Autism Caregiver Coaching in Africa

NCT05551728 | Recruiting

• 1 other identifier: Pro00111048
• Study Type: interventional
• Target: 320
• Locations: 1 country
• Sites: 1

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.

Conditions

Autism or Autistic Traits

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Baseline, 6 months

Secondary Outcomes (1)

• Change from Baseline JERI composite score at 4 months

  Baseline, 4 months

Study Arms (2)

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.

Behavioral: ESDM-informed caregiver coaching

Delayed intervention control group

NO INTERVENTION

Usual care.

Interventions

ESDM-informed caregiver coaching BEHAVIORAL

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.

Intervention group

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

University of Cape Town

Cape Town, West Cape, South Africa

RECRUITING

Related Publications (4)

• 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.

  PMID: 37210513 RESULT

• Franz 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.

  PMID: 38215154 RESULT

• Dawood 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.

  PMID: 41055175 RESULT

• Viljoen 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.

  PMID: 39655488 RESULT

MeSH Terms

Conditions

Autistic Disorder

Condition Hierarchy (Ancestors)

Autism Spectrum Disorder; Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Central Study Contacts

Lauren Franz, MBChB

CONTACT

+1919 681-0023; lauren.franz@duke.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Due to the nature of the intervention, it is not possible to blind participants to the allocation received. Outcome assessors and statisticians will be blinded to participant group.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: September 12, 2022
• First Posted: September 23, 2022
• Study Start: April 1, 2023
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: January 9, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

ZA (1)