NCT03229928: MOCHA

Clinical Testing of a Real-Time Behavior Measurement Tool: Measuring Outcomes for CHAnge

Completed Last updated 8 May 2018

What this trial tests

trial testing MOCHA in Neurodevelopmental Disorders in 10 participants. Completed in 1 May 2018.

Timeline

1 August 2017

Primary endpoint
1 May 2018

1 May 2018

Quick facts

Lead sponsor	University of North Carolina, Chapel Hill
Status	Completed
Study type	OBSERVATIONAL
Enrollment	10
Start date	1 August 2017
Primary completion	1 May 2018
Estimated completion	1 May 2018
Sites	1 location across United States

Drugs / interventions tested

• MOCHA

Conditions studied

• Neurodevelopmental Disorders — all drugs for Neurodevelopmental Disorders →

Sponsor

University of North Carolina, Chapel Hill

Who can join

5 and older, any sex, with Neurodevelopmental Disorders. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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 6 weeks of MOCHA use, all participants will receive a call or in person visit to conduct an exit interview about the participant's experiences using MOCHA. The overall goal of this study is to determine the feasibility of the use of the MOCHA application to track behaviors in populations of children with IDD. The MOCHA app does not act as an intervention and is not modifying the environment of the participants, but will be used as a tool by caregivers to track behaviors in real time.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.