Actively Recruiting

Phase Not Applicable
Age: 18Months - 72Months
All Genders
ID05551728

Autism Caregiver Coaching in Africa A Study of Non-Specialist Delivered Early Intervention for Young Children with Autism Conducted by Duke University

Led by Duke University · Updated on 2026-01-09

320

Participants Needed

1

Research Sites

26 weeks

Total Duration

On this page

Sponsors

D

Duke University

Lead Sponsor

U

University of Cape Town

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating a community-based early intervention program designed to improve the quality of life for young children with autism and their families in South Africa. This study focuses on training caregivers through coaching delivered by non-specialist Early Childhood Development practitioners, addressing the shortage of specialists in Africa. The coaching uses a Naturalistic Developmental Behavioral Intervention (NDBI) adapted to the South African context and aims to assess its real-world effectiveness, cost, and implementation factors while including diverse cultural perspectives. The intervention involves 12 one-hour caregiver coaching sessions based on the Early Start Denver Model (ESDM) principles, adapted for non-specialist delivery. Caregivers are taught strategies to enhance their child's social attention, communication, and engagement through everyday activities. The study compares this coaching approach to usual care, with sessions delivered by trained non-specialists within established community settings. The project also explores how caregiver and child characteristics affect response to the intervention and compares autism-related behaviors cross-culturally. Participants will engage in assessments at baseline, 4 months, and 6 months, including standardized communication and developmental measures like the VABS-3 and Griffiths III scales. Researchers will monitor changes in caregiver-child interactions and autism-related behaviors using digital tools and observational scores. The study includes safety and feasibility evaluations, with the total participation spanning at least six months. Data collected will inform scaling up early autism interventions in Africa and enhance research capacity in the region.

CONDITIONS

Brief Title

Autism Caregiver Coaching in Africa

Who Can Participate

Age: 18Months - 72Months
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Child is between 18 and 72 months old
  • Child meets DSM-5 criteria for autism spectrum disorder, confirmed by ADOS-2
  • Child's caregiver speaks isiXhosa, isiZulu, Afrikaans, or English
  • Child's race is African or Coloured (mixed race)
  • Caregiver-child pair live in the recruitment area
  • Caregiver is at least 18 years old
Not Eligible

You will not qualify if you...

  • Child has a genetic disorder of known cause (e.g., fragile X syndrome)
  • Child has significant sensory or motor impairments preventing use of play materials
  • Child has major physical abnormalities interfering with participation
  • Child has a history of serious head injury or neurological disease
  • Caregiver cannot attend assessments and all 12 coaching sessions

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Outpatient Treatment

Duration - 12 weeks

Participants receive 12, 1-hour caregiver coaching sessions delivered by non-specialists, focusing on strategies to improve child communication and interaction.

Weekly visits for up to 12 weeks

Follow-up

Duration - Up to 6 months from baseline

Participants have assessments to measure changes in communication and developmental outcomes after the intervention period.

2 visits (at 4 and 6 months post-baseline)

Trial Site Locations

Total: 1 location

1

University of Cape Town

Cape Town, West Cape, South Africa

Actively Recruiting

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Research Team

L

Lauren Franz, MBChB

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

Improving access to early intervention for autism: findings from a proof-of-principle cascaded task-sharing naturalistic developmental behavioural intervention in South Africa.

Amber D Rieder, Marisa Viljoen, Noleen Seris...

https://pubmed.ncbi.nlm.nih.gov/37210513

Adapting an early autism caregiver coaching intervention for telehealth delivery in low-resource settings: A South African study of the 'what' and the 'why'.

Marisa Viljoen, Noleen Seris, Nokuthula Shabalala...

https://pubmed.ncbi.nlm.nih.gov/39655488