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AAC Intervention for Intellectual Disability
N/A
Recruiting
Led By Emily D. Quinn, Ph.D.
Research Sponsored by Oregon Health and Science University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Children: sufficient motor skills to sit upright with support, interact with toys provided during the assessment, and access the AAC system
Children: diagnosis of IDD confirmed by caregiver or medical record
Timeline
Screening 3 weeks
Treatment Varies
Follow Up assessed 1-2 times per week through study completion, 3-4 months.
Awards & highlights
Study Summary
This trial aims to develop an intervention to improve communication for toddlers with IDD and their families. Qualitative methods and experiments are used to assess its feasibility and effectiveness.
Who is the study for?
This trial is for toddlers aged 24-36 months with intellectual and developmental disabilities (IDD) who have severe language delays but can sit up, interact, and use AAC systems. Caregivers must be fluent in English, over 18 years old, and experienced in early intervention. Speech-language pathologists should also speak English fluently, have experience with AAC in children with IDD, and work full or part-time providing language intervention.Check my eligibility
What is being tested?
The study tests an AAC intervention to improve communication in toddlers with IDD using a hybrid telehealth model. It involves interviews to tailor the approach based on caregiver preferences followed by pilot testing both in-person and via telehealth sessions to evaluate its effectiveness.See study design
What are the potential side effects?
As this is a non-medical intervention focusing on communication strategies rather than drugs or medical procedures, there are no traditional side effects; however, participants may experience varying levels of engagement or stress.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My child can sit with support and play with toys.
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My child has been diagnosed with an intellectual developmental disorder.
Select...
My child is between 2 and 3 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ assessed 1-2 times per week through study completion, 3-4 months.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~assessed 1-2 times per week through study completion, 3-4 months.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Caregiver Use of AAC Intervention Strategies
Secondary outcome measures
Change in Number of Child Communication Acts
Other outcome measures
Change in Acceptability of Intervention Measure (AIM)
Change in Communication Complexity Scale (CCS; Aim 3 Only)
Change in Communication Matrix (Aim 3 Only)
+3 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Early Augmentative and Alternative Communication (AAC) InterventionExperimental Treatment1 Intervention
After a period of stable baseline performance (3 to 5 sessions) on parent and child outcomes, the interventionist will apply the early AAC intervention.
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Who is running the clinical trial?
Oregon Health and Science UniversityLead Sponsor
978 Previous Clinical Trials
7,386,454 Total Patients Enrolled
Florida State UniversityOTHER
202 Previous Clinical Trials
31,737 Total Patients Enrolled
Emily D. Quinn, Ph.D.Principal InvestigatorOregon Health and Science University
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am the main caregiver for a child aged 2 to 3 years with intellectual and developmental disabilities.Children who have very limited ability to speak and communicate using words or gestures.Criterion: Speech-Language Pathologists who work with at least one child who uses AAC.Children must have normal hearing, which means their hearing test results should be between 0 to 25 decibels in at least one ear.Children who have a very significant delay in their development, as measured by a special test called the Mullen Scales of Early Learning.Children who use specific communication behaviors, as measured by a score higher than 7 on the Communication Complexity Scale.My child can sit with support and play with toys.Children must have normal vision, which means being able to see at least as well as 20/80 with at least one eye.My child has been diagnosed with an intellectual developmental disorder.My child's seizures are not controlled by medication.I am a caregiver and I am over 18 years old.My child is between 2 and 3 years old.I am a Speech-Language Pathologist and I am over 18 years old.Children must be able to understand and use at least 50 words, according to what their caregiver says on the MCDI-WG form.My child is exposed to English at home or in the community.I work with children aged 24-36 months with developmental delays, full or part-time.
Research Study Groups:
This trial has the following groups:- Group 1: Early Augmentative and Alternative Communication (AAC) Intervention
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are individuals currently being enrolled for participation in this experiment?
"According to records published on clinicaltrials.gov, this research study is presently accepting candidates. The initial post date of the trial was July 1st 2022 and it has been updated as recently as February 22nd 2023."
Answered by AI
What is the magnitude of the patient cohort participating in this investigation?
"Affirmative. The clinicaltrials.gov database indicates that this study is still actively recruiting participants, which began on July 1st 2022 and was last updated on February 22nd 2023. 50 patients are currently being sought out at a single medical center."
Answered by AI
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