- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05551728
Autism Caregiver Coaching in Africa (ACACIA)
January 25, 2024 updated by: Duke University
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Estimated)
320
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Lauren Franz, MBChB
- Phone Number: +1919 681-0023
- Email: lauren.franz@duke.edu
Study Locations
-
-
West Cape
-
Cape Town, West Cape, South Africa
- Recruiting
- University of Cape Town
-
Contact:
- Petrus de Vries
- Phone Number: +27 (0) 21 685 4103
- Email: petrus.devries@uct.ac.za
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 year to 6 years (Child)
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention group
12, 1-hour ESDM-informed caregiver coaching sessions, delivered by non-specialists.
Intervention materials and approach have been adapted for the South African context.
|
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.
|
No Intervention: Delayed intervention control group
Usual care.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Baseline, 6 months
|
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.
|
Baseline, 6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from Baseline JERI composite score at 4 months
Time Frame: Baseline, 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.
|
Baseline, 4 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 1, 2023
Primary Completion (Estimated)
March 1, 2027
Study Completion (Estimated)
September 1, 2027
Study Registration Dates
First Submitted
September 12, 2022
First Submitted That Met QC Criteria
September 20, 2022
First Posted (Actual)
September 23, 2022
Study Record Updates
Last Update Posted (Actual)
January 26, 2024
Last Update Submitted That Met QC Criteria
January 25, 2024
Last Verified
January 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Pro00111048
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
Individual-level data will be submitted to NDAR, along with appropriate supporting documentation to enable efficient data use.
Prior to submission, staff will review accuracy and conduct additional checks for presence of PHI in the submitted data.
In accordance with NDAR Data Sharing Policy, submissions from Duke will include protocols, questionnaires, study manuals, variables measured, and any other necessary documentation.
The grant will meet all requirements for NDAR and NIH Data Repository Data Sharing, including inclusion of necessary informed consent language to inform participants about the manner and extent to which their data will be shared, compilation of a list of collected structures from the NDAR Data Dictionary, determination of initial submission and sharing dates based on the NIH Data Sharing Regimen, generation of GUID, data validation through the NDAR Validation and Upload Tool with data correction, and final certification of the data by the PI.
IPD Sharing Time Frame
2 times per year (on or before 15th of Jan, July).
Cumulative submission of data will be included in each submission cycle, accommodating any changes.
IPD Sharing Access Criteria
All submitted data (both descriptive/raw and analyzed data) will be made available for access by members of the research community according to the provisions defined in the NDAR and the NIH/NIMH (National Institute of Mental Health) Data Repositories Data Sharing Policy.
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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