Autism Caregiver Coaching in Africa (NCT05551728) | Clinical Trial Compass
RecruitingNot Applicable
Autism Caregiver Coaching in Africa
South Africa320 participantsStarted 2023-04-01
Plain-language 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.
Who can participate
Age range
18 Months – 72 Months
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change from Baseline VABS-3 Communication Domain Standard Score at 6 months
Timeframe: Baseline, 6 months
2
Change from Baseline Griffiths III Language and Communication Developmental Quotient at 6 months