A Center Based Early Intervention Program For Preschoolers With Developmental Disorders

Study Overview
=================
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.

Official Title
-----------------
A Center Based Early Intervention Program For Preschoolers With Developmental Disorders

Conditions
-----------------
Development Disorder, Child, Developmental Disability, Development Delay, Autism Spectrum Disorder

Intervention / Treatment
-----------------
* Behavioral: Center Based or In Home Early Intervention Program


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 5 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Center Based or In-Home Early Intervention Program<br> | Behavioral: Center Based or In Home Early Intervention Program<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 Short Sensory Profile Questionnaire (SSPQ) Scores During Treatment. |  | Baseline, 12 Weeks | 
| Change From Baseline in Parent Rated General Self Efficacy Scale (GSES) Scores During Treatment. |  | Baseline, 12 Weeks |