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

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ClinicalTrials.gov Identifier: NCT03229928
Recruitment Status : Completed
First Posted : July 26, 2017
Last Update Posted : May 8, 2018
Sponsor:
Collaborators:
National Center for Advancing Translational Science (NCATS)
RTI International
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill

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.

Condition or disease Intervention/treatment
Neurodevelopmental Disorders Device: MOCHA

  Show Detailed Description

Study Type : Observational
Actual Enrollment : 10 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Clinical Testing of a Real-Time Behavior Measurement Tool: Measuring Outcomes for CHAnge
Actual Study Start Date : August 1, 2017
Actual Primary Completion Date : May 1, 2018
Actual Study Completion Date : May 1, 2018

Group/Cohort Intervention/treatment
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
  • 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
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
  • 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).

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
  • 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 Outcome Measures :
  1. MOCHA Exit Interview Score [ Time Frame: End of Treatment [or Study Period], approximately 6 weeks ]
    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.


Secondary Outcome Measures :
  1. MOCHA Use Frequency [ Time Frame: End of Treatment [or Study Period], approximately 6 weeks ]
    Data from the MOCHA application will be extracted to determine the frequency of use. Mean scores will be presented.

  2. MOCHA Clinician Interview Score [ Time Frame: At Study Completion, approximately 5 months ]
    The MOCHA clinician interview is a study developed survey used to better understand clinician 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. Qualitative responses will be coded for themes and presented.



Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Criteria

Inclusion Criteria:

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

Exclusion Criteria Individual being monitored through MOCHA - Those who do not have a caregiver who speaks English will be excluded due to lack of professionals and materials in other languages

Parent and teacher of individual being monitored through MOCHA

- Those who do not speak English


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03229928


Locations
United States, North Carolina
Carolina Institute for Developmental Disabilities
Chapel Hill, North Carolina, United States, 27510
Sponsors and Collaborators
University of North Carolina, Chapel Hill
National Center for Advancing Translational Science (NCATS)
RTI International
Investigators
Principal Investigator: Jean Mankowski, PhD University of North Carolina, Chapel Hill

Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT03229928     History of Changes
Other Study ID Numbers: 16-2083
4DR61604 ( Other Identifier: National Center for Advancing Translational Science )
First Posted: July 26, 2017    Key Record Dates
Last Update Posted: May 8, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Pediatric Postmarket Surveillance of a Device Product: No

Keywords provided by University of North Carolina, Chapel Hill:
Behavior
Outcome Measures
Intellectual/Developmental Disabilities

Additional relevant MeSH terms:
Neurodevelopmental Disorders
Mental Disorders