Clinical trial NCT01400269: 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
Overall status: COMPLETED
Phase: NA
Conditions: Autistic Disorder
Keywords: PACE
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2011-07-22
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Social Responsiveness Scale
timeFrame: Baseline and Week 12
Secondary outcomes:
measure: Repetitive Behavior Scale
timeFrame: Baseline and Week 12
measure: Family Empowerment Scale
timeFrame: Baseline and Week 12
measure: Caregiver Strain questionnaire
timeFrame: Baseline and Week 12
measure: Pediatric Quality of Life Inventory
timeFrame: Baseline and Week 12
measure: Sensory Profile Questionnaire
timeFrame: Baseline and Week 12
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
Study officials:
affiliation: Stanford University
name: Antonio Y. Hardan, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.