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 : April 26, 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 :||46 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|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.
No Intervention: Community care as usual
Community care typically consists of one, 1 hour speech therapy or occupational therapy session per month.
- 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.
- Change in caregiver stress [ Time Frame: Baseline, 12 week, and 16 weeks ]The Parenting Stress Index - Short Form 36 items -magnitude of stress in the caregiver-child system.
- Change in social affect domain score [ Time Frame: Baseline, 12 week, and 16 weeks ]The Autism Diagnostic Observational Schedule, second edition: semi structured standardized observation that measures autism symptoms in social relatedness, communication, play and repetitive behaviors. A standardized severity score based on codes within these domains will be calculated to compare autism symptoms across modules. The Social Affect domain score will be used as an outcome variable.
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|