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NCT03229928 · ClinicalTrials.gov registry record
Clinical Testing of a Real-Time Behavior Measurement Tool: Measuring Outcomes for CHAnge
A clinical trial, sponsored by University of North Carolina, Chapel Hill.
- Completed
- Registry status
- 10
- Enrollment target
NCT03229928 is a clinical trial that has completed, run by University of North Carolina, Chapel Hill. The registered enrollment target is 10 participants.
The verdict
NCT03229928 has completed, sponsored by University of North Carolina, Chapel Hill.
- COMPLETED
- Registry status
- 10 participants
- Enrollment target
Study Summary
The efficacy of clinical trials addressing behavioral issues in individuals with intellectual/developmental disabilities (IDD) has traditionally been hampered by lack of objective and sensitive measures. While there are many behavioral observation measures available, most of them either rely on recall of the event or are designed for use by trained professional observers, requiring a third party or extensive training for use. The Measuring Outcomes for CHange (MOCHA) phone based application was developed to address the need for feasible real-time tracking of behavior. For the current study, 2 parents of children with IDD, 2 special education teachers, and 2 behavior health professionals will be recruited to serve on a stakeholder advisory panel. These individuals will provide initial feedback on the use of the application. Primary participants will be the parents and teachers of 10 children or adolescents (age 5-17 years) who are seeking treatment and support for the child's challenging behaviors (aggression, self-injurious behaviors, severe irritability) from clinicians in the Behavior Medicine Clinic at the Carolina Institute for Developmental Disabilities. Participants in the study will use MOCHA to record the child's behavior each time it occurs over 6 weeks in order to test the feasibility of using MOCHA over time and in response to treatment. The first 2 weeks of data collection will occur prior to the participant's scheduled visit to the BMC. Following the clinic visit, where clinically determined treatment suggestions will be provided, participants will continue to collect data for 4 weeks to determine if long term data collection is feasible and if change can be detected in response to the treatment through MOCHA (and compared to pen and paper questionnaires). Two children will be chosen from this participant pool to wear a sensor device to determine feasibility of syncing wearable sensors with the MOCHA app for use in future research studies. Following the
Interventions
- DEVICE MOCHA
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2017-08-01 |
| Est. Completion | 2018-05-01 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03229928
The ClinicalTrials.gov registry entry for NCT03229928 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 10 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of North Carolina, Chapel Hill, which has 1,109 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which MOCHA is the first listed.
NCT03229928 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03229928 about?
NCT03229928 is a clinical study titled "Clinical Testing of a Real-Time Behavior Measurement Tool: Measuring Outcomes for CHAnge". The efficacy of clinical trials addressing behavioral issues in individuals with intellectual/developmental disabilities (IDD) has traditionally been hampered by lack of objective and sensitive measures. While there are many behavioral observation measures available, most of them either rely on reca...
What is the current status of trial NCT03229928?
This trial is currently completed. The enrollment target is 10 participants. The study started on 2017-08-01. Estimated completion is 2018-05-01.
What interventions are being tested in trial NCT03229928?
The interventions under investigation include: MOCHA (DEVICE).
Who is sponsoring clinical trial NCT03229928?
This trial is sponsored by University of North Carolina, Chapel Hill, which has 1,109 total clinical trials registered on ClinicalTrials.gov.
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