- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01400269
An Evaluation of a Developmentally-Based Parent Training Program for Children With Autism
February 15, 2022 updated by: Antonio Hardan, Stanford University
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).
Study Overview
Status
Completed
Conditions
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.
Study Type
Interventional
Enrollment (Actual)
48
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
Stanford, California, United States, 94305
- Stanford University School of Medicine
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 month to 4 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Pacific Autism Center for Education (PACE)
Behavioral: Pacific Autism Center for Education (PACE) developmentally based parent delivered intervention
|
Pacific Autism Center for Education (PACE ) developmentally based parent delivered intervention
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Social Responsiveness Scale
Time Frame: Baseline and Week 12
|
Outcome measure is the change from week 12 relative to baseline.
|
Baseline and Week 12
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Repetitive Behavior Scale
Time Frame: Baseline and Week 12
|
Outcome measure is the change from week 12 relative to baseline.
|
Baseline and Week 12
|
Family Empowerment Scale
Time Frame: Baseline and Week 12
|
Outcome measure is the change from week 12 relative to baseline.
|
Baseline and Week 12
|
Caregiver Strain questionnaire
Time Frame: Baseline and Week 12
|
Outcome measure is the change from week 12 relative to baseline.
|
Baseline and Week 12
|
Pediatric Quality of Life Inventory
Time Frame: Baseline and Week 12
|
Outcome measure is the change from week 12 relative to baseline.
|
Baseline and Week 12
|
Sensory Profile Questionnaire
Time Frame: Baseline and Week 12
|
Outcome measure is the change from week 12 relative to baseline.
|
Baseline and Week 12
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2010
Primary Completion (Actual)
January 1, 2014
Study Completion (Actual)
January 1, 2014
Study Registration Dates
First Submitted
May 31, 2011
First Submitted That Met QC Criteria
July 21, 2011
First Posted (Estimate)
July 22, 2011
Study Record Updates
Last Update Posted (Actual)
February 16, 2022
Last Update Submitted That Met QC Criteria
February 15, 2022
Last Verified
February 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SU-11022010-7169
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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