<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/NCT03807336</url>
  </required_header>
  <id_info>
    <org_study_id>Nadia_RCT_2018</org_study_id>
    <nct_id>NCT03807336</nct_id>
  </id_info>
  <brief_title>Clinical Trial of Emotion-Focused Skills Training for Parents</brief_title>
  <official_title>Improving Outcome for Children Through Treatment of Their Parents - Comparing Emotion-Focused Parent Skills Training With Emotion Coaching Parent Program for Children With Externalizing and Internalizing Symptoms: a Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Institutt for Psykologisk Radgivning</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Oslo</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The Research Council of Norway</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Bergen</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Institutt for Psykologisk Radgivning</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>
      Children with externalizing and internalizing symptoms has been linked to poor emotional&#xD;
      competence, problematic understanding and regulation of emotions. A number of recent studies&#xD;
      demonstrates the importance of parents' active involvement in the child's recovery process&#xD;
      and support the empirical relationship between parenting style and child symptoms. Emotional&#xD;
      awareness and acceptance of painful emotional experience in parents leads to reduction in how&#xD;
      these emotions are experienced in response to stressors in children. This makes the parent&#xD;
      less vulnerable to rumination or suppression of negative emotional experience related to the&#xD;
      child. In addition, it releases parents' emotional capacity to be mentally present and&#xD;
      emotionally available for their child. Although neuro-affective principles from research have&#xD;
      been incorporated in the therapeutic approaches for adults, there are currently no programs&#xD;
      that target these mechanisms in working with children with mental health difficulties.&#xD;
      Emotion Focused Skills Training (EFST) is an easily administrated, cost efficient treatment&#xD;
      program specifically directed towards the parental role in promoting change in children. In&#xD;
      this randomized controlled trial, we will compare experiential process oriented EFST with a&#xD;
      psycho-educational version of EFST on parents of children aged 6-13 with externalizing or&#xD;
      internalizing symptoms. Parents of 236 children will receive a two days course and 6 hours of&#xD;
      individually delivered treatment within a 10 weeks period, either with the experiential&#xD;
      version of EFST or the psycho-educational version. Feedback regarding outcome on&#xD;
      externalizing and internalizing problems will be obtained from parents and teachers at 5&#xD;
      different periods: baseline, treatment completion and at 3, 6 and 9 months follow-up.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 1, 2018</start_date>
  <completion_date type="Actual">January 30, 2021</completion_date>
  <primary_completion_date type="Actual">July 30, 2020</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 Clinical Trial</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in SDQ-P 4-17 - Strengths and Difficulties Questionnaire and impact supplement for the parents of 4-17 year olds All 5 subscales and total score will be used.</measure>
    <time_frame>Pre, post (0 months after completed intervention), 3, 6 and 9 months follow up</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in ASEBA Child Behavior Checklist for Ages 6-18 All eight subscales and total scores will be used.</measure>
    <time_frame>Pre, post (0 months after completed intervention), 3, 6 and 9 months follow up</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in ASEBA - Child Behavior Checklist - Teacher Report Form All eight subscales and total scores will be used.</measure>
    <time_frame>Pre, post (0 months after completed intervention), 3, 6 and 9 months follow up</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Outcome Questionnaire 45, Version 2, for the parents</measure>
    <time_frame>Pre, post (0 months after completed intervention), 3, 6 and 9 months follow up</time_frame>
    <description>Outcome questionnaire designed to evaluate a psychotherapy client's progress initially and throughout treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Difficulties in Emotion Regulation Scale</measure>
    <time_frame>Pre, post, 3 months, 6 months, 9 monthsPre, post (0 months after completed intervention), 3, 6 and 9 months follow up</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Forms of Self-Criticising/Attacking &amp; Self-Reassuring Scale All 3 subscales will be used: Inadequate self, Hated self, Reassured self.</measure>
    <time_frame>Pre, post (0 months after completed intervention), 3, 6 and 9 months follow up</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Parents Beliefs About Children's Emotions questionnaire Full scale</measure>
    <time_frame>Pre, post (0 months after completed intervention), 3, 6 and 9 months follow up</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Parents Sense of Competence Scale Full scale</measure>
    <time_frame>Pre, post (0 months after completed intervention), 3, 6 and 9 months follow up</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Coping with Children's Negative Emotion Scale Full scale</measure>
    <time_frame>Pre, post (0 months after completed intervention), 3, 6 and 9 months follow up</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Affect Integration Inventory Full scale: global affect integration</measure>
    <time_frame>Pre, post (0 months after completed intervention), 3, 6 and 9 months follow up</time_frame>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">220</enrollment>
  <condition>F01.318 Child Rearing</condition>
  <condition>F01.470 Emotions</condition>
  <condition>F01.145.179 Child Behavior</condition>
  <arm_group>
    <arm_group_label>Experiential Condition</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This group will receive an experiential version of the program Emotion-Focused Skills Training for Parents, meaning they will engage in tasks that are supposed to activate the parents emotional system, providing them with a deeper sense of understanding towards their child.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Psychoeducational version</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>This group will receive a non-experiential, psychoeducational version of the program Emotion-Focused Skills Training for Parents, meaning they will not engage in tasks that are meant to activate the parents emotional system.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Emotion-Focused Skills Training for Parents - Experiential</intervention_name>
    <description>The intervention consists of a 2-day work shop given in a group format, in addition to 6 hours of parent supervision within 6 weeks after the work shop.</description>
    <arm_group_label>Experiential Condition</arm_group_label>
    <arm_group_label>Psychoeducational version</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Emotion-Focused Skills Training for Parents - Psychoeducational</intervention_name>
    <description>The intervention consists of a 2-day work shop given in a group format, in addition to 6 hours of parent supervision within 6 weeks after the work shop.</description>
    <arm_group_label>Experiential Condition</arm_group_label>
    <arm_group_label>Psychoeducational version</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Parents of children between 6-13 with either internalizing problems, externalizing&#xD;
             problems, or both.&#xD;
&#xD;
          -  An overall final assessment of whether it is likely that the parents will be able to&#xD;
             fully participate in the study.&#xD;
&#xD;
          -  Parents who live with the child at least 50% of the time.&#xD;
&#xD;
          -  Parents who agree that they need help and are motivated for the treatment.&#xD;
&#xD;
          -  Parents and children who speak Norwegian&#xD;
&#xD;
          -  Parents who have the time to participate in the intervention program.&#xD;
&#xD;
          -  Parents who are willing to collaborate with the childs school and contact with the&#xD;
             school teacher.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Parents: Serious or chronic mental health difficulties such as psychosis, bipolar&#xD;
             disorder, organic disorder, ongoing substance abuse, do.&#xD;
&#xD;
          -  documented sexual abuse, serious mental health problems, organic disorder and/or&#xD;
             disability in the child.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Years</minimum_age>
    <maximum_age>13 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Institutt for Psykologisk rådgivning</name>
      <address>
        <city>Bergen</city>
        <zip>5012</zip>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Norway</country>
  </location_countries>
  <verification_date>August 2022</verification_date>
  <study_first_submitted>January 14, 2019</study_first_submitted>
  <study_first_submitted_qc>January 15, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 16, 2019</study_first_posted>
  <last_update_submitted>August 2, 2022</last_update_submitted>
  <last_update_submitted_qc>August 2, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">August 3, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </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/NCT03807336
org study id: Nadia_RCT_2018
nct id: NCT03807336
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Children with externalizing and internalizing symptoms has been linked to poor emotional
      competence, problematic understanding and regulation of emotions. A number of recent studies
      demonstrates the importance of parents' active involvement in the child's recovery process
      and support the empirical relationship between parenting style and child symptoms. Emotional
      awareness and acceptance of painful emotional experience in parents leads to reduction in how
      these emotions are experienced in response to stressors in children. This makes the parent
      less vulnerable to rumination or suppression of negative emotional experience related to the
      child. In addition, it releases parents' emotional capacity to be mentally present and
      emotionally available for their child. Although neuro-affective principles from research have
      been incorporated in the therapeutic approaches for adults, there are currently no programs
      that target these mechanisms in working with children with mental health difficulties.
      Emotion Focused Skills Training (EFST) is an easily administrated, cost efficient treatment
      program specifically directed towards the parental role in promoting change in children. In
      this randomized controlled trial, we will compare experiential process oriented EFST with a
      psycho-educational version of EFST on parents of children aged 6-13 with externalizing or
      internalizing symptoms. Parents of 236 children will receive a two days course and 6 hours of
      individually delivered treatment within a 10 weeks period, either with the experiential
      version of EFST or the psycho-educational version. Feedback regarding outcome on
      externalizing and internalizing problems will be obtained from parents and teachers at 5
      different periods: baseline, treatment completion and at 3, 6 and 9 months follow-up.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Randomized Clinical Trial
primary purpose: Treatment
masking: Single (Participant)
measure: Change in SDQ-P 4-17 - Strengths and Difficulties Questionnaire and impact supplement for the parents of 4-17 year olds All 5 subscales and total score will be used.
time frame: Pre, post (0 months after completed intervention), 3, 6 and 9 months follow up
measure: Change in ASEBA Child Behavior Checklist for Ages 6-18 All eight subscales and total scores will be used.
time frame: Pre, post (0 months after completed intervention), 3, 6 and 9 months follow up
measure: Change in ASEBA - Child Behavior Checklist - Teacher Report Form All eight subscales and total scores will be used.
time frame: Pre, post (0 months after completed intervention), 3, 6 and 9 months follow up
measure: Outcome Questionnaire 45, Version 2, for the parents
time frame: Pre, post (0 months after completed intervention), 3, 6 and 9 months follow up
description: Outcome questionnaire designed to evaluate a psychotherapy client's progress initially and throughout treatment.
measure: Difficulties in Emotion Regulation Scale
time frame: Pre, post, 3 months, 6 months, 9 monthsPre, post (0 months after completed intervention), 3, 6 and 9 months follow up
measure: Forms of Self-Criticising/Attacking & Self-Reassuring Scale All 3 subscales will be used: Inadequate self, Hated self, Reassured self.
time frame: Pre, post (0 months after completed intervention), 3, 6 and 9 months follow up
measure: Parents Beliefs About Children's Emotions questionnaire Full scale
time frame: Pre, post (0 months after completed intervention), 3, 6 and 9 months follow up
measure: Parents Sense of Competence Scale Full scale
time frame: Pre, post (0 months after completed intervention), 3, 6 and 9 months follow up
measure: Coping with Children's Negative Emotion Scale Full scale
time frame: Pre, post (0 months after completed intervention), 3, 6 and 9 months follow up
measure: Affect Integration Inventory Full scale: global affect integration
time frame: Pre, post (0 months after completed intervention), 3, 6 and 9 months follow up
arm group label: Experiential Condition
arm group type: Experimental
description: This group will receive an experiential version of the program Emotion-Focused Skills Training for Parents, meaning they will engage in tasks that are supposed to activate the parents emotional system, providing them with a deeper sense of understanding towards their child.
arm group label: Psychoeducational version
arm group type: Active Comparator
description: This group will receive a non-experiential, psychoeducational version of the program Emotion-Focused Skills Training for Parents, meaning they will not engage in tasks that are meant to activate the parents emotional system.
intervention type: Behavioral
intervention name: Emotion-Focused Skills Training for Parents - Experiential
description: The intervention consists of a 2-day work shop given in a group format, in addition to 6 hours of parent supervision within 6 weeks after the work shop.
arm group label: Experiential Condition
arm group label: Psychoeducational version
intervention type: Behavioral
intervention name: Emotion-Focused Skills Training for Parents - Psychoeducational
description: The intervention consists of a 2-day work shop given in a group format, in addition to 6 hours of parent supervision within 6 weeks after the work shop.
arm group label: Experiential Condition
arm group label: Psychoeducational version
criteria: 
gender: All
minimum age: 6 Years
maximum age: 13 Years
healthy volunteers: No
facility: 
country: Norway
responsible party type: Sponsor
sharing ipd: No