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

NCT02751957 | Completed

• 1 other identifier: Pro00064533
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Autism Spectrum Disorder

Outcome Measures

Primary Outcomes (2)

• The Griffiths Scales of Mental Development: Change in developmental quotient and language subdomain developmental quotient

  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.

  Baseline, 12 week, and 16 weeks

• The Vineland Adaptive Behavior Scales: Changes in communication and socialization standard scores

  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.

  Baseline, 12 week, and 16 weeks

Study Arms (1)

Intervention

EXPERIMENTAL

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

Interventions

Early Start Denver Model BEHAVIORAL

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.

Intervention

Eligibility Criteria

• Age: 18 Months - 72 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Duke University: lead
• University of Cape Town: collaborator

Study Sites (1)

University of Cape Town

Cape Town, Western Cape, South Africa

Location

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Lauren Franz, MBChB

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2016
• First Posted: April 26, 2016
• Study Start: July 1, 2016
• Primary Completion: July 1, 2020
• Study Completion: July 1, 2020
• Last Updated: August 25, 2020

Record last verified: 2020-05

Locations

ZA (1)