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OpenTrials
Completed

NCT Number: NCT01400269

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

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).

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Key information

Age range

18 month–6 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stanford University School of Medicine

Stanford, California, 94305, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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

Behavioral

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

Primary outcomes

  1. Social Responsiveness Scale

    Time frame: Baseline and Week 12

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

Secondary outcomes

  1. Repetitive Behavior Scale

    Time frame: Baseline and Week 12

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

  2. Family Empowerment Scale

    Time frame: Baseline and Week 12

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

  3. Caregiver Strain questionnaire

    Time frame: Baseline and Week 12

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

  4. Pediatric Quality of Life Inventory

    Time frame: Baseline and Week 12

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

  5. Sensory Profile Questionnaire

    Time frame: Baseline and Week 12

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

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Important dates

Study start
2010
Primary completion
2014
Study completion
2014
First posted
Jul 22, 2011
Registry last updated
Feb 16, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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