<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/NCT04505072</url>
  </required_header>
  <id_info>
    <org_study_id>GNC SiS PR-ESSENCE</org_study_id>
    <nct_id>NCT04505072</nct_id>
  </id_info>
  <brief_title>RCT of PR-ESSENCE - a Problem Solving Model for Youth With Challenging Behavior in Special (SiS) Treatment Homes</brief_title>
  <official_title>Randomized Controlled Study of PR-ESSENCE - a Problem Solving Model for Youth With Challenging Behavior in Special (SiS) Treatment Homes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Göteborg University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Göteborg University</source>
  <oversight_info>
    <has_dmc>No</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>
      Randomized controlled trial of PR-ESSENCE treatment for youth with challenging behavior in&#xD;
      two youth treatment homes, including 60-70 youth. Inclusion criteria: Youth aged 12-17 years,&#xD;
      staying at least 3 months at the home, with intellectual function in the normal range&#xD;
      according to WISC-test and clinical judgment, and exhibiting significant problem behaviors as&#xD;
      measured by Broset Violence Checklist (BVC). Subjects are randomized to 10 weeks of&#xD;
      PR-ESSENCE treatment or to the control condition &quot;treatment as usual&quot;. After the control&#xD;
      period, the control group will receive 10 weeks of PR-ESSENCE treatment. Outcome is assessed&#xD;
      at baseline, post-treatment/control period, and 3-6 months post-treatment (at the time when&#xD;
      the youth is planned to move from the home) with global assessments of problem severity and&#xD;
      improvement by blinded rater (CGI-I, CGI-S), ratings of SNAP-IV (ADHD and oppositional&#xD;
      symptoms), ECBI (behavior problems) and RPQ (relation problems) by the youth's contact&#xD;
      person, and self-ratings of psychiatric symptoms and self-concept with Becks Youth&#xD;
      Inventories. BVC ratings are also made daily by contact persons and teachers during the whole&#xD;
      study.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      PR-ESSENCE is a problem-solving training program developed by our research team, inspired by&#xD;
      Dr Greene´s model &quot;Collaborative and Proactive Solutions (CPS)&quot;. We recently completed an RCT&#xD;
      with PR-ESSENCE at the Gillberg Centre, Gothenburg University, including 108 children and&#xD;
      adolescents who had complex neurodevelopmental disorders such as autism, ADHD, ODD, Tourette,&#xD;
      learning difficulties etc and challenging behaviors. The study showed significant global&#xD;
      improvements in behavior problems with a large effect size.&#xD;
&#xD;
      The PR-ESSENCE model is designed to train and develop mutual problem solving strategies for&#xD;
      children and adolescents with neurodevelopmental disorders (ESSENCE, an umbrella term coined&#xD;
      by Gillberg 2010 = Early Symptomatic Syndromes Eliciting Neuropsychiatric Clinical&#xD;
      Examinations, which puts focus on the considerable overlap several of these syndromes have).&#xD;
      Many youth who are placed in youth treatment homes due to challenging and risk-taking&#xD;
      behaviors have been shown to have ESSENCE impairments.&#xD;
&#xD;
      The present study is a randomized controlled trial of PR-ESSENCE treatment for youth with&#xD;
      challenging behavior in two youth treatment homes in southwestern Sweden, Bjorkbacken (girls)&#xD;
      and Nereby (boys). We plan to include 60-70 youth. Inclusion criteria: Youth aged 12-17&#xD;
      years, staying at least 3 months at the home, with intellectual function in the normal range&#xD;
      according to WISC-test and clinical judgment, and exhibiting significant problem behaviors as&#xD;
      measured by Broset Violence Checklist (BVC). Exclusion criteria: Intellectual disability,&#xD;
      bipolar syndrome, psychosis, substance use, or other unstable psychiatric or medical&#xD;
      condition which would make study participation unsuitable. Psychoactive medication is allowed&#xD;
      if stable at least one month before baseline, and during the trial.&#xD;
&#xD;
      At baseline a medical and neuropsychiatric history is taken by psychologist and physician (a&#xD;
      standard assessment done for all youth placed at the homes), including rating of history of&#xD;
      risk behaviors with Youth Level of Service/Case Management Inventory (YLS/CMI), and a&#xD;
      DSM-5-diagnostic screening (DSM-5-CCSM) for psychiatric symptoms. Intellectual level will be&#xD;
      tested with WISC-V. The participants will do self-ratings of psychiatric symptoms and&#xD;
      self-concept with Becks Youth Inventories. The therapists interview parents/carers about&#xD;
      history of neuropsychiatric symptoms with the A-TAC-interview.&#xD;
&#xD;
      Subjects are randomized to 10 weeks of PR-ESSENCE treatment or to the control condition&#xD;
      &quot;treatment as usual&quot;. After the control period, the control group will also receive 10 weeks&#xD;
      of PR-ESSENCE treatment. Outcome is assessed at baseline, post treatment/control period, and&#xD;
      3-6 months post-treatment (at the time when the youth is planned to move from the home) with&#xD;
      global assessments of problem severity and improvement by blinded independent rater (CGI-I,&#xD;
      CGI-S), ratings of SNAP-IV (ADHD and oppositional symptoms), ECBI (behavior problems) and RPQ&#xD;
      (relation problems) by the youth's contact person, and self-ratings of psychiatric symptoms&#xD;
      and self-concept with Becks Youth Inventories. BVC ratings are made daily by contact persons&#xD;
      and teachers during the whole study. During treatment, therapists rate every week with a&#xD;
      Problem Rating Scale how many problem situations are completely or partly solved.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">February 10, 2021</start_date>
  <completion_date type="Anticipated">December 31, 2024</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2024</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>
    <intervention_model_description>Randomized Controlled Trial</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
    <masking_description>Primary outcome assessed by blinded rater</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Clinical Global Impression- Improvement (CGI-I)</measure>
    <time_frame>10 weeks, change</time_frame>
    <description>Global rating of improvement by blinded rater based on all available information, score range 1-7, lower is better</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Clinical Global Impression- Severity (CGI-S)</measure>
    <time_frame>10 weeks, change</time_frame>
    <description>Global rating of symptom severity by blinded rater based on all available information, score range 1-7, lower is better</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Broset Violence Checklist (BVC)</measure>
    <time_frame>10 weeks, change</time_frame>
    <description>Measures problem behaviors frequency/intensity, score range 0-36 per day, lower is better</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>SNAP-IV</measure>
    <time_frame>10 weeks, change</time_frame>
    <description>Measures ADHD and Oppositional Defiant symptoms, score range ADHD 0-54, ODD 24, lower is better</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Eyberg Child Behavior Inventory (ECBI)</measure>
    <time_frame>10 weeks, change</time_frame>
    <description>Measures behavior problems frequency/intensity, score range 36-252, lower is better</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Relationship Problems Questionnaire (RPQ)</measure>
    <time_frame>10 weeks, change</time_frame>
    <description>Measures relationship problems, score range 0-30, lower is better</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">70</enrollment>
  <condition>Behavior Problems</condition>
  <condition>Neurodevelopmental Disorders</condition>
  <arm_group>
    <arm_group_label>PR-ESSENCE treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>PR-ESSENCE treatment 10 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Treatment as usual 10 weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>PR-ESSENCE</intervention_name>
    <description>Manual-based training of mutual problem-solving</description>
    <arm_group_label>PR-ESSENCE treatment</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Treatment as usual</intervention_name>
    <description>General support in daily structure and activities that is given to all youth staying at the treatment homes</description>
    <arm_group_label>Control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Youth with problem behaviors, placed for at least 3 months in the youth treatment&#xD;
             homes Nereby (boys) and Bjorkbacken (girls).&#xD;
&#xD;
          2. Age 12-17 years&#xD;
&#xD;
          3. Intellectual function in the normal range according to WISC-test and clinical judgment&#xD;
&#xD;
          4. Problem behavior score of at least 5 points in one week on the Broset Violence&#xD;
             Checklist (BVC). Score is measured during 2 weeks before screening&#xD;
&#xD;
          5. Medium to high-risk score on the YLS/CMI behavior problem domain 7&#xD;
&#xD;
          6. Psychotropic medication is allowed if stable during one month before baseline and&#xD;
             during the randomized period of the trial&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        1. Intellectual disability, bipolar syndrome, psychosis, substance use, or other unstable&#xD;
        psychiatric or medical condition that would make study participation unsuitable&#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>Christopher Gillberg, Professor</last_name>
    <role>Study Chair</role>
    <affiliation>Gillberg Neuropsychiatry Centre, Gothenburg University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Mats Johnson, MD, PhD</last_name>
    <phone>031-3425971</phone>
    <email>mats.johnson@gnc.gu.se</email>
  </overall_contact>
  <location>
    <facility>
      <name>Gillberg Neuropsychiatry Centre</name>
      <address>
        <city>Gothenburg</city>
        <state>V. Gotaland</state>
        <zip>411 19</zip>
        <country>Sweden</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Mats Johnson, MD, PhD</last_name>
      <phone>0762109103</phone>
      <email>mats.johnson@gnc.gu.se</email>
    </contact>
    <contact_backup>
      <last_name>Ingrid Vinsa, BSc</last_name>
      <phone>031-3425970</phone>
      <email>ingrid.vinsa@gnc.gu.se</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Sweden</country>
  </location_countries>
  <verification_date>August 2022</verification_date>
  <study_first_submitted>August 2, 2020</study_first_submitted>
  <study_first_submitted_qc>August 6, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 7, 2020</study_first_posted>
  <last_update_submitted>August 13, 2022</last_update_submitted>
  <last_update_submitted_qc>August 13, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">August 16, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neurodevelopmental Disorders</mesh_term>
    <mesh_term>Problem Behavior</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>December 30, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/72/NCT04505072/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT04505072
org study id: GNC SiS PR-ESSENCE
nct id: NCT04505072
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Randomized controlled trial of PR-ESSENCE treatment for youth with challenging behavior in
      two youth treatment homes, including 60-70 youth. Inclusion criteria: Youth aged 12-17 years,
      staying at least 3 months at the home, with intellectual function in the normal range
      according to WISC-test and clinical judgment, and exhibiting significant problem behaviors as
      measured by Broset Violence Checklist (BVC). Subjects are randomized to 10 weeks of
      PR-ESSENCE treatment or to the control condition "treatment as usual". After the control
      period, the control group will receive 10 weeks of PR-ESSENCE treatment. Outcome is assessed
      at baseline, post-treatment/control period, and 3-6 months post-treatment (at the time when
      the youth is planned to move from the home) with global assessments of problem severity and
      improvement by blinded rater (CGI-I, CGI-S), ratings of SNAP-IV (ADHD and oppositional
      symptoms), ECBI (behavior problems) and RPQ (relation problems) by the youth's contact
      person, and self-ratings of psychiatric symptoms and self-concept with Becks Youth
      Inventories. BVC ratings are also made daily by contact persons and teachers during the whole
      study.
PR-ESSENCE is a problem-solving training program developed by our research team, inspired by
      Dr Greene´s model "Collaborative and Proactive Solutions (CPS)". We recently completed an RCT
      with PR-ESSENCE at the Gillberg Centre, Gothenburg University, including 108 children and
      adolescents who had complex neurodevelopmental disorders such as autism, ADHD, ODD, Tourette,
      learning difficulties etc and challenging behaviors. The study showed significant global
      improvements in behavior problems with a large effect size.

      The PR-ESSENCE model is designed to train and develop mutual problem solving strategies for
      children and adolescents with neurodevelopmental disorders (ESSENCE, an umbrella term coined
      by Gillberg 2010 = Early Symptomatic Syndromes Eliciting Neuropsychiatric Clinical
      Examinations, which puts focus on the considerable overlap several of these syndromes have).
      Many youth who are placed in youth treatment homes due to challenging and risk-taking
      behaviors have been shown to have ESSENCE impairments.

      The present study is a randomized controlled trial of PR-ESSENCE treatment for youth with
      challenging behavior in two youth treatment homes in southwestern Sweden, Bjorkbacken (girls)
      and Nereby (boys). We plan to include 60-70 youth. Inclusion criteria: Youth aged 12-17
      years, staying at least 3 months at the home, with intellectual function in the normal range
      according to WISC-test and clinical judgment, and exhibiting significant problem behaviors as
      measured by Broset Violence Checklist (BVC). Exclusion criteria: Intellectual disability,
      bipolar syndrome, psychosis, substance use, or other unstable psychiatric or medical
      condition which would make study participation unsuitable. Psychoactive medication is allowed
      if stable at least one month before baseline, and during the trial.

      At baseline a medical and neuropsychiatric history is taken by psychologist and physician (a
      standard assessment done for all youth placed at the homes), including rating of history of
      risk behaviors with Youth Level of Service/Case Management Inventory (YLS/CMI), and a
      DSM-5-diagnostic screening (DSM-5-CCSM) for psychiatric symptoms. Intellectual level will be
      tested with WISC-V. The participants will do self-ratings of psychiatric symptoms and
      self-concept with Becks Youth Inventories. The therapists interview parents/carers about
      history of neuropsychiatric symptoms with the A-TAC-interview.

      Subjects are randomized to 10 weeks of PR-ESSENCE treatment or to the control condition
      "treatment as usual". After the control period, the control group will also receive 10 weeks
      of PR-ESSENCE treatment. Outcome is assessed at baseline, post treatment/control period, and
      3-6 months post-treatment (at the time when the youth is planned to move from the home) with
      global assessments of problem severity and improvement by blinded independent rater (CGI-I,
      CGI-S), ratings of SNAP-IV (ADHD and oppositional symptoms), ECBI (behavior problems) and RPQ
      (relation problems) by the youth's contact person, and self-ratings of psychiatric symptoms
      and self-concept with Becks Youth Inventories. BVC ratings are made daily by contact persons
      and teachers during the whole study. During treatment, therapists rate every week with a
      Problem Rating Scale how many problem situations are completely or partly solved.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Randomized Controlled Trial
primary purpose: Treatment
masking: Single (Outcomes Assessor)
masking description: Primary outcome assessed by blinded rater
measure: Clinical Global Impression- Improvement (CGI-I)
time frame: 10 weeks, change
description: Global rating of improvement by blinded rater based on all available information, score range 1-7, lower is better
measure: Clinical Global Impression- Severity (CGI-S)
time frame: 10 weeks, change
description: Global rating of symptom severity by blinded rater based on all available information, score range 1-7, lower is better
measure: Broset Violence Checklist (BVC)
time frame: 10 weeks, change
description: Measures problem behaviors frequency/intensity, score range 0-36 per day, lower is better
measure: SNAP-IV
time frame: 10 weeks, change
description: Measures ADHD and Oppositional Defiant symptoms, score range ADHD 0-54, ODD 24, lower is better
measure: Eyberg Child Behavior Inventory (ECBI)
time frame: 10 weeks, change
description: Measures behavior problems frequency/intensity, score range 36-252, lower is better
measure: Relationship Problems Questionnaire (RPQ)
time frame: 10 weeks, change
description: Measures relationship problems, score range 0-30, lower is better
arm group label: PR-ESSENCE treatment
arm group type: Experimental
description: PR-ESSENCE treatment 10 weeks
arm group label: Control
arm group type: Active Comparator
description: Treatment as usual 10 weeks
intervention type: Behavioral
intervention name: PR-ESSENCE
description: Manual-based training of mutual problem-solving
arm group label: PR-ESSENCE treatment
intervention type: Behavioral
intervention name: Treatment as usual
description: General support in daily structure and activities that is given to all youth staying at the treatment homes
arm group label: Control
criteria: 
gender: All
minimum age: 12 Years
maximum age: 17 Years
healthy volunteers: No
last name: Christopher Gillberg, Professor
role: Study Chair
affiliation: Gillberg Neuropsychiatry Centre, Gothenburg University
last name: Mats Johnson, MD, PhD
phone: 031-3425971
email: mats.johnson@gnc.gu.se
facility: 
status: Recruiting
contact: 
contact backup: 
country: Sweden
responsible party type: Sponsor
mesh term: Neurodevelopmental Disorders
mesh term: Problem Behavior
sharing ipd: No
provided document: 