<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/NCT03807895</url>
  </required_header>
  <id_info>
    <org_study_id>19.175/24.10.2018</org_study_id>
    <nct_id>NCT03807895</nct_id>
  </id_info>
  <brief_title>REBT Intervention Program for Career Decision-making Difficulties in High School Pupils</brief_title>
  <official_title>The Effectiveness of an REBT Intervention Program on the Reduction of Career Decision-making Difficulties in High School Pupils</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Babes-Bolyai University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Babes-Bolyai University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Career decision-making difficulties are frequent problems for adolescents. Regular&#xD;
      intervention or prevention programs mainly provide information for the students about&#xD;
      themselves, about the world of work, about their interests and preferences etc. Rational&#xD;
      emotive behavioral therapy (REBT), a form of Cognitive behavioral therapy (CBT) provides help&#xD;
      for adolescents to efficiently cope with emotional problems (e.g., psychological distress)&#xD;
      related to the career decision-making process. The present study aims to investigate the&#xD;
      efficiency of an REBT career intervention program implemented in a school setting. School&#xD;
      settings are appropriate to deliver group intervention for students. Classes from Romanian&#xD;
      public high-schools will be randomized in either intervention or treatment as usual groups.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The intervention will be group based, delivered in 8 sessions, over 8 weeks. Each of the&#xD;
      eight modules aimed a different component: Psychoeducation, Information about self and world&#xD;
      of work, Steps of career decision-making, Problem solving. Additionally, for the REBT groups:&#xD;
      Relationship between cognitive distortions/irrational beliefs and emotions, Cognitive&#xD;
      restructuring, Exposure/behavioral activation and emotional problem solving, Maintenance of&#xD;
      gaining. Homework would be given at every session. REBT intervention programs delivered in&#xD;
      school settings represent ecological modalities to target vulnerable groups. Adolescents will&#xD;
      complete assessments at four time points: T1 (baseline), T2 (post-intervention), T3 (3 months&#xD;
      follow-up) and T4 (6 months follow-up).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 1, 2018</start_date>
  <completion_date type="Actual">April 1, 2019</completion_date>
  <primary_completion_date type="Actual">January 30, 2019</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>Treatment</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Career Decision-making Difficulties Questionnaire (CDDQ; Gati, Krausz, &amp; Osipow, 1996)</measure>
    <time_frame>Change from baseline career decision-making difficulties up to 24 weeks</time_frame>
    <description>Measure of career decision-making difficulties.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Emotional Distress Profile (PDA; Opris &amp; Macavei, 2005)</measure>
    <time_frame>Change from baseline distress up to 24 weeks</time_frame>
    <description>Measure of positive emotions, negative functional and negative dysfunctional emotions.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Penn State Worry Questionnaire for Children (PSWQ-C; Chorpita et al., 1997)</measure>
    <time_frame>Change from baseline worry up to 24 weeks</time_frame>
    <description>Measure of worry for children and adolescents.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>General Attitudes and Beliefs Scale Short Form (GABS-SF; Lindner et al., 1999)</measure>
    <time_frame>Change from baseline irrational beliefs up to 24 weeks</time_frame>
    <description>Measure of Irrational Beliefs.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Beck Depression Inventory for Youth (BDI-Y; Beck, 2005)</measure>
    <time_frame>Change from baseline depression, anxiety up to 24 weeks</time_frame>
    <description>Measure of depression of adolescents.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Beck Anxiety Inventory for Youth (BAI-Y; Beck, 2005)</measure>
    <time_frame>Change from baseline anxiety up to 24 weeks</time_frame>
    <description>Measure of anxiety of adolescents.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Career Decision-making Self-Efficacy Short Form (Betz et al., 1996)</measure>
    <time_frame>Change from baseline career decision-making self-efficacy up to 24 weeks</time_frame>
    <description>Measure of career decision-making self-efficacy.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Multidimensional Life Satisfaction (Seligson, Huebner, &amp; Valois, 2003)</measure>
    <time_frame>Change from baseline life satisfaction up to 24 weeks</time_frame>
    <description>Measure of five areas of life satisfaction.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">235</enrollment>
  <condition>Career Decision-making Difficulties</condition>
  <condition>Worry</condition>
  <condition>Psychological Distress</condition>
  <arm_group>
    <arm_group_label>REBT Career Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>High-school students in the experiment group attend to eight modules of career intervention with rational emotive behavioral therapy (REBT) techniques. The eight modules aim a different component: Psychoeducation, Information about the self and the world of work, Steps of Decision making, Relationship between cognitive distortions/irrational beliefs and emotions, Cognitive Restructuring, Exposure/behavior activation and problem solving, Planning, Goal Setting.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Regular Career Intervention</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>High-school students in the treatment as usual group attend to eight modules of career intervention with regular career intervention techniques. The eight modules aim a different component: Psychoeducation, Information about the self and the world of work, Steps of Decision making, Problem solving, Planning, Goal Setting.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>REBT Career Intervention</intervention_name>
    <description>Eight sessions of regular career intervention with rational emotive behavioral therapy (REBT) methods.</description>
    <arm_group_label>REBT Career Intervention</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Regular Career Intervention</intervention_name>
    <description>Eight sessions of regular career intervention.</description>
    <arm_group_label>Regular Career Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adolescents will have ages 16 years to 19 years (11th grade at high school).&#xD;
&#xD;
          -  Are attending high school.&#xD;
&#xD;
          -  Parents will sign the informed consent and adolescents provide informed assent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Age below 16 or above 19 years.&#xD;
&#xD;
          -  No signed informed consent from the parents.&#xD;
&#xD;
          -  Uninterpretable answers on the validation items of the CDDQ (items nr. 7 and 12)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>19 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Anca Dobrean</last_name>
    <role>Principal Investigator</role>
    <affiliation>Babes-Bolyai University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Babes-Bolyai University</name>
      <address>
        <city>Cluj-Napoca</city>
        <zip>400015</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Romania</country>
  </location_countries>
  <verification_date>August 2019</verification_date>
  <study_first_submitted>January 15, 2019</study_first_submitted>
  <study_first_submitted_qc>January 16, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 17, 2019</study_first_posted>
  <last_update_submitted>August 27, 2019</last_update_submitted>
  <last_update_submitted_qc>August 27, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">August 28, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Babes-Bolyai University</investigator_affiliation>
    <investigator_full_name>Viktoria Kulcsar</investigator_full_name>
    <investigator_title>Grad student</investigator_title>
  </responsible_party>
  <keyword>career indecision</keyword>
  <keyword>career decision-making difficulties</keyword>
  <keyword>worry</keyword>
  <keyword>psychological distress</keyword>
  <!-- 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/NCT03807895
org study id: 19.175/24.10.2018
nct id: NCT03807895
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Career decision-making difficulties are frequent problems for adolescents. Regular
      intervention or prevention programs mainly provide information for the students about
      themselves, about the world of work, about their interests and preferences etc. Rational
      emotive behavioral therapy (REBT), a form of Cognitive behavioral therapy (CBT) provides help
      for adolescents to efficiently cope with emotional problems (e.g., psychological distress)
      related to the career decision-making process. The present study aims to investigate the
      efficiency of an REBT career intervention program implemented in a school setting. School
      settings are appropriate to deliver group intervention for students. Classes from Romanian
      public high-schools will be randomized in either intervention or treatment as usual groups.
The intervention will be group based, delivered in 8 sessions, over 8 weeks. Each of the
      eight modules aimed a different component: Psychoeducation, Information about self and world
      of work, Steps of career decision-making, Problem solving. Additionally, for the REBT groups:
      Relationship between cognitive distortions/irrational beliefs and emotions, Cognitive
      restructuring, Exposure/behavioral activation and emotional problem solving, Maintenance of
      gaining. Homework would be given at every session. REBT intervention programs delivered in
      school settings represent ecological modalities to target vulnerable groups. Adolescents will
      complete assessments at four time points: T1 (baseline), T2 (post-intervention), T3 (3 months
      follow-up) and T4 (6 months follow-up).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Career Decision-making Difficulties Questionnaire (CDDQ; Gati, Krausz, & Osipow, 1996)
time frame: Change from baseline career decision-making difficulties up to 24 weeks
description: Measure of career decision-making difficulties.
measure: Emotional Distress Profile (PDA; Opris & Macavei, 2005)
time frame: Change from baseline distress up to 24 weeks
description: Measure of positive emotions, negative functional and negative dysfunctional emotions.
measure: Penn State Worry Questionnaire for Children (PSWQ-C; Chorpita et al., 1997)
time frame: Change from baseline worry up to 24 weeks
description: Measure of worry for children and adolescents.
measure: General Attitudes and Beliefs Scale Short Form (GABS-SF; Lindner et al., 1999)
time frame: Change from baseline irrational beliefs up to 24 weeks
description: Measure of Irrational Beliefs.
measure: Beck Depression Inventory for Youth (BDI-Y; Beck, 2005)
time frame: Change from baseline depression, anxiety up to 24 weeks
description: Measure of depression of adolescents.
measure: Beck Anxiety Inventory for Youth (BAI-Y; Beck, 2005)
time frame: Change from baseline anxiety up to 24 weeks
description: Measure of anxiety of adolescents.
measure: Career Decision-making Self-Efficacy Short Form (Betz et al., 1996)
time frame: Change from baseline career decision-making self-efficacy up to 24 weeks
description: Measure of career decision-making self-efficacy.
measure: Multidimensional Life Satisfaction (Seligson, Huebner, & Valois, 2003)
time frame: Change from baseline life satisfaction up to 24 weeks
description: Measure of five areas of life satisfaction.
arm group label: REBT Career Intervention
arm group type: Experimental
description: High-school students in the experiment group attend to eight modules of career intervention with rational emotive behavioral therapy (REBT) techniques. The eight modules aim a different component: Psychoeducation, Information about the self and the world of work, Steps of Decision making, Relationship between cognitive distortions/irrational beliefs and emotions, Cognitive Restructuring, Exposure/behavior activation and problem solving, Planning, Goal Setting.
arm group label: Regular Career Intervention
arm group type: Active Comparator
description: High-school students in the treatment as usual group attend to eight modules of career intervention with regular career intervention techniques. The eight modules aim a different component: Psychoeducation, Information about the self and the world of work, Steps of Decision making, Problem solving, Planning, Goal Setting.
intervention type: Behavioral
intervention name: REBT Career Intervention
description: Eight sessions of regular career intervention with rational emotive behavioral therapy (REBT) methods.
arm group label: REBT Career Intervention
intervention type: Behavioral
intervention name: Regular Career Intervention
description: Eight sessions of regular career intervention.
arm group label: Regular Career Intervention
criteria: 
gender: All
minimum age: 16 Years
maximum age: 19 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Anca Dobrean
role: Principal Investigator
affiliation: Babes-Bolyai University
facility: 
country: Romania
responsible party type: Principal Investigator
investigator affiliation: Babes-Bolyai University
investigator full name: Viktoria Kulcsar
investigator title: Grad student