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NCT Number: NCT04026386

A Center Based Early Intervention Program For Preschoolers With Developmental Disorders

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.

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Key information

Conditions

Development Disorder, Child Autism Spectrum Disorder Child Development Disorders, Pervasive Communication Disorders Development Delay Developmental Disabilities Developmental Disability Learning Disabilities Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurodevelopmental Disorders Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

2 year–5 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

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

    Time frame: 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 outcomes

  1. Change From Baseline in Parent Rated Repetitive Behavior Scale Revised (RBS-R) Scores During Treatment.

    Time frame: 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)

  2. Change From Baseline in Parent Rated Stanford Social Dimension Scale (SSDS) Scores During Treatment.

    Time frame: 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).

  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

  5. Change From Baseline in Parent Rated General Self Efficacy Scale (GSES) Scores During Treatment.

    Time frame: Baseline, 12 Weeks

Study contacts

Contact information is provided by the study sponsor or research team.

Beatrice Begley, BS

CONTACT

[email protected]

(650) 736-1235

Madeleine Clark, BS

CONTACT

[email protected]

(650) 736-1235

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Collaborators

  • John & Marcia Goldman Foundation

Registry information

Important dates

Study start
2019
Primary completion
2034
Study completion
2034
First posted
Jul 19, 2019
Registry last updated
Jun 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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