Development Disorder, ChildNCT04026386
A Center Based Early Intervention Program For Preschoolers With Developmental Disorders
A study testing Center Based or In Home Early Intervention Program in people with Development Disorder, Child and Developmental Disability, run by Stanford University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 to 5 years
- Conditions the study is for
- Development Disorder, Child, Developmental Disability, Development Delay
- What is being tested?
- Center Based or In Home Early Intervention Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Oct 2019to 30 Dec 2034
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- Current or lifetime diagnosis of severe psychiatric disorder (e.g., bipolar disorder, etc.);
- Lack of availability during program hours.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Stanford University School of Medicine
Stanford, California, 94305
Madeleine Clark, BS, 650-736-1235, PALprogram@stanford.edu
Beatrice Begley, BS, (650) 736-1235, PALprogram@stanford.edu
About this study
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.
- Conditions
- Development Disorder, Child, Developmental Disability, Development Delay, Autism Spectrum Disorder
- Being tested
- Center Based or In Home Early Intervention Program
- Medical subject headings
- Developmental Disabilities, Learning Disabilities, Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Center Based or In Home Early Intervention ProgramBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Center Based or In-Home Early Intervention Program | Experimental | Not described Receives: Behavioral: Center Based or In Home Early Intervention Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 )
Measured: Baseline, 12 Weeks
Secondary outcomes (5)
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)
Measured: 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).
Measured: Baseline, 12 Weeks
Change From Baseline in Parent Rated Vineland Adaptive Behavior Scale- 3 (VABS-3) Scores During Treatment.
Measured: Baseline, 12 Weeks
Change From Baseline in Parent Rated Short Sensory Profile Questionnaire (SSPQ) Scores During Treatment.
Measured: Baseline, 12 Weeks
Change From Baseline in Parent Rated General Self Efficacy Scale (GSES) Scores During Treatment.
Measured: Baseline, 12 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2019
- Study start19 Oct 2019
- Primary completion30 Dec 2034 (estimated)
- Study completion30 Dec 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Development Disorder, ChildStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- John & Marcia Goldman Foundation
- Responsible party
- Principal investigator, Antonio Hardan, Stanford University
- Investigators
- Antonio Hardan, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04026386
- Sponsor's protocol ID
- IRB-52348
- Status last verified
- Jun 2026
- First submitted
- 17 Jul 2019
- Last updated
- 25 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Center Based Early Intervention Program For Preschoolers With Developmental Disorders
- ClinicalTrials.gov ID
- NCT04026386
- Acronym / sponsor ID
- IRB-52348
- Conditions
- Development Disorder, Child, Developmental Disability, Development Delay, Autism Spectrum Disorder
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- John & Marcia Goldman Foundation
- Study start
- 19 Oct 2019 (actual)
- Primary completion
- 30 Dec 2034 (estimated)
- Study completion
- 30 Dec 2034 (estimated)
- First posted
- 19 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Center Based or In-Home Early Intervention Program | Experimental | Behavioral: Center Based or In Home Early Intervention Program |
Who may qualify
- Ages
- 2 to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- Current or lifetime diagnosis of severe psychiatric disorder (e.g., bipolar disorder, etc.);
- Lack of availability during program hours.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Center Based or In Home Early Intervention ProgramThis 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. | Behavioural | Center Based or In-Home Early Intervention Program |
Primary outcome
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 )
5 secondary outcomes
Change From Baseline in Parent Rated Repetitive Behavior Scale Revised (RBS-R) Scores During Treatment.
Time frame: Baseline, 12 Weeks
Change From Baseline in Parent Rated Stanford Social Dimension Scale (SSDS) Scores During Treatment.
Time frame: Baseline, 12 Weeks
Change From Baseline in Parent Rated Vineland Adaptive Behavior Scale- 3 (VABS-3) Scores During Treatment.
Time frame: Baseline, 12 Weeks
Change From Baseline in Parent Rated Short Sensory Profile Questionnaire (SSPQ) Scores During Treatment.
Time frame: Baseline, 12 Weeks
Change From Baseline in Parent Rated General Self Efficacy Scale (GSES) Scores During Treatment.
Time frame: Baseline, 12 Weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Antonio Hardan, MD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Center Based or In Home Early Intervention Program in people with Development Disorder, Child and Developmental Disability, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Madeleine Clark, BS ((650) 736-1235, PALprogram@stanford.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Parent Rated Social Responsiveness Scale, 2nd Edition (SRS-2) T-Score After Treatment. (time frame: Baseline, 12 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2026.