ClinicalTrials.gov
ClinicalTrials.gov Menu

Communication Outcomes for South African Children With Developmental Disabilities

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03409406
Recruitment Status : Not yet recruiting
First Posted : January 24, 2018
Last Update Posted : April 10, 2018
Sponsor:
Collaborators:
University of Pretoria
National Institute on Deafness and Other Communication Disorders (NIDCD)
Information provided by (Responsible Party):
Maryann Romski, Georgia State University

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.

Condition or disease Intervention/treatment Phase
Developmental Disability Behavioral: Caregiver Intervention Behavioral: ST Intervention Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Using Mobile Health Technology to Optimize Communication Outcomes for South African Children With Developmental Disabilities
Estimated Study Start Date : May 1, 2018
Estimated Primary Completion Date : September 30, 2018
Estimated Study Completion Date : June 30, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Caregiver Intervention + ST Intervention
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
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.

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




Primary Outcome Measures :
  1. Receptive Language Skills [ Time Frame: 3 months ]
    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.

  2. Expressive Language Skills [ Time Frame: 3 months ]
    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.


Secondary Outcome Measures :
  1. Caregiver Child Interaction Measures [ Time Frame: 3 months ]
    The 10-minute video interaction between the caregiver and child will be transcribed and mean length of utterance will be calculated for parent and child

  2. SA CPOLD [ Time Frame: 3 months ]
    South African Caregiver Perception of Language Development Measure consists of 15 statements that the caregiver rates on a 1-5 Likert scale. It provides a score of from a low score of 15 to a high score of 45.

  3. SA SLPPOLD [ Time Frame: 3 months ]
    South African Speech Language Pathologist Perception of Language Development Measure will consist of 15 statements that the speech therapist rates on a 1-5 Likert scale. It provides a score of from a low score of 15 to a high score of 45.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   3 Years to 6 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03409406


Contacts
Contact: MaryAnn Romski, Ph.D. 404-413-5666 mromski@gsu.edu
Contact: Rose A. Sevcik, Ph.D. 404-413-6296 rsevcik@gsu.edu

Locations
South Africa
Center for Augmentative and Alternative Communication Not yet recruiting
Pretoria, Guatung, South Africa
Contact: Juan Bornman, Ph.D.         
Sponsors and Collaborators
Georgia State University
University of Pretoria
National Institute on Deafness and Other Communication Disorders (NIDCD)
Investigators
Principal Investigator: Juan Bornman, Ph.D. University of Pretoria, South Africa
Principal Investigator: MaryAnn Romski, Ph.D. Georgia State University

Responsible Party: Maryann Romski, Regents Professor, Georgia State University
ClinicalTrials.gov Identifier: NCT03409406     History of Changes
Other Study ID Numbers: GeorgiaSU
R21DC015225 ( U.S. NIH Grant/Contract )
First Posted: January 24, 2018    Key Record Dates
Last Update Posted: April 10, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Maryann Romski, Georgia State University:
developmental disability
speech and language disorder
mobile health technology
parent training
communication intervention

Additional relevant MeSH terms:
Developmental Disabilities
Neurodevelopmental Disorders
Mental Disorders