<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/NCT01727882</url>
  </required_header>
  <id_info>
    <org_study_id>535629</org_study_id>
    <secondary_id>535629</secondary_id>
    <nct_id>NCT01727882</nct_id>
  </id_info>
  <brief_title>Automated Telephone Follow-up in the Swedish Prison and Probation Services</brief_title>
  <official_title>Automated Telephone Follow-up in the Swedish Prison and Probation Services. A Randomized Controlled Trail.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Region Skane</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Lund University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Malmö University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Region Skane</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to investigate whether automated telephony may be used for daily&#xD;
      assessments of paroled offenders, and whether a brief intervention based on these daily&#xD;
      assessments may result in a more positive development compared to daily assessments only.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      To study whether automated telephony could be used in paroled offenders to perform daily&#xD;
      assessment of variables associated with recidivism in crime and to study the effects of a&#xD;
      brief intervention based on these assessments during 30 days following probation.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>December 2009</start_date>
  <completion_date type="Actual">September 2010</completion_date>
  <primary_completion_date type="Actual">September 2010</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>Mental symptoms, SCL-8D</measure>
    <time_frame>During 30 days after probation</time_frame>
    <description>Mental Symptoms, assessed with SCL-8D (Fink et al. A Nordic multicentre investigation. Part I: Method and prevalence of psychiatric morbidity. Acta Psychiatrica Scandinavica. 1995;92(6):409-418).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Stress</measure>
    <time_frame>During 30 days after probation</time_frame>
    <description>Stress assessed with the Arnetz and hasson stress questionnaire(Andersson C et al. Measurement properties of the Arnetz and Hasson stress questionnaire in Swedish university freshmen. Scandinavian Journal of Public Health. 2009;37(3):273-279)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stress</measure>
    <time_frame>During 30 days after probation</time_frame>
    <description>Daily Assessment of Daily Experience (Stone AA, Neale JM. Development of a methodology for assessing daily experiences. In: Baum A, Singer J, eds. Advances in Environmental Psychology: Environment and Health. Vol 4. New York: Erlbaum; 1982:49-83).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Desire to use alcohol and drugs</measure>
    <time_frame>During 30 days after probation</time_frame>
    <description>Desire to use alcohol and drugs (Bohn MJ, Krahn DD, Staehler BA. Development and initial validation of a measure of drinking urges in abstinent alcoholics. Alcoholism: Clinical and Experimental Research. 1995;19(3):600-606).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Current use of alcohol and drugs</measure>
    <time_frame>During 30 days after probation</time_frame>
    <description>Current use was then assessed by simply asking whether the offender had drunk alcohol or used any drugs the previous day.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">108</enrollment>
  <condition>Affect</condition>
  <condition>Alcohol Consumption</condition>
  <condition>Substance Abuse</condition>
  <arm_group>
    <arm_group_label>Daily Assessments &amp; Brief Feedback</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Daily assessments during 30 days after parole and a feedback intervention based on these daily assessments.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Daily assessments</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Daily assessments during 30 days after parole.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Brief feedback</intervention_name>
    <description>A brief feedback was given on the results of the daily assessments, including a recommendation to the paroled offender and a email report was sent to the probation officer.</description>
    <arm_group_label>Daily Assessments &amp; Brief Feedback</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Daily assessments</intervention_name>
    <description>Daily assessment of stress, mental symptoms, alcohol and substance use during 30 consecutive days after parole.</description>
    <arm_group_label>Daily Assessments &amp; Brief Feedback</arm_group_label>
    <arm_group_label>Daily assessments</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Convicted criminals subject to parole&#xD;
&#xD;
          -  Access to a mobile telephone&#xD;
&#xD;
          -  Assigned parole officer at parole&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  No knowledge of spoken Swedish&#xD;
&#xD;
          -  Additional intervention such as intensive supervision with electronic monitoring, or&#xD;
             in-patient care at a health and rehabilitation clinic&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Claes Andersson, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Lund university and Malmö university</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The Swedish Prison and Probation Services, Region South and Region East</name>
      <address>
        <city>Norrköping</city>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Sweden</country>
  </location_countries>
  <verification_date>November 2012</verification_date>
  <study_first_submitted>November 4, 2012</study_first_submitted>
  <study_first_submitted_qc>November 12, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 16, 2012</study_first_posted>
  <last_update_submitted>November 12, 2012</last_update_submitted>
  <last_update_submitted_qc>November 12, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 16, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Region Skane</investigator_affiliation>
    <investigator_full_name>Claes Andersson</investigator_full_name>
    <investigator_title>PhD</investigator_title>
  </responsible_party>
  <keyword>Paroled offenders</keyword>
  <keyword>Interactive Voice Response</keyword>
  <keyword>Stress</keyword>
  <keyword>Mental symptoms</keyword>
  <keyword>Alcohol consumption</keyword>
  <keyword>Substance use</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Substance-Related Disorders</mesh_term>
    <mesh_term>Alcohol Drinking</mesh_term>
  </condition_browse>
  <!-- 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/NCT01727882
org study id: 535629
secondary id: 535629
nct id: NCT01727882
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
The purpose of this study is to investigate whether automated telephony may be used for daily
      assessments of paroled offenders, and whether a brief intervention based on these daily
      assessments may result in a more positive development compared to daily assessments only.
To study whether automated telephony could be used in paroled offenders to perform daily
      assessment of variables associated with recidivism in crime and to study the effects of a
      brief intervention based on these assessments during 30 days following probation.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Mental symptoms, SCL-8D
time frame: During 30 days after probation
description: Mental Symptoms, assessed with SCL-8D (Fink et al. A Nordic multicentre investigation. Part I: Method and prevalence of psychiatric morbidity. Acta Psychiatrica Scandinavica. 1995;92(6):409-418).
measure: Stress
time frame: During 30 days after probation
description: Stress assessed with the Arnetz and hasson stress questionnaire(Andersson C et al. Measurement properties of the Arnetz and Hasson stress questionnaire in Swedish university freshmen. Scandinavian Journal of Public Health. 2009;37(3):273-279)
measure: Stress
time frame: During 30 days after probation
description: Daily Assessment of Daily Experience (Stone AA, Neale JM. Development of a methodology for assessing daily experiences. In: Baum A, Singer J, eds. Advances in Environmental Psychology: Environment and Health. Vol 4. New York: Erlbaum; 1982:49-83).
measure: Desire to use alcohol and drugs
time frame: During 30 days after probation
description: Desire to use alcohol and drugs (Bohn MJ, Krahn DD, Staehler BA. Development and initial validation of a measure of drinking urges in abstinent alcoholics. Alcoholism: Clinical and Experimental Research. 1995;19(3):600-606).
measure: Current use of alcohol and drugs
time frame: During 30 days after probation
description: Current use was then assessed by simply asking whether the offender had drunk alcohol or used any drugs the previous day.
arm group label: Daily Assessments & Brief Feedback
arm group type: Experimental
description: Daily assessments during 30 days after parole and a feedback intervention based on these daily assessments.
arm group label: Daily assessments
arm group type: Active Comparator
description: Daily assessments during 30 days after parole.
intervention type: Behavioral
intervention name: Brief feedback
description: A brief feedback was given on the results of the daily assessments, including a recommendation to the paroled offender and a email report was sent to the probation officer.
arm group label: Daily Assessments & Brief Feedback
intervention type: Behavioral
intervention name: Daily assessments
description: Daily assessment of stress, mental symptoms, alcohol and substance use during 30 consecutive days after parole.
arm group label: Daily Assessments & Brief Feedback
arm group label: Daily assessments
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Claes Andersson, PhD
role: Principal Investigator
affiliation: Lund university and Malmö university
facility: 
country: Sweden
responsible party type: Principal Investigator
investigator affiliation: Region Skane
investigator full name: Claes Andersson
investigator title: PhD
mesh term: Substance-Related Disorders
mesh term: Alcohol Drinking