<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/NCT02991586</url>
  </required_header>
  <id_info>
    <org_study_id>FALGregorioMaranon</org_study_id>
    <nct_id>NCT02991586</nct_id>
  </id_info>
  <brief_title>Effectiveness Study of a Dialectical Behavioral Treatment for Adolescents With Emotional Instability and Their Families</brief_title>
  <official_title>Effectiveness Study of a Dialectical Behavioral Treatment for Adolescents With Emotional Instability and Their Families. Comparison of Family Functioning and Cope Strategies in Adolescents With Emotional Instability and Their Families and a Control Group</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospital General Universitario Gregorio Marañon</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospital General Universitario Gregorio Marañon</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Emotional instability disorder (IE) is appreciable since adolescence, and crises (suicidal&#xD;
      ideation, self-harm, impulsive acts and brief psychotic episodes) carry a high use of health&#xD;
      resources, coupled with the suffering of families who feel helpless and difficulties in&#xD;
      handling.&#xD;
&#xD;
      this study is composed of three diferents studies:&#xD;
&#xD;
      . The first study's goal is to determine if there are diferences and, which ones, between&#xD;
      family functioning and cope strategies between adolescents with IE and their families, and&#xD;
      families of a control group.&#xD;
&#xD;
        -  the purpose of the second study is to evaluate the effectivenes of a dialectical&#xD;
           behavior therapy for adolescents with IE and their families who are in treatment in the&#xD;
           Child Abd Adolescent Mental Heath Service of the Hospital sant Joan de Déu Terres de&#xD;
           Lleida. This treatment consist on 2 preliminary sessions with parents and patients and&#xD;
           12 group sessions which purpose is to teach skilss to manage emotions based on&#xD;
           dialectical Behavior Therapy.&#xD;
&#xD;
        -  finally, the third study is designed to evaluate the effectiveness of a dialectical&#xD;
           behavior therapy (DBT) for parents of adolescents with IE who are in treatment in the&#xD;
           different network devices of Child and Adolescent Mental Health of the Community of&#xD;
           Madrid. Treatment goals are the development of communication skills, validation and&#xD;
           crisis management as well as increase understanding and competence of the pathology. The&#xD;
           DBT intervention will begin with two individual sessions with parents of patients and 10&#xD;
           theoretical and practical seminars in group format (6-7 families) following the model&#xD;
           proposed by Marsha Linehan. The DBT interventions will be added to &quot;standard treatment&quot;&#xD;
           that a patient with IE receives in the investigative devices.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      -  In the first study, case group is composed by patients with IE and their families, both&#xD;
           from Madrid and Lérida. The control group is composed by adolescents without mental&#xD;
           pathologies, recruited from some high scholls from Madrid and Lérida.&#xD;
&#xD;
        -  In the second study, the results will be measured a after the end of treatment and 6&#xD;
           months after the treatment ends.&#xD;
&#xD;
      In the third study, the results will be measured a after the end of treatment and 6 months&#xD;
      after the treatment ends.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>May 2016</start_date>
  <completion_date type="Actual">April 2022</completion_date>
  <primary_completion_date type="Actual">January 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Difficulties in Emotional Regulation Scale (DERS). (Hervás 2008)</measure>
    <time_frame>one year</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Automatic Anger and Hostility Thoughts Scale (IPRI) (Magán 2010)</measure>
    <time_frame>one year</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Coping Styles and Strategies Scale (COPE) (Crespo 1997)</measure>
    <time_frame>one year</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Children Relapses and Self harms Questionnaire (Ad Hoc)</measure>
    <time_frame>one year</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">96</enrollment>
  <condition>Emotional Instability</condition>
  <arm_group>
    <arm_group_label>Dialectical Behavior Therapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Dialectical Behavior Therapy (DBT) is a cognitive behavioral treatment that was originally developed to treat chronically suicidal individuals diagnosed with borderline personality disorder (BPD) and it is now recognized as the gold standard psychological treatment for this population. In addition, research has shown that it is effective in treating a wide range of other disorders such as substance dependence, depression, post-traumatic stress disorder (PTSD), and eating disorders. In this research DBT skills will be taught to parents of adolescents with high emotional instability</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Control: The &quot;No intervention arm&quot; in this research is defined as follow:, sons and daughters are in their respective treatment but parents are nor receiving any DBT intervention</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Dialectical Behaviour Therapy</intervention_name>
    <description>Group of families</description>
    <arm_group_label>Dialectical Behavior Therapy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Parents of patients aged 12-17 years whose child is at least 3 criteria of borderline&#xD;
             personality disorder ( Diagnostic and Statistical Manual of Mental Disorders 5 ) .&#xD;
&#xD;
          -  Talk correctly Spanish correctly.&#xD;
&#xD;
          -  Coexistence with son and willingness to participate in the groups.&#xD;
&#xD;
          -  Informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Mental retardation.&#xD;
&#xD;
          -  Being involved in some other structured DBT family intervention.&#xD;
&#xD;
          -  Parents whose children are not receiving any treatment .&#xD;
&#xD;
          -  Participated in Actions for Treatment of Personality in Adolescence (ATRAPA TAI)&#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>Maria Mayoral, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Gregorio Marañon Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Instituto Provincial de Psiquiatria, Hospital General Universitario Gregorio Maranon. Calle Ibiza 43</name>
      <address>
        <city>Madrid</city>
        <zip>28009</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>May 2022</verification_date>
  <study_first_submitted>June 10, 2016</study_first_submitted>
  <study_first_submitted_qc>December 9, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 13, 2016</study_first_posted>
  <last_update_submitted>May 23, 2022</last_update_submitted>
  <last_update_submitted_qc>May 23, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">May 27, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hospital General Universitario Gregorio Marañon</investigator_affiliation>
    <investigator_full_name>María Mayoral</investigator_full_name>
    <investigator_title>Clinical Psychologist</investigator_title>
  </responsible_party>
  <keyword>Emotional Instability</keyword>
  <keyword>Family Therapy</keyword>
  <keyword>BPD</keyword>
  <keyword>DBT</keyword>
  <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/NCT02991586
org study id: FALGregorioMaranon
nct id: NCT02991586
lead sponsor: 
has dmc: No
Emotional instability disorder (IE) is appreciable since adolescence, and crises (suicidal
      ideation, self-harm, impulsive acts and brief psychotic episodes) carry a high use of health
      resources, coupled with the suffering of families who feel helpless and difficulties in
      handling.

      this study is composed of three diferents studies:

      . The first study's goal is to determine if there are diferences and, which ones, between
      family functioning and cope strategies between adolescents with IE and their families, and
      families of a control group.

        -  the purpose of the second study is to evaluate the effectivenes of a dialectical
           behavior therapy for adolescents with IE and their families who are in treatment in the
           Child Abd Adolescent Mental Heath Service of the Hospital sant Joan de Déu Terres de
           Lleida. This treatment consist on 2 preliminary sessions with parents and patients and
           12 group sessions which purpose is to teach skilss to manage emotions based on
           dialectical Behavior Therapy.

        -  finally, the third study is designed to evaluate the effectiveness of a dialectical
           behavior therapy (DBT) for parents of adolescents with IE who are in treatment in the
           different network devices of Child and Adolescent Mental Health of the Community of
           Madrid. Treatment goals are the development of communication skills, validation and
           crisis management as well as increase understanding and competence of the pathology. The
           DBT intervention will begin with two individual sessions with parents of patients and 10
           theoretical and practical seminars in group format (6-7 families) following the model
           proposed by Marsha Linehan. The DBT interventions will be added to "standard treatment"
           that a patient with IE receives in the investigative devices.
-  In the first study, case group is composed by patients with IE and their families, both
           from Madrid and Lérida. The control group is composed by adolescents without mental
           pathologies, recruited from some high scholls from Madrid and Lérida.

        -  In the second study, the results will be measured a after the end of treatment and 6
           months after the treatment ends.

      In the third study, the results will be measured a after the end of treatment and 6 months
      after the treatment ends.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Difficulties in Emotional Regulation Scale (DERS). (Hervás 2008)
time frame: one year
measure: Automatic Anger and Hostility Thoughts Scale (IPRI) (Magán 2010)
time frame: one year
measure: Coping Styles and Strategies Scale (COPE) (Crespo 1997)
time frame: one year
measure: Children Relapses and Self harms Questionnaire (Ad Hoc)
time frame: one year
arm group label: Dialectical Behavior Therapy
arm group type: Experimental
description: Dialectical Behavior Therapy (DBT) is a cognitive behavioral treatment that was originally developed to treat chronically suicidal individuals diagnosed with borderline personality disorder (BPD) and it is now recognized as the gold standard psychological treatment for this population. In addition, research has shown that it is effective in treating a wide range of other disorders such as substance dependence, depression, post-traumatic stress disorder (PTSD), and eating disorders. In this research DBT skills will be taught to parents of adolescents with high emotional instability
arm group label: Control
arm group type: No Intervention
description: Control: The "No intervention arm" in this research is defined as follow:, sons and daughters are in their respective treatment but parents are nor receiving any DBT intervention
intervention type: Behavioral
intervention name: Dialectical Behaviour Therapy
description: Group of families
arm group label: Dialectical Behavior Therapy
criteria: 
gender: All
minimum age: 12 Years
maximum age: 17 Years
healthy volunteers: No
last name: Maria Mayoral, PhD
role: Principal Investigator
affiliation: Gregorio Marañon Hospital
facility: 
country: Spain
responsible party type: Principal Investigator
investigator affiliation: Hospital General Universitario Gregorio Marañon
investigator full name: María Mayoral
investigator title: Clinical Psychologist
sharing ipd: No