Development of the ORCA Communication Measure for Rett Syndrome

NCT04920110 | Completed

• 1 other identifier: ORCA-101-RSRT
• Study Type: observational
• Target: 272
• Locations: 1 country
• Sites: 1

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 child's communication abilities including expressive, receptive and pragmatic communication types. Caregivers will participate via phone interviews and online surveys. Approximately 270 participants will be enrolled.

Conditions

Rett Syndrome

Keywords

ORCA; Communication; Duke; MECP2; RSRT

Outcome Measures

Primary Outcomes (1)

• Observer-Reported Communication Ability Measure (ORCA)

  Using qualitative and quantitative methodology the existing ORCA measure will be evaluated for use in Rett syndrome and modified if needed. The ORCA measure produces a single score that is an estimate of an individual's overall level of communication ability. Higher ORCA scores reflect greater communication ability; the mastery of expressive, receptive, and pragmatic types of communication and higher vocabularies for verbal words and symbols on assistive devices. The ORCA T-score range is from 26.82 to 83.24.

  1 year

Study Arms (2)

Phase 1: Qualitative Interviews

Approximately 20 parents/caregivers will discuss typical communication abilities of their loved one and complete the ORCA measure for determination of its content validity through a hybrid approach of concept elicitation and cognitive testing.

Phase 2: Cross-Sectional Assessment of Psychometric Properties

Approximately 250 parents/caregivers will complete the ORCA measure and additional measures to determine its psychometric properties including reliability, floor/ceiling effects and construct validity.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Parents/caregivers of individuals with Rett syndrome confirmed by an MECP2 genetic mutation, who are fluent in English.

You may qualify if:

• Parent or caregiver at least 18 years of age, with a female child, age 2 or older, diagnosed with Rett syndrome confirmed by a disease-causing MECP2 genetic mutation.
• Fluency in the English language
• Currently lives with the child with Rett syndrome
• Ability and willingness to participate in all study activities.
• Access to a telephone and/or access to a device with internet access that is capable of supporting electronic survey completion

You may not qualify if:

• Parent or caregiver with clinically significant condition or situation that makes them not be suitable for the study, in the opinion of research staff.
• Parent or caregiver of a child with Rett syndrome who also has another diagnosis in addition to Rett syndrome.

Sponsors & Collaborators

• Rett Syndrome Research Trust: lead
• Duke University: collaborator

Study Sites (1)

Duke University

Durham, North Carolina, 27701, United States

Location

MeSH Terms

Conditions

Rett Syndrome; Communication

Condition Hierarchy (Ancestors)

X-Linked Intellectual Disability; Intellectual Disability; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Genetic Diseases, X-Linked; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Heredodegenerative Disorders, Nervous System; Behavior

Study Officials

• Bryce B Reeve, PhD

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2021
• First Posted: June 9, 2021
• Study Start: July 2, 2021
• Primary Completion: February 10, 2022
• Study Completion: February 10, 2022
• Last Updated: April 22, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)