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

Sponsor
Stanford University (Other)
Overall Status
Completed
CT.gov ID
NCT01400269
Collaborator
(none)
48
1
1
40
1.2

Study Details

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).

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Pacific Autism Center for Education (PACE ) developmentally based parent delivered intervention
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
48 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
An Evaluation of a Developmentally-Based Parent Training Program for Children With Autism
Study Start Date :
Sep 1, 2010
Actual Primary Completion Date :
Jan 1, 2014
Actual Study Completion Date :
Jan 1, 2014

Arms and Interventions

Arm Intervention/Treatment
Experimental: Pacific Autism Center for Education (PACE)

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

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

Outcome Measures

Primary Outcome Measures

  1. Social Responsiveness Scale [Baseline and Week 12]

    Outcome measure is the change from week 12 relative to baseline.

Secondary Outcome Measures

  1. Repetitive Behavior Scale [Baseline and Week 12]

    Outcome measure is the change from week 12 relative to baseline.

  2. Family Empowerment Scale [Baseline and Week 12]

    Outcome measure is the change from week 12 relative to baseline.

  3. Caregiver Strain questionnaire [Baseline and Week 12]

    Outcome measure is the change from week 12 relative to baseline.

  4. Pediatric Quality of Life Inventory [Baseline and Week 12]

    Outcome measure is the change from week 12 relative to baseline.

  5. Sensory Profile Questionnaire [Baseline and Week 12]

    Outcome measure is the change from week 12 relative to baseline.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Months to 6 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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)

Contacts and Locations

Locations

Site City State Country Postal Code
1 Stanford University School of Medicine Stanford California United States 94305

Sponsors and Collaborators

  • Stanford University

Investigators

  • Principal Investigator: Antonio Y. Hardan, MD, Stanford University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Antonio Hardan, Associate Professor, Stanford University
ClinicalTrials.gov Identifier:
NCT01400269
Other Study ID Numbers:
  • SU-11022010-7169
First Posted:
Jul 22, 2011
Last Update Posted:
Feb 16, 2022
Last Verified:
Feb 1, 2022
Keywords provided by Antonio Hardan, Associate Professor, Stanford University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 16, 2022