<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/NCT03258905</url>
  </required_header>
  <id_info>
    <org_study_id>R44AA026746-02A1</org_study_id>
    <secondary_id>R44AA026746-02A1</secondary_id>
    <nct_id>NCT03258905</nct_id>
  </id_info>
  <brief_title>Phone App for Grounding</brief_title>
  <official_title>Phone App for Grounding (De-escalation) of Substance-abusing Transition-age Youth</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Treatment Innovations</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institutes of Health (NIH)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Institute on Alcohol Abuse and Alcoholism (NIAAA)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Treatment Innovations</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The goal of this project is to continue to develop a smartphone application (&quot;app&quot;) to help&#xD;
      youth from ages 18-25 who have a substance abuse problem. The app will engage them in&#xD;
      grounding, which is a sensory-based experience to help them feel calm by reducing intense&#xD;
      negative feelings and impulses (such as the urge to use a substance or hurt themselves or&#xD;
      others).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Substance use disorder (SUD) is the second most common psychiatric diagnosis in the U.S.&#xD;
      population. Transition-age youth (TAY) from ages 18-25 are especially vulnerable to substance&#xD;
      use and SUD. This time period represents a distinct stage separate from adolescence and later&#xD;
      adulthood. It includes tasks such as leaving home to enter college, the workforce, or the&#xD;
      military; clarifying vocational goals; and attaining legal drinking age. This period is also&#xD;
      prime for experimentation with substance use and associated risks such as driving under the&#xD;
      influence, accidents, fighting and violence, HIV, and vulnerability to sexual assault. This&#xD;
      project focused on a major strategy, grounding, to help TAY de-escalate (reduce) intense&#xD;
      negative emotions and impulses. Grounding has long been used in psychiatric hospitals to&#xD;
      provide a safe, quick, and powerful way to reduce any intense negative feeling such as&#xD;
      impulses to hurt self or others, substance craving, anger, anxiety, etc. Described in detail&#xD;
      in the book Seeking Safety (SS), grounding using three pathways to focus the mind (mental),&#xD;
      body (physical), and heart (soothing). Grounding provides a way to regulate emotion, which is&#xD;
      a major challenge for TAY, especially given their hormone changes and emotional intensity.&#xD;
      Indeed substance use is often described as a short-term way to regulate emotion. Grounding is&#xD;
      a key module of SS, a widely-implemented, evidence-based SUD treatment model. In phase 1 the&#xD;
      investigator developed a beta version of a grounding app. The app promotes the use of&#xD;
      grounding in any environment in which emotions and impulses need to be regulated. It&#xD;
      capitalizes on TAYs' widespread use of mobile devices; and because grounding is a stand-alone&#xD;
      skill and sensory-oriented, it lends itself wonderfully to an app approach. An iterative&#xD;
      product development methodology was used based on end-user feedback and the impact of the app&#xD;
      was studied in a pilot randomized controlled trial (RCT) with 24 TAY. Half received the app&#xD;
      and the other half received grounding handouts. Results showed that the app was consistently&#xD;
      more positively rated than the handouts and was associated with significantly more use of&#xD;
      grounding and a higher score on a grounding knowledge test. All phase 1 benchmarks were met.&#xD;
      In phase 2 the investigator proposes to scale up both the app and the evaluation of it. There&#xD;
      are two specific aims: (1) To enhance the mobile grounding app by using exciting, innovative&#xD;
      technology approaches as well as expanding the grounding content in amount and type. (2) To&#xD;
      conduct an RCT with 68 TAY to evaluate the grounding app versus a control app. The control&#xD;
      app would control for both the use of a mobile device and the grounding content. The primary&#xD;
      outcome is based on power analysis from the phase 1 pilot; other outcomes and measures are&#xD;
      also included. The RCT uses rigorous scientific methods in its design, measures, and&#xD;
      statistics.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 1, 2019</start_date>
  <completion_date type="Actual">September 3, 2020</completion_date>
  <primary_completion_date type="Actual">September 3, 2020</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Grounding Knowledge Test</measure>
    <time_frame>6 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Total time spent on the app</measure>
    <time_frame>6 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>BASIS-32 Impulsive and Addictive Behavior subscale</measure>
    <time_frame>6 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Difficulties in Emotion Regulation Scale</measure>
    <time_frame>6 weeks</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Brief Addiction Monitor</measure>
    <time_frame>6 weeks</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Coping Self-Efficacy Scale</measure>
    <time_frame>6 weeks</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>BASIS-32 total score</measure>
    <time_frame>6 weeks</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Perceived Stress Scale</measure>
    <time_frame>6 weeks</time_frame>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">62</enrollment>
  <condition>Substance-Related Disorders</condition>
  <arm_group>
    <arm_group_label>Grounding enhanced app</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>A mobile app that uses the Seeking Safety grounding chapter content, enhanced with features designed to create strong engagement and interactivity</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Grounding text-only app</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>A mobile app that uses the Seeking Safety grounding chapter content in text format only</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Grounding enhanced app</intervention_name>
    <description>A mobile app that uses the Seeking Safety grounding chapter content, enhanced with features designed to create strong engagement and interactivity</description>
    <arm_group_label>Grounding enhanced app</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Grounding text-only app</intervention_name>
    <description>A mobile app that uses the Seeking Safety grounding chapter content in text format only</description>
    <arm_group_label>Grounding text-only app</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  outpatient&#xD;
&#xD;
          -  meets criteria for substance use disorder per the treatment site&#xD;
&#xD;
          -  has a smartphone (either Android or iOS)&#xD;
&#xD;
          -  has not attended and is not currently attending Seeking Safety treatment&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  current uncontrolled psychotic or bipolar disorder&#xD;
&#xD;
          -  currently criminal-justice involved such that we would need to report substance use or&#xD;
             other possible criminal behavior (e.g., to a parole or probation officer)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>25 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Lisa Najavits, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Treatment Innovations</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Treatment Innovations</name>
      <address>
        <city>Newton</city>
        <state>Massachusetts</state>
        <zip>02459</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2021</verification_date>
  <study_first_submitted>August 16, 2017</study_first_submitted>
  <study_first_submitted_qc>August 22, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 23, 2017</study_first_posted>
  <last_update_submitted>December 12, 2021</last_update_submitted>
  <last_update_submitted_qc>December 12, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">December 14, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>transition-age youth</keyword>
  <keyword>mobile app</keyword>
  <keyword>grounding</keyword>
  <keyword>Seeking Safety</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Substance-Related 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/NCT03258905
org study id: R44AA026746-02A1
secondary id: R44AA026746-02A1
nct id: NCT03258905
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The goal of this project is to continue to develop a smartphone application ("app") to help
      youth from ages 18-25 who have a substance abuse problem. The app will engage them in
      grounding, which is a sensory-based experience to help them feel calm by reducing intense
      negative feelings and impulses (such as the urge to use a substance or hurt themselves or
      others).
Substance use disorder (SUD) is the second most common psychiatric diagnosis in the U.S.
      population. Transition-age youth (TAY) from ages 18-25 are especially vulnerable to substance
      use and SUD. This time period represents a distinct stage separate from adolescence and later
      adulthood. It includes tasks such as leaving home to enter college, the workforce, or the
      military; clarifying vocational goals; and attaining legal drinking age. This period is also
      prime for experimentation with substance use and associated risks such as driving under the
      influence, accidents, fighting and violence, HIV, and vulnerability to sexual assault. This
      project focused on a major strategy, grounding, to help TAY de-escalate (reduce) intense
      negative emotions and impulses. Grounding has long been used in psychiatric hospitals to
      provide a safe, quick, and powerful way to reduce any intense negative feeling such as
      impulses to hurt self or others, substance craving, anger, anxiety, etc. Described in detail
      in the book Seeking Safety (SS), grounding using three pathways to focus the mind (mental),
      body (physical), and heart (soothing). Grounding provides a way to regulate emotion, which is
      a major challenge for TAY, especially given their hormone changes and emotional intensity.
      Indeed substance use is often described as a short-term way to regulate emotion. Grounding is
      a key module of SS, a widely-implemented, evidence-based SUD treatment model. In phase 1 the
      investigator developed a beta version of a grounding app. The app promotes the use of
      grounding in any environment in which emotions and impulses need to be regulated. It
      capitalizes on TAYs' widespread use of mobile devices; and because grounding is a stand-alone
      skill and sensory-oriented, it lends itself wonderfully to an app approach. An iterative
      product development methodology was used based on end-user feedback and the impact of the app
      was studied in a pilot randomized controlled trial (RCT) with 24 TAY. Half received the app
      and the other half received grounding handouts. Results showed that the app was consistently
      more positively rated than the handouts and was associated with significantly more use of
      grounding and a higher score on a grounding knowledge test. All phase 1 benchmarks were met.
      In phase 2 the investigator proposes to scale up both the app and the evaluation of it. There
      are two specific aims: (1) To enhance the mobile grounding app by using exciting, innovative
      technology approaches as well as expanding the grounding content in amount and type. (2) To
      conduct an RCT with 68 TAY to evaluate the grounding app versus a control app. The control
      app would control for both the use of a mobile device and the grounding content. The primary
      outcome is based on power analysis from the phase 1 pilot; other outcomes and measures are
      also included. The RCT uses rigorous scientific methods in its design, measures, and
      statistics.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Investigator)
measure: Grounding Knowledge Test
time frame: 6 weeks
measure: Total time spent on the app
time frame: 6 weeks
measure: BASIS-32 Impulsive and Addictive Behavior subscale
time frame: 6 weeks
measure: Difficulties in Emotion Regulation Scale
time frame: 6 weeks
measure: Brief Addiction Monitor
time frame: 6 weeks
measure: Coping Self-Efficacy Scale
time frame: 6 weeks
measure: BASIS-32 total score
time frame: 6 weeks
measure: Perceived Stress Scale
time frame: 6 weeks
arm group label: Grounding enhanced app
arm group type: Experimental
description: A mobile app that uses the Seeking Safety grounding chapter content, enhanced with features designed to create strong engagement and interactivity
arm group label: Grounding text-only app
arm group type: Active Comparator
description: A mobile app that uses the Seeking Safety grounding chapter content in text format only
intervention type: Behavioral
intervention name: Grounding enhanced app
description: A mobile app that uses the Seeking Safety grounding chapter content, enhanced with features designed to create strong engagement and interactivity
arm group label: Grounding enhanced app
intervention type: Behavioral
intervention name: Grounding text-only app
description: A mobile app that uses the Seeking Safety grounding chapter content in text format only
arm group label: Grounding text-only app
criteria: 
gender: All
minimum age: 18 Years
maximum age: 25 Years
healthy volunteers: No
last name: Lisa Najavits, PhD
role: Principal Investigator
affiliation: Treatment Innovations
facility: 
country: United States
responsible party type: Sponsor
mesh term: Substance-Related Disorders
sharing ipd: No