Clinical trial NCT04068688: Tailoring Treatment Targets for Early Autism Intervention in Africa
Official title: Tailoring Treatment Targets for Early Autism Intervention in Africa
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Autism Spectrum Disorder
Keywords: NDBI
Autism
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: University of Cape Town
name: National Institute of Mental Health (NIMH)
First posted: 2019-08-28
Enrollment: 73
Sex: ALL
Minimum age (years): 18
Maximum age (years): 72
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Note the autism group will be the only group to receive intervention. The typically developing and developmental delay group will receive one baseline assessment, and no intervention. COVID-19 necessitated a pivot from in-person to telehealth coaching.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Supported Joint Engagement Measured by the Joint Engagement Rating Inventory (JERI)
timeFrame: Baseline and Follow-up (after 12 intervention sessions, up to 3 months)
measure: Coordinated Joint Engagement Measured by the Joint Engagement Rating Inventory (JERI)
timeFrame: Baseline and Follow-up (after 12 intervention sessions, up to 3 months)
measure: Symbol-infused Joint Engagement Measured by the Joint Engagement Rating Inventory (JERI)
timeFrame: Baseline and Follow-up (after 12 intervention sessions, up to 3 months)
measure: Fluency and Connectedness Measured by the Joint Engagement Rating Inventory (JERI)
timeFrame: Baseline and Follow-up (after 12 intervention sessions, up to 3 months)
measure: Shared Routines and Rituals Measured by the Joint Engagement Rating Inventory (JERI)
timeFrame: Baseline and Follow-up (after 12 intervention sessions, up to 3 months)
measure: Scaffolding Measured by the Joint Engagement Rating Inventory (JERI)
timeFrame: Baseline and Follow-up (after 12 intervention sessions, up to 3 months)
measure: Following in on a Child's Focus Measured by the Joint Engagement Rating Inventory (JERI)
timeFrame: Baseline and Follow-up (after 12 intervention sessions, up to 3 months)
measure: Caregiver Affect Measured by the Joint Engagement Rating Inventory (JERI)
timeFrame: Baseline and Follow-up (after 12 intervention sessions, up to 3 months)
measure: Initiation of Joint Attention (IJA) Measured by the Early Social Communication Scales (ESCS)
timeFrame: Baseline
measure: Response to Joint Attention (RJA) Measured by the Early Social Communication Scales (ESCS)
timeFrame: Baseline
measure: Language and Communication Developmental Quotient on the Griffiths Scales of Child Development 3rd Edition (Griffiths-III)
timeFrame: Baseline and Follow up (after 12 intervention sessions, up to 3 months)
measure: Personal-Social-Emotional Developmental Quotient on the Griffiths Scales of Child Development 3rd Edition (Griffiths-III)
timeFrame: Baseline and Follow up (after 12 intervention sessions, up to 3 months)
measure: Socialization Subscale Standard Score on the Vineland Adaptive Behavior Scales - 3rd Edition (VABS-3)
timeFrame: Baseline and Follow up (after 12 intervention sessions, up to 3 months)
measure: Communication Subscale Standard Score on the Vineland Adaptive Behavior Scales - 3rd Edition (VABS-3)
timeFrame: Baseline and Follow up (after 12 intervention sessions, up to 3 months)
Secondary outcomes:
measure: Acceptability of Telehealth Intervention (as Measured by the Acceptability of Intervention Measure, AIM)
timeFrame: Follow-up (within 2 weeks of ending sessions)
measure: Appropriateness of Telehealth Intervention (as Measured by the Intervention Appropriateness Measure, IAM)
timeFrame: Follow-up (within 2 weeks of ending sessions)
measure: Feasibility of Intervention (as Measured by the Feasibility of Intervention Measure, FIM)
timeFrame: Follow-up (within 2 weeks of ending sessions)
measure: Fidelity of Intervention Delivery, as Measured by the Caregiver ESDM Fidelity Rating System
timeFrame: Baseline and Follow-up (up to 4 months)
Other outcomes:
measure: Postural Sway Measured by the SenseToKnow App
timeFrame: Baseline and Baseline and Follow up (after 12 intervention sessions, up to 3 months) ASD group; Baseline typically developing and developmental delay group
measure: Gaze Patterns Measured by the SenseToKnow App
timeFrame: Baseline and Baseline and Follow up (after 12 intervention sessions, up to 3 months) ASD group; Baseline typically developing and developmental delay group
measure: Social Referencing Measured by the SenseToKnow App
timeFrame: Baseline and Baseline and Follow up (after 12 intervention sessions, up to 3 months) ASD group; Baseline typically developing and developmental delay group
measure: Affective Response Measured by the SenseToKnow App
timeFrame: Baseline and fBaseline and Follow up (after 12 intervention sessions, up to 3 months) ASD group; Baseline typically developing and developmental delay group
Locations:
city: Cape Town
country: South Africa
facility: University of Cape Town
state: West Cape
Study officials:
affiliation: Duke University
name: Lauren Franz, MB, CHB
role: PRINCIPAL_INVESTIGATOR
References: