<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/NCT03014596</url>
  </required_header>
  <id_info>
    <org_study_id>2016/FO77493</org_study_id>
    <nct_id>NCT03014596</nct_id>
  </id_info>
  <brief_title>What Matters to You?</brief_title>
  <acronym>Assert</acronym>
  <official_title>What Matters to You? How to Strengthen Adolescent User Involvement in Primary Mental Health Services With Systematic Idiographic Assessment</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Regionsenter for barn og unges psykiske helse</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Norwegian Extra Foundation for Health and Rehabilitation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Regionsenter for barn og unges psykiske helse</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>
      Procedures for systematic user involvement in primary mental health services are lacking, and&#xD;
      several adolescents are dissatisfied with their opportunities to influence the service&#xD;
      provided. The research on the effects of user involvement is scarce, especially regarding&#xD;
      user involvement for children and adolescents. Hence, we suggest introducing an idiographic&#xD;
      assessment tool in a selection of Norwegian primary mental health services. Idiographic&#xD;
      assessment is a way of measuring psychological constructs, by using tools specifically&#xD;
      adapted for each individual respondent.&#xD;
&#xD;
      This protocol describes the implementation and evaluation of a user involvement tool called&#xD;
      'Assert', in Norwegian primary mental health services. Assert is a simple tool where the&#xD;
      adolescents themselves decide the goals or themes that they would like to address in&#xD;
      collaboration with their service provider. Assert is scored each time the adolescent and the&#xD;
      service provider meet, to monitor progress toward the goal. A randomised controlled trial&#xD;
      design is proposed for this study. Assert will be implemented in 5-10 Norwegian&#xD;
      municipalities, and will include 250 participants between 12 and 23 years. The objective of&#xD;
      the study is to examine the relationship between Assert and perceived user involvement. Are&#xD;
      idiographic measures an adequate way to operationalise user involvement on an individual&#xD;
      level? And if so, can user involvement (i.e. Assert) have an effect on quality of life and&#xD;
      mental health in adolescents? And lastly qualitative analyses of the adolescents' themes and&#xD;
      goals will be conducted to explore what matters to the adolescents that visit primary mental&#xD;
      health services in Norwegian municipalities.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 2017</start_date>
  <completion_date type="Actual">June 2018</completion_date>
  <primary_completion_date type="Actual">June 2018</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>Strengths and difficulties questionnaire (SDQ)</measure>
    <time_frame>One year</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Inventory of Life Quality in Children and Adolescents (ILC)</measure>
    <time_frame>One year</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Multidimensional Health Locus of Control (MHLC)</measure>
    <time_frame>One year</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>The Assert measurement tool</measure>
    <time_frame>One year</time_frame>
    <description>An ideographic assessment and monitoring tool, used as a part of the Assert method</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>User involvement questionnaire</measure>
    <time_frame>One year</time_frame>
    <description>Perceived degree of user involvement</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">150</enrollment>
  <condition>Behavioural, Emotional, and Psychosocial Problems</condition>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The Assert-method will be used in the counselling of adolescents with mental health problems</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Treatment as usual, i.e. tha Assert-method will not be used in the counselling</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Assert</intervention_name>
    <description>The Assert-method is a counselling method used to assess and systematically follow up the individual adolescents' perceived needs.</description>
    <arm_group_label>Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adolescents between 12 and 23 years, with behavioural, emotional, and psychosocial&#xD;
             problems&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  severe psychopathological disorders&#xD;
&#xD;
          -  severe drug addiction&#xD;
&#xD;
          -  intellectual disabilities&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>12 Years</minimum_age>
    <maximum_age>23 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Turid Suzanne Berg-Nielsen, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Regional Centre for Child and Adolescent Mental Health, Eastern and Southern Norway (RBUP)</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Ringerike kommune</name>
      <address>
        <city>Hønefoss</city>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kongsberg kommune</name>
      <address>
        <city>Kongsberg</city>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Skedsmo kommune</name>
      <address>
        <city>Lillestrøm</city>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lørenskog kommune</name>
      <address>
        <city>Lørenskog</city>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Eidsberg Kommune</name>
      <address>
        <city>Mysen</city>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bydel Søndre Nordstrand</name>
      <address>
        <city>Oslo</city>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UngArena</name>
      <address>
        <city>Oslo</city>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Familiehuset Adler</name>
      <address>
        <city>Tønsberg</city>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nome kommune</name>
      <address>
        <city>Ulefoss</city>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Våler kommune</name>
      <address>
        <city>Våler</city>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ål kommune</name>
      <address>
        <city>Ål</city>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Norway</country>
  </location_countries>
  <verification_date>February 2020</verification_date>
  <study_first_submitted>January 4, 2017</study_first_submitted>
  <study_first_submitted_qc>January 5, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 9, 2017</study_first_posted>
  <last_update_submitted>February 7, 2020</last_update_submitted>
  <last_update_submitted_qc>February 7, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">February 10, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Regionsenter for barn og unges psykiske helse</investigator_affiliation>
    <investigator_full_name>Simon-Peter Neumer</investigator_full_name>
    <investigator_title>PhD</investigator_title>
  </responsible_party>
  <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/NCT03014596
org study id: 2016/FO77493
nct id: NCT03014596
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Procedures for systematic user involvement in primary mental health services are lacking, and
      several adolescents are dissatisfied with their opportunities to influence the service
      provided. The research on the effects of user involvement is scarce, especially regarding
      user involvement for children and adolescents. Hence, we suggest introducing an idiographic
      assessment tool in a selection of Norwegian primary mental health services. Idiographic
      assessment is a way of measuring psychological constructs, by using tools specifically
      adapted for each individual respondent.

      This protocol describes the implementation and evaluation of a user involvement tool called
      'Assert', in Norwegian primary mental health services. Assert is a simple tool where the
      adolescents themselves decide the goals or themes that they would like to address in
      collaboration with their service provider. Assert is scored each time the adolescent and the
      service provider meet, to monitor progress toward the goal. A randomised controlled trial
      design is proposed for this study. Assert will be implemented in 5-10 Norwegian
      municipalities, and will include 250 participants between 12 and 23 years. The objective of
      the study is to examine the relationship between Assert and perceived user involvement. Are
      idiographic measures an adequate way to operationalise user involvement on an individual
      level? And if so, can user involvement (i.e. Assert) have an effect on quality of life and
      mental health in adolescents? And lastly qualitative analyses of the adolescents' themes and
      goals will be conducted to explore what matters to the adolescents that visit primary mental
      health services in Norwegian municipalities.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Strengths and difficulties questionnaire (SDQ)
time frame: One year
measure: Inventory of Life Quality in Children and Adolescents (ILC)
time frame: One year
measure: Multidimensional Health Locus of Control (MHLC)
time frame: One year
measure: The Assert measurement tool
time frame: One year
description: An ideographic assessment and monitoring tool, used as a part of the Assert method
measure: User involvement questionnaire
time frame: One year
description: Perceived degree of user involvement
arm group label: Intervention
arm group type: Experimental
description: The Assert-method will be used in the counselling of adolescents with mental health problems
arm group label: Control
arm group type: No Intervention
description: Treatment as usual, i.e. tha Assert-method will not be used in the counselling
intervention type: Other
intervention name: Assert
description: The Assert-method is a counselling method used to assess and systematically follow up the individual adolescents' perceived needs.
arm group label: Intervention
criteria: 
gender: All
minimum age: 12 Years
maximum age: 23 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Turid Suzanne Berg-Nielsen, PhD
role: Principal Investigator
affiliation: Regional Centre for Child and Adolescent Mental Health, Eastern and Southern Norway (RBUP)
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Norway
responsible party type: Principal Investigator
investigator affiliation: Regionsenter for barn og unges psykiske helse
investigator full name: Simon-Peter Neumer
investigator title: PhD
sharing ipd: No