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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 : May 2, 2019
Sponsor:
Collaborator:
University of Cape Town
Information provided by (Responsible Party):
Duke University

Brief Summary:
This Mentored Career Development Award will lay the foundation for a career focused on addressing two Grand Challenges in Global Mental Health priorities: 1) improving child access to evidence-based mental health care, and 2) reducing the duration of untreated illness by developing culturally-sensitive early interventions. The proposed research aims to assess implementation barriers and facilitators as well as the impact of a brief caregiver coaching early autism intervention adapted for use in a low resource setting. Data from this pilot study would inform scalable early autism intervention programs for implementation in underserved, low resource, and low-literacy populations globally.

Condition or disease Intervention/treatment Phase
Autism Spectrum Disorder Behavioral: Early Start Denver Model Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 26 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intervention
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.




Primary Outcome Measures :
  1. 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.

  2. 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.



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Ages Eligible for Study:   18 Months to 72 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of ASD based on DSM-5 criteria by a developmental pediatrician.
  • a caretaker who speaks isiXhosa, Afrikaans or English
  • lives within an area served by the Red Cross Neurodevelopmental clinic;
  • willing to participate in the intervention and be randomized to the intervention or control group.

Exclusion Criteria:

  • a neurodevelopmental disorder of known genetic etiology (eg. Downs syndrome)
  • significant sensory or motor impairment (e.g. cerebral palsy)
  • major physical problems
  • uncontrolled seizures
  • IQ below 35 as measured by mean age equivalence score on the Griffiths Scales of Mental Development
  • unable to attend 3 assessments and 12, 1-hour, weekly consecutive intervention sessions.

Information from the National Library of Medicine

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


Contacts
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Contact: Lauren Franz, MBChB 9196810045 lauren.franz@dm.duke.edu

Locations
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South Africa
University of Cape Town Recruiting
Cape Town, Western Cape Province, South Africa
Contact: Petrus de Vries, MBChB, Phd         
Sponsors and Collaborators
Duke University
University of Cape Town
Investigators
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Principal Investigator: Lauren Franz, MBChB Duke University

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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT02751957     History of Changes
Other Study ID Numbers: Pro00064533
First Posted: April 26, 2016    Key Record Dates
Last Update Posted: May 2, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Autistic Disorder
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders