An Evaluation of a Developmentally-Based Parent Training Program for Children With Autism

Autistic Disorder Clinical Trial

Official title:

An Evaluation of a Developmentally-Based Parent Training Program for Children With Autism

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01400269
• Other study ID #: SU-11022010-7169
• Status: Completed
• Phase: N/A
• 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
• 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)

Related Conditions & MeSH terms

• Autistic Disorder

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