Intensive Dysarthria Sessions in Adults and Children With Down Syndrome

NCT01684670 | Completed DMC

• 1 other identifier: Pro00039730
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

This research study is designed to investigate the feasibility and treatment effects of a behavioral speech treatment in adults and children with Down Syndrome (DS) and dysarthria. The speech sessions will provide an intensive, articulation-based intervention focused on increasing effort during speech production via use of "clear speech." A single subject multiple baselines across subjects design will be employed in a total of six subjects divided into two groups of three. Changes in dependent measures will be determined by visual inspection, effect size determination, and time series analysis. The study follows accepted procedures in rehabilitation treatment and research and there are minimal foreseeable risks associated with participation.

Conditions

Dysarthria; Down Syndrome

Outcome Measures

Primary Outcomes (1)

• Speech intelligibility

  Speech intelligibility in sentences scored by naive listeners.

  3-6 months

Study Arms (1)

Behavioral speech treatment

EXPERIMENTAL

Behavioral: Speech sessions

Interventions

Speech sessions BEHAVIORAL

Subjects will be instructed to use clear speech and increased effort when speaking.

Behavioral speech treatment

Eligibility Criteria

• Age: 8 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults and children with Downs Syndrome and dysarthria
• Ages 8 years and older
• Ability to verbally communicate; follow simple commands and/or imitate others; hear speech at a conversational level; and participate in assessment and speech sessions activities

You may not qualify if:

• Additional serious medical problems which prevent meaningful participation in the study.

Sponsors & Collaborators

• Duke University: lead
• University of Rhode Island: collaborator
• University of Florida: collaborator
• University of North Carolina, Chapel Hill: collaborator

Study Sites (1)

Duke University Health System

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Dysarthria; Down Syndrome

Condition Hierarchy (Ancestors)

Articulation Disorders; Speech Disorders; Language Disorders; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Intellectual Disability; Abnormalities, Multiple; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Chromosome Disorders; Genetic Diseases, Inborn

Study Officials

• Harrison N Jones, PhD

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2012
• First Posted: September 13, 2012
• Study Start: February 1, 2014
• Primary Completion: May 1, 2016
• Study Completion: May 1, 2016
• Last Updated: November 23, 2016

Record last verified: 2016-11

Locations

US (1)