Pilot Study to Improve Access to Early Intervention for Autism in Africa
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|ClinicalTrials.gov Identifier: NCT02751957|
Recruitment Status : Recruiting
First Posted : April 26, 2016
Last Update Posted : November 14, 2018
|Condition or disease||Intervention/treatment||Phase|
|Autism Spectrum Disorder||Behavioral: Early Start Denver Model||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||26 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Pilot Study to Improve Access to Early Intervention for Autism in Africa|
|Actual Study Start Date :||July 1, 2016|
|Estimated Primary Completion Date :||July 2020|
|Estimated Study Completion Date :||July 2020|
Receives caregiver coaching version of the Early Start Denver Model (ESDM) intervention, delivered by non-specialist workers. ESDM is an evidence based, behavioral intervention for young children who have an autism spectrum disorder. It is a behavioral treatment informed by the principles of applied behavior analysis.
Behavioral: Early Start Denver Model
The Early Start Denver Model is an evidence based, behavioral intervention for young children who have an autism spectrum disorder. It is a behavioral treatment informed by the principles of applied behavior analysis.
- The Griffiths Scales of Mental Development: Change in developmental quotient and language subdomain developmental quotient [ Time Frame: Baseline, 12 week, and 16 weeks ]The Griffiths Scales of Mental Development: a standardized developmental test for children birth to 96 months. The composite developmental quotient and the language subdomain developmental quotient will be used as outcome variables.
- The Vineland Adaptive Behavior Scales: Changes in communication and socialization standard scores [ Time Frame: Baseline, 12 week, and 16 weeks ]The Vineland Adaptive Behavior Scales, Third Edition (Vineland-3) is an individually-administered measure of adaptive behavior that is widely used to assess individuals with intellectual, developmental, and other disabilities.
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): NCT02751957
|Contact: Lauren Franz, MBChBfirstname.lastname@example.org|
|University of Cape Town||Recruiting|
|Cape Town, Western Cape Province, South Africa|
|Contact: Petrus de Vries, MBChB, Phd|
|Principal Investigator:||Lauren Franz, MBChB||Duke University|