ClinicalTrials.gov
ClinicalTrials.gov Menu

Pilot Study to Improve Access to Early Intervention for Autism in Africa

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02751957
Recruitment Status : Recruiting
First Posted : April 26, 2016
Last Update Posted : April 26, 2018
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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 46 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
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.

No Intervention: Community care as usual
Community care typically consists of one, 1 hour speech therapy or occupational therapy session per month.



Primary Outcome Measures :
  1. 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. 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.

  3. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   24 Months to 59 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
Contact: Lauren Franz, MBChB 9196810045 lauren.franz@dm.duke.edu

Locations
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
Principal Investigator: Lauren Franz, MBChB Duke University

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: April 26, 2018
Last Verified: April 2018

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

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