Health TrialsbyHealthPanel

Autism Caregiver Coaching in Africa

ConditionAutism or Autistic Traits
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-72
SponsorDuke University

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

320 Participants
are divided into 2 treatment groups
Group A: Intervention groupExperimental treatment 1 intervention
Group B: Delayed intervention control groupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
Baseline, 6 months
2

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.

Time frame
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.

Time frame
Baseline, 4 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Duke University

Lead sponsor

University of Cape Town

Collaborator

Source ClinicalTrials.gov
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