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/NCT06004726</url>
    </required_header>
    <id_info>
      <org_study_id>220500003</org_study_id>
      <nct_id>NCT06004726</nct_id>
    </id_info>
    <brief_title>&quot;Effectiveness of School-based Substance Abuse Prevention Programme Among Adolescents .</brief_title>
    <official_title>&quot;Effectiveness of School-based Substance Abuse Prevention Programme (SSPP) on Awareness, Attitude, Peer Pressure, and Life Skills Among Adolescents in Selected Public Schools of Pokhara, Nepal-A Cluster Randomized Trial&quot;</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Manipal college of Nursing</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Manipal University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Manipal college of Nursing</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 objectives of the study is to&#xD;
  &#xD;
          1. &quot;to explore the perception of teachers, parents &amp; students in the prevention of&#xD;
             substance abuse among adolescents&quot;.&#xD;
  &#xD;
          2. &quot;to develop and determine the effectiveness of a School-based substance abuse Prevention&#xD;
             Programme (SSPP) on awareness, attitude, peer pressure, and life skills towards&#xD;
             prevention of substance abuse&quot;.&#xD;
  &#xD;
        In this study, SSPP refers to a Bilingual Multicomponent Training Programme which includes&#xD;
        psychoeducation and video-assisted teaching to enhance awareness of substance abuse,&#xD;
        role-play to develop a positive attitude towards prevention of substance abuse, Case based&#xD;
        scenario to increase resistance to peer pressure and storytelling and demonstration to&#xD;
        increase life skills towards prevention of substance abuse among adolescents of selected&#xD;
        schools of Pokhara, Nepal.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        DETAILED METHODOLOGY&#xD;
  &#xD;
        Phase I:&#xD;
  &#xD;
          -  Research Design: Qualitative&#xD;
  &#xD;
          -  Research Setting: Selected public schools of Pokhara, Nepal&#xD;
  &#xD;
          -  Population: Teachers, Parents, and Students of Pokhara, Nepal&#xD;
  &#xD;
          -  Samples: Selected Teachers, Parents &amp; students&#xD;
  &#xD;
          -  Sample Size: 38 (The sample will be collected till data Saturation)&#xD;
  &#xD;
          -  Data collection Technique: Focus group discussion&#xD;
  &#xD;
          -  Data collection Tool: Focus group lead questions&#xD;
  &#xD;
          -  Data Analysis: Thematic analysis (Atlas.ti) Phase II Research design: Cluster Randomized&#xD;
             Trial Randomization method: Cluster Randomization Research Setting: Selected public&#xD;
             schools of Pokhara, Nepal Population: Adolescent students of Pokhara, Nepal Sample:&#xD;
             Selected Adolescents, who are in the age group 13-15 years old and studying in 8th &amp; 9th&#xD;
             grades Variables&#xD;
  &#xD;
          -  Independent variables: School-based Substance abuse Prevention Programme (SSPP)&#xD;
  &#xD;
          -  Dependent variables: awareness, attitudes, peer pressure, and life skills related to&#xD;
             prevention of substance abuse.&#xD;
  &#xD;
          -  Demographic variables: age in years, gender, religion, education/grade, family type,&#xD;
             residence, number of siblings, education of parents, occupation of parents, sources of&#xD;
             information, history of substance abuse in the family.&#xD;
  &#xD;
        Sample size: 210&#xD;
  &#xD;
        The expected outcomes of the study is to enhance awareness towards prevention of substance&#xD;
        abuse,develop a positive attitude towards the prevention of substance abuse,develop drug&#xD;
        refusal skills among adolescents,improve life skills and helps in th reduction of drug abuse&#xD;
        behaviour adolescents&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Anticipated">October 1, 2023</start_date>
    <completion_date type="Anticipated">July 1, 2027</completion_date>
    <primary_completion_date type="Anticipated">July 1, 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>Parallel Assignment</intervention_model>
      <primary_purpose>Prevention</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Change from baseline awareness towards substance abuse</measure>
      <time_frame>Baseline,3months &amp;6mobths</time_frame>
      <description>Awareness towards substance abuse among adolescents using structured awareness towards substance abuse using structured awareness towards substance abuse which is of 30 items multiple choice questions with one right answer &amp; three distracters. Higher the score higher awareness towards substance abuse</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change from baseline attitude at 3 &amp; 6 months</measure>
      <time_frame>Baseline,3months &amp; 6months</time_frame>
      <description>Attitude towards substance abuse using Alcohol &amp; drug attitude scale which is of 28 items.minimum score is 61 ,Higher score is 86.higher scores indicate higher attitude t towards using Alcohol and drug</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change from baseline peer pressure at 3months &amp; 6months</measure>
      <time_frame>Baseline,3months&amp; 6months</time_frame>
      <description>Peer pressure towards substance abuse using peer pressure scale which is of 25 items scale.the minimum score is 55 &amp; higher score is more than 72.higher the score high peer pressure.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change from baseline lifeskills at 3months and 6months</measure>
      <time_frame>Baseline,3months &amp; 6months</time_frame>
      <description>Life skills among adolescents using life skills evaluation questionnaire .Higher score indicates higher life skills.</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">210</enrollment>
    <condition>Substance Abuse</condition>
    <arm_group>
      <arm_group_label>Experimental and control</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Experimental group will get 4 module of intervention</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>control group will not get intervention ,Information Booklet and video assisted teaching will be given after posttest</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>School-based Substance abuse Prevention Programme (SSPP)</intervention_name>
      <description>Module 1 :Introduction&#xD;
  Orientation about Training Programme using PowerPoint slides&#xD;
  Psychoeducation and Video Assisted Teaching to enhance awareness of substance abuse.&#xD;
  Distribution of informational booklet on basics about substance abuse&#xD;
  Module 2:&#xD;
  Role play to develop a positive attitude towards the prevention of substance abuse.&#xD;
  Case-based scenario to increase resistance to peer pressure.&#xD;
  Demonstration of drug refusal techniques.&#xD;
  Module3:• Storytelling on Life skills Training Components (Problem solving, Emotion Management)&#xD;
  Module 4:• Demonstration of Life skills training components (Communication skills, Decision making skills, Creative thinking skills, Stress Management strategies )</description>
      <arm_group_label>Experimental and control</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Adolescents of 13-15 years age group.&#xD;
  &#xD;
            -  Those who are studying in selected public Schools of Pokhara, Nepal.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  o Adolescents who are not willing to provide informed consent (assent) and parental&#xD;
               consent.&#xD;
  &#xD;
                 -  Adolescents who do not belong to Nepal.&#xD;
  &#xD;
                 -  Adolescents who are absent during data collection&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>13 Years</minimum_age>
      <maximum_age>15 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Sandhya Shrestha</last_name>
      <role>Principal Investigator</role>
      <affiliation>Manipal</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Sandhya shrestha</last_name>
      <phone>9779846038525</phone>
      <email>sandhya.mconmpl2022@learner.manipal.edu</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Binil V</last_name>
      <phone>9844387432</phone>
      <email>Vp.binil@manipal.edu</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Sandhya Shrestha</name>
        <address>
          <city>Pokhara</city>
          <state>Gandaki</state>
          <zip>009771</zip>
          <country>Nepal</country>
        </address>
      </facility>
      <status>Enrolling by invitation</status>
    </location>
    <location>
      <facility>
        <name>Bal mandir Mavi and Bindobasini Ma vi</name>
        <address>
          <city>Pokhara</city>
          <state>Gandaki</state>
          <zip>00977</zip>
          <country>Nepal</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>sandhya shrestha, master</last_name>
        <phone>9846038525</phone>
        <email>shrestha_sandhu@yahoo.com</email>
      </contact>
      <contact_backup>
        <last_name>binil v, phD</last_name>
        <phone>9844387432</phone>
        <email>vp.binil@manipal.edu</email>
      </contact_backup>
    </location>
    <location>
      <facility>
        <name>Sandhya shrestha</name>
        <address>
          <city>Pokhara</city>
          <state>Gandaki</state>
          <zip>00977</zip>
          <country>Nepal</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>Binil V</last_name>
        <phone>91 -9844387432</phone>
        <email>vp.binil@manipal.edu</email>
      </contact>
      <contact_backup>
        <last_name>Shashidhara YN</last_name>
        <phone>91-9886344627</phone>
        <email>Shashidhara.Yn@manipal.edu</email>
      </contact_backup>
    </location>
    <location_countries>
      <country>Nepal</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 13, 2023</study_first_submitted>
    <study_first_submitted_qc>August 20, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 22, 2023</study_first_posted>
    <last_update_submitted>August 22, 2023</last_update_submitted>
    <last_update_submitted_qc>August 22, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 24, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Manipal college of Nursing</investigator_affiliation>
      <investigator_full_name>Sandhya Shrestha</investigator_full_name>
      <investigator_title>Principal investigator (phD Scholar)</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Substance-Related Disorders</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
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/NCT06004726
  org study id: 220500003
  nct id: NCT06004726
  lead sponsor: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  The objectives of the study is to
  
          1. "to explore the perception of teachers, parents & students in the prevention of
             substance abuse among adolescents".
  
          2. "to develop and determine the effectiveness of a School-based substance abuse Prevention
             Programme (SSPP) on awareness, attitude, peer pressure, and life skills towards
             prevention of substance abuse".
  
        In this study, SSPP refers to a Bilingual Multicomponent Training Programme which includes
        psychoeducation and video-assisted teaching to enhance awareness of substance abuse,
        role-play to develop a positive attitude towards prevention of substance abuse, Case based
        scenario to increase resistance to peer pressure and storytelling and demonstration to
        increase life skills towards prevention of substance abuse among adolescents of selected
        schools of Pokhara, Nepal.
  DETAILED METHODOLOGY
  
        Phase I:
  
          -  Research Design: Qualitative
  
          -  Research Setting: Selected public schools of Pokhara, Nepal
  
          -  Population: Teachers, Parents, and Students of Pokhara, Nepal
  
          -  Samples: Selected Teachers, Parents & students
  
          -  Sample Size: 38 (The sample will be collected till data Saturation)
  
          -  Data collection Technique: Focus group discussion
  
          -  Data collection Tool: Focus group lead questions
  
          -  Data Analysis: Thematic analysis (Atlas.ti) Phase II Research design: Cluster Randomized
             Trial Randomization method: Cluster Randomization Research Setting: Selected public
             schools of Pokhara, Nepal Population: Adolescent students of Pokhara, Nepal Sample:
             Selected Adolescents, who are in the age group 13-15 years old and studying in 8th & 9th
             grades Variables
  
          -  Independent variables: School-based Substance abuse Prevention Programme (SSPP)
  
          -  Dependent variables: awareness, attitudes, peer pressure, and life skills related to
             prevention of substance abuse.
  
          -  Demographic variables: age in years, gender, religion, education/grade, family type,
             residence, number of siblings, education of parents, occupation of parents, sources of
             information, history of substance abuse in the family.
  
        Sample size: 210
  
        The expected outcomes of the study is to enhance awareness towards prevention of substance
        abuse,develop a positive attitude towards the prevention of substance abuse,develop drug
        refusal skills among adolescents,improve life skills and helps in th reduction of drug abuse
        behaviour adolescents
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Prevention
  masking: None (Open Label)
  measure: Change from baseline awareness towards substance abuse
  time frame: Baseline,3months &6mobths
  description: Awareness towards substance abuse among adolescents using structured awareness towards substance abuse using structured awareness towards substance abuse which is of 30 items multiple choice questions with one right answer & three distracters. Higher the score higher awareness towards substance abuse
  measure: Change from baseline attitude at 3 & 6 months
  time frame: Baseline,3months & 6months
  description: Attitude towards substance abuse using Alcohol & drug attitude scale which is of 28 items.minimum score is 61 ,Higher score is 86.higher scores indicate higher attitude t towards using Alcohol and drug
  measure: Change from baseline peer pressure at 3months & 6months
  time frame: Baseline,3months& 6months
  description: Peer pressure towards substance abuse using peer pressure scale which is of 25 items scale.the minimum score is 55 & higher score is more than 72.higher the score high peer pressure.
  measure: Change from baseline lifeskills at 3months and 6months
  time frame: Baseline,3months & 6months
  description: Life skills among adolescents using life skills evaluation questionnaire .Higher score indicates higher life skills.
  arm group label: Experimental and control
  arm group type: Experimental
  description: Experimental group will get 4 module of intervention
  arm group label: Control
  arm group type: No Intervention
  description: control group will not get intervention ,Information Booklet and video assisted teaching will be given after posttest
  intervention type: Other
  intervention name: School-based Substance abuse Prevention Programme (SSPP)
  description: Module 1 :Introduction
  Orientation about Training Programme using PowerPoint slides
  Psychoeducation and Video Assisted Teaching to enhance awareness of substance abuse.
  Distribution of informational booklet on basics about substance abuse
  Module 2:
  Role play to develop a positive attitude towards the prevention of substance abuse.
  Case-based scenario to increase resistance to peer pressure.
  Demonstration of drug refusal techniques.
  Module3:• Storytelling on Life skills Training Components (Problem solving, Emotion Management)
  Module 4:• Demonstration of Life skills training components (Communication skills, Decision making skills, Creative thinking skills, Stress Management strategies )
  arm group label: Experimental and control
  criteria: 
  gender: All
  minimum age: 13 Years
  maximum age: 15 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Sandhya Shrestha
  role: Principal Investigator
  affiliation: Manipal
  last name: Sandhya shrestha
  phone: 9779846038525
  email: sandhya.mconmpl2022@learner.manipal.edu
  last name: Binil V
  phone: 9844387432
  email: Vp.binil@manipal.edu
  facility: 
  status: Enrolling by invitation
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  facility: 
  status: Not yet recruiting
  contact: 
  contact backup: 
  country: Nepal
  responsible party type: Principal Investigator
  investigator affiliation: Manipal college of Nursing
  investigator full name: Sandhya Shrestha
  investigator title: Principal investigator (phD Scholar)
  mesh term: Substance-Related Disorders
  sharing ipd: No