NCT01400269

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2010

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2010

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

May 31, 2011

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 22, 2011

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
Last Updated

February 16, 2022

Status Verified

February 1, 2022

Enrollment Period

3.3 years

First QC Date

May 31, 2011

Last Update Submit

February 15, 2022

Conditions

Autistic Disorder

Keywords

PACE

Outcome Measures

Primary Outcomes (1)

  • Social Responsiveness Scale

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

    Baseline and Week 12

Secondary Outcomes (5)

  • Repetitive Behavior Scale

    Baseline and Week 12

  • Family Empowerment Scale

    Baseline and Week 12

  • Caregiver Strain questionnaire

    Baseline and Week 12

  • Pediatric Quality of Life Inventory

    Baseline and Week 12

  • Sensory Profile Questionnaire

    Baseline and Week 12

Study Arms (1)

Pacific Autism Center for Education (PACE)

EXPERIMENTAL

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

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

Interventions

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

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

Pacific Autism Center for Education (PACE)

Eligibility Criteria

Age18 Months - 6 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

Related 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: 10.1177/1362361318775538. Epub 2018 May 18.

    PMID: 29775078RESULT

MeSH Terms

Conditions

Autistic Disorder

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Autism Spectrum DisorderChild Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Socioeconomic FactorsPopulation Characteristics

Study Officials

  • Antonio Y. Hardan, MD

    Stanford University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

May 31, 2011

First Posted

July 22, 2011

Study Start

September 1, 2010

Primary Completion

January 1, 2014

Study Completion

January 1, 2014

Last Updated

February 16, 2022

Record last verified: 2022-02

Locations

US(1)