| NCT ID | NCT05551728 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Duke University |
| Condition | Autism or Autistic Traits |
| Study Type | INTERVENTIONAL |
| Enrollment | 320 participants |
| Start Date | 2023-04-01 |
| Primary Completion | 2027-03 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 320 participants in total. It began in 2023-04-01 with a primary completion date of 2027-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Around the world there is a growing need to develop early intervention services in local communities that support a better quality of life for all autistic people. The South African study will test an approach where caregivers are coached by non-specialists in early intervention strategies. Caregivers can then use these strategies during everyday activities with their young autistic child.
Eligibility Criteria
Inclusion Criteria: * Child's age is 18-72 months * Child meets DSM-5 criteria for autism spectrum disorder (ASD), informed by Autism Diagnostic Observation Schedule, Second Edition (ADOS-2) * Child's caregiver speaks isiXhosa, isiZulu, Afrikaans, or English * Child's race is African or Coloured (South African term for mixed race) * Caregiver-child dyad live in recruitment area * Caregiver is ≥18 years Exclusion Criteria: * Genetic disorder of known etiology (e.g., fragile X syndrome) * Significant sensory or motor impairment that would preclude use of the play materials * Major physical abnormalities that would interfere with participation in the intervention * History of serious head injury and/or neurological disease * Caregiver indicates they will be unable to attend assessments and 12 sessions
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05551728 clinical trial?
This trial is open to participants of all sexes, aged 18 Months or older, up to 72 Months, studying Autism or Autistic Traits. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05551728 currently recruiting?
Yes, NCT05551728 is actively recruiting participants. Contact the research team at lauren.franz@duke.edu for enrollment information.
Where is the NCT05551728 trial being conducted?
This trial is being conducted at Cape Town, South Africa.
Who is sponsoring the NCT05551728 clinical trial?
NCT05551728 is sponsored by Duke University. The trial plans to enroll 320 participants.