Autism Spectrum DisorderNCT01591707
Evaluating a Social and Communication Intervention for Preschoolers
A study testing ISC+PRT Intervention in people with Autism Spectrum Disorder, run by Hugo W. Moser Research Institute at Kennedy Krieger, Inc. at 3 sites in United States.
Trial summary
The purpose of this study is to test the effectiveness of a school-based treatment aimed at increasing language and social skills in preschool-aged children with autism spectrum disorder (ASD). Read more about this study
- Who is it for?
- Ages 3 to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- ISC+PRT Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 700 participants
- Where
- 3 sitesUnited States
- Study dates
- Jul 2012to 15 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 3 to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- For Teachers:
- Work in an ASD preschool classroom within a cooperating Baltimore County Public School.
- For Children:
- Meet Autism Diagnostic Observation Schedule-Generic (ADOS; Lord et al., 2002) and expert clinical judgment criteria for ASD
- Have an IQ or Developmental Quotient of at least 40 based on the Early Learning Composite from the Mullen Scales of Early Learning (Mullen, 1995)
- Be enrolled in a participating Baltimore County Public School ASD preschool classroom
- Be between the ages of 3 and 6 and enrolled in a participating ASD preschool classroom.
Who cannot join
- Children and educators may be taken out of the study if they:
- Are unable to comply with the study protocol
- Change schools due to relocation
- Children may also be taken out of this study if they:
- Sustain a head injury or other serious physical injury during the study
- Are not being brought in for testing as designated in the protocol
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Kennedy Krieger Institute/Howard County Public Schools
Baltimore, Maryland, 21211
Elwyn Early Childhood Services
Media, Pennsylvania, 19063
Brennen School
Newark, Delaware, 19713
About this study
The purpose of this study is to test the effectiveness of a school-based treatment aimed at increasing language and social skills in preschool-aged children with autism spectrum disorder (ASD). Through interactive development (continually seeking educator feedback for intervention improvement) and implementation of the intervention, the investigators hope to provide a feasible and practical means for educators to work with children with ASD in real world, large scale settings. ASD preschool educators, the children enrolled in their classes, between the ages of 3 and 6 years and their families may join.
Read the detailed description
In Phase 4, KKI staff trained Delaware preschool teachers to serve as model coaches and educators through the Delaware Autism Program. Families whose children were enrolled in participating classrooms were consented through DAP using the school's consent to be videotaped. Any families who did not consent for their child to be videotaped for this training received the nonparticipant consent form currently utilized in this study and staff videotaping took every effort to keep those children out of frame when taping. This cohort involved KKI study team members training 1-2 coaches, who then trained five Delaware school teachers. The IES model was implemented in the teacher's classrooms (n= 5-10 students participating in each classroom; 20-40 children total).
In the current phase of the study, Phase 5 and 6, KKI study team members will continue the evaluation of the IES model, by testing the efficacy of the intervention model in a larger sample (Phase 5) and then analyzing the corresponding data (Phase 6). The larger efficacy study (phase 5) will be conducted on teachers and students recruited from public school districts in Maryland, Delaware, and Pennsylvania using the same IES model and recruitment methods in the previous phases.
- Conditions
- Autism Spectrum Disorder
- Being tested
- ISC+PRT Intervention
- Keywords
- autism spectrum disorders, school, language, social
- Medical subject headings
- Autism Spectrum Disorder, Language
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ISC+PRT InterventionBehavioural
Teachers will be trained to implement an intervention in preschool ASD classrooms that provides a learning environment in which social and communication skills are focused on.
| Study group | Role | What they receive |
|---|---|---|
| ISC+PRT Intervention | Experimental | For the duration of at least one school year children will receive 45-90 minutes of intervention in the classroom in an attempt to increase social and communication skills. Receives: Behavioral: ISC+PRT Intervention |
| Instruction As Usual | No intervention | For the duration of at least one year children will receive the typical classroom instruction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in educator instruction to meet fidelity of intervention.
Fidelity will be monitored throughout the duration of the intervention by KKI staff to assess the quality and consistency with which educators implement the intervention.
Measured: approximately 4-, 8-, 12-, 16-, 20-, 24-, 28-, 32-, and 36-weeks into the intervention
Secondary outcomes (5)
Change in Baseline Autism Diagnostic Observation Schedule
Measured: 9 months into treatment
Change in Baseline Mullen Scales of Early Learning
Measured: 9 months into treatment
Change in Child's Baseline Spontaneous Imitation Task
Measured: 9 months into treatment
Change in Child Classroom-based Social Communication Performance
Measured: 9 months into treatment
Change in parent perception of child behavior as recorded by the Autism Composite score of the PDDBI (parent version)
Measured: 9 months into treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2012 (estimated)
- Study startJul 2012
- Primary completion1 Sep 2020
- Study completion15 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 700 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- U.S. Department of Education
- Responsible party
- Principal investigator, Rebecca Landa, Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
- Investigators
- Rebecca Landa, PhD, CCC-SLP, Principal investigator, Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01591707
- Sponsor's protocol ID
- NA_00073501
- Status last verified
- Mar 2026
- First submitted
- 30 Apr 2012
- Last updated
- 24 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Individual participant data for teachers will be shared with the Delaware Autism Program to determine feasibility of model implementation. Child participant data will not be shared.
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating a Social and Communication Intervention for Preschoolers
- ClinicalTrials.gov ID
- NCT01591707
- Acronym / sponsor ID
- NA_00073501
- Conditions
- Autism Spectrum Disorder
- Keywords
- autism spectrum disorders, school, language, social
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 700 participants (estimated)
- Lead sponsor
- Hugo W. Moser Research Institute at Kennedy Krieger, Inc.University, hospital or other
- Collaborators
- U.S. Department of Education
- Study start
- Jul 2012
- Primary completion
- 1 Sep 2020 (actual)
- Study completion
- 15 Dec 2020 (actual)
- First posted
- 4 May 2012 (estimated)
- 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 test the effectiveness of a school-based treatment aimed at increasing language and social skills in preschool-aged children with autism spectrum disorder (ASD). Through interactive development (continually seeking educator feedback for intervention improvement) and implementation of the intervention, the investigators hope to provide a feasible and practical means for educators to work with children with ASD in real world, large scale settings. ASD preschool educators, the children enrolled in their classes, between the ages of 3 and 6 years and their families may join.
Detailed description
In Phase 4, KKI staff trained Delaware preschool teachers to serve as model coaches and educators through the Delaware Autism Program. Families whose children were enrolled in participating classrooms were consented through DAP using the school's consent to be videotaped. Any families who did not consent for their child to be videotaped for this training received the nonparticipant consent form currently utilized in this study and staff videotaping took every effort to keep those children out of frame when taping. This cohort involved KKI study team members training 1-2 coaches, who then trained five Delaware school teachers. The IES model was implemented in the teacher's classrooms (n= 5-10 students participating in each classroom; 20-40 children total).
In the current phase of the study, Phase 5 and 6, KKI study team members will continue the evaluation of the IES model, by testing the efficacy of the intervention model in a larger sample (Phase 5) and then analyzing the corresponding data (Phase 6). The larger efficacy study (phase 5) will be conducted on teachers and students recruited from public school districts in Maryland, Delaware, and Pennsylvania using the same IES model and recruitment methods in the previous phases.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ISC+PRT Intervention | Experimental | Behavioral: ISC+PRT InterventionFor the duration of at least one school year children will receive 45-90 minutes of intervention in the classroom in an attempt to increase social and communication skills. |
| Instruction As Usual | No intervention | –For the duration of at least one year children will receive the typical classroom instruction |
Who may qualify
- Ages
- 3 to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Work in an ASD preschool classroom within a cooperating Baltimore County Public School.
- Meet Autism Diagnostic Observation Schedule-Generic (ADOS; Lord et al., 2002) and expert clinical judgment criteria for ASD
- Have an IQ or Developmental Quotient of at least 40 based on the Early Learning Composite from the Mullen Scales of Early Learning (Mullen, 1995)
- Be enrolled in a participating Baltimore County Public School ASD preschool classroom
- Be between the ages of 3 and 6 and enrolled in a participating ASD preschool classroom.
Key exclusion criteria (6 listed)
- Are unable to comply with the study protocol
- Change schools due to relocation
- Sustain a head injury or other serious physical injury during the study
- Are not being brought in for testing as designated in the protocol
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 |
|---|---|---|
| ISC+PRT InterventionTeachers will be trained to implement an intervention in preschool ASD classrooms that provides a learning environment in which social and communication skills are focused on. | Behavioural | ISC+PRT Intervention |
Primary outcome
Change in educator instruction to meet fidelity of intervention.
Time frame: approximately 4-, 8-, 12-, 16-, 20-, 24-, 28-, 32-, and 36-weeks into the intervention
Fidelity will be monitored throughout the duration of the intervention by KKI staff to assess the quality and consistency with which educators implement the intervention.
5 secondary outcomes
Change in Baseline Autism Diagnostic Observation Schedule
Time frame: 9 months into treatment
Change in Baseline Mullen Scales of Early Learning
Time frame: 9 months into treatment
Change in Child's Baseline Spontaneous Imitation Task
Time frame: 9 months into treatment
Change in Child Classroom-based Social Communication Performance
Time frame: 9 months into treatment
Change in parent perception of child behavior as recorded by the Autism Composite score of the PDDBI (parent version)
Time frame: 9 months into treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2026.
- Individual participant dataSharing planned: Yes. Individual participant data for teachers will be shared with the Delaware Autism Program to determine feasibility of model implementation. Child participant data will not be shared.
Related trials for Autism Spectrum Disorder
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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. This study is not recruiting at the moment.
Rebecca Landa, PhD, CCC-SLP principal investigator
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ISC+PRT Intervention in people with Autism Spectrum Disorder, run by Hugo W. Moser Research Institute at Kennedy Krieger, Inc. at 3 sites 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 7 inclusion and 6 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: finished, as of the sponsor's last update on 24 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in educator instruction to meet fidelity of intervention. (time frame: approximately 4-, 8-, 12-, 16-, 20-, 24-, 28-, 32-, and 36-weeks into the intervention). 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 24 Mar 2026.