Changing Developmental Trajectories Through Early Treatment
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|ClinicalTrials.gov Identifier: NCT01985022|
Recruitment Status : Unknown
Verified June 2021 by Nathan A. Call, Ph.D., BCBA-D, Emory University.
Recruitment status was: Recruiting
First Posted : November 15, 2013
Last Update Posted : June 10, 2021
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|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 :||July 2022|
|Estimated Study Completion Date :||December 2022|
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.
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|Ages Eligible for Study:||9 Months to 24 Months (Child)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Participants will be recruited who have already completed Project 1 and Project 2 of the Emory Autism Center of Excellence project.
- Participants will be the younger siblings of children with a diagnosed ASD
- Positive screen on 2 of 3 measures of risk for an autism spectrum disorder before treatment 15 months of age or younger by the start of treatment
- Normal hearing and adequate motor control to make simple actions (giving, reaching)
- Families agree to twice monthly play group sessions for 9 months and 2-3 intervention sessions per week for 9 months (usually within work-day hours)
- Families agree to monthly evaluations and videotaping of intervention sessions and weekly or monthly video check during the 18 months of 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): 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|
|Responsible Party:||Nathan A. Call, Ph.D., BCBA-D, Principal Investigator, Emory University|
|Other Study ID Numbers:||
P50MH100029-02 ( U.S. NIH Grant/Contract )
|First Posted:||November 15, 2013 Key Record Dates|
|Last Update Posted:||June 10, 2021|
|Last Verified:||June 2021|
autism spectrum disorders
pervasive developmental disorders
Autism Spectrum Disorder
Child Development Disorders, Pervasive