Ignite Creation Date:
2024-05-06 @ 4:15 PM
Last Modification Date:
2024-10-26 @ 2:06 PM
Study NCT ID:
NCT04920110
Status:
COMPLETED
Last Update Posted:
2022-04-22
First Post:
2021-06-02
Brief Title:
Development of the ORCA Communication Measure for Rett Syndrome
Sponsor:
Rett Syndrome Research Trust
Organization:
Rett Syndrome Research Trust
Study Overview
Official Title:
Validation of the Observer-Reported Communication Ability ORCA Measure in Rett Syndrome
Status:
COMPLETED
Status Verified Date:
2022-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Rett-ORCA
Brief Summary:
This measurement validation study will use qualitative and quantitative methodology to evaluate the Observer-Reported Communication Ability Measure ORCA to appropriately capture communication abilities in individuals with Rett syndrome The ORCA Measure is a caregiver-reported questionnaire that collects caregiver observations of their childs communication abilities including expressive receptive and pragmatic communication types Caregivers will participate via phone interviews and online surveys Approximately 270 participants will be enrolled
Detailed Description:
This study will develop the Observer-Reported Communication Ability Measure ORCA originally validated for Angelman syndrome to appropriately capture communication abilities in individuals with Rett syndrome The ORCA Measure is a caregiver-reported questionnaire that collects caregiver observations of their childs communication abilities including expressive receptive and pragmatic communication The goal of the study is to generate a validated tool to comprehensively assess communication in Rett syndrome and create an important endpoint for use in clinical trials
In phase 1 a hybrid approach to concept elicitation and cognitive testing will occur with caregivers to assess the existing ORCA measure and evaluate ORCA content validity Approximately 20 parentscaregivers of individuals with Rett syndrome will participate in qualitative in-depth interviews The ORCA measure instructions recall period and response choices will be evaluated
In phase 2 psychometric properties including reliability floorceiling effects construct validity and test-retest will be evaluated with approximately 250 caregiver-parents of individuals with Rett syndrome Caregivers will also complete additional questionnaires to allow comparison between the ORCA measure and existing measures Analysts will use a variety of statistical methods to evaluate the psychometric properties of the ORCA measure in Rett syndrome
In phase 1 a hybrid approach to concept elicitation and cognitive testing will occur with caregivers to assess the existing ORCA measure and evaluate ORCA content validity Approximately 20 parentscaregivers of individuals with Rett syndrome will participate in qualitative in-depth interviews The ORCA measure instructions recall period and response choices will be evaluated
In phase 2 psychometric properties including reliability floorceiling effects construct validity and test-retest will be evaluated with approximately 250 caregiver-parents of individuals with Rett syndrome Caregivers will also complete additional questionnaires to allow comparison between the ORCA measure and existing measures Analysts will use a variety of statistical methods to evaluate the psychometric properties of the ORCA measure in Rett syndrome
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None