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A Center Based Early Intervention Program For Preschoolers With Developmental Disorders

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ClinicalTrials.gov Identifier: NCT04026386
Recruitment Status : Not yet recruiting
First Posted : July 19, 2019
Last Update Posted : July 19, 2019
Sponsor:
Information provided by (Responsible Party):
Antonio Hardan, Stanford University

Brief Summary:
The purpose of this study is to examine the effectiveness of a 12-week early intervention program that will include 12 weekly hours in an intensive center-based preschool environment to treat social communication deficits in children with developmental disorders. The study will include children with developmental disorders, such as Autism Spectrum Disorder, neurogenetic disorders, or intellectual disability.

Condition or disease Intervention/treatment Phase
Development Disorder, Child Developmental Disability Development Delay Autism Spectrum Disorder Behavioral: Center Based Early Intervention Program Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Center Based Early Intervention Program For Preschoolers With Developmental Disorders
Estimated Study Start Date : September 2019
Estimated Primary Completion Date : December 2024
Estimated Study Completion Date : December 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Center Based Early Intervention Program Behavioral: Center Based Early Intervention Program
This is a 12-week early intervention program that will include 12 weekly hours of treatment in an intensive center-based preschool environment to treat social communication deficits in children with developmental disorders.




Primary Outcome Measures :
  1. Change From Baseline in Parent Rated Social Responsiveness Scale, 2nd Edition (SRS-2) T-Score After Treatment. [ Time Frame: Baseline, 12 Weeks ]
    Social Responsiveness Scale, 2nd Edition (SRS) scores measure social abilities with lower scores meaning better social abilities. (T-Score Range: 37- above 90 )


Secondary Outcome Measures :
  1. Change From Baseline in Parent Rated Repetitive Behavior Scale Revised (RBS-R) Scores During Treatment. [ Time Frame: Baseline, 12 Weeks ]
    Higher scores on the Repetitive Behavior Scale- Revised mean higher levels of repetitive and restricted behaviors. (Raw Score Total Range: 0 - 129)

  2. Change From Baseline in Parent Rated Stanford Social Dimension Scale (SSDS) Scores During Treatment. [ Time Frame: Baseline, 12 Weeks ]
  3. Change From Baseline in Parent Rated Vineland Adaptive Behavior Scale- 3 (VABS-3) Scores During Treatment. [ Time Frame: Baseline, 12 Weeks ]
  4. Change From Baseline in Parent Rated Short Sensory Profile Questionnaire (SSPQ) Scores During Treatment. [ Time Frame: Baseline, 12 Weeks ]
  5. Change From Baseline in Parent Rated General Self Efficacy Scale (GSES) Scores During Treatment. [ Time Frame: Baseline, 12 Weeks ]


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Ages Eligible for Study:   2 Years to 4 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of Developmental Disorder, such as Autism Spectrum Disorder, neurogenetic disorder, or intellectual disability, based on clinical interview;
  • Boys and girls between 2.0 years and 4.11 years at time of enrollment;
  • Ability to participate in the testing procedures to the extent that valid standard scores can be obtained.

Exclusion Criteria:

  • Current or lifetime diagnosis of severe psychiatric disorder (e.g., bipolar disorder, etc.);
  • Child's primary language other than English;
  • Lack of availability during program hours.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04026386


Contacts
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Contact: Jane Shkel, MS, BCBA (650) 736-1235 jshkel@stanford.edu

Locations
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United States, California
Stanford University School of Medicine Not yet recruiting
Stanford, California, United States, 94305
Contact: Robin Libove    650-736-1235    rlibove@stanford.edu   
Principal Investigator: Antonio Hardan, MD         
Sponsors and Collaborators
Stanford University
Investigators
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Principal Investigator: Antonio Hardan, MD Stanford University

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Responsible Party: Antonio Hardan, Professor, Stanford University
ClinicalTrials.gov Identifier: NCT04026386     History of Changes
Other Study ID Numbers: IRB-52348
First Posted: July 19, 2019    Key Record Dates
Last Update Posted: July 19, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Disease
Autism Spectrum Disorder
Developmental Disabilities
Pathologic Processes
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders