NCT03409406

Communication Outcomes for South African Children With Developmental Disabilities

Completed NA Last updated 10 April 2020

What this trial tests

NA trial testing Caregiver Intervention in Developmental Disability in 100 participants. Completed in 30 December 2019.

Timeline

1 July 2018

Primary endpoint
30 September 2019

30 December 2019

Quick facts

Lead sponsor	Georgia State University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	100
Start date	1 July 2018
Primary completion	30 September 2019
Estimated completion	30 December 2019
Sites	1 location across South Africa

Drugs / interventions tested

• Caregiver Intervention
• ST Intervention

Conditions studied

• Developmental Disability — all drugs for Developmental Disability →

Sponsor

Georgia State University

Who can join

Adults 3 to 6, any sex, with Developmental Disability. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.