Status:
COMPLETED
Tailoring Treatment Targets for Early Autism Intervention in Africa
Lead Sponsor:
Duke University
Collaborating Sponsors:
University of Cape Town
National Institute of Mental Health (NIMH)
Conditions:
Autism Spectrum Disorder
Eligibility:
All Genders
18-72 years
Phase:
NA
Brief Summary
Naturalistic Developmental Behavioral Interventions (NDBIs), an evidence-based early autism spectrum disorder (ASD) intervention approach, target key behaviors that help language development. While ef...
Detailed Description
COVID-19 has significantly impacted autism spectrum disorder (ASD) clinical research and disrupted access to intervention services for children and families globally. In this ongoing study in Cape Tow...
Eligibility Criteria
Inclusion
- For ASD, DD, TD groups
- Subject family speaks isiXhosa, Afrikaans, or English
- Child's ethnicity/race is African or Coloured (A South African term for individuals with mixed racial heritage)
- Child lives within an area served by the recruitment sites
- For the ASD group only:
- Child meets criteria for an ASD diagnosis based upon DSM-5 (Diagnostic and Statistical Manual of Mental Disorders) criteria and informed by the ADOS-2 (Autism Diagnostic Observation Schedule) administered by research reliable raters
- Caregiver is at least 18 years old
- For the developmental delay (DD) group only:
- Child screens positive on the Ten Questions and negative for ASD on the ABC
- Child has been diagnosed with developmental delay by a developmental pediatrician
- For the typically developing (TD) group only:
- Child screens negative on the Ten Questions and negative for ASD on the ABC
- For the Early Childhood Development (ECD) Practitioners and Early Childhood Development Practitioner School Supervisors group:
- Employed by participating recruitment partners (Western Cape Education Department Schools)
- Involved in delivery of the caregiver coaching sessions, either in person or remotely
- For the Early Start Denver Model (ESDM) supervisors group:
- Trained ESDM therapist
- Supervise weekly coaching sessions in the schools, and/or
- Supervise remote intervention delivery sessions
Exclusion
- For all groups (ASD, DD, TD)
- Significant sensory or motor impairment
- Major physical abnormalities
- History of serious head injury and/or neurological disease
- For the ASD group:
- Presence of a neurological disorder of known etiology (for e.g., Downs Syndrome)
- Caregiver-child dyad unable to attend assessments and 12 coaching sessions
- For the developmental delay (DD) group
- Autism diagnosis based on DSM 5 criteria
- For typically developing (TD group:
- Autism diagnosis based on DSM 5 criteria
Key Trial Info
Start Date :
September 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 26 2021
Estimated Enrollment :
73 Patients enrolled
Trial Details
Trial ID
NCT04068688
Start Date
September 1 2019
End Date
August 26 2021
Last Update
December 2 2022
Active Locations (1)
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1
University of Cape Town
Cape Town, West Cape, South Africa