Tailoring Treatment Targets for Early Autism Intervention in Africa

NCT04068688 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 73

Last updated 2022-12-02

Study results available
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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.

Conditions

Interventions

BEHAVIORAL

Early Start Denver Model (ESDM)

Twelve one hour sessions, skill is introduced by "Help is in your hands" Community ESDM videos. Session skills include specific strategies caregivers can use to increase their child's attention to people and their child's communication; strategies to identify, create and use joint activity routines to engage with and teach their child; in addition to ways to use the ABCs of learning to teach their child new behaviors. "Help is in your hands" Community ESDM materials also provide video examples of other caregivers using the session skill with their child. The early childhood development practitioner then coaches the caregiver in the session skill, in at least two activities. The goal of coaching was to provide enough support for the caregiver to experience success in implementing the new skill with their child. Coaching is followed by caregiver reflection and a discussion of generalization of the new skill across various daily activities, using a daily activities visual aid.

BEHAVIORAL

Telehealth coaching

The telehealth coaching intervention was informed by the Community-Early Start Denver Model (C-ESDM) materials. Twelve session-specific visuals with simple-text (for caregivers) and session scripts (for non-specialist coaches) were developed by the research team. Over 12, 1-hour asynchronous caregiver coaching sessions that are delivered by non-specialists, caregivers were 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. The session itself being delivered via phone. Prior to the coaching session staff shared session materials with the family via WhatsApp. Prior to the session the caregiver shared a 6-min video of an interaction with their child. During the session, the caregiver and coach reviewed the video, and the caregiver completed a self-reflection checklist.

Sponsors & Collaborators

  • University of Cape Town

    collaborator OTHER
  • National Institute of Mental Health (NIMH)

    collaborator NIH
  • Duke University

    lead OTHER

Principal Investigators

  • Lauren Franz, MB, CHB · Duke University

Study Design

Allocation
NON_RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Months
Max Age
72 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-09-01
Primary Completion
2021-08-26
Completion
2021-08-26

Countries

  • South Africa

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04068688 on ClinicalTrials.gov