Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03538925
Other study ID # 1061417
Secondary ID R01DC016321
Status Completed
Phase Phase 2
First received
Last updated
Start date May 11, 2018
Est. completion date December 31, 2023

Study information

Verified date January 2024
Source University of Central Florida
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The focus of this investigation is to compare the effectiveness of the AAC Generative Language Intervention approach to an AAC Standard of Care condition on preschool sentence productions. All children will use existing AAC iPad applications.


Description:

The central hypothesis is that preschoolers receiving AAC Generative Language Intervention will create longer, more grammatically complete sentences compared with the Standard of Care condition. Specific Aim 1 compares these interventions for preschoolers with severe speech impairments and typical receptive language, and Specific Aim 2 does the same for children with Down syndrome. Specific Aim 3 tests for possible moderation of the intervention effect by age, dynamic assessment scores, sentence type, receptive language abilities, prior AAC use, sex, mental age, and disability. Aims 1 and 2 will be accomplished using randomized controlled trials.


Recruitment information / eligibility

Status Completed
Enrollment 70
Est. completion date December 31, 2023
Est. primary completion date June 30, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 3 Years to 4 Years
Eligibility Inclusion Criteria: - Clinical Identification of Significant Speech Impairment - Must Speak English as a Primary Language - Must Be Able to Express At Least 25 Words (using any communication mode) - Must Be Able to Accurately Select Picture Symbols on iPad Communication App with at Least 50% Accuracy - Vision and Hearing within Functional Limits or Corrected to be within Functional Limits for Study Activities Exclusion Criteria: - Clinical Diagnosis of Autism or Social Communication Disorder - Primary Language Spoken is a Language Other than English

Study Design


Intervention

Behavioral:
AAC Generative Language Intervention
Parent/Caregiver AAC App Operational Training + Direct AAC Input-Output Language Intervention
Standard of Care / Business as Usual
Parent/Caregiver AAC App Operational Training

Locations

Country Name City State
United States University of New Mexico Department of Speech and Hearing Sciences Albuquerque New Mexico
United States FAAST Center at the University of Central Florida Orlando Florida

Sponsors (3)

Lead Sponsor Collaborator
University of Central Florida National Institute on Deafness and Other Communication Disorders (NIDCD), University of New Mexico

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Aided AAC Utterance Length Aided AAC sentence length measured in morphemes 6 Months
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