A Center Based Early Intervention Program For Preschoolers With Developmental Disorders

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age2-5
SponsorStanford University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Current or lifetime diagnosis of severe psychiatric disorder (e.g., bipolar disorder, etc.);

Lack of availability during program hours.

Trial design

Design model

Single group

Treatments tested in this trial

  • Center Based or In Home Early Intervention Program

    Behavioral

    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.

Treatment groups

75 Participants
are divided into 1 treatment group
Group A: Center Based or In-Home Early Intervention ProgramExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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 )

Time frame
Baseline, 12 Weeks

Secondary outcomes

1

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)

Time frame
Baseline, 12 Weeks
2

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).

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

Other outcomes

Sponsors and contacts

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Stanford University

Lead sponsor

John & Marcia Goldman Foundation

Collaborator