A Center Based Early Intervention Program For Preschoolers With Developmental Disorders

Autism Spectrum Disorder Clinical Trial

Official title:

A Center Based Early Intervention Program For Preschoolers With Developmental Disorders

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04026386
• Other study ID #: IRB-52348
• Status: Recruiting
• Phase: N/A
• Start date: October 19, 2019
• Est. completion date: December 2024

Study information

• Verified date: December 2023
• Source: Stanford University
• Contact: Madeleine Clark, BS
• Phone: (650) 736-1235
• Email: mclark11[@]stanford.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 75
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 5 Years

Eligibility

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.

Related Conditions & MeSH terms

• Autism Spectrum Disorder
• Development Delay
• Development Disorder, Child
• Developmental Disabilities
• Developmental Disability

Intervention

Behavioral:
• Center Based or In Home 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 or in home to treat social communication deficits in children with developmental disorders.

Locations

Country	Name	City	State
United States	Stanford University School of Medicine	Stanford	California

Sponsors (2)

Lead Sponsor	Collaborator
Stanford University	John & Marcia Goldman Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 )	Baseline, 12 Weeks
Secondary	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)	Baseline, 12 Weeks
Secondary	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).	Baseline, 12 Weeks
Secondary	Change From Baseline in Parent Rated Vineland Adaptive Behavior Scale- 3 (VABS-3) Scores During Treatment.		Baseline, 12 Weeks
Secondary	Change From Baseline in Parent Rated Short Sensory Profile Questionnaire (SSPQ) Scores During Treatment.		Baseline, 12 Weeks
Secondary	Change From Baseline in Parent Rated General Self Efficacy Scale (GSES) Scores During Treatment.		Baseline, 12 Weeks