Communication Outcomes for South African Children With Developmental Disabilities

NCT03409406 | Completed

• 1 other identifier: R21DC015225
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

developmental disability; speech and language disorder; mobile health technology; parent training; communication intervention

Outcome Measures

Primary Outcomes (2)

• Receptive Language Skills

  Receptive Language sub-scale of the Mullen Scales of Early Learning (MSEL) in child's native language. It provides a score in months of age.

  3 months

• Expressive Language Skills

  Expressive Language sub-scale of the Mullen Scales of Early Learning (MSEL) in child's native language. It provides a score in months of age.

  3 months

Secondary Outcomes (3)

• Caregiver Child Interaction Measures

  3 months

• SA CPOLD

  3 months

• SA SLPPOLD

  3 months

Study Arms (2)

Caregiver Intervention + ST Intervention

EXPERIMENTAL

Parents/caregivers receive web-based tablet protocol containing sequenced communication information for working with their child at home in addition to the Standard of Care Intervention.

Behavioral: Caregiver Intervention; Behavioral: ST Intervention

ST Intervention

ACTIVE COMPARATOR

This intervention is the once monthly standard of care intervention 30-minutes speech therapy (ST) session that the child receives at the hospital.

Behavioral: ST Intervention

Interventions

Caregiver Intervention BEHAVIORAL

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

Caregiver Intervention + ST Intervention

ST Intervention BEHAVIORAL

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

Caregiver Intervention + ST Intervention; ST Intervention

Eligibility Criteria

• Age: 3 Years - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• child diagnosis of severe developmental delay with beginning communication skills;
• child receiving monthly speech and language therapy in secondary/tertiary care hospital in northern South Africa

You may not qualify if:

• None

Sponsors & Collaborators

• Georgia State University: lead
• University of Pretoria: collaborator
• National Institute on Deafness and Other Communication Disorders (NIDCD): collaborator

Study Sites (1)

Center for Augmentative and Alternative Communication

Pretoria, Guatung, South Africa

Location

MeSH Terms

Conditions

Developmental Disabilities; Speech; Language Disorders

Condition Hierarchy (Ancestors)

Neurodevelopmental Disorders; Mental Disorders; Verbal Behavior; Communication; Behavior; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Juan Bornman, Ph.D.

  University of Pretoria, South Africa

  PRINCIPAL INVESTIGATOR

• MaryAnn Romski, Ph.D.

  Georgia State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Regents Professor

Study Record Dates

• First Submitted: January 10, 2018
• First Posted: January 24, 2018
• Study Start: July 1, 2018
• Primary Completion: September 30, 2019
• Study Completion: December 30, 2019
• Last Updated: April 10, 2020

Record last verified: 2020-04

Locations

ZA (1)