Autism or Autistic TraitsACACIANCT05551728
Autism Caregiver Coaching in Africa
A study testing ESDM-informed caregiver coaching in people with Autism or Autistic Traits, run by Duke University at 1 site in South Africa.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 72 months
- Conditions the study is for
- Autism or Autistic Traits
- What is being tested?
- ESDM-informed caregiver coaching
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 320 participants
- Where
- 1 siteSouth Africa
- Study dates
- 1 Apr 2023to Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 72 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Africa1 site, 1 recruiting
- Recruiting
University of Cape Town
Cape Town, West Cape
Petrus de Vries, +27 (0) 21 685 4103, petrus.devries@uct.ac.za
About this study
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.
Read the detailed description
Globally there is a growing need to implement community-based services that support improvements in quality of life of autistic people. Early autism intervention is critical because it can significantly improve both child and family outcomes, but implementation gaps exist worldwide. These gaps are starkest in Africa, where by 2050, forty percent of the world's children will live. Given the lack of specialists in Africa, task shifting early autism intervention to non-specialists will be a key implementation strategy. Naturalistic Developmental Behavioral Interventions (NDBI), are a class of early autism intervention approaches, that can be effectively delivered by caregivers. Through a partnership between Duke University and the University of Cape Town, the team laid the groundwork for an innovative and scalable coaching intervention for young autistic children. A caregiver coaching NDBI was systematically adapted for the South African context in which coaching is effectively delivered by non-specialist Early Childhood Development practitioners employed by the Education Department. The proposed study will build on this foundational work by conducting a type 1 hybrid effectiveness implementation trial of the coaching intervention, delivered by non-specialists, within an existing system of care in South Africa. The goal is to implement a feasible, scalable early autism intervention model in Africa by conducting research with culturally and linguistically diverse participants in community-based settings, that is inclusive of diverse stakeholder perspectives and incorporates task-shifting. The proposed study will build on current relationships with families, practitioners, and policy makers by formalizing these relationships and including other key stakeholder groups such as South African autistic self-advocates through a community-academic partnership, a key bridging factor in the EPIS (Exploration, Preparation, Implementation, Sustainment) implementation framework. The proposed project has three main objectives. First, to evaluate the real-world effectiveness of non-specialist delivered NDBI caregiver coaching for improving patterns of caregiver-child interaction and child developmental outcomes, and assess the cost-effectiveness of this approach. Second, to identify implementation determinants to inform scale-up. Third, to expand African autism research capacity to enhance scalability. This project also offers a unique opportunity to study variability in autism-related behaviors and phenomenology. The study will therefore assess the degree to which response to intervention is moderated by caregiver and dimensional child characteristics. In addition, using an innovative digital assessment method, changes in dimensional quantitative measures of autism-related behaviors will be examined. Finally, cross-cultural differences in dimensional autism-related behaviors will be evaluated via comparison with existing quantitative phenotypic data gathered in U.S. studies. This study is timely and innovative and will inform scale-up of autism early intervention in Africa. Assessing the impact of a scalable intervention in an environment like South Africa which faces significant contextual challenges, increases the ecological validity and relevance of findings for many regions of the world that face with similar challenges.
- Conditions
- Autism or Autistic Traits
- Being tested
- ESDM-informed caregiver coaching
- Medical subject headings
- Autistic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ESDM-informed caregiver coachingBehavioural
The coaching intervention is informed by the Community-Early Start Denver Model (C-ESDM). The intervention has been adapted for the South African context. Training procedures have been adapted for delivery by non-specialist coaches. Twelve session-specific visuals with simple-text (for caregivers) and session scripts (for non-specialist coaches) have been developed. Over 12, 1-hour caregiver coaching sessions that are delivered by non-specialists, caregivers are coached in strategies to increase child attention to their social world, increase child communication, create and build joint activity routines, and understand and use the ABCs to support the development of new behaviors.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | 12, 1-hour ESDM-informed caregiver coaching sessions, delivered by non-specialists. Intervention materials and approach have been adapted for the South African context. Receives: Behavioral: ESDM-informed caregiver coaching |
| Delayed intervention control group | No intervention | Usual care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline VABS-3 Communication Domain Standard Score at 6 months
The Vineland Adaptive Behavior Scales-3 (VABS-3) is a semi-structured, clinician-administered, caregiver interview that assesses the degree to which a child routinely performs specified adaptive behaviors compared to age-based norms, and yields standard scores for each subscale as well as an overall composite score. The measure examines domains of communication (receptive, expressive, and written language skills), socialization (play, interpersonal relationships, and coping skills),daily living skills (personal, domestic, and community living skills), and motor skills (gross and fine motor). Subscale score ranges from 20-140 where a higher score indicates greater frequency of target behavior.
Measured: Baseline, 6 months
Change from Baseline Griffiths III Language and Communication Developmental Quotient at 6 months
The Griffiths Scales of Child Development, Third Edition (Griffiths III) is a comprehensive clinician-administered developmental measure designed for evaluation of children ranging in ages from birth to eight years. The Griffiths-III provides a profile of both strengths and weaknesses in child development across 5 domains: foundations of learning, language, and communication (expressive/receptive and social), eye and hand coordination (fine motor skills and visual perception), personal-social-emotional (emotional development and social interactions), and gross motor (postural control, balance, and body coordination). Developmental quotients (DQs) will be calculated by (Developmental Age/Chronological Age) *100, and range from 0-100 with higher scores indicating a higher degree of congruence between child developmental and chronological age.
Measured: Baseline, 6 months
Secondary outcomes (1)
Change from Baseline JERI composite score at 4 months
The Joint Engagement Rating Inventory (JERI) is a behavioral coding scheme designed to measure multiple aspects of caregiver-child interactions. The JERI includes 32 items rated on a 7-point Likert scale across four categories: 1) child engagement state items, 2) child activity items, 3) caregiver activity items, and 4) dyadic interaction items. For this study a JERI composite score will include the sum of 5 caregiver activity items including: scaffolding, following the child's interests, affect, language facilitation, and use of communicative temptations. Each caregiver activity item is rated on a 1-7 scale, with 1 indicating a low frequency and quality of the behavior and 7 indicating a high frequency and quality of the behavior.
Measured: Baseline, 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2022
- Study start1 Apr 2023
- Primary completionMar 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Autism or Autistic TraitsStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study design will be an individually randomized group treatment RCT with a delayed treatment control group. 150 children, ages 18-72 months, with a DSM-5 diagnosis of autism spectrum disorder (ASD) and their caregivers will be recruited on a rolling basis, with arm allocation (coaching vs. delayed treatment control) conducted using a minimization approach with child sex balanced across groups. The intervention will be offered to the delayed treatment control group immediately after follow-up assessment (6-months after baseline). Offering the intervention to both groups is of ethical importance in an environment with few services and will enhance retention. Once control dyads have completed the intervention, the degree to which the trend in the control group is consistent with any treatment effect detected in the main trial comparison will be assessed. Note that a total of 320 participants will be enrolled in the study (150 caregiver-child dyads and 20 Aim 2 participants).
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 320 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Cape Town
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05551728
- Sponsor's protocol ID
- Pro00111048
- Acronym
- ACACIA
- Status last verified
- Jan 2026
- First submitted
- 12 Sep 2022
- Last updated
- 9 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rieder AD, Viljoen M, Seris N, Shabalala N, Ndlovu M, Turner EL, Simmons R, de Vries PJ, Franz L. Improving access to early intervention for autism: findings from a proof-of-principle cascaded task-sharing naturalistic developmental behavioural intervention in South Africa. Child Adolesc Psychiatry Ment Health. 2023 May 20;17(1):64. doi: 10.1186/s13034-023-00611-0.
PubMed 37210513Franz L, Viljoen M, Askew S, Brown M, Dawson G, Di Martino JM, Sapiro G, Sebolai K, Seris N, Shabalala N, Stahmer A, Turner EL, de Vries PJ. Autism Caregiver Coaching in Africa (ACACIA): Protocol for a type 1-hybrid effectiveness-implementation trial. PLoS One. 2024 Jan 12;19(1):e0291883. doi: 10.1371/journal.pone.0291883. eCollection 2024.
PubMed 38215154Dawood Z, Sebolai K, Ndlovu M, Viljoen M, Seris N, Shabalala N, De Vries PJ, Franz L, Harty M. Detecting change in a caregiver-mediated autism intervention using the Joint Engagement Rating Inventory. S Afr J Commun Disord. 2025 Sep 26;72(1):e1-e11. doi: 10.4102/sajcd.v72i1.1102.
PubMed 41055175Viljoen M, Seris N, Shabalala N, Ndlovu M, de Vries PJ, Franz L. Adapting an early autism caregiver coaching intervention for telehealth delivery in low-resource settings: A South African study of the 'what' and the 'why'. Autism. 2025 May;29(5):1246-1262. doi: 10.1177/13623613241300774. Epub 2024 Dec 10.
PubMed 39655488
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Autism Caregiver Coaching in Africa
- ClinicalTrials.gov ID
- NCT05551728
- Acronym / sponsor ID
- ACACIA / Pro00111048
- Conditions
- Autism or Autistic Traits
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 320 participants (estimated)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- University of Cape Town
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 23 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Globally there is a growing need to implement community-based services that support improvements in quality of life of autistic people. Early autism intervention is critical because it can significantly improve both child and family outcomes, but implementation gaps exist worldwide. These gaps are starkest in Africa, where by 2050, forty percent of the world's children will live. Given the lack of specialists in Africa, task shifting early autism intervention to non-specialists will be a key implementation strategy. Naturalistic Developmental Behavioral Interventions (NDBI), are a class of early autism intervention approaches, that can be effectively delivered by caregivers. Through a partnership between Duke University and the University of Cape Town, the team laid the groundwork for an innovative and scalable coaching intervention for young autistic children. A caregiver coaching NDBI was systematically adapted for the South African context in which coaching is effectively delivered by non-specialist Early Childhood Development practitioners employed by the Education Department. The proposed study will build on this foundational work by conducting a type 1 hybrid effectiveness implementation trial of the coaching intervention, delivered by non-specialists, within an existing system of care in South Africa. The goal is to implement a feasible, scalable early autism intervention model in Africa by conducting research with culturally and linguistically diverse participants in community-based settings, that is inclusive of diverse stakeholder perspectives and incorporates task-shifting. The proposed study will build on current relationships with families, practitioners, and policy makers by formalizing these relationships and including other key stakeholder groups such as South African autistic self-advocates through a community-academic partnership, a key bridging factor in the EPIS (Exploration, Preparation, Implementation, Sustainment) implementation framework. The proposed project has three main objectives. First, to evaluate the real-world effectiveness of non-specialist delivered NDBI caregiver coaching for improving patterns of caregiver-child interaction and child developmental outcomes, and assess the cost-effectiveness of this approach. Second, to identify implementation determinants to inform scale-up. Third, to expand African autism research capacity to enhance scalability. This project also offers a unique opportunity to study variability in autism-related behaviors and phenomenology. The study will therefore assess the degree to which response to intervention is moderated by caregiver and dimensional child characteristics. In addition, using an innovative digital assessment method, changes in dimensional quantitative measures of autism-related behaviors will be examined. Finally, cross-cultural differences in dimensional autism-related behaviors will be evaluated via comparison with existing quantitative phenotypic data gathered in U.S. studies. This study is timely and innovative and will inform scale-up of autism early intervention in Africa. Assessing the impact of a scalable intervention in an environment like South Africa which faces significant contextual challenges, increases the ecological validity and relevance of findings for many regions of the world that face with similar challenges.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- The study design will be an individually randomized group treatment RCT with a delayed treatment control group. 150 children, ages 18-72 months, with a DSM-5 diagnosis of autism spectrum disorder (ASD) and their caregivers will be recruited on a rolling basis, with arm allocation (coaching vs. delayed treatment control) conducted using a minimization approach with child sex balanced across groups. The intervention will be offered to the delayed treatment control group immediately after follow-up assessment (6-months after baseline). Offering the intervention to both groups is of ethical importance in an environment with few services and will enhance retention. Once control dyads have completed the intervention, the degree to which the trend in the control group is consistent with any treatment effect detected in the main trial comparison will be assessed. Note that a total of 320 participants will be enrolled in the study (150 caregiver-child dyads and 20 Aim 2 participants).
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: ESDM-informed caregiver coaching12, 1-hour ESDM-informed caregiver coaching sessions, delivered by non-specialists. Intervention materials and approach have been adapted for the South African context. |
| Delayed intervention control group | No intervention | –Usual care. |
Who may qualify
- Ages
- 18 to 72 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ESDM-informed caregiver coachingThe coaching intervention is informed by the Community-Early Start Denver Model (C-ESDM). The intervention has been adapted for the South African context. Training procedures have been adapted for delivery by non-specialist coaches. Twelve session-specific visuals with simple-text (for caregivers) and session scripts (for non-specialist coaches) have been developed. Over 12, 1-hour caregiver coaching sessions that are delivered by non-specialists, caregivers are coached in strategies to increase child attention to their social world, increase child communication, create and build joint activity routines, and understand and use the ABCs to support the development of new behaviors. | Behavioural | Intervention group |
Primary outcome
Change from Baseline VABS-3 Communication Domain Standard Score at 6 months
Time frame: Baseline, 6 months
The Vineland Adaptive Behavior Scales-3 (VABS-3) is a semi-structured, clinician-administered, caregiver interview that assesses the degree to which a child routinely performs specified adaptive behaviors compared to age-based norms, and yields standard scores for each subscale as well as an overall composite score. The measure examines domains of communication (receptive, expressive, and written language skills), socialization (play, interpersonal relationships, and coping skills),daily living skills (personal, domestic, and community living skills), and motor skills (gross and fine motor). Subscale score ranges from 20-140 where a higher score indicates greater frequency of target behavior.
Change from Baseline Griffiths III Language and Communication Developmental Quotient at 6 months
Time frame: Baseline, 6 months
The Griffiths Scales of Child Development, Third Edition (Griffiths III) is a comprehensive clinician-administered developmental measure designed for evaluation of children ranging in ages from birth to eight years. The Griffiths-III provides a profile of both strengths and weaknesses in child development across 5 domains: foundations of learning, language, and communication (expressive/receptive and social), eye and hand coordination (fine motor skills and visual perception), personal-social-emotional (emotional development and social interactions), and gross motor (postural control, balance, and body coordination). Developmental quotients (DQs) will be calculated by (Developmental Age/Chronological Age) *100, and range from 0-100 with higher scores indicating a higher degree of congruence between child developmental and chronological age.
1 secondary outcome
Change from Baseline JERI composite score at 4 months
Time frame: Baseline, 4 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2026.
- Results publication: PubMed 37210513Rieder AD, Viljoen M, Seris N, Shabalala N, Ndlovu M, Turner EL, Simmons R, de Vries PJ, Franz L. Improving access to early intervention for autism: findings from a proof-of-principle cascaded task-sharing naturalistic developmental behavioural intervention in South Africa. Child Adolesc Psychiatry Ment Health. 2023 May 20;17(1):64. doi: 10.1186/s13034-023-00611-0.
- Results publication: PubMed 38215154Franz L, Viljoen M, Askew S, Brown M, Dawson G, Di Martino JM, Sapiro G, Sebolai K, Seris N, Shabalala N, Stahmer A, Turner EL, de Vries PJ. Autism Caregiver Coaching in Africa (ACACIA): Protocol for a type 1-hybrid effectiveness-implementation trial. PLoS One. 2024 Jan 12;19(1):e0291883. doi: 10.1371/journal.pone.0291883. eCollection 2024.
- Results publication: PubMed 41055175Dawood Z, Sebolai K, Ndlovu M, Viljoen M, Seris N, Shabalala N, De Vries PJ, Franz L, Harty M. Detecting change in a caregiver-mediated autism intervention using the Joint Engagement Rating Inventory. S Afr J Commun Disord. 2025 Sep 26;72(1):e1-e11. doi: 10.4102/sajcd.v72i1.1102.
- Results publication: PubMed 39655488Viljoen M, Seris N, Shabalala N, Ndlovu M, de Vries PJ, Franz L. Adapting an early autism caregiver coaching intervention for telehealth delivery in low-resource settings: A South African study of the 'what' and the 'why'. Autism. 2025 May;29(5):1246-1262. doi: 10.1177/13623613241300774. Epub 2024 Dec 10.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ESDM-informed caregiver coaching in people with Autism or Autistic Traits, run by Duke University at 1 site in South Africa.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lauren Franz, MBChB (+1919 681-0023, lauren.franz@duke.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline VABS-3 Communication Domain Standard Score at 6 months (time frame: Baseline, 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05551728, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2026.