<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/NCT03780413</url>
  </required_header>
  <id_info>
    <org_study_id>GNC PR-ESSENCE</org_study_id>
    <nct_id>NCT03780413</nct_id>
  </id_info>
  <brief_title>PR-ESSENCE for Youth With Challenging Behavior</brief_title>
  <official_title>Randomized Controlled Trial of PR-ESSENCE - an Intervention Model for Young People With Explosive and Challenging Behavior</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>
      The method &quot;Collaborative and Proactive Solutions&quot; (CPS) was developed by Dr. Ross Greene,&#xD;
      Harvard University, to understand and help kids with social, emotional, and behavioral&#xD;
      challenges. The underlying theory is that challenging behavior is caused by lagging cognitive&#xD;
      skills, commonly in the domains of flexibility/adaptability, frustration tolerance, and&#xD;
      problem-solving. Thus, challenging behavior can be seen as a form of developmental delay, and&#xD;
      the most effective way for adults to help the children and to facilitate interaction with&#xD;
      them is to understand the lagging skills behind the behavior and to change their own mindset&#xD;
      accordingly.&#xD;
&#xD;
      ADHD and autism belong in a group of overlapping neurodevelopmental conditions now often&#xD;
      referred to under the umbrella term of ESSENCE (Early Symptomatic Syndromes Eliciting&#xD;
      Neurodevelopmental Clinical Examinations). A common impairing problem in both autism and ADHD&#xD;
      - and in several of the other disorders in the group of ESSENCE (including Tourette syndrome&#xD;
      and other tic disorders) - is the marked inability to control temper, coupled with&#xD;
      oppositional-defiant behaviors.&#xD;
&#xD;
      The CPS-method has been evaluated by Ross Greene et al. in United States studies for&#xD;
      families, in schools, and in institutions for young people with serious behavior problems.&#xD;
      Our research group published the first Swedish study with the method in 2012, a small open&#xD;
      pilot study. Based on experiences in clinical work after that study our group reached the&#xD;
      conclusion that, in order for the intervention to be useful for families with severely&#xD;
      impairing ESSENCE, the CPS model needed to be modified. After a number of research meetings&#xD;
      and seminars, we therefore designed a new model, based on our CPS-experience, that we now&#xD;
      refer to as PR-ESSENCE (Problem Resolution in ESSENCE).&#xD;
&#xD;
      The present study is a randomized controlled trial for approximately 130 children and&#xD;
      adolescents aged 5-18 years, with neuropsychiatric disorders (for instance Attention Deficit&#xD;
      Hyperactivity Disorder (ADHD), Oppositional Defiant Disorder (ODD), Conduct Disorder (CD),&#xD;
      Autism Spectrum Disorder (ASD), Tourette syndrome, learning difficulties), children who have&#xD;
      been assessed at our Child Neuropsychiatry Clinic (CNC), and from the Habilitation Services,&#xD;
      Child Psychiatry Units or schools in the Göteborg region.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The &quot;Collaborative Problem Solving&quot; model was developed by Greene for the treatment of youth&#xD;
      with oppositional behavior, and is now called Collaborative &amp; Proactive Solutions (CPS). The&#xD;
      aim of CPS is to help caregivers and children practice and learn problem solving strategies&#xD;
      in collaboration. The theoretical base of the model is that problematic behavior is mainly&#xD;
      caused by lagging skills, especially regarding frustration tolerance, flexibility and problem&#xD;
      solving ability. The CPS model engages both the child and the parents in training, and may&#xD;
      therefore have potential to give long-term improvement of lagging skills in handling&#xD;
      problematic situations and to change the mindset towards strategies of mutual problem&#xD;
      solving.&#xD;
&#xD;
      The CPS model was evaluated in a United States trial comparing CPS to Barkley's Parent&#xD;
      Management Training program (PMT) in 47 children aged 4-12 years with ODD and affective&#xD;
      dysregulation. Outcomes were similar between the two methods in most measures post-treatment&#xD;
      and at 4 months follow-up. A recent larger randomized controlled US trial enrolled 134&#xD;
      children with ODD, aged 7 - 14 years, who were randomized to three groups (CPS, PMT or&#xD;
      Waitlist Control). Both treatment groups had equivalent results in treatment response and&#xD;
      remission of diagnostic status (50% were much to very much improved and no longer met&#xD;
      diagnostic criteria), and both were superior to the WLC condition.&#xD;
&#xD;
      The first Swedish study of CPS, published by our research team 2012, was a small open pilot&#xD;
      trial of 3 months CPS for 17 families and children aged 7-13 years, with ADHD, ODD and&#xD;
      explosive behavior, showed promising results. At post-treatment 53% of the children were much&#xD;
      or very much improved on global symptom and function ratings (Clinical Global&#xD;
      Impression-Improvement; CGI-I rating 1-2), and after another 6 months when the children with&#xD;
      severe residual ADHD symptoms also had received stimulant medication, 81% reached CGI-I&#xD;
      levels of 1-2.&#xD;
&#xD;
      Thus previous research has suggested that CPS is an effective treatment for ODD in youth, but&#xD;
      effectiveness in samples of children with various neurodevelopmental disorders has not yet&#xD;
      been documented. Oppositional and explosive behavior is a major problem among youth with&#xD;
      neurodevelopmental disorders and the demand for treatment strategies is great.&#xD;
&#xD;
      Experiences from treatment of children with complex neurodevelopmental disorders - ESSENCE&#xD;
      (mainly including autism) have led the therapists in our team to make ESSENCE-adapted&#xD;
      modifications to the CPS model, particularly regarding communication, structure,&#xD;
      predictability, and focusing on the child's interests to facilitate interaction. We therefore&#xD;
      designed a new model, based on our CPS-experience, that we now refer to as PR-ESSENCE&#xD;
      (Problem Resolution in ESSENCE). During the early phases of this study, Dr. Greene gave&#xD;
      advice and supervision to our treatment team, and the whole PR-ESSENCE model would not have&#xD;
      been developed without this input.&#xD;
&#xD;
      Research questions&#xD;
&#xD;
        1. Can the PR-ESSENCE model reduce problematic behaviors? Outcome measures are the rating&#xD;
           scales Swanson, Nolan and Pelham scale (SNAP-IV), Family Burden of Illness Module&#xD;
           (FBIM), Eyberg Child Behavior Inventory (ECBI), Clinical Global Impression-Severity&#xD;
           scale (CGI-S), Clinical Global Impression-Improvement scale (CGI-I) (see below).&#xD;
&#xD;
        2. Can the PR-ESSENCE model contribute to solve specific problem situations. Outcome&#xD;
           measure is a Problem Rating Scale developed for this study&#xD;
&#xD;
        3. Can the PR-ESSENCE model improve psychiatric well-being and self-image in the&#xD;
           participants? Outcome measure is the Beck Youth Inventories.&#xD;
&#xD;
      Method The present study is designed to investigate how well PR-ESSENCE works for challenging&#xD;
      behaviors in well-defined clinical samples of children with complex neurodevelopmental&#xD;
      disorders. Participants are children and adolescents aged 5-18 years, with any&#xD;
      neurodevelopmental diagnosis, and with intellectual level in the normal range.&#xD;
&#xD;
      After neuropsychiatric assessment and diagnosis at our centre or at the Child Psychiatry&#xD;
      Centres in Gothenburg 130 children and adolescents aged 5-18 years with complex&#xD;
      neurodevelopmental disorders (i.e. autism, ADHD, learning disorders, dyslexia, tics, and&#xD;
      Conduct Disorder) and problematic behaviors are invited to participate in the trial. They are&#xD;
      randomized to a PR-ESSENCE treatment group and a control group. The treatment group receives&#xD;
      PR-ESSENCE for 10 weeks. The control group receives 10 weeks of &quot;treatment as usual (TAU)&quot;&#xD;
      (that is the standard psychoeducation, support and treatment given to all youth after&#xD;
      neuropsychiatric assessment at our clinic), followed by 10 weeks of PR-ESSENCE. Outcome&#xD;
      measures are collected pre- and post-treatment, and after 6 months and one year. During the&#xD;
      PR-ESSENCE treatment period the parents and children meet the therapists at approximately 10&#xD;
      visits, at which they collaborate to find problem solving strategies, which they then&#xD;
      practice at home between visits.&#xD;
&#xD;
      Inclusion criteria&#xD;
&#xD;
        1. Children and adolescents aged 5-18 years with neurodevelopmental disorders and serious&#xD;
           problematic behaviors.&#xD;
&#xD;
        2. Intellectual function in the normal range, according to WISC-test and clinical judgment&#xD;
&#xD;
        3. Participants taking psychoactive medication can be included if the medication has been&#xD;
           unchanged for at least one month before baseline, and remains unchanged during the&#xD;
           treatment period.&#xD;
&#xD;
      Exclusion criteria&#xD;
&#xD;
        1. Bipolar disorder, psychosis, or other unstable psychiatric or medical disorder which in&#xD;
           the investigator's judgment makes participation in the trial unsuitable.&#xD;
&#xD;
        2. Substance use.&#xD;
&#xD;
      Outcome measures The following measures are collected at baseline (pre-treatment), after the&#xD;
      treatment/TAU period (post-treatment), after 6 months (6-month follow-up) and 1 year&#xD;
      (one-year follow-up). To obtain results from different perspectives ratings from four sources&#xD;
      were used, i.e. ratings by independent blinded assessors, and by parents, children and&#xD;
      therapists.&#xD;
&#xD;
      Rating of independent blinded assessor CGI-I: Scale for global rating of improvement or&#xD;
      deterioration of problems/symptoms (scale from 1-7; 1 very much improved, 7 very much worse)&#xD;
      CGI-S: Scale for global rating of problem/symptom severity (scale from 1-7; 1 no problems, 7&#xD;
      very severe problems)&#xD;
&#xD;
      Parent ratings SNAP-IV - rating scale for ADHD symptoms FBIM - rating scale of family&#xD;
      stress/burden ECBI - rating of behavior problems&#xD;
&#xD;
      Child self-rating Beck Youth Inventories: For rating of depression, anxiety, irritability,&#xD;
      externalizing behavior, and self image (child interviewed).&#xD;
&#xD;
      Therapist ratings Problem Rating Scale (in which the severity of the problematic situations&#xD;
      before and after treatment is rated)&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 1, 2014</start_date>
  <completion_date type="Actual">December 31, 2019</completion_date>
  <primary_completion_date type="Actual">December 31, 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>Crossover Assignment</intervention_model>
    <intervention_model_description>RCT in which participants are randomized to active group (PR-ESSENCE for 10 weeks) or control group (treatment as usual for 10 weeks, followed PR-ESSENCE for 10 weeks)</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
    <masking_description>Blinded assessors</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>CGI-S/CGI-I change</measure>
    <time_frame>Baseline, post-treatment/control period (3 months), 6 months and 1 year post-treatment</time_frame>
    <description>Clinical Global Impression - Severity and Improvement (by blinded assessor). Range 1-7 points, lower is better. A global assessment of severity and change in behavior problems and everyday function.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>ODD Scale change</measure>
    <time_frame>Baseline, post-treatment/control period (3 months), 6 months and 1 year post-treatment</time_frame>
    <description>Oppositional Defiant Rating Scale (Ross Greene's), parent-rated. An assessment of DSM-5 Oppositional Defiant Disorder symptoms. Range 34-170, lower is better.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>SNAP-IV change</measure>
    <time_frame>Baseline, post-treatment/control period (3 months), 6 months and 1 year post-treatment</time_frame>
    <description>Rating scale of ADHD symptoms (parent-rated). Range 0-54 Points, lower is better.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>FBIM change</measure>
    <time_frame>Baseline, post-treatment/control period (3 months), 6 months and 1 year post-treatment</time_frame>
    <description>Family Burden of Illness Module (measure of family stress - parent-rated). Range 0-24, lower is better.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ECBI change</measure>
    <time_frame>Baseline, post-treatment/control period (3 months), 6 months and 1 year post-treatment</time_frame>
    <description>Eyberg Child Behavior Inventory (measure of behavior problems, parent-rated). Range 0-216, lower is better.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>RPQ change</measure>
    <time_frame>Baseline, post-treatment/control period (3 months), 6 months and 1 year post-treatment</time_frame>
    <description>Relationship Problems Questionnaire (measure of relation and attachment, parent-rated). Range 0-30 Points, lower is better.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Beck's Youth Inventory change</measure>
    <time_frame>Baseline, post-treatment/control period (3 months), 6 months and 1 year post-treatment</time_frame>
    <description>Self-rating of depression, anxiety, irritability, behavior problems, and self-image. Self-rated by interview. Range 0-300, lower is better.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Problem solving scale change</measure>
    <time_frame>Baseline, post-treatment/control period (3 months), 6 months and 1 year post-treatment</time_frame>
    <description>Measures number and type of problem situations solved (therapist-rated). Range 0-infinite number, higher is better.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">108</enrollment>
  <condition>Behavior Problem of Childhood and Adolescence</condition>
  <arm_group>
    <arm_group_label>PR-ESSENCE treatment</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The treatment group receives PR-ESSENCE for 10 weeks. Outcome measures are collected pre- and post-treatment, and after 6 months and one year.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control (TAU)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The control group receives 10 weeks of &quot;treatment as usual (TAU)&quot; (that is the standard psychoeducation, support and treatment given to all youth after neuropsychiatric assessment at our clinic), followed by 10 weeks of PR-ESSENCE. Outcome measures were collected pre- and post-treatment, and after 6 months and one year.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>PR-ESSENCE treatment</intervention_name>
    <arm_group_label>PR-ESSENCE treatment</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Control (TAU)</intervention_name>
    <arm_group_label>Control (TAU)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Children and adolescents aged 5 to18 years with neuropsychiatric diagnoses and serious&#xD;
             challenging behaviors/explosive reactions.&#xD;
&#xD;
          2. Intellectual function in the normal range, according to WISC-test, adaptive function&#xD;
             and clinical judgment.&#xD;
&#xD;
          3. Participants treated with psychoactive medication (e.g. for ADHD) can be included if&#xD;
             the medication has been unchanged during at least one month prior to baseline, and is&#xD;
             unchanged during the treatment period.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Bipolar disorder, psychosis, or other unstable psychiatric or medical condition that&#xD;
             according to the investigators opinion makes study participation unsuitable.&#xD;
&#xD;
          2. Substance Use.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>5 Years</minimum_age>
    <maximum_age>18 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, Goteborg University</affiliation>
  </overall_official>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>December 13, 2018</study_first_submitted>
  <study_first_submitted_qc>December 15, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 19, 2018</study_first_posted>
  <last_update_submitted>July 29, 2020</last_update_submitted>
  <last_update_submitted_qc>July 29, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 31, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Göteborg University</investigator_affiliation>
    <investigator_full_name>Mats Johnson</investigator_full_name>
    <investigator_title>MD PhD</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Problem Behavior</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03780413
org study id: GNC PR-ESSENCE
nct id: NCT03780413
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The method "Collaborative and Proactive Solutions" (CPS) was developed by Dr. Ross Greene,
      Harvard University, to understand and help kids with social, emotional, and behavioral
      challenges. The underlying theory is that challenging behavior is caused by lagging cognitive
      skills, commonly in the domains of flexibility/adaptability, frustration tolerance, and
      problem-solving. Thus, challenging behavior can be seen as a form of developmental delay, and
      the most effective way for adults to help the children and to facilitate interaction with
      them is to understand the lagging skills behind the behavior and to change their own mindset
      accordingly.

      ADHD and autism belong in a group of overlapping neurodevelopmental conditions now often
      referred to under the umbrella term of ESSENCE (Early Symptomatic Syndromes Eliciting
      Neurodevelopmental Clinical Examinations). A common impairing problem in both autism and ADHD
      - and in several of the other disorders in the group of ESSENCE (including Tourette syndrome
      and other tic disorders) - is the marked inability to control temper, coupled with
      oppositional-defiant behaviors.

      The CPS-method has been evaluated by Ross Greene et al. in United States studies for
      families, in schools, and in institutions for young people with serious behavior problems.
      Our research group published the first Swedish study with the method in 2012, a small open
      pilot study. Based on experiences in clinical work after that study our group reached the
      conclusion that, in order for the intervention to be useful for families with severely
      impairing ESSENCE, the CPS model needed to be modified. After a number of research meetings
      and seminars, we therefore designed a new model, based on our CPS-experience, that we now
      refer to as PR-ESSENCE (Problem Resolution in ESSENCE).

      The present study is a randomized controlled trial for approximately 130 children and
      adolescents aged 5-18 years, with neuropsychiatric disorders (for instance Attention Deficit
      Hyperactivity Disorder (ADHD), Oppositional Defiant Disorder (ODD), Conduct Disorder (CD),
      Autism Spectrum Disorder (ASD), Tourette syndrome, learning difficulties), children who have
      been assessed at our Child Neuropsychiatry Clinic (CNC), and from the Habilitation Services,
      Child Psychiatry Units or schools in the Göteborg region.
The "Collaborative Problem Solving" model was developed by Greene for the treatment of youth
      with oppositional behavior, and is now called Collaborative & Proactive Solutions (CPS). The
      aim of CPS is to help caregivers and children practice and learn problem solving strategies
      in collaboration. The theoretical base of the model is that problematic behavior is mainly
      caused by lagging skills, especially regarding frustration tolerance, flexibility and problem
      solving ability. The CPS model engages both the child and the parents in training, and may
      therefore have potential to give long-term improvement of lagging skills in handling
      problematic situations and to change the mindset towards strategies of mutual problem
      solving.

      The CPS model was evaluated in a United States trial comparing CPS to Barkley's Parent
      Management Training program (PMT) in 47 children aged 4-12 years with ODD and affective
      dysregulation. Outcomes were similar between the two methods in most measures post-treatment
      and at 4 months follow-up. A recent larger randomized controlled US trial enrolled 134
      children with ODD, aged 7 - 14 years, who were randomized to three groups (CPS, PMT or
      Waitlist Control). Both treatment groups had equivalent results in treatment response and
      remission of diagnostic status (50% were much to very much improved and no longer met
      diagnostic criteria), and both were superior to the WLC condition.

      The first Swedish study of CPS, published by our research team 2012, was a small open pilot
      trial of 3 months CPS for 17 families and children aged 7-13 years, with ADHD, ODD and
      explosive behavior, showed promising results. At post-treatment 53% of the children were much
      or very much improved on global symptom and function ratings (Clinical Global
      Impression-Improvement; CGI-I rating 1-2), and after another 6 months when the children with
      severe residual ADHD symptoms also had received stimulant medication, 81% reached CGI-I
      levels of 1-2.

      Thus previous research has suggested that CPS is an effective treatment for ODD in youth, but
      effectiveness in samples of children with various neurodevelopmental disorders has not yet
      been documented. Oppositional and explosive behavior is a major problem among youth with
      neurodevelopmental disorders and the demand for treatment strategies is great.

      Experiences from treatment of children with complex neurodevelopmental disorders - ESSENCE
      (mainly including autism) have led the therapists in our team to make ESSENCE-adapted
      modifications to the CPS model, particularly regarding communication, structure,
      predictability, and focusing on the child's interests to facilitate interaction. We therefore
      designed a new model, based on our CPS-experience, that we now refer to as PR-ESSENCE
      (Problem Resolution in ESSENCE). During the early phases of this study, Dr. Greene gave
      advice and supervision to our treatment team, and the whole PR-ESSENCE model would not have
      been developed without this input.

      Research questions

        1. Can the PR-ESSENCE model reduce problematic behaviors? Outcome measures are the rating
           scales Swanson, Nolan and Pelham scale (SNAP-IV), Family Burden of Illness Module
           (FBIM), Eyberg Child Behavior Inventory (ECBI), Clinical Global Impression-Severity
           scale (CGI-S), Clinical Global Impression-Improvement scale (CGI-I) (see below).

        2. Can the PR-ESSENCE model contribute to solve specific problem situations. Outcome
           measure is a Problem Rating Scale developed for this study

        3. Can the PR-ESSENCE model improve psychiatric well-being and self-image in the
           participants? Outcome measure is the Beck Youth Inventories.

      Method The present study is designed to investigate how well PR-ESSENCE works for challenging
      behaviors in well-defined clinical samples of children with complex neurodevelopmental
      disorders. Participants are children and adolescents aged 5-18 years, with any
      neurodevelopmental diagnosis, and with intellectual level in the normal range.

      After neuropsychiatric assessment and diagnosis at our centre or at the Child Psychiatry
      Centres in Gothenburg 130 children and adolescents aged 5-18 years with complex
      neurodevelopmental disorders (i.e. autism, ADHD, learning disorders, dyslexia, tics, and
      Conduct Disorder) and problematic behaviors are invited to participate in the trial. They are
      randomized to a PR-ESSENCE treatment group and a control group. The treatment group receives
      PR-ESSENCE for 10 weeks. The control group receives 10 weeks of "treatment as usual (TAU)"
      (that is the standard psychoeducation, support and treatment given to all youth after
      neuropsychiatric assessment at our clinic), followed by 10 weeks of PR-ESSENCE. Outcome
      measures are collected pre- and post-treatment, and after 6 months and one year. During the
      PR-ESSENCE treatment period the parents and children meet the therapists at approximately 10
      visits, at which they collaborate to find problem solving strategies, which they then
      practice at home between visits.

      Inclusion criteria

        1. Children and adolescents aged 5-18 years with neurodevelopmental disorders and serious
           problematic behaviors.

        2. Intellectual function in the normal range, according to WISC-test and clinical judgment

        3. Participants taking psychoactive medication can be included if the medication has been
           unchanged for at least one month before baseline, and remains unchanged during the
           treatment period.

      Exclusion criteria

        1. Bipolar disorder, psychosis, or other unstable psychiatric or medical disorder which in
           the investigator's judgment makes participation in the trial unsuitable.

        2. Substance use.

      Outcome measures The following measures are collected at baseline (pre-treatment), after the
      treatment/TAU period (post-treatment), after 6 months (6-month follow-up) and 1 year
      (one-year follow-up). To obtain results from different perspectives ratings from four sources
      were used, i.e. ratings by independent blinded assessors, and by parents, children and
      therapists.

      Rating of independent blinded assessor CGI-I: Scale for global rating of improvement or
      deterioration of problems/symptoms (scale from 1-7; 1 very much improved, 7 very much worse)
      CGI-S: Scale for global rating of problem/symptom severity (scale from 1-7; 1 no problems, 7
      very severe problems)

      Parent ratings SNAP-IV - rating scale for ADHD symptoms FBIM - rating scale of family
      stress/burden ECBI - rating of behavior problems

      Child self-rating Beck Youth Inventories: For rating of depression, anxiety, irritability,
      externalizing behavior, and self image (child interviewed).

      Therapist ratings Problem Rating Scale (in which the severity of the problematic situations
      before and after treatment is rated)
allocation: Randomized
intervention model: Crossover Assignment
intervention model description: RCT in which participants are randomized to active group (PR-ESSENCE for 10 weeks) or control group (treatment as usual for 10 weeks, followed PR-ESSENCE for 10 weeks)
primary purpose: Treatment
masking: Single (Outcomes Assessor)
masking description: Blinded assessors
measure: CGI-S/CGI-I change
time frame: Baseline, post-treatment/control period (3 months), 6 months and 1 year post-treatment
description: Clinical Global Impression - Severity and Improvement (by blinded assessor). Range 1-7 points, lower is better. A global assessment of severity and change in behavior problems and everyday function.
measure: ODD Scale change
time frame: Baseline, post-treatment/control period (3 months), 6 months and 1 year post-treatment
description: Oppositional Defiant Rating Scale (Ross Greene's), parent-rated. An assessment of DSM-5 Oppositional Defiant Disorder symptoms. Range 34-170, lower is better.
measure: SNAP-IV change
time frame: Baseline, post-treatment/control period (3 months), 6 months and 1 year post-treatment
description: Rating scale of ADHD symptoms (parent-rated). Range 0-54 Points, lower is better.
measure: FBIM change
time frame: Baseline, post-treatment/control period (3 months), 6 months and 1 year post-treatment
description: Family Burden of Illness Module (measure of family stress - parent-rated). Range 0-24, lower is better.
measure: ECBI change
time frame: Baseline, post-treatment/control period (3 months), 6 months and 1 year post-treatment
description: Eyberg Child Behavior Inventory (measure of behavior problems, parent-rated). Range 0-216, lower is better.
measure: RPQ change
time frame: Baseline, post-treatment/control period (3 months), 6 months and 1 year post-treatment
description: Relationship Problems Questionnaire (measure of relation and attachment, parent-rated). Range 0-30 Points, lower is better.
measure: Beck's Youth Inventory change
time frame: Baseline, post-treatment/control period (3 months), 6 months and 1 year post-treatment
description: Self-rating of depression, anxiety, irritability, behavior problems, and self-image. Self-rated by interview. Range 0-300, lower is better.
measure: Problem solving scale change
time frame: Baseline, post-treatment/control period (3 months), 6 months and 1 year post-treatment
description: Measures number and type of problem situations solved (therapist-rated). Range 0-infinite number, higher is better.
arm group label: PR-ESSENCE treatment
arm group type: Active Comparator
description: The treatment group receives PR-ESSENCE for 10 weeks. Outcome measures are collected pre- and post-treatment, and after 6 months and one year.
arm group label: Control (TAU)
arm group type: Active Comparator
description: The control group receives 10 weeks of "treatment as usual (TAU)" (that is the standard psychoeducation, support and treatment given to all youth after neuropsychiatric assessment at our clinic), followed by 10 weeks of PR-ESSENCE. Outcome measures were collected pre- and post-treatment, and after 6 months and one year.
intervention type: Behavioral
intervention name: PR-ESSENCE treatment
arm group label: PR-ESSENCE treatment
intervention type: Behavioral
intervention name: Control (TAU)
arm group label: Control (TAU)
criteria: 
gender: All
minimum age: 5 Years
maximum age: 18 Years
healthy volunteers: No
last name: Christopher Gillberg, Professor
role: Study Chair
affiliation: Gillberg Neuropsychiatry Centre, Goteborg University
responsible party type: Principal Investigator
investigator affiliation: Göteborg University
investigator full name: Mats Johnson
investigator title: MD PhD
mesh term: Problem Behavior
sharing ipd: No