Using Mobile Health Technology to Optimize Communication Outcomes for South African Children With Developmental Disabilities
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Receptive Language Skills
研究概览
简要总结
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.
详细描述
Children with developmental disorders (DD), such as intellectual disability, autism spectrum disorder, cerebral palsy and other genetic disorders, that affect development and functioning, are at extremely high risk for developing speech and language disorders secondary to their primary condition. Speech and language disorders result in great difficulty communicating with others including primary caregivers, families, peers, and health care providers. These disorders and resulting communication difficulties negatively impact the child's growth, quality of life, long-term development, and later employment reducing the child's ability to contribute to society. Critical barriers to progress in intervention to remediate these difficulties, in countries such as South Africa, are that (1) children with DD and their families often live far from secondary and tertiary hospitals where speech and language intervention services are provided, (2) the families have diverse linguistic backgrounds and (3) health care providers have overwhelmingly large caseloads that result in reduced access to interventions. These issues impact the delivery of services to children with DD, whose speech, language and communication skills are significantly delayed and negatively affect the children's ability to participate, develop and learn at home and in the community.
This clinical trial will improve scientific knowledge about the effects of communication intervention on children's development by enhancing health care service delivery via mobile health technology (MHT) to South African children with DD and differing language backgrounds and their families by remediating speech and language disorders. This project will provide empirical data about the intervention approach and child and caregiver communication outcomes across languages that can be used as the basis for improvement of existing intervention programs. Using a web-based tablet intervention to assist caregivers in communicating with their children on a daily basis in the natural environment providing increased intervention opportunities for the child; 2) manipulate the interventions to promote and improve communication skills for both the child and caregiver; and 3) improve caregiver and speech-language pathologist satisfaction with child communication intervention;
The monthly interventions that the children currently receive at secondary/tertiary hospitals will be supplemented by providing caregivers with improved and enhanced training about communication with their children. This training will be coupled with regular ongoing information via MHT when they return home. This intervention strategy will provide empirical evidence for the role of communication intervention enhanced by MHT in assisting caregivers to implement communication strategies at home on a regular basis.
When the proposed aims are achieved, South African health care service delivery related to speech and language disorders for children with DD will have an empirically-tested strategy for caregiver enhanced intervention of speech and language disorders that can be delivered via MHT in local communities in the family's language. This outcome is in line with the mission and needs of the Fogarty International Center (FIC) and National Institute of Deafness and Other Communication Disorders (NIDCD). Our project will provide a novel approach to health care service delivery that will allow for enhanced collaboration between the speech-language pathologist and the caregiver.The advantages of the program includes the ability to implement communication interventions for children with DD in more locations and provide these children with more frequent communication intervention services through the use of MHT.
Approach The approach is to test the hypothesis that children with DD and their primary caregivers who receive a communication intervention enhanced by MHT will have more developed communication interaction skills than children who receive the standard secondary/tertiary care intervention. The interventions will be manipulated and measure child and caregiver communication interactions and caregiver and speech-language pathologist satisfaction with child communication intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 3 Years 至 6 Years(Child)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- 未提供
结局指标
主要结局
Receptive Language Skills
时间窗: 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.
Expressive Language Skills
时间窗: 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.
次要结局
- Caregiver Child Interaction Measures(3 months)
- SA CPOLD(3 months)
- SA SLPPOLD(3 months)
研究者
Maryann Romski
Regents Professor
Georgia State University
