<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/NCT01709526</url>
  </required_header>
  <id_info>
    <org_study_id>KUH5702803</org_study_id>
    <secondary_id>KUH5702803</secondary_id>
    <nct_id>NCT01709526</nct_id>
  </id_info>
  <brief_title>How the Adolescent Inpatients Are Rehabilitated After Discharge</brief_title>
  <acronym>AdolInpRehabi</acronym>
  <official_title>Prospective Study the Adolescent Inpatients Rehabilitation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kuopio University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Eastern Finland</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Kuopio University Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aims of this six month follow-up study are which treatment components will correlate or&#xD;
      which clinical treatments interventions contribute adolescent inpatients recovering in the&#xD;
      psychiatric treatment after discharge. Comparisons will be made between the 47 adolescents&#xD;
      aged 13 to 18 years, with major depression and conduct disorders, and between those with and&#xD;
      without suicide attempts by multivariate analyses. Are the adolescent psychiatric inpatients&#xD;
      recovered?&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The whole prospective study sample consisted of 63 adolescents aged 13 to 18 years (40 girls&#xD;
      and 23 boys)referred for psychiatric treatment to the adolescent psychiatric inpatient unit&#xD;
      of Kuopio University Hospital, Finland. This study is part of the &quot;Kliininen Laatuprojekti&quot;-&#xD;
      Depression Project in Kuopio University Hospital. Researcher UH, Doctor of Philosophy, has&#xD;
      been the head of the study project. She has done this study by carrying, analysing, doing&#xD;
      articles and writing abstracts and keeping lectures and congress sessions in Finland and&#xD;
      aboard. In the same time she has done clinical work by caring adolescents in the hospital&#xD;
      ward and in the therapy settings. UH has been the first writer in the articles, one article&#xD;
      in national and three in international articles. This Doctoral dissertation has been&#xD;
      presented 17th November 2007, supervisor was professor, MD. Mauri Marttunen.&#xD;
&#xD;
      The prospective study set out to investigate gender differences, psychosocial and cognitive&#xD;
      functioning, self-image, and changes in these structured parameters, and the role of working&#xD;
      alliance. More girls than boys were admitted to inpatient care. Mood and conduct disorders&#xD;
      were the most common diagnoses. Girls more commonly had poor family relationships but more&#xD;
      peers than boys. Violent and destructive behaviour were more common among boys, and they&#xD;
      performed worse in tests assessing nonverbal cognitive performance and total immediate recall&#xD;
      memory than girls. Both girls and boys had an impaired IQ at entry. Major impairment in&#xD;
      functioning in several areas such as school, family relations, judgement and thinking was&#xD;
      found among both genders.&#xD;
&#xD;
      The psychosocial functioning and cognitive performance of inpatients improved during&#xD;
      treatment.&#xD;
&#xD;
      There were also improvements in intrapsychic constructs: in the psychological self-image,&#xD;
      especially body-image, and in relationships with family members, particularly among&#xD;
      emotionally-disturbed adolescents. Cognitive performance was significantly enhanced among&#xD;
      subjects both with a good and with a poor working alliance. According to multivariate&#xD;
      analyses, a better quality of working alliance and a greater number of therapy sessions were&#xD;
      associated with positive changes in cognitive performance and self-image.&#xD;
&#xD;
      When subjects with major depression and conduct disorder were compared, nonverbal cognitive&#xD;
      and general cognitive performance, body and self-image, and overall psychosocial functioning&#xD;
      improved in both groups of subjects during treatment. More positive changes in self-image and&#xD;
      family functioning were found among subjects with MDD.&#xD;
&#xD;
      Suicidal adolescents' treatment compliance and outcome were as good as those of non-suicidal&#xD;
      patients. Their psychosocial functioning, cognitive performance, and both the psychological&#xD;
      self and body-image improved during treatment. Positive changes in body-image associated&#xD;
      significantly with a higher probability of improvement in psychosocial functioning, while a&#xD;
      higher GAS score at entry was associated with a lower probability of functional improvement.&#xD;
      In clinical practice, attention needs to be paid to structured assessment of adolescent&#xD;
      psychiatric inpatients. This study suggests a need to combine at least regular individual&#xD;
      therapy, pharmacotherapy, family interventions, and a school program. Since a good working&#xD;
      alliance between the therapist and the adolescent patient seems to modify the treatment&#xD;
      outcome, particular attention to creating a good alliance with the patient and intensive&#xD;
      involvement of the parents in treatment are recommended. Prospective studies with a&#xD;
      sufficient follow-up after discharge and well-designed intervention studies among adolescent&#xD;
      inpatients are needed.&#xD;
&#xD;
      Now it is interested in how they are in recovery with the role of working alliance and&#xD;
      improvement in the psychosocial functioning after discharge?&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Study couldn´t start due to investigator&#xD;
  </why_stopped>
  <start_date>January 2009</start_date>
  <completion_date type="Actual">October 2012</completion_date>
  <primary_completion_date type="Actual">October 2012</primary_completion_date>
  <phase>Phase 2/Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">63</enrollment>
  <condition>Psychiatric Diseases</condition>
  <arm_group>
    <arm_group_label>Improvement after psychiatric inpatient treatment</arm_group_label>
    <arm_group_type>Other</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Improvement after psychiatric inpatient treatment</intervention_name>
    <description>Cognition, psychosocial functioning</description>
    <arm_group_label>Improvement after psychiatric inpatient treatment</arm_group_label>
    <other_name>After adolescents treatment</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  psychiatric disease&#xD;
&#xD;
          -  adolescents&#xD;
&#xD;
          -  inpatient treatment&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  emergency psychiatric treatment&#xD;
&#xD;
          -  under 4 weeks treatment&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>14 Years</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ulla Hintikka</last_name>
    <role>Principal Investigator</role>
    <affiliation>Kuopio University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Kuopio University Hospital</name>
      <address>
        <city>Kuopio</city>
        <country>Finland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Finland</country>
  </location_countries>
  <verification_date>October 2012</verification_date>
  <study_first_submitted>June 29, 2011</study_first_submitted>
  <study_first_submitted_qc>October 17, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 18, 2012</study_first_posted>
  <last_update_submitted>October 17, 2012</last_update_submitted>
  <last_update_submitted_qc>October 17, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 18, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Kuopio University Hospital</investigator_affiliation>
    <investigator_full_name>Helena Pehkonen</investigator_full_name>
    <investigator_title>assistant</investigator_title>
  </responsible_party>
  <keyword>Psychosocial functioning</keyword>
  <keyword>Cognitive performance of inpatients</keyword>
  <keyword>Psychiatric diseases</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Mental Disorders</mesh_term>
  </condition_browse>
  <!-- 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/NCT01709526
org study id: KUH5702803
secondary id: KUH5702803
nct id: NCT01709526
lead sponsor: 
collaborator: 
has dmc: Yes
The aims of this six month follow-up study are which treatment components will correlate or
      which clinical treatments interventions contribute adolescent inpatients recovering in the
      psychiatric treatment after discharge. Comparisons will be made between the 47 adolescents
      aged 13 to 18 years, with major depression and conduct disorders, and between those with and
      without suicide attempts by multivariate analyses. Are the adolescent psychiatric inpatients
      recovered?
The whole prospective study sample consisted of 63 adolescents aged 13 to 18 years (40 girls
      and 23 boys)referred for psychiatric treatment to the adolescent psychiatric inpatient unit
      of Kuopio University Hospital, Finland. This study is part of the "Kliininen Laatuprojekti"-
      Depression Project in Kuopio University Hospital. Researcher UH, Doctor of Philosophy, has
      been the head of the study project. She has done this study by carrying, analysing, doing
      articles and writing abstracts and keeping lectures and congress sessions in Finland and
      aboard. In the same time she has done clinical work by caring adolescents in the hospital
      ward and in the therapy settings. UH has been the first writer in the articles, one article
      in national and three in international articles. This Doctoral dissertation has been
      presented 17th November 2007, supervisor was professor, MD. Mauri Marttunen.

      The prospective study set out to investigate gender differences, psychosocial and cognitive
      functioning, self-image, and changes in these structured parameters, and the role of working
      alliance. More girls than boys were admitted to inpatient care. Mood and conduct disorders
      were the most common diagnoses. Girls more commonly had poor family relationships but more
      peers than boys. Violent and destructive behaviour were more common among boys, and they
      performed worse in tests assessing nonverbal cognitive performance and total immediate recall
      memory than girls. Both girls and boys had an impaired IQ at entry. Major impairment in
      functioning in several areas such as school, family relations, judgement and thinking was
      found among both genders.

      The psychosocial functioning and cognitive performance of inpatients improved during
      treatment.

      There were also improvements in intrapsychic constructs: in the psychological self-image,
      especially body-image, and in relationships with family members, particularly among
      emotionally-disturbed adolescents. Cognitive performance was significantly enhanced among
      subjects both with a good and with a poor working alliance. According to multivariate
      analyses, a better quality of working alliance and a greater number of therapy sessions were
      associated with positive changes in cognitive performance and self-image.

      When subjects with major depression and conduct disorder were compared, nonverbal cognitive
      and general cognitive performance, body and self-image, and overall psychosocial functioning
      improved in both groups of subjects during treatment. More positive changes in self-image and
      family functioning were found among subjects with MDD.

      Suicidal adolescents' treatment compliance and outcome were as good as those of non-suicidal
      patients. Their psychosocial functioning, cognitive performance, and both the psychological
      self and body-image improved during treatment. Positive changes in body-image associated
      significantly with a higher probability of improvement in psychosocial functioning, while a
      higher GAS score at entry was associated with a lower probability of functional improvement.
      In clinical practice, attention needs to be paid to structured assessment of adolescent
      psychiatric inpatients. This study suggests a need to combine at least regular individual
      therapy, pharmacotherapy, family interventions, and a school program. Since a good working
      alliance between the therapist and the adolescent patient seems to modify the treatment
      outcome, particular attention to creating a good alliance with the patient and intensive
      involvement of the parents in treatment are recommended. Prospective studies with a
      sufficient follow-up after discharge and well-designed intervention studies among adolescent
      inpatients are needed.

      Now it is interested in how they are in recovery with the role of working alliance and
      improvement in the psychosocial functioning after discharge?
allocation: Non-Randomized
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
arm group label: Improvement after psychiatric inpatient treatment
arm group type: Other
intervention type: Behavioral
intervention name: Improvement after psychiatric inpatient treatment
description: Cognition, psychosocial functioning
arm group label: Improvement after psychiatric inpatient treatment
other name: After adolescents treatment
criteria: 
gender: All
minimum age: 14 Years
maximum age: 18 Years
healthy volunteers: No
last name: Ulla Hintikka
role: Principal Investigator
affiliation: Kuopio University Hospital
facility: 
country: Finland
responsible party type: Principal Investigator
investigator affiliation: Kuopio University Hospital
investigator full name: Helena Pehkonen
investigator title: assistant
mesh term: Mental Disorders