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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01400269
Other study ID # SU-11022010-7169
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 2010
Est. completion date January 2014

Study information

Verified date February 2022
Source Stanford University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


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.


Recruitment information / eligibility

Status Completed
Enrollment 48
Est. completion date January 2014
Est. primary completion date January 2014
Accepts healthy volunteers No
Gender All
Age group 18 Months to 6 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Pacific Autism Center for Education (PACE ) developmentally based parent delivered intervention
Pacific Autism Center for Education (PACE ) developmentally based parent delivered intervention

Locations

Country Name City State
United States Stanford University School of Medicine Stanford California

Sponsors (1)

Lead Sponsor Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

References & Publications (1)

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: — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Social Responsiveness Scale Outcome measure is the change from week 12 relative to baseline. Baseline and Week 12
Secondary Repetitive Behavior Scale Outcome measure is the change from week 12 relative to baseline. Baseline and Week 12
Secondary Family Empowerment Scale Outcome measure is the change from week 12 relative to baseline. Baseline and Week 12
Secondary Caregiver Strain questionnaire Outcome measure is the change from week 12 relative to baseline. Baseline and Week 12
Secondary Pediatric Quality of Life Inventory Outcome measure is the change from week 12 relative to baseline. Baseline and Week 12
Secondary Sensory Profile Questionnaire Outcome measure is the change from week 12 relative to baseline. Baseline and Week 12
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