N/A N=72 Health Services Research

Tailoring Treatment Targets for Early Autism Intervention in Africa

Autism Spectrum Disorder

Bottom Line

View on ClinicalTrials.gov: NCT04068688 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Dec 2022

Primary outcome: Primary: Supported Joint Engagement Measured by the Joint Engagement Rating Inventory (JERI) — 6; 4; 2; 4 score on a scale — p=1.00

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Early Start Denver Model (ESDM) (Behavioral); Telehealth coaching (Behavioral)
Age: Pediatric · 0+ yrs
Sex: All
Sponsor: Duke University
Primary completion: Aug 2021

Outcome Measures

Outcome	Result	p-value
PRIMARY Supported Joint Engagement Measured by the Joint Engagement Rating Inventory (JERI)	6; 4; 2; 4; 5.5; 5	1.00
PRIMARY Coordinated Joint Engagement Measured by the Joint Engagement Rating Inventory (JERI)	1; 1; 6; 2; 1; 1	0.655
PRIMARY Symbol-infused Joint Engagement Measured by the Joint Engagement Rating Inventory (JERI)	2; 2; 6.5; 2; 3; 1	0.014 sig
PRIMARY Fluency and Connectedness Measured by the Joint Engagement Rating Inventory (JERI)	4; 4; 6; 3; 5; 5	0.096
PRIMARY Shared Routines and Rituals Measured by the Joint Engagement Rating Inventory (JERI)	1; 1; 1; 1; 1; 1	1.00
PRIMARY Scaffolding Measured by the Joint Engagement Rating Inventory (JERI)	5; 4; 5; 2; 5; 4	0.442
PRIMARY Following in on a Child's Focus Measured by the Joint Engagement Rating Inventory (JERI)	5; 5; 5; 2; 6; 5	0.35
PRIMARY Caregiver Affect Measured by the Joint Engagement Rating Inventory (JERI)	4; 5; 5; 3; 4.5; 5	—
PRIMARY Initiation of Joint Attention (IJA) Measured by the Early Social Communication Scales (ESCS)	8.33; 69; 27	—
PRIMARY Response to Joint Attention (RJA) Measured by the Early Social Communication Scales (ESCS)	5; 15; 7	—
PRIMARY Language and Communication Developmental Quotient on the Griffiths Scales of Child Development 3rd Edition (Griffiths-III)	57.73; 114; 50; 62.24	0.004 sig
PRIMARY Personal-Social-Emotional Developmental Quotient on the Griffiths Scales of Child Development 3rd Edition (Griffiths-III)	63.41; 115; 83.33; 65.53	0.084
PRIMARY Socialization Subscale Standard Score on the Vineland Adaptive Behavior Scales - 3rd Edition (VABS-3)	61; 63; 67.5; 61	0.42
PRIMARY Communication Subscale Standard Score on the Vineland Adaptive Behavior Scales - 3rd Edition (VABS-3)	41; 34; 50; 40	0.011 sig
SECONDARY Acceptability of Telehealth Intervention (as Measured by the Acceptability of Intervention Measure, AIM)	4.25; 4.66; 4.78	—
SECONDARY Appropriateness of Telehealth Intervention (as Measured by the Intervention Appropriateness Measure, IAM)	4.47; 4.66; 4.66	—
SECONDARY Feasibility of Intervention (as Measured by the Feasibility of Intervention Measure, FIM)	4.14; 4.66; 4.9	—
SECONDARY Fidelity of Intervention Delivery, as Measured by the Caregiver ESDM Fidelity Rating System	60; 55; 75; 68	0.003 sig

Summary

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.

Eligibility Criteria

Inclusion Criteria

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
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
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
For the typically developing (TD) group only:

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

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
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

For all groups (ASD, DD, TD)
Significant sensory or motor impairment
Major physical abnormalities
History of serious head injury and/or neurological disease
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
For the developmental delay (DD) group

-Autism diagnosis based on DSM 5 criteria

For typically developing (TD group:
Autism diagnosis based on DSM 5 criteria

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04068688). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.