NCT04026386

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
105mo left

Started Oct 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress43%
Oct 2019Dec 2034

First Submitted

Initial submission to the registry

July 17, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 19, 2019

Completed
3 months until next milestone

Study Start

First participant enrolled

October 19, 2019

Completed
15.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2034

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2034

Last Updated

November 12, 2025

Status Verified

November 1, 2025

Enrollment Period

15.2 years

First QC Date

July 17, 2019

Last Update Submit

November 7, 2025

Conditions

Development Disorder, ChildDevelopmental DisabilityDevelopment DelayAutism Spectrum Disorder

Outcome Measures

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 )

    Baseline, 12 Weeks

Secondary Outcomes (5)

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

    Baseline, 12 Weeks

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

    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

Study Arms (1)

Center Based or In-Home Early Intervention Program

EXPERIMENTAL
Behavioral: Center Based or In Home Early Intervention Program

Interventions

Center Based or In Home Early Intervention ProgramBEHAVIORAL

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.

Center Based or In-Home Early Intervention Program

Eligibility Criteria

Age2 Years - 5 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94305, United States

RECRUITING

MeSH Terms

Conditions

Developmental DisabilitiesLearning DisabilitiesAutism Spectrum Disorder

Condition Hierarchy (Ancestors)

Neurodevelopmental DisordersMental DisordersCommunication DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsChild Development Disorders, Pervasive

Study Officials

  • Antonio Hardan, MD

    Stanford University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Madeleine Clark, BS

CONTACT

(650) 736-1235mclark11@stanford.edu

Robin Libove, BS

CONTACT

(650) 736-1235rlibove@stanford.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 17, 2019

First Posted

July 19, 2019

Study Start

October 19, 2019

Primary Completion (Estimated)

December 30, 2034

Study Completion (Estimated)

December 30, 2034

Last Updated

November 12, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations

US(1)