A Center Based Early Intervention Program for Preschoolers with Developmental Disorders

Not Applicable

Recruiting

• Conditions: Development Delay; Developmental Disability; Development Disorder, Child; Autism Spectrum Disorder
• Interventions: Behavioral: Center Based or In Home Early Intervention Program

• Registration Number: NCT04026386
• Lead Sponsor: 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 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-07-17
• Study First Submitted QC: 2019-07-17
• Study First Posted: 2019-07-19
• Study Start: 2019-10-19
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-07
• Last Update Posted: 2024-10-09
• Primary Completion: 2034-12-30
• Study Completion: 2034-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 75

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.

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Exclusion Criteria

• Current or lifetime diagnosis of severe psychiatric disorder (e.g., bipolar disorder, etc.);
• Lack of availability during program hours.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Center Based or In-Home Early Intervention Program	Center Based or In Home Early Intervention Program	-

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Parent Rated Social Responsiveness Scale, 2nd Edition (SRS-2) T-Score After Treatment.	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

Name	Time	Method
Change From Baseline in Parent Rated Short Sensory Profile Questionnaire (SSPQ) Scores During Treatment.	Baseline, 12 Weeks
Change From Baseline in Parent Rated Repetitive Behavior Scale Revised (RBS-R) Scores During Treatment.	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)
Change From Baseline in Parent Rated Stanford Social Dimension Scale (SSDS) Scores During Treatment.	Baseline, 12 Weeks	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.	Baseline, 12 Weeks
Change From Baseline in Parent Rated General Self Efficacy Scale (GSES) Scores During Treatment.	Baseline, 12 Weeks

Trial Locations

Locations (1)

Stanford University School of Medicine; 🇺🇸 Stanford, California, United States