Delivering Early Intervention to Children With Down Syndrome

Status Completed

Clinical Trial Summary

Children with Down syndrome (DS) are at risk for significant language and communication impairments. Enhancing the service delivery of early intervention for children with DS is a key research and policy issue given the prevalence and detrimental effects of persistent language impairments. Using a telemedicine approach allows clinicians to provide evidence-based treatment to families from a wide geographic area in Oregon who may not otherwise have access to a language intervention specialized for children with DS. Our innovative project involves the creation of a new treatment optimized for children with DS, as it will be the first study that translates an existing evidence-based language intervention-Enhanced Milieu Teaching (EMT) into a telemedicine model. The goal of this study is to examine whether a telemedicine approach is effective for training parents to implement EMT language support strategies and whether changes in parent behavior are associated with child communication and language growth. The investigators will pilot the telemedicine initiative to provide early intervention services to ten children with DS (aged 18- 48 months) and their families who live in rural and /or under-served areas of Oregon. The investigators will use single-case research design methodology to pilot this intervention research. The investigators will use secure video-teleconferencing technology to provide EMT. Clinicians will provide EMT to parents through interactive coaching, teaching them how to foster their children's social communication and language skills. Outcomes will focus on parents' use of language support strategies and children's social communication and language skills. Delivering early intervention to children with DS and providing parent-training at a distance using a telemedicine approach has the potential to transform the delivery of early language interventions for children with DS. Results of this study will directly inform the development and refinement of language interventions for young children with DS.

Clinical Trial Description

1. Aim 1: To examine the effect of using a telemedicine service delivery model to teach parents of children with DS to use EMT language support strategies. The investigators hypothesize that parents will learn to use EMT language support strategies from the personalized instruction provided during 36 intervention sessions. 2. Aim 2: To examine the effect of delivering EMT using a telemedicine service delivery model to improve the spoken language and social communication skills of children with DS. The investigators hypothesize that improvements in child communication and language skills will result from increasing parents' use of EMT language support strategies during everyday parent-child interactions such as play with toys, singing songs, book reading, and mealtimes. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03935620
Study type	Interventional
Source	Oregon Health and Science University
Contact
Status	Completed
Phase	N/A
Start date	June 1, 2019
Completion date	December 1, 2021

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT04854122` - Blood Flow Regulation in Individuals With Down Syndrome - Training Study	N/A
Completed	`NCT04020302` - Self-Monitoring Shopping Intervention	N/A
Recruiting	`NCT01950624` - DS-Connect {TM}: The Down Syndrome Registry
Completed	`NCT04751136` - the Effect of Cerebrolysin on Physical and Mental Functions of Down Syndrome	Phase 2
Completed	`NCT04767412` - Inspiratory Muscle Training and Physical Fitness in Children With Down Syndrome Randomized Control Trial	N/A
Not yet recruiting	`NCT04037579` - Protocol for a Non-randomized Survey in Down Syndrome People Who Practice Sports. Self and Observers´ Perception.
Completed	`NCT04536506` - Bobath and Vojta Therapy for DS	N/A
Completed	`NCT02882698` - Performance Analysis in Down Syndrome on Mobile Phone	N/A
Completed	`NCT01791725` - A 4-Week Safety Study of Oral ELND005 in Young Adults With Down Syndrome Without Dementia	Phase 2
Unknown status	`NCT01975545` - Fluor Varnish With Silver Nanoparticles for Dental Remineralization in Patients With Trisomy 21	Phase 2
Completed	`NCT01808508` - Obstructive Sleep Apnea and Neurocognitive and Cardiovascular Function in Children With Down Syndrome	N/A
Terminated	`NCT00754052` - Evaluating The Efficacy And Safety Of Donepezil Hydrochloride (Aricept) In The Treatment Of The Cognitive Dysfunction Exhibited By Children With Down Syndrome, Aged 11 To 17	Phase 3
Terminated	`NCT00754013` - Evaluating The Efficacy And Safety Of Donepezil Hydrochloride (Aricept) In The Treatment Of The Cognitive Dysfunction Exhibited By Children With Down Syndrome, Aged 6 To 10	Phase 3
Completed	`NCT01313325` - Hippotherapy to Improve the Balance of Children With Movement Disorders	N/A
Completed	`NCT01256112` - Parent Supported Weight Reduction in Down Syndrome	N/A
Completed	`NCT01594346` - Multicenter Vitamin E Trial in Aging Persons With Down Syndrome	Phase 3
Completed	`NCT05343468` - Life Skills Improved in Children With Down Syndrome After Using Assistive Technology	N/A
Suspended	`NCT05755464` - Evaluation of Patients With Down Syndrome Compliance to Dental Therapy
Recruiting	`NCT04022460` - Using Personal Mobile Technology to Identify Obstructive Sleep Apnea in Children With Down Syndrome (UPLOAD)
Completed	`NCT04818437` - Effect of Core Stability Exercises and Balance Training in Postural Control Among Down Syndrome	N/A