This trial is active, not recruiting.

Conditions dysarthria, down syndrome
Treatment speech sessions
Sponsor Duke University
Collaborator University of Rhode Island
Start date February 2014
End date November 2016
Trial size 3 participants
Trial identifier NCT01684670, Pro00039730


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose treatment
speech sessions
Subjects will be instructed to use clear speech and increased effort when speaking.

Primary Outcomes

Speech intelligibility
time frame: 3-6 months

Eligibility Criteria

Male or female participants at least 8 years old.

Inclusion Criteria: - 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 Exclusion Criteria: - Additional serious medical problems which prevent meaningful participation in the study.

Additional Information

Official title Intensive Dysarthria Sessions in Adults and Children With Down Syndrome
Trial information was received from ClinicalTrials.gov and was last updated in February 2016.
Information provided to ClinicalTrials.gov by Duke University.