Tailoring Treatment Targets for Early Autism Intervention in Africa

Duke University

Status: Completed

Conditions: Autism Spectrum Disorder

Treatments: Behavioral: Early Start Denver Model (ESDM); Behavioral: Telehealth coaching

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04068688

Pro00103045

1R21MH120696 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

Naturalistic Developmental Behavioral Interventions (NDBIs), an evidence-based early autism spectrum disorder (ASD) intervention approach, target key behaviors that help language development. While efforts to use NDBIs are increasing worldwide, important gaps in our knowledge remain on whether the behaviors targeted by NDBIs are cross-culturally valid. This study in South Africa, a multi-cultural setting, will provide critical information on NDBI treatment targets and a novel digital outcome measure of treatment response.

COVID-19 adaptations: We aim to develop and implement telehealth NDBI coaching and utilize a mixed methods approach to gather implementation and preliminary effectiveness data on the telehealth intervention.

Full description

COVID-19 has significantly impacted autism spectrum disorder (ASD) clinical research and disrupted access to intervention services for children and families globally. In this ongoing study in Cape Town South Africa, a caregiver coaching Naturalistic Developmental Behavioral Intervention (NDBI) for young children with ASD has been adapted for implementation by non-specialists and implementation and clinical outcomes are being evaluated. For ongoing clinical trials, the University of Cape Town Institutional Review Board (IRB) has encouraged researchers to switch to a virtual platform, where possible. Telehealth caregiver coaching is cost-effective, increases access to rural and underserved populations, and improves understanding of family home and caregiving routines. We aim to develop and implement telehealth NDBI coaching and utilize a mixed methods approach and a longitudinal pre-post design to gather implementation and preliminary effectiveness data on the telehealth intervention.

Enrollment: 73 patients

Sex: All

Ages: 18 to 72 months old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. For ASD, DD, TD groups

   • Subject family speaks isiXhosa, Afrikaans, or English
   • Child's ethnicity/race is African or Coloured (A South African term for individuals with mixed racial heritage)
   • Child lives within an area served by the recruitment sites

2. For the ASD group only:

   • Child meets criteria for an ASD diagnosis based upon DSM-5 (Diagnostic and Statistical Manual of Mental Disorders) criteria and informed by the ADOS-2 (Autism Diagnostic Observation Schedule) administered by research reliable raters
   • Caregiver is at least 18 years old

3. For the developmental delay (DD) group only:

   • Child screens positive on the Ten Questions and negative for ASD on the ABC
   • Child has been diagnosed with developmental delay by a developmental pediatrician

4. For the typically developing (TD) group only:

   -Child screens negative on the Ten Questions and negative for ASD on the ABC

5. For the Early Childhood Development (ECD) Practitioners and Early Childhood Development Practitioner School Supervisors group:

   • Employed by participating recruitment partners (Western Cape Education Department Schools)
   • Involved in delivery of the caregiver coaching sessions, either in person or remotely

6. For the Early Start Denver Model (ESDM) supervisors group:

   • Trained ESDM therapist
   • Supervise weekly coaching sessions in the schools, and/or
   • Supervise remote intervention delivery sessions

Exclusion criteria

1. For all groups (ASD, DD, TD)

   • Significant sensory or motor impairment
   • Major physical abnormalities
   • History of serious head injury and/or neurological disease

2. For the ASD group:

   • Presence of a neurological disorder of known etiology (for e.g., Downs Syndrome)
   • Caregiver-child dyad unable to attend assessments and 12 coaching sessions

3. For the developmental delay (DD) group

   -Autism diagnosis based on DSM 5 criteria

4. For typically developing (TD group:

   • Autism diagnosis based on DSM 5 criteria

Trial design

Primary purpose: Health Services Research

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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73 participants in 6 patient groups

Caregiver-Child Dyads with ASD (Autism Spectrum Disorder)

Experimental group

Description:

Participants in this arm will be caregivers of and children with ASD.

Treatment:

Behavioral: Early Start Denver Model (ESDM)

Children with typical development

No Intervention group

Description:

Participants in this arm will be children with typical development.

Children with developmental delay

No Intervention group

Description:

Participants in this arm will be children with developmental delay.

Caregiver-Child Dyads with ASD (Autism Spectrum Disorder) Telehealth Adaptation

Experimental group

Description:

Participants in this arm will be caregivers of and children with ASD receiving telehealth intervention (adaptation due to COVID-19 restrictions).

Treatment:

Behavioral: Telehealth coaching

Early Childhood Development (ECD) Practitioners and ECD Practitioner School Supervisors

No Intervention group

Description:

The ECD worker and/or school supervisor are 1) employed by our participating recruitment partners (Western Cape Education Department Schools) and 2) involved in delivery of the caregiver coaching sessions, either in person or remotely.

Early Start Denver Model (ESDM) Supervisors

No Intervention group

Description:

The local supervisors are 1) trained ESDM therapist, 2) supervise weekly coaching sessions in the schools, and/or 3) supervise remote intervention delivery sessions.