Evaluating a Social and Communication Intervention for Preschoolers
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01591707|
Recruitment Status : Recruiting
First Posted : May 4, 2012
Last Update Posted : December 23, 2019
|Condition or disease||Intervention/treatment||Phase|
|Autism Spectrum Disorder||Behavioral: ISC+PRT Intervention||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||700 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Evaluating a Social and Communication Intervention for Preschoolers|
|Study Start Date :||July 2012|
|Estimated Primary Completion Date :||January 2022|
|Estimated Study Completion Date :||January 2022|
Experimental: ISC+PRT Intervention
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.
Behavioral: ISC+PRT Intervention
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.
No Intervention: Instruction As Usual
For the duration of at least one year children will receive the typical classroom instruction
- 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.
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01591707
|Contact: Rebecca Landa, PhD, CCC-SLPemail@example.com|
|United States, Delaware|
|Brennen School||Enrolling by invitation|
|Newark, Delaware, United States, 19713|
|United States, Maryland|
|Kennedy Krieger Institute/Howard County Public Schools||Recruiting|
|Baltimore, Maryland, United States, 21211|
|Contact: Rebecca Landa, Phd, CCC-SLP 443-923-7680 firstname.lastname@example.org|
|United States, Pennsylvania|
|Elwyn Early Childhood Services||Recruiting|
|Media, Pennsylvania, United States, 19063|
|Contact: Kyu Hwang 610-891-2196 Kyu_hwang@elwyn.org|
|Principal Investigator:||Rebecca Landa, PhD, CCC-SLP||Hugo W. Moser Research Institute at Kennedy Krieger, Inc.|