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: December 2, 2015
Last verified: December 2015

May 31, 2011
December 2, 2015
September 2010
January 2014   (final data collection date for primary outcome measure)
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.
  • Aberrant Behavior Checklist [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
    Outcome measure is the change from week 12 relative to baseline.
  • 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.
  • Clinical Global Impressions [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
    Outcome measure is the change from week 12 relative to baseline.
  • Structured Lab Observation [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
    Outcome measure is the change from week 12 relative to baseline.
  • Communicative Developmental Inventories [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
    Outcome measure is the change from week 12 relative to baseline.
  • Vineland Adaptive Behavior Scales [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
    Outcome measure is the change from week 12 relative to baseline.
Complete list of historical versions of study NCT01400269 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
An Evaluation of a Developmentally-Based Parent Training Program for Children With Autism
An Evaluation of a Developmentally-Based Parent Training Program for Children With Autism
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).
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.
Interventional
Not Provided
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Autistic Disorder
Behavioral: Pacific Autism Center for Education (PACE ) developmentally based parent delivered intervention
Pacific Autism Center for Education (PACE ) developmentally based parent delivered intervention
Experimental: Pacific Autism Center for Education (PACE)
Behavioral: Pacific Autism Center for Education (PACE) developmentally based parent delivered intervention
Intervention: Behavioral: Pacific Autism Center for Education (PACE ) developmentally based parent delivered intervention
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
48
January 2014
January 2014   (final data collection date for primary outcome measure)

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)
Both
18 Months to 6 Years   (Child)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01400269
SU-11022010-7169
No
Not Provided
Not Provided
Antonio Hardan, Stanford University
Stanford University
Not Provided
Principal Investigator: Antonio Y. Hardan, MD Stanford University
Stanford University
December 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP