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/NCT05976867</url>
    </required_header>
    <id_info>
      <org_study_id>R01HD108209</org_study_id>
      <nct_id>NCT05976867</nct_id>
    </id_info>
    <brief_title>Parent-focused Primary Prevention of Child Sexual Abuse: An Effectiveness-implementation Hybrid Trial</brief_title>
    <official_title>Parent-focused Primary Prevention of Child Sexual Abuse: An Effectiveness-implementation Hybrid Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>New York University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>New York University</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>
        The goal of this clinical trial is to test the effectiveness of a parent-focused child sexual&#xD;
        abuse prevention program (Smart Parents) delivered to parents enrolled in a parent education&#xD;
        program (Parents as Teachers; PAT). The main questions the trial aims to answer are:&#xD;
  &#xD;
          1. Does PAT + Smart Parents improve parents' CSA-related awareness and protective behaviors&#xD;
             compared to PAT as usual?&#xD;
  &#xD;
          2. Are potential gains maintained 12- and 24-months post intervention?&#xD;
  &#xD;
          3. What parent-, provider-, and organizational-level factors hold promise for future&#xD;
             dissemination and implementation efforts?&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        To expand the empirical evidence for the effectiveness of Smart Parents and to explore the&#xD;
        implementation factors that might promote or hinder adoption, fidelity, and scalability, the&#xD;
        proposed study uses a type 2 hybrid effectiveness-implementation design. Designed to&#xD;
        efficiently bridge the research to practice gap, the type 2 hybrid design tests the&#xD;
        effectiveness of an intervention while concurrently exploring the viability of an explicit&#xD;
        implementation strategy in a real world setting. To determine effectiveness (Aims 1 &amp; 2), the&#xD;
        investigators will conduct a pragmatic, quasi-experimental, stepped wedge cluster randomized&#xD;
        trial (SW-CRT; N = 400) of CSA-related awareness (i.e., knowledge and attitudes about CSA and&#xD;
        CSA prevention) and intention to use CSA protective behaviors for parents receiving Smart&#xD;
        Parents when added to PAT (PAT+Smart Parents) compared to parents receiving PAT treatment as&#xD;
        usual (PAT-TAU; Aim 1). The investigators will follow-up participating parents in both&#xD;
        conditions at 12- and 24-months to determine retention of awareness (i.e., knowledge and&#xD;
        attitudes) and actual use of protective behaviors (Aim 2).&#xD;
  &#xD;
        A variation of a crossover experimental design, the SW-CRT is a pragmatic experimental design&#xD;
        wherein randomized clusters sequentially transition from control to intervention until all&#xD;
        clusters are exposed to the intervention. Once introduced to a cluster, the intervention is&#xD;
        never removed. Facilitated by PAT National, 25 PAT sites will be recruited at the start of&#xD;
        the study period. Sites will then be randomized into 1 of 5 clustered sequences (or steps)&#xD;
        each containing 5 sites (or clusters). At the time on randomization, providers at all sites&#xD;
        will begin recruiting eligible parents for participation in research and parents will begin&#xD;
        the data collection protocols. At the point of the wedge, sites will be trained to deliver&#xD;
        Smart Parents and will transition from control (PAT+TAU) to intervention (PAT+Smart Parents)&#xD;
        conditions, the timing of which will be determined by the randomized step assignment.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 1, 2023</start_date>
    <completion_date type="Anticipated">August 31, 2027</completion_date>
    <primary_completion_date type="Anticipated">August 31, 2026</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>Parallel Assignment</intervention_model>
      <primary_purpose>Prevention</primary_purpose>
      <masking>Single (Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Assessment of Sexual Abuse Knowledge</measure>
      <time_frame>Baseline (T0)</time_frame>
      <description>The Assessment of SmartParents Knowledge will be used to evaluate (a) CSA knowledge, norms, and attitudes (e.g., items regarding the degree to which parents endorsed accurate facts about CSA, the role of a parent in CSA prevention, and what is appropriate to discuss with children), and (b) intention to use CSA prevention related behaviors (e.g., items regarding identifying signs of CSA, talking to children and other adults about CSA prevention, and knowing how to respond appropriately if CSA is suspected).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Assessment of Sexual Abuse Knowledge</measure>
      <time_frame>Up to 4 months (Post Session 6) (T1)</time_frame>
      <description>The Assessment of SmartParents Knowledge will be used to evaluate (a) CSA knowledge, norms, and attitudes (e.g., items regarding the degree to which parents endorsed accurate facts about CSA, the role of a parent in CSA prevention, and what is appropriate to discuss with children), and (b) intention to use CSA prevention related behaviors (e.g., items regarding identifying signs of CSA, talking to children and other adults about CSA prevention, and knowing how to respond appropriately if CSA is suspected).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Assessment of Sexual Abuse Knowledge</measure>
      <time_frame>12-month assessment (T2)</time_frame>
      <description>The Assessment of SmartParents Knowledge will be used to evaluate (a) CSA knowledge, norms, and attitudes (e.g., items regarding the degree to which parents endorsed accurate facts about CSA, the role of a parent in CSA prevention, and what is appropriate to discuss with children), and (b) intention to use CSA prevention related behaviors (e.g., items regarding identifying signs of CSA, talking to children and other adults about CSA prevention, and knowing how to respond appropriately if CSA is suspected).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Assessment of Sexual Abuse Knowledge</measure>
      <time_frame>24-month assessment (T3)</time_frame>
      <description>The Assessment of SmartParents Knowledge will be used to evaluate (a) CSA knowledge, norms, and attitudes (e.g., items regarding the degree to which parents endorsed accurate facts about CSA, the role of a parent in CSA prevention, and what is appropriate to discuss with children), and (b) intention to use CSA prevention related behaviors (e.g., items regarding identifying signs of CSA, talking to children and other adults about CSA prevention, and knowing how to respond appropriately if CSA is suspected).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Parental Use of Behavioral Strategies Interview</measure>
      <time_frame>12-month assessment (T2)</time_frame>
      <description>The Parental Use of Behavioral Strategies Interview (PUBSI) is a project created semi-structured behavioral interview deeply assess the use of behavior strategies at four levels: (1) community-level intentions, awareness, and behaviors; (2) personal environment; (3) personal actions/behaviors; and (4) personal behaviors. In addition to parents' reports of behaviors across the four levels, parents rate (on a scale of 1 to 5) their confidence in their ability to engage in each behavior as well as as their success in communicating with others about the various CSA related topics assessed.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Parental Use of Behavioral Strategies Interview</measure>
      <time_frame>24-month assessment (T3)</time_frame>
      <description>The Parental Use of Behavioral Strategies Interview (PUBSI) is a project created semi-structured behavioral interview deeply assess the use of behavior strategies at four levels: (1) community-level intentions, awareness, and behaviors; (2) personal environment; (3) personal actions/behaviors; and (4) personal behaviors. In addition to parents' reports of behaviors across the four levels, parents rate (on a scale of 1 to 5) their confidence in their ability to engage in each behavior as well as as their success in communicating with others about the various CSA related topics assessed.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Preventive Behaviors Questionnaire</measure>
      <time_frame>Baseline (T0)</time_frame>
      <description>A 10-item instrument designed to assess the frequency with which parents perform protective behaviors within the past month (e.g., &quot;Told my child never to keep secrets about touching&quot; or &quot;Talked to my relatives about my child's personal safety rules.&quot;). This quantitative assessment of behaviors will complement the PUBSI.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Preventive Behaviors Questionnaire</measure>
      <time_frame>Up to 4 months (Post Session 6) (T1)</time_frame>
      <description>A 10-item instrument designed to assess the frequency with which parents perform protective behaviors within the past month (e.g., &quot;Told my child never to keep secrets about touching&quot; or &quot;Talked to my relatives about my child's personal safety rules.&quot;). This quantitative assessment of behaviors will complement the PUBSI.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Preventive Behaviors Questionnaire</measure>
      <time_frame>12-month assessment (T2)</time_frame>
      <description>A 10-item instrument designed to assess the frequency with which parents perform protective behaviors within the past month (e.g., &quot;Told my child never to keep secrets about touching&quot; or &quot;Talked to my relatives about my child's personal safety rules.&quot;). This quantitative assessment of behaviors will complement the PUBSI.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Preventive Behaviors Questionnaire</measure>
      <time_frame>24-month assessment (T3)</time_frame>
      <description>A 10-item instrument designed to assess the frequency with which parents perform protective behaviors within the past month (e.g., &quot;Told my child never to keep secrets about touching&quot; or &quot;Talked to my relatives about my child's personal safety rules.&quot;). This quantitative assessment of behaviors will complement the PUBSI.</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">400</enrollment>
    <condition>Child Sexual Abuse</condition>
    <arm_group>
      <arm_group_label>PAT + Smart Parents</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants in this arm will receive the additional Smart Parents module, added to Parents as Teachers (PAT) in which they are already enrolled. This is the experimental condition.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>PAT as usual</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Participants in this arm will continue to receive Parents as Teachers (PAT) as usual. This is the treatment as usual condition (comparison).</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Parents as Teachers (PAT) as usual</intervention_name>
      <description>Parents as Teachers parent-education program as designed. Delivered in the home to parents of children under 5. Parents begin with the foundational curriculum (mostly taught within the first six sessions) focused on healthy child development, parenting behaviors including parent-child interactions and communication, and creating a safe home environment in terms of avoiding accidents and injuries. After the foundational curriculum, additional sessions are delivered based on the continued needs of the family until the child ages out or the parent discontinues services. PAT uses development-centered parenting, family well-being, and community connections to reinforce this foundational curriculum.</description>
      <arm_group_label>PAT as usual</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Parents as Teachers (PAT) + Smart Parents</intervention_name>
      <description>Added session to PAT following foundational visit 6. Smart Parents is comprised of 3 CSA specific prevention components: (1) healthy child sexual development, (2) communication about sexual concepts and sexual behaviors, and (3) safety strategies (including online safety.&#xD;
  Delivered in one session (~60 min). Parents return to PAT as usual following this session.</description>
      <arm_group_label>PAT + Smart Parents</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  One parent per household that is currently enrolled in PAT qualified to receive&#xD;
               bi-weekly visits;&#xD;
  &#xD;
            -  English or Spanish speaking;&#xD;
  &#xD;
            -  Has at least one child at home over 12-mo;&#xD;
  &#xD;
            -  Only newly enrolled parents (i.e., parents who have not received the PAT foundational&#xD;
               sessions).&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Not currently enrolled in PAT;&#xD;
  &#xD;
            -  Not English or Spanish speaking;&#xD;
  &#xD;
            -  Does not have a child over 12-mo old;&#xD;
  &#xD;
            -  Previously enrolled in PAT (i.e., parents who have received the PAT foundational&#xD;
               sessions)&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Kate Guastaferro, PhD, MPH</last_name>
      <phone>2129929032</phone>
      <email>kate.guastaferro@nyu.edu</email>
    </overall_contact>
    <location>
      <facility>
        <name>New York University</name>
        <address>
          <city>New York</city>
          <state>New York</state>
          <zip>10003</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Kate Guastaferro, PhD, MPH</last_name>
        <phone>212-992-9032</phone>
        <email>kate.guastaferro@nyu.edu</email>
      </contact>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>December 2022</verification_date>
    <study_first_submitted>December 6, 2022</study_first_submitted>
    <study_first_submitted_qc>August 3, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 4, 2023</study_first_posted>
    <last_update_submitted>August 3, 2023</last_update_submitted>
    <last_update_submitted_qc>August 3, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 4, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>primary prevention</keyword>
    <keyword>child sexual abuse</keyword>
    <keyword>implementation science</keyword>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
    </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/NCT05976867
  org study id: R01HD108209
  nct id: NCT05976867
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this clinical trial is to test the effectiveness of a parent-focused child sexual
        abuse prevention program (Smart Parents) delivered to parents enrolled in a parent education
        program (Parents as Teachers; PAT). The main questions the trial aims to answer are:
  
          1. Does PAT + Smart Parents improve parents' CSA-related awareness and protective behaviors
             compared to PAT as usual?
  
          2. Are potential gains maintained 12- and 24-months post intervention?
  
          3. What parent-, provider-, and organizational-level factors hold promise for future
             dissemination and implementation efforts?
  To expand the empirical evidence for the effectiveness of Smart Parents and to explore the
        implementation factors that might promote or hinder adoption, fidelity, and scalability, the
        proposed study uses a type 2 hybrid effectiveness-implementation design. Designed to
        efficiently bridge the research to practice gap, the type 2 hybrid design tests the
        effectiveness of an intervention while concurrently exploring the viability of an explicit
        implementation strategy in a real world setting. To determine effectiveness (Aims 1 & 2), the
        investigators will conduct a pragmatic, quasi-experimental, stepped wedge cluster randomized
        trial (SW-CRT; N = 400) of CSA-related awareness (i.e., knowledge and attitudes about CSA and
        CSA prevention) and intention to use CSA protective behaviors for parents receiving Smart
        Parents when added to PAT (PAT+Smart Parents) compared to parents receiving PAT treatment as
        usual (PAT-TAU; Aim 1). The investigators will follow-up participating parents in both
        conditions at 12- and 24-months to determine retention of awareness (i.e., knowledge and
        attitudes) and actual use of protective behaviors (Aim 2).
  
        A variation of a crossover experimental design, the SW-CRT is a pragmatic experimental design
        wherein randomized clusters sequentially transition from control to intervention until all
        clusters are exposed to the intervention. Once introduced to a cluster, the intervention is
        never removed. Facilitated by PAT National, 25 PAT sites will be recruited at the start of
        the study period. Sites will then be randomized into 1 of 5 clustered sequences (or steps)
        each containing 5 sites (or clusters). At the time on randomization, providers at all sites
        will begin recruiting eligible parents for participation in research and parents will begin
        the data collection protocols. At the point of the wedge, sites will be trained to deliver
        Smart Parents and will transition from control (PAT+TAU) to intervention (PAT+Smart Parents)
        conditions, the timing of which will be determined by the randomized step assignment.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Prevention
  masking: Single (Outcomes Assessor)
  measure: Assessment of Sexual Abuse Knowledge
  time frame: Baseline (T0)
  description: The Assessment of SmartParents Knowledge will be used to evaluate (a) CSA knowledge, norms, and attitudes (e.g., items regarding the degree to which parents endorsed accurate facts about CSA, the role of a parent in CSA prevention, and what is appropriate to discuss with children), and (b) intention to use CSA prevention related behaviors (e.g., items regarding identifying signs of CSA, talking to children and other adults about CSA prevention, and knowing how to respond appropriately if CSA is suspected).
  measure: Assessment of Sexual Abuse Knowledge
  time frame: Up to 4 months (Post Session 6) (T1)
  description: The Assessment of SmartParents Knowledge will be used to evaluate (a) CSA knowledge, norms, and attitudes (e.g., items regarding the degree to which parents endorsed accurate facts about CSA, the role of a parent in CSA prevention, and what is appropriate to discuss with children), and (b) intention to use CSA prevention related behaviors (e.g., items regarding identifying signs of CSA, talking to children and other adults about CSA prevention, and knowing how to respond appropriately if CSA is suspected).
  measure: Assessment of Sexual Abuse Knowledge
  time frame: 12-month assessment (T2)
  description: The Assessment of SmartParents Knowledge will be used to evaluate (a) CSA knowledge, norms, and attitudes (e.g., items regarding the degree to which parents endorsed accurate facts about CSA, the role of a parent in CSA prevention, and what is appropriate to discuss with children), and (b) intention to use CSA prevention related behaviors (e.g., items regarding identifying signs of CSA, talking to children and other adults about CSA prevention, and knowing how to respond appropriately if CSA is suspected).
  measure: Assessment of Sexual Abuse Knowledge
  time frame: 24-month assessment (T3)
  description: The Assessment of SmartParents Knowledge will be used to evaluate (a) CSA knowledge, norms, and attitudes (e.g., items regarding the degree to which parents endorsed accurate facts about CSA, the role of a parent in CSA prevention, and what is appropriate to discuss with children), and (b) intention to use CSA prevention related behaviors (e.g., items regarding identifying signs of CSA, talking to children and other adults about CSA prevention, and knowing how to respond appropriately if CSA is suspected).
  measure: Parental Use of Behavioral Strategies Interview
  time frame: 12-month assessment (T2)
  description: The Parental Use of Behavioral Strategies Interview (PUBSI) is a project created semi-structured behavioral interview deeply assess the use of behavior strategies at four levels: (1) community-level intentions, awareness, and behaviors; (2) personal environment; (3) personal actions/behaviors; and (4) personal behaviors. In addition to parents' reports of behaviors across the four levels, parents rate (on a scale of 1 to 5) their confidence in their ability to engage in each behavior as well as as their success in communicating with others about the various CSA related topics assessed.
  measure: Parental Use of Behavioral Strategies Interview
  time frame: 24-month assessment (T3)
  description: The Parental Use of Behavioral Strategies Interview (PUBSI) is a project created semi-structured behavioral interview deeply assess the use of behavior strategies at four levels: (1) community-level intentions, awareness, and behaviors; (2) personal environment; (3) personal actions/behaviors; and (4) personal behaviors. In addition to parents' reports of behaviors across the four levels, parents rate (on a scale of 1 to 5) their confidence in their ability to engage in each behavior as well as as their success in communicating with others about the various CSA related topics assessed.
  measure: Preventive Behaviors Questionnaire
  time frame: Baseline (T0)
  description: A 10-item instrument designed to assess the frequency with which parents perform protective behaviors within the past month (e.g., "Told my child never to keep secrets about touching" or "Talked to my relatives about my child's personal safety rules."). This quantitative assessment of behaviors will complement the PUBSI.
  measure: Preventive Behaviors Questionnaire
  time frame: Up to 4 months (Post Session 6) (T1)
  description: A 10-item instrument designed to assess the frequency with which parents perform protective behaviors within the past month (e.g., "Told my child never to keep secrets about touching" or "Talked to my relatives about my child's personal safety rules."). This quantitative assessment of behaviors will complement the PUBSI.
  measure: Preventive Behaviors Questionnaire
  time frame: 12-month assessment (T2)
  description: A 10-item instrument designed to assess the frequency with which parents perform protective behaviors within the past month (e.g., "Told my child never to keep secrets about touching" or "Talked to my relatives about my child's personal safety rules."). This quantitative assessment of behaviors will complement the PUBSI.
  measure: Preventive Behaviors Questionnaire
  time frame: 24-month assessment (T3)
  description: A 10-item instrument designed to assess the frequency with which parents perform protective behaviors within the past month (e.g., "Told my child never to keep secrets about touching" or "Talked to my relatives about my child's personal safety rules."). This quantitative assessment of behaviors will complement the PUBSI.
  arm group label: PAT + Smart Parents
  arm group type: Experimental
  description: Participants in this arm will receive the additional Smart Parents module, added to Parents as Teachers (PAT) in which they are already enrolled. This is the experimental condition.
  arm group label: PAT as usual
  arm group type: Active Comparator
  description: Participants in this arm will continue to receive Parents as Teachers (PAT) as usual. This is the treatment as usual condition (comparison).
  intervention type: Behavioral
  intervention name: Parents as Teachers (PAT) as usual
  description: Parents as Teachers parent-education program as designed. Delivered in the home to parents of children under 5. Parents begin with the foundational curriculum (mostly taught within the first six sessions) focused on healthy child development, parenting behaviors including parent-child interactions and communication, and creating a safe home environment in terms of avoiding accidents and injuries. After the foundational curriculum, additional sessions are delivered based on the continued needs of the family until the child ages out or the parent discontinues services. PAT uses development-centered parenting, family well-being, and community connections to reinforce this foundational curriculum.
  arm group label: PAT as usual
  intervention type: Behavioral
  intervention name: Parents as Teachers (PAT) + Smart Parents
  description: Added session to PAT following foundational visit 6. Smart Parents is comprised of 3 CSA specific prevention components: (1) healthy child sexual development, (2) communication about sexual concepts and sexual behaviors, and (3) safety strategies (including online safety.
  Delivered in one session (~60 min). Parents return to PAT as usual following this session.
  arm group label: PAT + Smart Parents
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Kate Guastaferro, PhD, MPH
  phone: 2129929032
  email: kate.guastaferro@nyu.edu
  facility: 
  contact: 
  country: United States
  responsible party type: Sponsor
  sharing ipd: Undecided