A Center Based Early Intervention Program For Preschoolers With Developmental Disorders
Primary Purpose
Development Disorder, Child, Developmental Disability, Development Delay
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Center Based or In Home Early Intervention Program
Sponsored by
About this trial
This is an interventional treatment trial for Development Disorder, Child
Eligibility 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.);
- Lack of availability during program hours.
Sites / Locations
- Stanford University School of MedicineRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Center Based or In-Home Early Intervention Program
Arm Description
Outcomes
Primary Outcome Measures
Change From Baseline in Parent Rated Social Responsiveness Scale, 2nd Edition (SRS-2) T-Score After Treatment.
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
Change From Baseline in Parent Rated Repetitive Behavior Scale Revised (RBS-R) Scores During Treatment.
Higher scores on the Repetitive Behavior Scale- Revised mean higher levels of repetitive and restricted behaviors. (Raw Score Total Range: 0 - 129)
Change From Baseline in Parent Rated Stanford Social Dimension Scale (SSDS) Scores During Treatment.
Higher Scores on the Stanford Social Dimension Scale mean better social functioning and lower scores mean worse social functioning (Range: 58-290).
Change From Baseline in Parent Rated Vineland Adaptive Behavior Scale- 3 (VABS-3) Scores During Treatment.
Change From Baseline in Parent Rated Short Sensory Profile Questionnaire (SSPQ) Scores During Treatment.
Change From Baseline in Parent Rated General Self Efficacy Scale (GSES) Scores During Treatment.
Full Information
NCT ID
NCT04026386
First Posted
July 17, 2019
Last Updated
December 1, 2022
Sponsor
Stanford University
Collaborators
John & Marcia Goldman Foundation
1. Study Identification
Unique Protocol Identification Number
NCT04026386
Brief Title
A Center Based Early Intervention Program For Preschoolers With Developmental Disorders
Official Title
A Center Based Early Intervention Program For Preschoolers With Developmental Disorders
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 19, 2019 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University
Collaborators
John & Marcia Goldman Foundation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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 or in the home 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Development Disorder, Child, Developmental Disability, Development Delay, Autism Spectrum Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
75 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Center Based or In-Home Early Intervention Program
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Center Based or In Home Early Intervention Program
Intervention Description
This is a 12-week early intervention program that will include 12 weekly hours of treatment in an intensive center-based preschool environment or in home to treat social communication deficits in children with developmental disorders.
Primary Outcome Measure Information:
Title
Change From Baseline in Parent Rated Social Responsiveness Scale, 2nd Edition (SRS-2) T-Score After Treatment.
Description
Social Responsiveness Scale, 2nd Edition (SRS) scores measure social abilities with lower scores meaning better social abilities. (T-Score Range: 37- above 90 )
Time Frame
Baseline, 12 Weeks
Secondary Outcome Measure Information:
Title
Change From Baseline in Parent Rated Repetitive Behavior Scale Revised (RBS-R) Scores During Treatment.
Description
Higher scores on the Repetitive Behavior Scale- Revised mean higher levels of repetitive and restricted behaviors. (Raw Score Total Range: 0 - 129)
Time Frame
Baseline, 12 Weeks
Title
Change From Baseline in Parent Rated Stanford Social Dimension Scale (SSDS) Scores During Treatment.
Description
Higher Scores on the Stanford Social Dimension Scale mean better social functioning and lower scores mean worse social functioning (Range: 58-290).
Time Frame
Baseline, 12 Weeks
Title
Change From Baseline in Parent Rated Vineland Adaptive Behavior Scale- 3 (VABS-3) Scores During Treatment.
Time Frame
Baseline, 12 Weeks
Title
Change From Baseline in Parent Rated Short Sensory Profile Questionnaire (SSPQ) Scores During Treatment.
Time Frame
Baseline, 12 Weeks
Title
Change From Baseline in Parent Rated General Self Efficacy Scale (GSES) Scores During Treatment.
Time Frame
Baseline, 12 Weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
No
Eligibility 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 5.11 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.);
Lack of availability during program hours.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Madeleine Clark, BS
Phone
(650) 736-1235
Email
mclark11@stanford.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Robin Libove, BS
Phone
(650) 736-1235
Email
rlibove@stanford.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Antonio Hardan, MD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University School of Medicine
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Madeleine Clark, BS
Phone
650-736-1235
Email
mclark11@stanford.edu
First Name & Middle Initial & Last Name & Degree
Robin Libove, BS
Phone
(650) 736-1235
Email
rlibove@stanford.edu
First Name & Middle Initial & Last Name & Degree
Antonio Hardan, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Center Based Early Intervention Program For Preschoolers With Developmental Disorders
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