Changing Developmental Trajectories Through Early Treatment
|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: NCT01985022|
Recruitment Status : Recruiting
First Posted : November 15, 2013
Last Update Posted : January 16, 2019
|Condition or disease||Intervention/treatment||Phase|
|Autism Spectrum Disorders||Behavioral: PII with IES Behavioral: IES||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||108 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Autism Center of Excellence: Project 3 - Changing Developmental Trajectories Through Early Treatment|
|Study Start Date :||May 2013|
|Estimated Primary Completion Date :||December 2019|
|Estimated Study Completion Date :||December 2019|
Experimental: PII with IES
The treatment condition that this group receives is PII with IES for 9 months.
Behavioral: PII with IES
This is an individualized parent-implemented intervention (PII) offered weekly to teach parents how to embed strategies to support social communication skills for 25 hours a week within everyday routines, activities, and places for 9 months. In addition parent will receive twice weekly the IES condition of the study.
The treatment condition that this group receives is IES for 9 months.
Parents will receive information, education, and support. They once a week for 75 minutes.
- Child's social communication [ Time Frame: End of treatment (9 months) ]Standardized measure of child's social communication: Communication and Symbolic Behavior Scales (CSBS)
- Child's Autism Symptoms [ Time Frame: End of treatment (9 months) ]Standardized Measure of autism symptoms: Autism Diagnostic Observation Schedule (ADOS).
- Child's Developmental Level [ Time Frame: End of treatment (9 months) ]Standardized measure of child development: Mullen Scales of Early Learning (MSEL)
- Child's Adaptive Behavior [ Time Frame: End of treatment (9 months) ]Standardized measure of adaptive behavior: Vineland Adaptive Behavior Scales (VABS-II)
- Parent Report [ Time Frame: End of treatment (9 months) ]Parent measures of family functioning, daily hassles, and treatment satisfaction.
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): NCT01985022
|Contact: Nathan Call, PhDemail@example.com|
|Contact: Amy Wetherby, PhD|
|United States, Georgia|
|Marcus Autism Center||Recruiting|
|Atlanta, Georgia, United States, 30329|
|Principal Investigator:||Nathan Call, PhD||Emory University, Marcus Autism Center, Children's Healthcare of Atlanta|
|Study Director:||Amy Wetherby, Ph.D.||Florida State University|