Communication Outcomes for South African Children With Developmental Disabilities

NCT03409406 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2020-04-10

No results posted yet for this study

Summary

The goal is to remediate speech and language disorders early in the lives of South African children with significant developmental disorders (DD) by enhancing the health care service delivery system to better serve families across diverse backgrounds. This study assesses a new hybrid intervention to promote better communication skills for both the child and caregiver. The hybrid intervention includes a mobile health technology (MHT) web-based tablet protocol that assists parents/caregivers in communicating with their children on a daily basis at home over a 12-week period in addition to the current standard of care intervention, a 30-minute speech-language therapy session at the secondary/tertiary hospitals once a month. The hybrid intervention adds to the child's monthly therapy session by providing parents/caregivers with instruction about communication with their children via a sequenced web-based tablet protocol across a 12 week time period and face-to-face monthly follow-up at the hospital where the child receives therapy. Fifty parent/caregiver-child pairs (25 per group) will be assigned to either the hybrid intervention or the standard of care intervention. Child receptive and expressive language skills, child and parent/caregiver communication interactions and parent/caregiver and speech therapist satisfaction with child communication will be measured prior to the intervention and then again at the end of the 12-week period. The effects of the hybrid intervention and standard of care intervention on child communication skills, caregiver perception and satisfaction and speech therapist perception and satisfaction will be measured. The expectation is that the new MHT enhanced hybrid intervention program that is applicable and deliverable in culturally and linguistically diverse settings will enhance the child's receptive and expressive communication skills and result in greater parent/caregiver and speech therapist satisfaction related to the child. The impact includes enhanced health care service delivery to South African children with DD and their families so as to better serve the children with DD by remediating speech and language disorders on a daily basis.

Conditions

  • Developmental Disability

Interventions

BEHAVIORAL

Caregiver Intervention

This intervention is a 3-month (or 12 weeks) sequenced mobile health intervention provided to the parent/caregiver to use at home with the child. It supplements the 30 minute speech and language therapy session provided to the child at the hospital once a month

BEHAVIORAL

ST Intervention

This intervention is the 30 minute speech and language therapy session provided to the child at the hospital once a month for three months.

Sponsors & Collaborators

  • University of Pretoria

    collaborator OTHER
  • National Institute on Deafness and Other Communication Disorders (NIDCD)

    collaborator NIH
  • Georgia State University

    lead OTHER

Principal Investigators

  • Juan Bornman, Ph.D. · University of Pretoria, South Africa

  • MaryAnn Romski, Ph.D. · Georgia State University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
3 Years
Max Age
6 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-07-01
Primary Completion
2019-09-30
Completion
2019-12-30

Countries

  • South Africa

Study Locations

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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 NCT03409406 on ClinicalTrials.gov