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

NCT03229928 | Completed FDA Device

• 2 other identifiers: 16-20834DR61604
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Behavior; Outcome Measures; Intellectual/Developmental Disabilities

Outcome Measures

Primary Outcomes (1)

• MOCHA Exit Interview Score

  The MOCHA exit interview is a study developed survey used to better understand client usability of MOCHA. Questions include items measured on a Likert scale measuring range of agree-ability (Strongly Disagree \[0\] to Strongly Agree \[5\]), frequency (Never \[0\] to Very Often \[4\]), or likelihood of use (Very Unlikely \[0\] to Very Likely \[5\]) to a question prompt. Additional open-ended questions are also included. The investigators will present the mean score obtained on these interview questions and compare the number of individuals who fell above and below that score. Qualitative responses will be coded for themes and presented.

  End of Treatment [or Study Period], approximately 6 weeks

Secondary Outcomes (2)

• MOCHA Use Frequency

  End of Treatment [or Study Period], approximately 6 weeks

• MOCHA Clinician Interview Score

  At Study Completion, approximately 5 months

Study Arms (3)

Stakeholder Advisory Panel

The investigators will recruit 2 parents of children with IDD, 2 special education teachers, and 2 behavior health professionals to assist with the development and initial testing of the upgraded MOCHA application features to test usability.

Device: MOCHA

Primary Participants

The study primarily involves recruitment of clinically referred minor patients with IDD and their parents and teachers. Parents and teachers of 10 patients with IDD and co-morbid behavior problems will be asked to collect data via the MOCHA application on the frequency, antecedents,consequences, and other correlates of specific behavioral concerns.

Device: MOCHA

Sensor Wearing Participants

These will be the same participants from aim 2. All participants will be offered the opportunity to wear the sensors and provide and chose which ones they would prefer to wear. Two participants will be asked to wear the sensor for 48 hours in order to pilot test the feasibility of syncing sensor and MOCHA application data collection.

Device: MOCHA

Interventions

MOCHA DEVICE

* 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).

Primary Participants; Sensor Wearing Participants; Stakeholder Advisory Panel

Eligibility Criteria

• Age: 5 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The population includes individuals with IDD who have been referred to the Behavior Medicine Clinic at the Carolina Institute for Developmental Disabilities.

You may qualify if:

• Individual being monitored through MOCHA
• Ages 5-17 years
• Documented intellectual/developmental disability
• Presentation of aggression, self-injurious behavior, pica, or similar behavioral challenges
• Has at least 1 parent who speaks English
• Seeking consultation with professionals through the Behavior Medicine Clinic at the Carolina Institute for Developmental Disabilities
• Parent and teacher of individual being monitored through MOCHA
• Unlimited age range
• English speaking

You may not qualify if:

• Parent and teacher of individual being monitored through MOCHA
• \- Those who do not speak English

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• National Center for Advancing Translational Sciences (NCATS): collaborator
• RTI International: collaborator

Study Sites (1)

Carolina Institute for Developmental Disabilities

Chapel Hill, North Carolina, 27510, United States

Location

MeSH Terms

Conditions

Neurodevelopmental Disorders; Behavior; Developmental Disabilities

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Jean Mankowski, PhD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: July 19, 2017
• First Posted: July 26, 2017
• Study Start: August 1, 2017
• Primary Completion: May 1, 2018
• Study Completion: May 1, 2018
• Last Updated: May 8, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)