xml: <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/NCT06018285</url>
    </required_header>
    <id_info>
      <org_study_id>STUDY00002515</org_study_id>
      <secondary_id>1P50MH127476</secondary_id>
      <secondary_id>7956</secondary_id>
      <nct_id>NCT06018285</nct_id>
    </id_info>
    <brief_title>Stepped Approach to Reducing Risk of Suicide in Primary Care</brief_title>
    <acronym>STARRS-PC</acronym>
    <official_title>Stepped Approach to Reducing Risk of Suicide in Primary Care</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Cynthia Fontanella</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>National Institute of Mental Health (NIMH)</agency>
        <agency_class>NIH</agency_class>
      </collaborator>
      <collaborator>
        <agency>Ohio State University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Holzer Gallipolis</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Holzer Jackson</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Holzer Athens</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Eastglen Pediatrics</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Signature Health Ashtabula</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Signature Health Willoughby</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Signature Health Painesville</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>AxessPointe - Arlington</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Dayton Children's - Main Campus</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Dayton Children's - Northwest Campus</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Cornerstone Pediatrics</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Kettering Pediatric and Family Care</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Franklin Avenue Primary Care Center</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Village Square Primary Care Center</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Spring Valley Primary Care Center</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Nationwide Children's Hospital</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>
        Suicide is the second leading cause of death among young people aged 12-17 years in the&#xD;
        United States, yet many youth at risk for suicide are not identified or go untreated. Stepped&#xD;
        care approaches have been shown to be effective at reducing suicide risk in clinical&#xD;
        settings, including primary care. The goal of this hybrid I stepped wedge&#xD;
        effectiveness-implementation study is to test the effectiveness of a population-based quality&#xD;
        improvement (QI) intervention, entitled STARRS-PC (Stepped Approach to Reducing Risk of&#xD;
        Suicide in Primary Care) compared to treatment as usual (TAU), in reducing the risk of&#xD;
        suicidal behavior among youth in the pediatric primary care setting. STARRS-PC implements a&#xD;
        clinical pathway for youth at elevated risk for suicide in pediatric primary care clinics.&#xD;
        Clinical pathways are tools used by health professionals to guide evidence-informed practice.&#xD;
        The STARRS-PC pathway consists of three evidence-based suicide clinical care processes: risk&#xD;
        detection, assessment and triage, and, if needed, follow-up transitional care.&#xD;
  &#xD;
        STARRS-PC is guided by the Practical, Robust Implementation, and Sustainability Model&#xD;
        (PRISM), which allows for the study of factors that influence effective implementation of the&#xD;
        suicide prevention clinical pathway and is focused on scalability.&#xD;
  &#xD;
        The main questions the study aims to answer are:&#xD;
  &#xD;
          -  Will STARRS-PC be more effective than TAU at reducing the rate of suicide attempt at 12&#xD;
             months post-baseline (primary outcome)?&#xD;
  &#xD;
          -  Will STARRS-PC be more effective than TAU at reducing suicidal ideation and non-suicidal&#xD;
             self-injury, and improving family satisfaction at 12 months post-baseline (secondary&#xD;
             outcomes)?&#xD;
  &#xD;
          -  What are the barriers and facilitators of effective implementation and sustainability of&#xD;
             STARRS-PC?&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This five-year multi-site study consists of the following essential elements: (1) recruitment&#xD;
        of 2,324 adolescents ages 12-17 years inclusive at baseline, and their parent/guardian; (2)&#xD;
        initial assessment of youth and parent/guardian participants using direct interviews and&#xD;
        standardized questionnaires; and (3) follow-up assessments of all participants at 3-months,&#xD;
        6-months, and 1-year post-baseline. To achieve the study objectives, the project will be&#xD;
        conducted in 16 pediatric primary care practices.&#xD;
  &#xD;
        The study consists of three phases of data collection: TAU, intervention, and sustainability.&#xD;
        One thousand thirty-three suicidal youth will be enrolled during the TAU phase, and 1,291&#xD;
        suicidal youth will be enrolled during the intervention phase (total number of youth&#xD;
        participants = 2,324). Youth and parent participants enrolled in the study will complete&#xD;
        multiple questionnaires at four time points (baseline, 3-months, 6-months, and 12-months).&#xD;
        Medical record reviews of youth participant files will occur throughout the study and be&#xD;
        reviewed by research staff. The intervention phase is followed by a 6-month sustainability&#xD;
        phase during which the participating practices will work on maintaining or further improving&#xD;
        upon the anticipated gains made during the intervention phase.&#xD;
  &#xD;
        Phase 1: TAU&#xD;
  &#xD;
        TAU immediately precedes the intervention phase and ranges in length from 6 to 26 months.&#xD;
        During TAU, participants will be treated according to usual and customary care, thus&#xD;
        establishing each site's baseline rate of suicide risk screening and detection. Usual care at&#xD;
        each participating practice involves screening for depression and suicide risk with the&#xD;
        PHQ-9. This baseline rate will serve as the control for subsequent study phases.&#xD;
  &#xD;
        Phase 2: Intervention&#xD;
  &#xD;
        The intervention phase will range from 11 to 30 months. During this phase, each site will&#xD;
        implement the clinical pathway, which includes universal screening for suicide risk using the&#xD;
        Ask Suicide-Screening Questions (ASQ), a four-item questionnaire. Those who screen positive&#xD;
        will then be evaluated using the Brief Suicide Safety Assessment (BSSA). The BSSA allows the&#xD;
        clinician to assess the level of suicide risk to then choose how to proceed with clinical&#xD;
        next steps. Clinicians will triage care based on three categories of risk: low-risk, further&#xD;
        evaluation needed, and imminent-risk. The risk assessment will determine the type of care the&#xD;
        individual then receives (e.g., mental health referrals, mental health evaluation and safety&#xD;
        plan, tele-psychiatry crisis intervention consultation, send to ED).&#xD;
  &#xD;
        We will also conduct in-depth qualitative interviews with a purposive sample of providers&#xD;
        (e.g., physicians, nurses, social workers) at each of the participating sites. Purposive&#xD;
        sampling is a way to identify and recruit participants that are especially experienced with&#xD;
        or knowledgeable about a phenomenon of interest. Provider participants will complete a series&#xD;
        of questionnaires at three separate times: 1) prior to clinical pathway training, 2) after&#xD;
        training, and 3) 6 months after training. Provider participants will also be trained on the&#xD;
        quality improvement process for implementing the intervention strategy. Some provider&#xD;
        participants will be asked to complete up to four qualitative interviews that will focus on&#xD;
        the implementation process, barriers and facilitators to successful implementation of the&#xD;
        clinical pathway, and lessons learned.&#xD;
  &#xD;
        Phase 3: Sustainability&#xD;
  &#xD;
        The intervention phase is followed by a 6-month sustainability phase during which the site&#xD;
        will work on maintaining or further improving upon the anticipated gains made during the&#xD;
        intervention phase. No participants will be recruited during the sustainability phase and&#xD;
        this phase will not be used to evaluate intervention effectiveness.&#xD;
  &#xD;
        The specific aims include:&#xD;
  &#xD;
        Aim 1: To implement, study, and improve through a Plan-Do-Study-Act (PDSA) cycle, the&#xD;
        STARRS-PC intervention that includes suicide risk detection, assessment and triage, and care&#xD;
        management based on risk profile. PDSA is a systematic way to test a change that is&#xD;
        implemented by breaking down the implementation process into specific steps, and then&#xD;
        evaluating the outcome, improving on it, and testing again.&#xD;
  &#xD;
        Aim 2: Test the effectiveness of STARRS-PC compared to TAU on the primary patient outcome,&#xD;
        suicide attempts, secondary patient outcomes (suicidal ideation, non-suicidal self-injury&#xD;
        (NSSI), and family satisfaction) at 12 months post-baseline, as well as mediators and&#xD;
        moderators, through a stepped wedge design.&#xD;
  &#xD;
          -  Hypotheses: STARRS-PC will significantly reduce the rate of: 1) suicide attempts&#xD;
             (nonfatal and fatal) and 2) suicidal ideation, NSSI, and improve family satisfaction&#xD;
             during the 12-month post-baseline follow-up period compared with TAU.&#xD;
  &#xD;
          -  Exploratory Aim 2a: To examine whether increases in provider knowledge, self-efficacy,&#xD;
             and buy-in regarding suicide risk screening, assessment, and management will mediate the&#xD;
             intervention effect on patient outcomes.&#xD;
  &#xD;
          -  Exploratory Aim 2b: To examine whether organization readiness and practice integration&#xD;
             will moderate effects of intervention on patient outcomes.&#xD;
  &#xD;
        Aim 3: To identify barriers to and facilitators of implementation and sustainability of an&#xD;
        intervention designed to improve suicide risk detection and risk management using qualitative&#xD;
        interviews and surveys with clinical stakeholders at each study site.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 8, 2023</start_date>
    <completion_date type="Anticipated">July 31, 2027</completion_date>
    <primary_completion_date type="Anticipated">July 31, 2027</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>Sequential Assignment</intervention_model>
      <intervention_model_description>Stepped Wedge Design</intervention_model_description>
      <primary_purpose>Prevention</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Columbia Suicide Severity Rating Scale (C-SSRS) [suicide attempt]</measure>
      <time_frame>Baseline, 3, 6, 12 Months</time_frame>
      <description>Columbia Suicide Severity Rating Scale (C-SSRS) is a semi-structured interview that tracks suicidal ideation and behavior severity over time.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Pierce Suicide Intent Scale (SIS) [suicide attempt]</measure>
      <time_frame>Based on most recent attempt from CSSRS at baseline, 3, 6 and 12 months</time_frame>
      <description>Pierce Suicide Intent Scale (SIS) is a questionnaire that assesses behavior and circumstances surrounding the suicide attempt, including plans, preparation, communicative elements, and concept of lethality of the chosen method.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Non-Suicidal Self-Injury (NSSI) [NSSI]</measure>
      <time_frame>This measure will be administered to youth only at baseline as well as at 3-, 6-, and 12-months after baseline to track NSSI over time. This is a youth only assessment.</time_frame>
      <description>The Non-Suicidal Self-Injury (NSSI) Assessment measures recent and lifetime NSSI.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Suicidal Ideation Questionnaire-JR [Suicidal ideation]</measure>
      <time_frame>Baseline, 3, 6, 12 Months</time_frame>
      <description>Suicidal Ideation Questionnaire-JR is a 15-item modified version of the SIQ, a 30 item self-report measure of suicidal ideation severity in adolescents, that has been tested in a variety of cultural settings and has been used as an outcome measure in several pediatric treatment studies.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Client Satisfaction Questionnaire-8 (CSQ-8) [Family satisfaction]</measure>
      <time_frame>Baseline ONLY, Parent and Child receive survey independently.</time_frame>
      <description>Client Satisfaction Questionnaire-8 (CSQ-8) is an 8-item self-report measure with items scored on a 1-4 scale (1=the lowest satisfaction, 4=the highest satisfaction). The CSQ assesses parent and youth perceptions of treatment acceptability and helpfulness.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>AIM (Acceptability of Intervention Measure) [Family satisfaction]</measure>
      <time_frame>Baseline ONLY, Parent and Child receive survey independently.</time_frame>
      <description>AIM (Acceptability of Intervention Measure) is a 4-item measure used to determine the extent the parent and child finds the intervention pathway acceptable.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">4648</enrollment>
    <condition>Suicidal Ideation</condition>
    <condition>Suicide, Attempted</condition>
    <condition>Suicide Prevention</condition>
    <arm_group>
      <arm_group_label>Treatment As Usual</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>Treatment as Usual</description>
    </arm_group>
    <arm_group>
      <arm_group_label>STARRS-PC</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Intervention consists of implementation of clinical pathway for youth suicide risk</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Stepped Approach to Reducing Risk of Suicide in Primary Care</intervention_name>
      <description>Intervention consists of implementation of clinical pathway for youth suicide risk</description>
      <arm_group_label>STARRS-PC</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria (Youth and Parent):&#xD;
  &#xD;
            -  All patients between the ages of 12 - 17 years and their parent/guardian at time of&#xD;
               consent who are identified as being at risk for suicide and receive primary care&#xD;
               services at one of 16 participating sites are eligible for study inclusion.&#xD;
  &#xD;
            -  Youth will be recruited without regard to current or past histories of mental health&#xD;
               problems.&#xD;
  &#xD;
            -  Youth with comorbid physical illness (e.g., asthma) and those receiving medication&#xD;
               treatment for a comorbid physical or psychiatric condition will be eligible to&#xD;
               participate provide they otherwise meet study entry criteria.&#xD;
  &#xD;
          Inclusion Criteria (Provider):&#xD;
  &#xD;
            -  Providers must work with patients at one of the participating PCCs.&#xD;
  &#xD;
          Exclusion Criteria (Youth and Parent):&#xD;
  &#xD;
          Subjects will be excluded for being:&#xD;
  &#xD;
            -  medically or cognitively unable to participate in study procedures&#xD;
  &#xD;
            -  without permanent residence or access to a telephone&#xD;
  &#xD;
            -  unable to speak English adequately to understand study procedures&#xD;
  &#xD;
          Exclusion Criteria (Provider):&#xD;
  &#xD;
            -  Unable to give consent&#xD;
  &#xD;
            -  Unable to speak English adequately to understand study procedures.&#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>Jeffrey Bridge, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Abigail Wexner Research Institute at NCH</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Alex Kemper, MD, MPH, MS</last_name>
      <role>Principal Investigator</role>
      <affiliation>Abigail Wexner Research Institute at NCH</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Cynthia Fontanella, PhD</last_name>
      <role>Study Director</role>
      <affiliation>Abigail Wexner Research Institute at NCH</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Cynthia Fontanella, PhD</last_name>
      <phone>(614) 938-0323</phone>
      <email>cynthia.fontanella@nationwidechildrens.org</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Priyanka Desirazu, MSE</last_name>
      <phone>(614) 938-1113</phone>
      <email>STARRS@nationwidechildrens.org</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>AxessPointe Community Health Centers/Arlington</name>
        <address>
          <city>Akron</city>
          <state>Ohio</state>
          <zip>44333</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>Terah Omaits, LPN</last_name>
        <email>tomaits@axesspointe.org</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Signature Health</name>
        <address>
          <city>Ashtabula</city>
          <state>Ohio</state>
          <zip>44004</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>Libbie Stansifer, MD</last_name>
        <phone>440-992-8552</phone>
        <email>lstansifer@shinc.org</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Holzer Health System</name>
        <address>
          <city>Athens</city>
          <state>Ohio</state>
          <zip>45701</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>Jonathan Mathis, MD</last_name>
        <phone>740-589-3100</phone>
        <email>jmathis@Holzer.org</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Nationwide Children's Hospital</name>
        <address>
          <city>Columbus</city>
          <state>Ohio</state>
          <zip>43205</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>Cynthia Fontanella, PhD</last_name>
        <phone>614-938-0323</phone>
        <email>cynthia.fontanella@nationwidechildrens.org</email>
      </contact>
      <contact_backup>
        <last_name>Priyanka Desirazu, MSE</last_name>
        <phone>(614) 938-1113</phone>
        <email>STARRS@nationwidechildrens.org</email>
      </contact_backup>
      <investigator>
        <last_name>Jeffrey Bridge, PhD</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>Alex Kemper, MD, MPH, MS</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Eastglen Pediatrics</name>
        <address>
          <city>Columbus</city>
          <state>Ohio</state>
          <zip>43213</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Cynthia Black, MD</last_name>
        <phone>614-866-8077</phone>
        <email>cblack@copcp.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Dayton Children's Hospital - Main</name>
        <address>
          <city>Dayton</city>
          <state>Ohio</state>
          <zip>45404</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>Shipla Sangvai, MD,MPH</last_name>
        <email>sangvai@childrensdayton.org</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Dayton Children's Hospital - NW</name>
        <address>
          <city>Dayton</city>
          <state>Ohio</state>
          <zip>45404</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>Shipla Sangvai, MD, MPH</last_name>
        <email>sangvai@childrensdayton.org</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Holzer Health System</name>
        <address>
          <city>Gallipolis</city>
          <state>Ohio</state>
          <zip>45613</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>Jonathan Mathis, MD</last_name>
        <phone>740-446-5937</phone>
        <email>jmathis@Holzer.org</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Hilliard Pediatrics</name>
        <address>
          <city>Hilliard</city>
          <state>Ohio</state>
          <zip>43026</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Cathy Homick</last_name>
        <phone>614-777-1800</phone>
        <email>chomick@hilliardpeds.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Spring Valley Primary Care Center</name>
        <address>
          <city>Holland</city>
          <state>Ohio</state>
          <zip>43528</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>Amy Hardy</last_name>
        <email>amy.hardy@nationwidechildrens.org</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Holzer Health System</name>
        <address>
          <city>Jackson</city>
          <state>Ohio</state>
          <zip>45640</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>Jonathan Mathis, MD</last_name>
        <phone>740-395-8801</phone>
        <email>jmathis@Holzer.org</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Kettering Pediatric and Family Care</name>
        <address>
          <city>Kettering</city>
          <state>Ohio</state>
          <zip>45429</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>Ramzieh Azmeh, MD</last_name>
        <phone>937-293-4168</phone>
        <email>ramziehazmeh@yahoo.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Cornerstone Pediatrics</name>
        <address>
          <city>Miamisburg</city>
          <state>Ohio</state>
          <zip>45342</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>Signature Health</name>
        <address>
          <city>Painesville</city>
          <state>Ohio</state>
          <zip>44077</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>Libbie Stansifer, MD</last_name>
        <phone>440-853-1501</phone>
        <email>lstansifer@shinc.org</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Village Square Primary Care Center</name>
        <address>
          <city>Perrysburg</city>
          <state>Ohio</state>
          <zip>43551</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>Amy Hardy</last_name>
        <email>amy.hardy@nationwidechildrens.org</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Franklin Avenue Primary Care Center</name>
        <address>
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      <citation>Sales A. Review: mediation Package in R. Journal of Educational and Behavioral Statistics. 2016;42doi:10.3102/1076998616670371</citation>
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    <reference>
      <citation>Jakobsen JC, Gluud C, Wetterslev J, Winkel P. When and how should multiple imputation be used for handling missing data in randomised clinical trials - a practical guide with flowcharts. BMC Med Res Methodol. 2017 Dec 6;17(1):162. doi: 10.1186/s12874-017-0442-1.</citation>
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      <citation>Xie H, Gao W, Xing B, Heitjan DF, Hedeker D, Yuan C. Measuring the Impact of Nonignorable Missingness Using the R Package isni. Comput Methods Programs Biomed. 2018 Oct;164:207-220. doi: 10.1016/j.cmpb.2018.06.014. Epub 2018 Jul 4.</citation>
      <PMID>30195428</PMID>
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    <reference>
      <citation>Nock MK, Green JG, Hwang I, McLaughlin KA, Sampson NA, Zaslavsky AM, Kessler RC. Prevalence, correlates, and treatment of lifetime suicidal behavior among adolescents: results from the National Comorbidity Survey Replication Adolescent Supplement. JAMA Psychiatry. 2013 Mar;70(3):300-10. doi: 10.1001/2013.jamapsychiatry.55.</citation>
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      <citation>Palinkas LA, Horwitz SM, Green CA, Wisdom JP, Duan N, Hoagwood K. Purposeful Sampling for Qualitative Data Collection and Analysis in Mixed Method Implementation Research. Adm Policy Ment Health. 2015 Sep;42(5):533-44. doi: 10.1007/s10488-013-0528-y.</citation>
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    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 25, 2023</study_first_submitted>
    <study_first_submitted_qc>August 25, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 30, 2023</study_first_posted>
    <last_update_submitted>August 25, 2023</last_update_submitted>
    <last_update_submitted_qc>August 25, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 30, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor-Investigator</responsible_party_type>
      <investigator_affiliation>Nationwide Children's Hospital</investigator_affiliation>
      <investigator_full_name>Cynthia Fontanella</investigator_full_name>
      <investigator_title>Principal Investigator</investigator_title>
    </responsible_party>
    <keyword>Suicide</keyword>
    <keyword>STARRS-PC</keyword>
    <keyword>Adolescent</keyword>
    <keyword>Risk Assessment</keyword>
    <keyword>Triage</keyword>
    <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 Prevention</mesh_term>
      <mesh_term>Suicide, Attempted</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>Data will be made available through the National Institute of Mental Health (NIMH) Data Archive (NDA) system.</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
      <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
      <ipd_time_frame>We will follow NIMH guidelines for dissemination of study data and related materials.</ipd_time_frame>
      <ipd_access_criteria>To be provided.</ipd_access_criteria>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06018285
  org study id: STUDY00002515
  secondary id: 1P50MH127476
  secondary id: 7956
  nct id: NCT06018285
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  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  Suicide is the second leading cause of death among young people aged 12-17 years in the
        United States, yet many youth at risk for suicide are not identified or go untreated. Stepped
        care approaches have been shown to be effective at reducing suicide risk in clinical
        settings, including primary care. The goal of this hybrid I stepped wedge
        effectiveness-implementation study is to test the effectiveness of a population-based quality
        improvement (QI) intervention, entitled STARRS-PC (Stepped Approach to Reducing Risk of
        Suicide in Primary Care) compared to treatment as usual (TAU), in reducing the risk of
        suicidal behavior among youth in the pediatric primary care setting. STARRS-PC implements a
        clinical pathway for youth at elevated risk for suicide in pediatric primary care clinics.
        Clinical pathways are tools used by health professionals to guide evidence-informed practice.
        The STARRS-PC pathway consists of three evidence-based suicide clinical care processes: risk
        detection, assessment and triage, and, if needed, follow-up transitional care.
  
        STARRS-PC is guided by the Practical, Robust Implementation, and Sustainability Model
        (PRISM), which allows for the study of factors that influence effective implementation of the
        suicide prevention clinical pathway and is focused on scalability.
  
        The main questions the study aims to answer are:
  
          -  Will STARRS-PC be more effective than TAU at reducing the rate of suicide attempt at 12
             months post-baseline (primary outcome)?
  
          -  Will STARRS-PC be more effective than TAU at reducing suicidal ideation and non-suicidal
             self-injury, and improving family satisfaction at 12 months post-baseline (secondary
             outcomes)?
  
          -  What are the barriers and facilitators of effective implementation and sustainability of
             STARRS-PC?
  This five-year multi-site study consists of the following essential elements: (1) recruitment
        of 2,324 adolescents ages 12-17 years inclusive at baseline, and their parent/guardian; (2)
        initial assessment of youth and parent/guardian participants using direct interviews and
        standardized questionnaires; and (3) follow-up assessments of all participants at 3-months,
        6-months, and 1-year post-baseline. To achieve the study objectives, the project will be
        conducted in 16 pediatric primary care practices.
  
        The study consists of three phases of data collection: TAU, intervention, and sustainability.
        One thousand thirty-three suicidal youth will be enrolled during the TAU phase, and 1,291
        suicidal youth will be enrolled during the intervention phase (total number of youth
        participants = 2,324). Youth and parent participants enrolled in the study will complete
        multiple questionnaires at four time points (baseline, 3-months, 6-months, and 12-months).
        Medical record reviews of youth participant files will occur throughout the study and be
        reviewed by research staff. The intervention phase is followed by a 6-month sustainability
        phase during which the participating practices will work on maintaining or further improving
        upon the anticipated gains made during the intervention phase.
  
        Phase 1: TAU
  
        TAU immediately precedes the intervention phase and ranges in length from 6 to 26 months.
        During TAU, participants will be treated according to usual and customary care, thus
        establishing each site's baseline rate of suicide risk screening and detection. Usual care at
        each participating practice involves screening for depression and suicide risk with the
        PHQ-9. This baseline rate will serve as the control for subsequent study phases.
  
        Phase 2: Intervention
  
        The intervention phase will range from 11 to 30 months. During this phase, each site will
        implement the clinical pathway, which includes universal screening for suicide risk using the
        Ask Suicide-Screening Questions (ASQ), a four-item questionnaire. Those who screen positive
        will then be evaluated using the Brief Suicide Safety Assessment (BSSA). The BSSA allows the
        clinician to assess the level of suicide risk to then choose how to proceed with clinical
        next steps. Clinicians will triage care based on three categories of risk: low-risk, further
        evaluation needed, and imminent-risk. The risk assessment will determine the type of care the
        individual then receives (e.g., mental health referrals, mental health evaluation and safety
        plan, tele-psychiatry crisis intervention consultation, send to ED).
  
        We will also conduct in-depth qualitative interviews with a purposive sample of providers
        (e.g., physicians, nurses, social workers) at each of the participating sites. Purposive
        sampling is a way to identify and recruit participants that are especially experienced with
        or knowledgeable about a phenomenon of interest. Provider participants will complete a series
        of questionnaires at three separate times: 1) prior to clinical pathway training, 2) after
        training, and 3) 6 months after training. Provider participants will also be trained on the
        quality improvement process for implementing the intervention strategy. Some provider
        participants will be asked to complete up to four qualitative interviews that will focus on
        the implementation process, barriers and facilitators to successful implementation of the
        clinical pathway, and lessons learned.
  
        Phase 3: Sustainability
  
        The intervention phase is followed by a 6-month sustainability phase during which the site
        will work on maintaining or further improving upon the anticipated gains made during the
        intervention phase. No participants will be recruited during the sustainability phase and
        this phase will not be used to evaluate intervention effectiveness.
  
        The specific aims include:
  
        Aim 1: To implement, study, and improve through a Plan-Do-Study-Act (PDSA) cycle, the
        STARRS-PC intervention that includes suicide risk detection, assessment and triage, and care
        management based on risk profile. PDSA is a systematic way to test a change that is
        implemented by breaking down the implementation process into specific steps, and then
        evaluating the outcome, improving on it, and testing again.
  
        Aim 2: Test the effectiveness of STARRS-PC compared to TAU on the primary patient outcome,
        suicide attempts, secondary patient outcomes (suicidal ideation, non-suicidal self-injury
        (NSSI), and family satisfaction) at 12 months post-baseline, as well as mediators and
        moderators, through a stepped wedge design.
  
          -  Hypotheses: STARRS-PC will significantly reduce the rate of: 1) suicide attempts
             (nonfatal and fatal) and 2) suicidal ideation, NSSI, and improve family satisfaction
             during the 12-month post-baseline follow-up period compared with TAU.
  
          -  Exploratory Aim 2a: To examine whether increases in provider knowledge, self-efficacy,
             and buy-in regarding suicide risk screening, assessment, and management will mediate the
             intervention effect on patient outcomes.
  
          -  Exploratory Aim 2b: To examine whether organization readiness and practice integration
             will moderate effects of intervention on patient outcomes.
  
        Aim 3: To identify barriers to and facilitators of implementation and sustainability of an
        intervention designed to improve suicide risk detection and risk management using qualitative
        interviews and surveys with clinical stakeholders at each study site.
  allocation: Randomized
  intervention model: Sequential Assignment
  intervention model description: Stepped Wedge Design
  primary purpose: Prevention
  masking: None (Open Label)
  measure: Columbia Suicide Severity Rating Scale (C-SSRS) [suicide attempt]
  time frame: Baseline, 3, 6, 12 Months
  description: Columbia Suicide Severity Rating Scale (C-SSRS) is a semi-structured interview that tracks suicidal ideation and behavior severity over time.
  measure: Pierce Suicide Intent Scale (SIS) [suicide attempt]
  time frame: Based on most recent attempt from CSSRS at baseline, 3, 6 and 12 months
  description: Pierce Suicide Intent Scale (SIS) is a questionnaire that assesses behavior and circumstances surrounding the suicide attempt, including plans, preparation, communicative elements, and concept of lethality of the chosen method.
  measure: Non-Suicidal Self-Injury (NSSI) [NSSI]
  time frame: This measure will be administered to youth only at baseline as well as at 3-, 6-, and 12-months after baseline to track NSSI over time. This is a youth only assessment.
  description: The Non-Suicidal Self-Injury (NSSI) Assessment measures recent and lifetime NSSI.
  measure: Suicidal Ideation Questionnaire-JR [Suicidal ideation]
  time frame: Baseline, 3, 6, 12 Months
  description: Suicidal Ideation Questionnaire-JR is a 15-item modified version of the SIQ, a 30 item self-report measure of suicidal ideation severity in adolescents, that has been tested in a variety of cultural settings and has been used as an outcome measure in several pediatric treatment studies.
  measure: Client Satisfaction Questionnaire-8 (CSQ-8) [Family satisfaction]
  time frame: Baseline ONLY, Parent and Child receive survey independently.
  description: Client Satisfaction Questionnaire-8 (CSQ-8) is an 8-item self-report measure with items scored on a 1-4 scale (1=the lowest satisfaction, 4=the highest satisfaction). The CSQ assesses parent and youth perceptions of treatment acceptability and helpfulness.
  measure: AIM (Acceptability of Intervention Measure) [Family satisfaction]
  time frame: Baseline ONLY, Parent and Child receive survey independently.
  description: AIM (Acceptability of Intervention Measure) is a 4-item measure used to determine the extent the parent and child finds the intervention pathway acceptable.
  arm group label: Treatment As Usual
  arm group type: No Intervention
  description: Treatment as Usual
  arm group label: STARRS-PC
  arm group type: Experimental
  description: Intervention consists of implementation of clinical pathway for youth suicide risk
  intervention type: Behavioral
  intervention name: Stepped Approach to Reducing Risk of Suicide in Primary Care
  description: Intervention consists of implementation of clinical pathway for youth suicide risk
  arm group label: STARRS-PC
  criteria: 
  gender: All
  minimum age: 12 Years
  maximum age: 17 Years
  healthy volunteers: No
  last name: Jeffrey Bridge, PhD
  role: Principal Investigator
  affiliation: Abigail Wexner Research Institute at NCH
  last name: Alex Kemper, MD, MPH, MS
  role: Principal Investigator
  affiliation: Abigail Wexner Research Institute at NCH
  last name: Cynthia Fontanella, PhD
  role: Study Director
  affiliation: Abigail Wexner Research Institute at NCH
  last name: Cynthia Fontanella, PhD
  phone: (614) 938-0323
  email: cynthia.fontanella@nationwidechildrens.org
  last name: Priyanka Desirazu, MSE
  phone: (614) 938-1113
  email: STARRS@nationwidechildrens.org
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  country: United States
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  responsible party type: Sponsor-Investigator
  investigator affiliation: Nationwide Children's Hospital
  investigator full name: Cynthia Fontanella
  investigator title: Principal Investigator
  mesh term: Suicide
  mesh term: Suicidal Ideation
  mesh term: Suicide Prevention
  mesh term: Suicide, Attempted
  sharing ipd: Yes
  ipd description: Data will be made available through the National Institute of Mental Health (NIMH) Data Archive (NDA) system.
  ipd info type: Study Protocol
  ipd info type: Statistical Analysis Plan (SAP)
  ipd info type: Informed Consent Form (ICF)
  ipd time frame: We will follow NIMH guidelines for dissemination of study data and related materials.
  ipd access criteria: To be provided.