<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03229928</url>
  </required_header>
  <id_info>
    <org_study_id>16-2083</org_study_id>
    <secondary_id>4DR61604</secondary_id>
    <nct_id>NCT03229928</nct_id>
  </id_info>
  <brief_title>Clinical Testing of a Real-Time Behavior Measurement Tool: Measuring Outcomes for CHAnge</brief_title>
  <acronym>MOCHA</acronym>
  <official_title>Clinical Testing of a Real-Time Behavior Measurement Tool: Measuring Outcomes for CHAnge</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of North Carolina, Chapel Hill</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Center for Advancing Translational Sciences (NCATS)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
    <collaborator>
      <agency>RTI International</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of North Carolina, Chapel Hill</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_unapproved_device>Yes</is_unapproved_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The efficacy of clinical trials addressing behavioral issues in individuals with&#xD;
      intellectual/developmental disabilities (IDD) has traditionally been hampered by lack of&#xD;
      objective and sensitive measures. While there are many behavioral observation measures&#xD;
      available, most of them either rely on recall of the event or are designed for use by trained&#xD;
      professional observers, requiring a third party or extensive training for use. The Measuring&#xD;
      Outcomes for CHange (MOCHA) phone based application was developed to address the need for&#xD;
      feasible real-time tracking of behavior. For the current study, 2 parents of children with&#xD;
      IDD, 2 special education teachers, and 2 behavior health professionals will be recruited to&#xD;
      serve on a stakeholder advisory panel. These individuals will provide initial feedback on the&#xD;
      use of the application. Primary participants will be the parents and teachers of 10 children&#xD;
      or adolescents (age 5-17 years) who are seeking treatment and support for the child's&#xD;
      challenging behaviors (aggression, self-injurious behaviors, severe irritability) from&#xD;
      clinicians in the Behavior Medicine Clinic at the Carolina Institute for Developmental&#xD;
      Disabilities. Participants in the study will use MOCHA to record the child's behavior each&#xD;
      time it occurs over 6 weeks in order to test the feasibility of using MOCHA over time and in&#xD;
      response to treatment. The first 2 weeks of data collection will occur prior to the&#xD;
      participant's scheduled visit to the BMC. Following the clinic visit, where clinically&#xD;
      determined treatment suggestions will be provided, participants will continue to collect data&#xD;
      for 4 weeks to determine if long term data collection is feasible and if change can be&#xD;
      detected in response to the treatment through MOCHA (and compared to pen and paper&#xD;
      questionnaires). Two children will be chosen from this participant pool to wear a sensor&#xD;
      device to determine feasibility of syncing wearable sensors with the MOCHA app for use in&#xD;
      future research studies. Following the 6 weeks of MOCHA use, all participants will receive a&#xD;
      call or in person visit to conduct an exit interview about the participant's experiences&#xD;
      using MOCHA. The overall goal of this study is to determine the feasibility of the use of the&#xD;
      MOCHA application to track behaviors in populations of children with IDD. The MOCHA app does&#xD;
      not act as an intervention and is not modifying the environment of the participants, but will&#xD;
      be used as a tool by caregivers to track behaviors in real time.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Behavior problems occur frequently and are a persistent source of treatment needs in&#xD;
      individuals with intellectual and developmental disabilities (IDD). Problem behaviors such as&#xD;
      aggression, self-injurious behaviors (SIB), destruction of property, and irritability can&#xD;
      result in harm to self or others, interfere with social relationships, disrupt important&#xD;
      family processes, and compromise positive individual and family adaptation. The impact of&#xD;
      problem behaviors can have long term impacts for the individual, including reduced exposure&#xD;
      to education, reduced quantity and quality of social interactions, and increased likelihood&#xD;
      of more restrictive learning and living environments. Individuals with IDD who exhibit severe&#xD;
      aggression are more likely to be placed in residential treatment facilities and to be placed&#xD;
      on antipsychotic medications. Challenging behaviors have also repeatedly been shown to be&#xD;
      strongly associated with poorer mental and physical health in caregivers. While there is a&#xD;
      long history of both behavioral and pharmacologic interventions for aggression and SIB, the&#xD;
      evidence base is considered slim compared to other fields in health care. A key challenge for&#xD;
      clinicians and researchers in the IDD field is determining the efficacy of treatments to meet&#xD;
      the complex needs of their patients. The ability to adequately assess the efficacy of any&#xD;
      pharmacological or behavioral treatment has been limited by the lack of objective, real-time&#xD;
      measurement tools. While there are many measures of behavior, including behavioral&#xD;
      observation tools designed to assess the frequency, severity, and functions of specific&#xD;
      behaviors, these measures are often limited. Most behavior measures rely either on recall&#xD;
      (e.g., parent rating scales), or trained observers who, in addition to requiring specific&#xD;
      training in behavior observation techniques also, as a factor of their presence, may change&#xD;
      the behaviors and/or outcomes. The limitations inherent in these traditional measurement&#xD;
      techniques have at best made it difficult to test the true efficacy of a clinical&#xD;
      intervention, and, at worst, potentially resulted in the failure of clinical trials for&#xD;
      medications which may have shown positive results with more sensitive and objective outcome&#xD;
      measures.&#xD;
&#xD;
      MOCHA was developed in response to these challenges as an innovative yet simple method to&#xD;
      capture behaviors in real time. MOCHA is available for both iOS and android platforms and can&#xD;
      be sent remotely via a link to an individual's phone. MOCHA allows parents or teachers to&#xD;
      record a behavior event simply by opening an app on their phone or tablet. A series of&#xD;
      questions about the event allow for a brief yet comprehensive description of the event for&#xD;
      use in understanding potential antecedents and functions of the behavior. Data is securely&#xD;
      uploaded to a remote server at RTI whenever the participant is online. MOCHA was originally&#xD;
      developed and piloted through internal funding to Dr. Wheeler at RTI International. The pilot&#xD;
      study of four parents and three teachers of children with IDD was conducted primarily to&#xD;
      establish feasibility and acceptability data and to engage stakeholders in a user-centered&#xD;
      design approach to the development of the tool. Results from the pilot suggest that MOCHA is&#xD;
      an acceptable and feasible tool to capture behaviors during or shortly after a behavior&#xD;
      event. All parents and teachers in the pilot endorsed that MOCHA was easy to learn, clear and&#xD;
      understandable, easy to answer questions, easy to use and a useful tool. Participants also&#xD;
      reported the ability to record the behaviors and answer all follow up questions either when&#xD;
      the behavior occurred or shortly after. In order to optimize the potential for MOCHA as an&#xD;
      outcome measure there is a need to test its utility for measuring behaviors over time and in&#xD;
      response to treatment.&#xD;
&#xD;
      The aims for this next phase of feasibility of MOCHA are as follows:&#xD;
&#xD;
      Aim 1. Expand the current MOCHA application to include additional clinically relevant&#xD;
      features. Several features were suggested by participants in the development study to improve&#xD;
      the usability of MOCHA. Specifically, the ability to personalize the target behaviors ahead&#xD;
      of data collection; the use of a sync-able, wearable external event marker (EEM); and a&#xD;
      feedback feature with graphed data to assist with monitoring behavior over time were&#xD;
      requested features. Fortunately, MOCHA was developed using the Personal Health Informatics&#xD;
      Toolkit (PHIT), a RTI developed, configurable, mHealth platform for developing apps and&#xD;
      facilitating research. The PHIT platform has been used successfully for other apps with&#xD;
      features such EEM and physiological sensors, similar to the features the investigators are&#xD;
      proposing. Further, RTI has become an international leader in clinical informatics and&#xD;
      provides shared resources and access to experts through its iSHARE (Integrating Signals and&#xD;
      Human Response) program. Capitalizing on these resources, our first goal will be to develop&#xD;
      and integrate these proposed features, using user-centered design procedures and engaging&#xD;
      stakeholders in development.&#xD;
&#xD;
      Aim 2. Test the use of the MOCHA application to measure change in behaviors over time and in&#xD;
      response to intervention. In order to assess the ability to use MOCHA the investigators will&#xD;
      provide MOCHA to 10 families of individuals with IDD who are receiving intervention services&#xD;
      through an established behavioral medicine clinic. The primary purpose of this aim is to&#xD;
      examine the feasibility of the MOCHA app for use in recording frequency, intensity, and&#xD;
      occurrence of behaviors and considering that information with parent perception/report.&#xD;
&#xD;
      Aim 3. Explore the ability to sync MOCHA with physiological data via wearable sensors. An&#xD;
      ultimate vision of the MOCHA system includes the ability for the app to provide &quot;ground&#xD;
      truth&quot; observable behavior that occurs in conjunction with physiological changes. Although&#xD;
      full testing of a syncable system is outside the budgetary and time restrictions of this&#xD;
      funding mechanism, the investigators propose to move this vision closer to reality by a)&#xD;
      identifying wearable sensors that are acceptable and tolerable to the population and b)&#xD;
      testing the feasibility of time syncing physiological markers with MOCHA identified&#xD;
      behaviors.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 1, 2017</start_date>
  <completion_date type="Actual">May 1, 2018</completion_date>
  <primary_completion_date type="Actual">May 1, 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>MOCHA Exit Interview Score</measure>
    <time_frame>End of Treatment [or Study Period], approximately 6 weeks</time_frame>
    <description>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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>MOCHA Use Frequency</measure>
    <time_frame>End of Treatment [or Study Period], approximately 6 weeks</time_frame>
    <description>Data from the MOCHA application will be extracted to determine the frequency of use. Mean scores will be presented.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>MOCHA Clinician Interview Score</measure>
    <time_frame>At Study Completion, approximately 5 months</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Actual">10</enrollment>
  <condition>Neurodevelopmental Disorders</condition>
  <arm_group>
    <arm_group_label>Stakeholder Advisory Panel</arm_group_label>
    <description>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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Primary Participants</arm_group_label>
    <description>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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sensor Wearing Participants</arm_group_label>
    <description>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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>MOCHA</intervention_name>
    <description>MOCHA phone-based application&#xD;
Event tracker button that marks the beginning and end of a behavioral event. Similar to a FOB that connects to MOCHA application via bluetooth&#xD;
Wrist based sensor (applicable only to sensor wearing participants).</description>
    <arm_group_label>Primary Participants</arm_group_label>
    <arm_group_label>Sensor Wearing Participants</arm_group_label>
    <arm_group_label>Stakeholder Advisory Panel</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The population includes individuals with IDD who have been referred to the Behavior&#xD;
        Medicine Clinic at the Carolina Institute for Developmental Disabilities.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Individual being monitored through MOCHA&#xD;
&#xD;
          -  Ages 5-17 years&#xD;
&#xD;
          -  Documented intellectual/developmental disability&#xD;
&#xD;
          -  Presentation of aggression, self-injurious behavior, pica, or similar behavioral&#xD;
             challenges&#xD;
&#xD;
          -  Has at least 1 parent who speaks English&#xD;
&#xD;
          -  Seeking consultation with professionals through the Behavior Medicine Clinic at the&#xD;
             Carolina Institute for Developmental Disabilities&#xD;
&#xD;
        Parent and teacher of individual being monitored through MOCHA&#xD;
&#xD;
          -  Unlimited age range&#xD;
&#xD;
          -  English speaking&#xD;
&#xD;
        Exclusion Criteria Individual being monitored through MOCHA - Those who do not have a&#xD;
        caregiver who speaks English will be excluded due to lack of professionals and materials in&#xD;
        other languages&#xD;
&#xD;
        Parent and teacher of individual being monitored through MOCHA&#xD;
&#xD;
        - Those who do not speak English&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>5 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jean Mankowski, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of North Carolina, Chapel Hill</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Carolina Institute for Developmental Disabilities</name>
      <address>
        <city>Chapel Hill</city>
        <state>North Carolina</state>
        <zip>27510</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2018</verification_date>
  <study_first_submitted>July 19, 2017</study_first_submitted>
  <study_first_submitted_qc>July 24, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 26, 2017</study_first_posted>
  <last_update_submitted>May 7, 2018</last_update_submitted>
  <last_update_submitted_qc>May 7, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">May 8, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Behavior</keyword>
  <keyword>Outcome Measures</keyword>
  <keyword>Intellectual/Developmental Disabilities</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neurodevelopmental Disorders</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03229928
org study id: 16-2083
secondary id: 4DR61604
nct id: NCT03229928
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is unapproved device: Yes
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.
Behavior problems occur frequently and are a persistent source of treatment needs in
      individuals with intellectual and developmental disabilities (IDD). Problem behaviors such as
      aggression, self-injurious behaviors (SIB), destruction of property, and irritability can
      result in harm to self or others, interfere with social relationships, disrupt important
      family processes, and compromise positive individual and family adaptation. The impact of
      problem behaviors can have long term impacts for the individual, including reduced exposure
      to education, reduced quantity and quality of social interactions, and increased likelihood
      of more restrictive learning and living environments. Individuals with IDD who exhibit severe
      aggression are more likely to be placed in residential treatment facilities and to be placed
      on antipsychotic medications. Challenging behaviors have also repeatedly been shown to be
      strongly associated with poorer mental and physical health in caregivers. While there is a
      long history of both behavioral and pharmacologic interventions for aggression and SIB, the
      evidence base is considered slim compared to other fields in health care. A key challenge for
      clinicians and researchers in the IDD field is determining the efficacy of treatments to meet
      the complex needs of their patients. The ability to adequately assess the efficacy of any
      pharmacological or behavioral treatment has been limited by the lack of objective, real-time
      measurement tools. While there are many measures of behavior, including behavioral
      observation tools designed to assess the frequency, severity, and functions of specific
      behaviors, these measures are often limited. Most behavior measures rely either on recall
      (e.g., parent rating scales), or trained observers who, in addition to requiring specific
      training in behavior observation techniques also, as a factor of their presence, may change
      the behaviors and/or outcomes. The limitations inherent in these traditional measurement
      techniques have at best made it difficult to test the true efficacy of a clinical
      intervention, and, at worst, potentially resulted in the failure of clinical trials for
      medications which may have shown positive results with more sensitive and objective outcome
      measures.

      MOCHA was developed in response to these challenges as an innovative yet simple method to
      capture behaviors in real time. MOCHA is available for both iOS and android platforms and can
      be sent remotely via a link to an individual's phone. MOCHA allows parents or teachers to
      record a behavior event simply by opening an app on their phone or tablet. A series of
      questions about the event allow for a brief yet comprehensive description of the event for
      use in understanding potential antecedents and functions of the behavior. Data is securely
      uploaded to a remote server at RTI whenever the participant is online. MOCHA was originally
      developed and piloted through internal funding to Dr. Wheeler at RTI International. The pilot
      study of four parents and three teachers of children with IDD was conducted primarily to
      establish feasibility and acceptability data and to engage stakeholders in a user-centered
      design approach to the development of the tool. Results from the pilot suggest that MOCHA is
      an acceptable and feasible tool to capture behaviors during or shortly after a behavior
      event. All parents and teachers in the pilot endorsed that MOCHA was easy to learn, clear and
      understandable, easy to answer questions, easy to use and a useful tool. Participants also
      reported the ability to record the behaviors and answer all follow up questions either when
      the behavior occurred or shortly after. In order to optimize the potential for MOCHA as an
      outcome measure there is a need to test its utility for measuring behaviors over time and in
      response to treatment.

      The aims for this next phase of feasibility of MOCHA are as follows:

      Aim 1. Expand the current MOCHA application to include additional clinically relevant
      features. Several features were suggested by participants in the development study to improve
      the usability of MOCHA. Specifically, the ability to personalize the target behaviors ahead
      of data collection; the use of a sync-able, wearable external event marker (EEM); and a
      feedback feature with graphed data to assist with monitoring behavior over time were
      requested features. Fortunately, MOCHA was developed using the Personal Health Informatics
      Toolkit (PHIT), a RTI developed, configurable, mHealth platform for developing apps and
      facilitating research. The PHIT platform has been used successfully for other apps with
      features such EEM and physiological sensors, similar to the features the investigators are
      proposing. Further, RTI has become an international leader in clinical informatics and
      provides shared resources and access to experts through its iSHARE (Integrating Signals and
      Human Response) program. Capitalizing on these resources, our first goal will be to develop
      and integrate these proposed features, using user-centered design procedures and engaging
      stakeholders in development.

      Aim 2. Test the use of the MOCHA application to measure change in behaviors over time and in
      response to intervention. In order to assess the ability to use MOCHA the investigators will
      provide MOCHA to 10 families of individuals with IDD who are receiving intervention services
      through an established behavioral medicine clinic. The primary purpose of this aim is to
      examine the feasibility of the MOCHA app for use in recording frequency, intensity, and
      occurrence of behaviors and considering that information with parent perception/report.

      Aim 3. Explore the ability to sync MOCHA with physiological data via wearable sensors. An
      ultimate vision of the MOCHA system includes the ability for the app to provide "ground
      truth" observable behavior that occurs in conjunction with physiological changes. Although
      full testing of a syncable system is outside the budgetary and time restrictions of this
      funding mechanism, the investigators propose to move this vision closer to reality by a)
      identifying wearable sensors that are acceptable and tolerable to the population and b)
      testing the feasibility of time syncing physiological markers with MOCHA identified
      behaviors.
observational model: Cohort
time perspective: Prospective
measure: MOCHA Exit Interview Score
time frame: End of Treatment [or Study Period], approximately 6 weeks
description: 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.
measure: MOCHA Use Frequency
time frame: End of Treatment [or Study Period], approximately 6 weeks
description: Data from the MOCHA application will be extracted to determine the frequency of use. Mean scores will be presented.
measure: MOCHA Clinician Interview Score
time frame: At Study Completion, approximately 5 months
description: 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.
arm group label: Stakeholder Advisory Panel
description: 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.
arm group label: Primary Participants
description: 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.
arm group label: Sensor Wearing Participants
description: 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.
intervention type: Device
intervention name: MOCHA
description: 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).
arm group label: Primary Participants
arm group label: Sensor Wearing Participants
arm group label: Stakeholder Advisory Panel
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 5 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Jean Mankowski, PhD
role: Principal Investigator
affiliation: University of North Carolina, Chapel Hill
facility: 
country: United States
responsible party type: Sponsor
mesh term: Neurodevelopmental Disorders
sharing ipd: No