Back to resultsAn Evaluation of a Developmentally-Based Parent Training Program for Children With Autism
Primary Purpose
Autistic Disorder
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Pacific Autism Center for Education (PACE ) developmentally based parent delivered intervention
Sponsored by
About this trial
This is an interventional treatment trial for Autistic Disorder focused on measuring PACE
Eligibility 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)
Sites / Locations
- Stanford University School of Medicine
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Pacific Autism Center for Education (PACE)
Arm Description
Behavioral: Pacific Autism Center for Education (PACE) developmentally based parent delivered intervention
Outcomes
Primary Outcome Measures
Social Responsiveness Scale
Outcome measure is the change from week 12 relative to baseline.
Secondary Outcome Measures
Repetitive Behavior Scale
Outcome measure is the change from week 12 relative to baseline.
Family Empowerment Scale
Outcome measure is the change from week 12 relative to baseline.
Caregiver Strain questionnaire
Outcome measure is the change from week 12 relative to baseline.
Pediatric Quality of Life Inventory
Outcome measure is the change from week 12 relative to baseline.
Sensory Profile Questionnaire
Outcome measure is the change from week 12 relative to baseline.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01400269
Brief Title
An Evaluation of a Developmentally-Based Parent Training Program for Children With Autism
Official Title
An Evaluation of a Developmentally-Based Parent Training Program for Children With Autism
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
September 2010 (undefined)
Primary Completion Date
January 2014 (Actual)
Study Completion Date
January 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autistic Disorder
Keywords
PACE
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
48 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Pacific Autism Center for Education (PACE)
Arm Type
Experimental
Arm Description
Behavioral: Pacific Autism Center for Education (PACE) developmentally based parent delivered intervention
Intervention Type
Behavioral
Intervention Name(s)
Pacific Autism Center for Education (PACE ) developmentally based parent delivered intervention
Intervention Description
Pacific Autism Center for Education (PACE ) developmentally based parent delivered intervention
Primary Outcome Measure Information:
Title
Social Responsiveness Scale
Description
Outcome measure is the change from week 12 relative to baseline.
Time Frame
Baseline and Week 12
Secondary Outcome Measure Information:
Title
Repetitive Behavior Scale
Description
Outcome measure is the change from week 12 relative to baseline.
Time Frame
Baseline and Week 12
Title
Family Empowerment Scale
Description
Outcome measure is the change from week 12 relative to baseline.
Time Frame
Baseline and Week 12
Title
Caregiver Strain questionnaire
Description
Outcome measure is the change from week 12 relative to baseline.
Time Frame
Baseline and Week 12
Title
Pediatric Quality of Life Inventory
Description
Outcome measure is the change from week 12 relative to baseline.
Time Frame
Baseline and Week 12
Title
Sensory Profile Questionnaire
Description
Outcome measure is the change from week 12 relative to baseline.
Time Frame
Baseline and Week 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Months
Maximum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Antonio Y. Hardan, MD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University School of Medicine
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
29775078
Citation
Gengoux GW, Schapp S, Burton S, Ardel CM, Libove RA, Baldi G, Berquist KL, Phillips JM, Hardan AY. Effects of a parent-implemented Developmental Reciprocity Treatment Program for children with autism spectrum disorder. Autism. 2019 Apr;23(3):713-725. doi: 10.1177/1362361318775538. Epub 2018 May 18.
Results Reference
result
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An Evaluation of a Developmentally-Based Parent Training Program for Children With Autism
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