Developmentally-Based Parent Training Program for Children With Autism

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Antonio Hardan, Stanford University
ClinicalTrials.gov Identifier:
NCT01400269
First received: May 31, 2011
Last updated: August 12, 2016
Last verified: August 2016
  Purpose
The purpose of this study is to assess the efficacy of a parent training program in the treatment of social and communication deficits in children with autism. Specifically, this study will evaluate a developmentally based parent delivered intervention in the community developed by Pacific Autism Center for Education (PACE).

Condition Intervention
Autistic Disorder
Behavioral: Pacific Autism Center for Education (PACE ) developmentally based parent delivered intervention

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Evaluation of a Developmentally-Based Parent Training Program for Children With Autism

Further study details as provided by Stanford University:

Primary Outcome Measures:
  • Social Responsiveness Scale [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
    Outcome measure is the change from week 12 relative to baseline.


Secondary Outcome Measures:
  • Repetitive Behavior Scale [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
    Outcome measure is the change from week 12 relative to baseline.

  • Family Empowerment Scale [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
    Outcome measure is the change from week 12 relative to baseline.

  • Caregiver Strain questionnaire [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
    Outcome measure is the change from week 12 relative to baseline.

  • Pediatric Quality of Life Inventory [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
    Outcome measure is the change from week 12 relative to baseline.

  • Sensory Profile Questionnaire [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
    Outcome measure is the change from week 12 relative to baseline.


Enrollment: 48
Study Start Date: September 2010
Study Completion Date: January 2014
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Pacific Autism Center for Education (PACE)
Behavioral: Pacific Autism Center for Education (PACE) developmentally based parent delivered intervention
Behavioral: Pacific Autism Center for Education (PACE ) developmentally based parent delivered intervention
Pacific Autism Center for Education (PACE ) developmentally based parent delivered intervention

Detailed Description:
There are many treatments that claim to be effective for children with autism; however many of these treatments have not been investigated using scientifically rigorous methodology. A variety of developmentally based parent delivered interventions are gaining popularity as a type of treatment parents utilize to improve symptoms related to their child's diagnosis of autism. Pacific Autism Center for Education (PACE)is a agency that provides a developmentally based parent delivered intervention in the community. Currently, this parent training program has not been evaluated using scientific methodology. Investigation into this community delivered treatment and its effectiveness to improve social and communication deficits will aid clinicians in providing better care for children with autism.
  Eligibility

Ages Eligible for Study:   18 Months to 6 Years   (Child)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • meets DSM-IV-TR criteria for an autism spectrum disorder (pervasive developmental disorder) on the basis of clinical evaluation and the research diagnostic methods
  • age range between 18 months and 6.11 years
  • male or female in good medical health
  • will be starting PACE parent training program
  • intends on continuing PACE program for a minimum of 12 weeks

Exclusion Criteria:

  • medically unstable (e.g., more than one seizure a month)
  • a medical diagnosis that causes autism like symptomology (e.g., Fragile X, Down syndrome, Angelman's syndrome, tuberous sclerosis, Rett's disorder)
  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: NCT01400269

Locations
United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Antonio Y. Hardan, MD Stanford University
  More Information

Responsible Party: Antonio Hardan, Associate Professor, Stanford University
ClinicalTrials.gov Identifier: NCT01400269     History of Changes
Other Study ID Numbers: SU-11022010-7169 
Study First Received: May 31, 2011
Last Updated: August 12, 2016
Health Authority: United States: Institutional Review Board

Keywords provided by Stanford University:
PACE

Additional relevant MeSH terms:
Autistic Disorder
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders

ClinicalTrials.gov processed this record on August 25, 2016