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

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 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.

Conditions

• Neurodevelopmental Disorders

Interventions

DEVICE

MOCHA

* MOCHA phone-based application * Event tracker button that marks the beginning and end of a behavioral event. Similar to a FOB that connects to MOCHA application via bluetooth * Wrist based sensor (applicable only to sensor wearing participants).

Sponsors & Collaborators

• National Center for Advancing Translational Sciences (NCATS)

  collaborator NIH

• RTI International

  collaborator OTHER

• University of North Carolina, Chapel Hill

  lead OTHER

Principal Investigators

• Jean Mankowski, PhD · University of North Carolina, Chapel Hill

Eligibility

Min Age

5 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2017-08-01

Primary Completion

2018-05-01

Completion

2018-05-01

FDA Device

Yes

Countries

• United States

Study Locations