<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/NCT03825588</url>
  </required_header>
  <id_info>
    <org_study_id>STU 112016-057</org_study_id>
    <nct_id>NCT03825588</nct_id>
  </id_info>
  <brief_title>Establishing Efficacy of an Inpatient Intervention and Phone App to Reduce Suicidal Risk</brief_title>
  <acronym>ASAP+BRITE</acronym>
  <official_title>As Safe As Possible (ASAP): A Balanced, Two-by-Two Design To Test Conjoint and Unique Efficacy of an Inpatient Intervention and an Emotion Regulation/Safety Planning App in Preventing Suicide Attempts Post-Discharge</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Texas Southwestern Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Pittsburgh</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>American Foundation for Suicide Prevention</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Texas Southwestern Medical Center</source>
  <oversight_info>
    <has_dmc>Yes</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>
      In this 2-site study, University of Texas Southwestern Medical Center (UTSW) and Western&#xD;
      Psychiatric Institute and Clinic (WPIC), the investigators will conduct a randomized clinical&#xD;
      trial (RCT) in 240 psychiatrically hospitalized suicidal adolescents, examining the single&#xD;
      and additive effects of two components of an inpatient unit intervention for suicidal&#xD;
      adolescents, As Safe As Possible (ASAP), which focuses on emotion regulation and safety&#xD;
      planning, and an emotion regulation/safety plan phone app (BRITE).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The investigators aim to randomize 240 adolescents psychiatrically hospitalized for suicidal&#xD;
      ideation with a plan or a suicide attempt to one of four treatment arms: (1) ASAP + BRITE +&#xD;
      TAU (treatment as usual); (2) BRITE + TAU (treatment as usual); (3) ASAP + TAU (treatment as&#xD;
      usual); and (4) TAU (treatment as usual) alone. The investigators will assess suicidal&#xD;
      ideation and behavior at 4, 12, and 24 weeks post-intake, in order to:&#xD;
&#xD;
        1. Assess the relative efficacy of ASAP, BRITE and the combination on suicidal ideation,&#xD;
           non-suicidal self-injury (NSSI), and suicide attempts, and re-hospitalizations.&#xD;
&#xD;
        2. Examine mediators and moderators of treatment outcome.&#xD;
&#xD;
        3. Examine the costs and cost efficacy of ASAP and BRITE and the combination.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 1, 2019</start_date>
  <completion_date type="Actual">December 15, 2022</completion_date>
  <primary_completion_date type="Actual">December 15, 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Factorial Assignment</intervention_model>
    <intervention_model_description>Investigators will randomize 240 hospitalized suicidal adolescents with a history of a suicide attempt or ideation with plan to one of 4 conditions in a 2 by 2 design: (1) ASAP + BRITE; (2) BRITE + TAU (treatment as usual); (3) ASAP + TAU; or (4) TAU alone to determine the single and additive effects of ASAP and BRITE on suicide attempts in the subsequent six months.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
    <masking_description>During the RCT, the independent evaluator (IE) will be blinded to the assigned condition and will take the following steps to preserve the blind: participants and families will be asked not to share with the IE which condition they are assigned to; at staff meetings when cases are reviewed, IEs will not be present; IEs will be asked to guess what the treatment assignment is at the end of each interview, and they will notify the project coordinator if they become unblinded. Participants will complete complementary self-report forms that will not be influenced by interviewer bias.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Columbia Suicide Severity Rating Scale (C-SSRS)</measure>
    <time_frame>1 - 24 weeks</time_frame>
    <description>The primary outcome measure is the time to a suicide attempt or suicidal event. Ideation Intensity subscale range = 0-5 (higher values represent more severe intensity of ideation); Ideation Frequency subscale range =0-5 (higher values represent higher frequency); Suicidal Behavior subscales are categorical (yes/no) to define 1) actual attempt, 2) non-suicidal self-injurious behavior, 3) interrupted attempt, 4) aborted attempt, 5) preparatory acts or behavior, and 6) completed suicide.&#xD;
Actual Lethality/Medical Damage of Suicidal Behavior subscale range = 0-5 (higher values represent greater lethality/medical damage); Potential Lethality of Suicidal Behavior subscale range = 0-2 (higher values represent greater potential lethality</description>
  </primary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">241</enrollment>
  <condition>Suicidal Ideation</condition>
  <condition>Suicide, Attempted</condition>
  <arm_group>
    <arm_group_label>ASAP + BRITE + TAU (treatment as usual)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants in this arm receive the ASAP (As Safe As Possible) intervention, during their transition from inpatient to outpatient care, as well as the BRITE smart phone app for distress tolerance/emotion regulation and safety planning. Participants will also receive usual treatment protocols that all adolescents admitted to their respective Inpatient Psychiatry program receive. Participants complete paper safety plans as part of their regular treatment, which is a standard of care for suicidal youth.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>BRITE + TAU (treatment as usual)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants in this arm will receive the BRITE smart phone app for distress tolerance/emotion regulation and safety planning as they proceed from inpatient to outpatient care, in addition to usual treatment protocols that all adolescents admitted to their respective Inpatient Psychiatry program receive. Participants complete paper safety plans as part of their regular treatment, which is a standard of care for suicidal youth.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ASAP + TAU (treatment as usual)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants in this arm will receive the ASAP (As Safe As Possible) intervention during their transition from inpatient to outpatient care, in addition to usual treatment protocols that all adolescents admitted to their respective Inpatient Psychiatry program receive. Participants complete paper safety plans as part of their regular treatment, which is a standard of care for suicidal youth.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>TAU (treatment as usual) alone</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants in this grouping are studied as they proceed from inpatient to outpatient care, per usual treatment protocols at each site. Participants complete paper safety plans as part of their regular treatment, which is a standard of care for suicidal youth.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>ASAP (As Safe As Possible)</intervention_name>
    <description>ASAP (As Safe As Possible) is a brief intervention for adolescents hospitalized for suicide risk that focuses on the development of a safety plan, teaching emotion regulation and distress tolerance skills, along with 1-2 post-discharge follow-up calls to encourage adherence to use of the safety plan and to outpatient treatment.</description>
    <arm_group_label>ASAP + BRITE + TAU (treatment as usual)</arm_group_label>
    <arm_group_label>ASAP + TAU (treatment as usual)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>BRITE smart phone app</intervention_name>
    <description>BRITE is a smart phone app that aims to support daily emotion regulation and a safety plan that is personalized to the needs and preferences of each adolescent.</description>
    <arm_group_label>ASAP + BRITE + TAU (treatment as usual)</arm_group_label>
    <arm_group_label>BRITE + TAU (treatment as usual)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>TAU (treatment as usual)</intervention_name>
    <description>TAU (treatment as usual) is the standard treatment that all adolescents admitted to their respective Inpatient Psychiatry Program receive.</description>
    <arm_group_label>ASAP + BRITE + TAU (treatment as usual)</arm_group_label>
    <arm_group_label>ASAP + TAU (treatment as usual)</arm_group_label>
    <arm_group_label>BRITE + TAU (treatment as usual)</arm_group_label>
    <arm_group_label>TAU (treatment as usual) alone</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Youth admitted to the inpatient unit at either site for a recent suicide attempt or&#xD;
             significant suicidal ideation with a plan or intent.&#xD;
&#xD;
          -  The youth and parent are able to complete assessments in English, and the youth is&#xD;
             able to complete therapy.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  The youth currently exhibits psychosis.&#xD;
&#xD;
          -  The youth currently exhibits mania.&#xD;
&#xD;
          -  The youth is currently &lt;85% of their ideal body weight.&#xD;
&#xD;
          -  The youth is intellectually incapable of completing the study, e.g. has an&#xD;
             intelligence quotient (IQ) &lt; 70.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>12 Years</minimum_age>
    <maximum_age>17 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Beth D. Kennard, PsyD</last_name>
    <role>Principal Investigator</role>
    <affiliation>UT Southwestern Medical Center</affiliation>
  </overall_official>
  <overall_official>
    <last_name>David A Brent, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Pittsburgh</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Pittsburgh</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15213</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Texas Southwestern Medical Center</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75390</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Kennard BD, Goldstein T, Foxwell AA, McMakin DL, Wolfe K, Biernesser C, Moorehead A, Douaihy A, Zullo L, Wentroble E, Owen V, Zelazny J, Iyengar S, Porta G, Brent D. As Safe as Possible (ASAP): A Brief App-Supported Inpatient Intervention to Prevent Postdischarge Suicidal Behavior in Hospitalized, Suicidal Adolescents. Am J Psychiatry. 2018 Sep 1;175(9):864-872. doi: 10.1176/appi.ajp.2018.17101151. Epub 2018 Jul 19. Erratum In: Am J Psychiatry. 2019 Sep 1;176(9):764.</citation>
    <PMID>30021457</PMID>
  </reference>
  <reference>
    <citation>Kennard BD, Biernesser C, Wolfe KL, Foxwell AA, Craddock Lee SJ, Rial KV, Patel S, Cheng C, Goldstein T, McMakin D, Blastos B, Douaihy A, Zelazny J, Brent DA. Developing a Brief Suicide Prevention Intervention and Mobile Phone Application: a Qualitative Report. J Technol Hum Serv. 2015 Oct 1;33(4):345-357. doi: 10.1080/15228835.2015.1106384. Epub 2015 Dec 14.</citation>
    <PMID>26977137</PMID>
  </reference>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>December 10, 2018</study_first_submitted>
  <study_first_submitted_qc>January 29, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 31, 2019</study_first_posted>
  <last_update_submitted>February 22, 2023</last_update_submitted>
  <last_update_submitted_qc>February 22, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 27, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Texas Southwestern Medical Center</investigator_affiliation>
    <investigator_full_name>Beth Kennard</investigator_full_name>
    <investigator_title>PROFESSOR</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Suicide</mesh_term>
    <mesh_term>Suicidal Ideation</mesh_term>
    <mesh_term>Suicide, Attempted</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03825588
org study id: STU 112016-057
nct id: NCT03825588
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
In this 2-site study, University of Texas Southwestern Medical Center (UTSW) and Western
      Psychiatric Institute and Clinic (WPIC), the investigators will conduct a randomized clinical
      trial (RCT) in 240 psychiatrically hospitalized suicidal adolescents, examining the single
      and additive effects of two components of an inpatient unit intervention for suicidal
      adolescents, As Safe As Possible (ASAP), which focuses on emotion regulation and safety
      planning, and an emotion regulation/safety plan phone app (BRITE).
The investigators aim to randomize 240 adolescents psychiatrically hospitalized for suicidal
      ideation with a plan or a suicide attempt to one of four treatment arms: (1) ASAP + BRITE +
      TAU (treatment as usual); (2) BRITE + TAU (treatment as usual); (3) ASAP + TAU (treatment as
      usual); and (4) TAU (treatment as usual) alone. The investigators will assess suicidal
      ideation and behavior at 4, 12, and 24 weeks post-intake, in order to:

        1. Assess the relative efficacy of ASAP, BRITE and the combination on suicidal ideation,
           non-suicidal self-injury (NSSI), and suicide attempts, and re-hospitalizations.

        2. Examine mediators and moderators of treatment outcome.

        3. Examine the costs and cost efficacy of ASAP and BRITE and the combination.
allocation: Randomized
intervention model: Factorial Assignment
intervention model description: Investigators will randomize 240 hospitalized suicidal adolescents with a history of a suicide attempt or ideation with plan to one of 4 conditions in a 2 by 2 design: (1) ASAP + BRITE; (2) BRITE + TAU (treatment as usual); (3) ASAP + TAU; or (4) TAU alone to determine the single and additive effects of ASAP and BRITE on suicide attempts in the subsequent six months.
primary purpose: Treatment
masking: Single (Outcomes Assessor)
masking description: During the RCT, the independent evaluator (IE) will be blinded to the assigned condition and will take the following steps to preserve the blind: participants and families will be asked not to share with the IE which condition they are assigned to; at staff meetings when cases are reviewed, IEs will not be present; IEs will be asked to guess what the treatment assignment is at the end of each interview, and they will notify the project coordinator if they become unblinded. Participants will complete complementary self-report forms that will not be influenced by interviewer bias.
measure: Columbia Suicide Severity Rating Scale (C-SSRS)
time frame: 1 - 24 weeks
description: The primary outcome measure is the time to a suicide attempt or suicidal event. Ideation Intensity subscale range = 0-5 (higher values represent more severe intensity of ideation); Ideation Frequency subscale range =0-5 (higher values represent higher frequency); Suicidal Behavior subscales are categorical (yes/no) to define 1) actual attempt, 2) non-suicidal self-injurious behavior, 3) interrupted attempt, 4) aborted attempt, 5) preparatory acts or behavior, and 6) completed suicide.
Actual Lethality/Medical Damage of Suicidal Behavior subscale range = 0-5 (higher values represent greater lethality/medical damage); Potential Lethality of Suicidal Behavior subscale range = 0-2 (higher values represent greater potential lethality
arm group label: ASAP + BRITE + TAU (treatment as usual)
arm group type: Experimental
description: Participants in this arm receive the ASAP (As Safe As Possible) intervention, during their transition from inpatient to outpatient care, as well as the BRITE smart phone app for distress tolerance/emotion regulation and safety planning. Participants will also receive usual treatment protocols that all adolescents admitted to their respective Inpatient Psychiatry program receive. Participants complete paper safety plans as part of their regular treatment, which is a standard of care for suicidal youth.
arm group label: BRITE + TAU (treatment as usual)
arm group type: Experimental
description: Participants in this arm will receive the BRITE smart phone app for distress tolerance/emotion regulation and safety planning as they proceed from inpatient to outpatient care, in addition to usual treatment protocols that all adolescents admitted to their respective Inpatient Psychiatry program receive. Participants complete paper safety plans as part of their regular treatment, which is a standard of care for suicidal youth.
arm group label: ASAP + TAU (treatment as usual)
arm group type: Experimental
description: Participants in this arm will receive the ASAP (As Safe As Possible) intervention during their transition from inpatient to outpatient care, in addition to usual treatment protocols that all adolescents admitted to their respective Inpatient Psychiatry program receive. Participants complete paper safety plans as part of their regular treatment, which is a standard of care for suicidal youth.
arm group label: TAU (treatment as usual) alone
arm group type: Active Comparator
description: Participants in this grouping are studied as they proceed from inpatient to outpatient care, per usual treatment protocols at each site. Participants complete paper safety plans as part of their regular treatment, which is a standard of care for suicidal youth.
intervention type: Behavioral
intervention name: ASAP (As Safe As Possible)
description: ASAP (As Safe As Possible) is a brief intervention for adolescents hospitalized for suicide risk that focuses on the development of a safety plan, teaching emotion regulation and distress tolerance skills, along with 1-2 post-discharge follow-up calls to encourage adherence to use of the safety plan and to outpatient treatment.
arm group label: ASAP + BRITE + TAU (treatment as usual)
arm group label: ASAP + TAU (treatment as usual)
intervention type: Behavioral
intervention name: BRITE smart phone app
description: BRITE is a smart phone app that aims to support daily emotion regulation and a safety plan that is personalized to the needs and preferences of each adolescent.
arm group label: ASAP + BRITE + TAU (treatment as usual)
arm group label: BRITE + TAU (treatment as usual)
intervention type: Behavioral
intervention name: TAU (treatment as usual)
description: TAU (treatment as usual) is the standard treatment that all adolescents admitted to their respective Inpatient Psychiatry Program receive.
arm group label: ASAP + BRITE + TAU (treatment as usual)
arm group label: ASAP + TAU (treatment as usual)
arm group label: BRITE + TAU (treatment as usual)
arm group label: TAU (treatment as usual) alone
criteria: 
gender: All
minimum age: 12 Years
maximum age: 17 Years
healthy volunteers: No
last name: Beth D. Kennard, PsyD
role: Principal Investigator
affiliation: UT Southwestern Medical Center
last name: David A Brent, MD
role: Principal Investigator
affiliation: University of Pittsburgh
facility: 
facility: 
country: United States
citation: Kennard BD, Goldstein T, Foxwell AA, McMakin DL, Wolfe K, Biernesser C, Moorehead A, Douaihy A, Zullo L, Wentroble E, Owen V, Zelazny J, Iyengar S, Porta G, Brent D. As Safe as Possible (ASAP): A Brief App-Supported Inpatient Intervention to Prevent Postdischarge Suicidal Behavior in Hospitalized, Suicidal Adolescents. Am J Psychiatry. 2018 Sep 1;175(9):864-872. doi: 10.1176/appi.ajp.2018.17101151. Epub 2018 Jul 19. Erratum In: Am J Psychiatry. 2019 Sep 1;176(9):764.
PMID: 30021457
citation: Kennard BD, Biernesser C, Wolfe KL, Foxwell AA, Craddock Lee SJ, Rial KV, Patel S, Cheng C, Goldstein T, McMakin D, Blastos B, Douaihy A, Zelazny J, Brent DA. Developing a Brief Suicide Prevention Intervention and Mobile Phone Application: a Qualitative Report. J Technol Hum Serv. 2015 Oct 1;33(4):345-357. doi: 10.1080/15228835.2015.1106384. Epub 2015 Dec 14.
PMID: 26977137
responsible party type: Principal Investigator
investigator affiliation: University of Texas Southwestern Medical Center
investigator full name: Beth Kennard
investigator title: PROFESSOR
mesh term: Suicide
mesh term: Suicidal Ideation
mesh term: Suicide, Attempted
sharing ipd: Undecided