<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/NCT02217072</url>
  </required_header>
  <id_info>
    <org_study_id>SFI 2691</org_study_id>
    <nct_id>NCT02217072</nct_id>
  </id_info>
  <brief_title>Educational Support Interventions for Children in Care</brief_title>
  <official_title>A Randomized Controlled Trial of Educational Support Interventions for Children in Care</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>VIVE - The Danish Center for Social Science Research</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Ministry of Social Affairs</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>VIVE - The Danish Center for Social Science Research</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      A Randomized controlled study of two different educational support interventions developed&#xD;
      for children in foster care (age 6-13).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A Randomized controlled study of two different educational support interventions developed&#xD;
      for children in foster care (age 6-13). One intervention is school-based and involves a team&#xD;
      of professionals at the child's school, and the other is a home-based tutoring intervention&#xD;
      provided by the foster parents. The participants in the study are assigned to three groups&#xD;
      (the two intervention groups and control group). Based on power calculation we aim to recruit&#xD;
      approximately 180-200 foster children, their foster parents and public schools to participate&#xD;
      in the study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>September 2013</start_date>
  <completion_date type="Anticipated">December 2017</completion_date>
  <primary_completion_date type="Anticipated">December 2017</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>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Academic performance</measure>
    <time_frame>17 months after intervention start</time_frame>
    <description>Reading test and mathematical test</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Cognitive functions</measure>
    <time_frame>17 months after intervention start</time_frame>
    <description>Wechsler Intelligence Scale for Children IV and Contingency Naming Test</description>
  </secondary_outcome>
  <other_outcome>
    <measure>well-being</measure>
    <time_frame>17 months after intervention start</time_frame>
    <description>The Strengths and Difficulties Questionnaire</description>
  </other_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">190</enrollment>
  <condition>Learning Problems</condition>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Control</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Parents as Tutors</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Educational support intervention</description>
  </arm_group>
  <arm_group>
    <arm_group_label>school intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Educational support intervention</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>School intervention</intervention_name>
    <description>A school-based intervention that builds on the promising Swedish programme SkolFam, but is adapted to a Danish school context. The two main components of the programme are a) comprehensive assessment of the child, involving testing of the child's cognitive and academic abilities and difficulties as well as an evaluation of the child's behaviour, school-related social relations and well-being, and b) a systematic and individually targeted intervention plan, made in collaboration between a psychologist, the teachers, and a special educational teacher at the school (e.g., the reading counsellor).</description>
    <arm_group_label>school intervention</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Parents as Tutors</intervention_name>
    <description>A home-based intervention, comprising a structured tutoring programme that allows foster parents to systematically support the foster child's school performance. Foster parents will attend an introductory tutor training seminar at which they will be introduced to relevant theory on learning and counselled on tutoring practice. The intervention itself is designed to provide approximately three hours per week of individual home-based tutoring for a period of 40 weeks.</description>
    <arm_group_label>Parents as Tutors</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age 6-13&#xD;
&#xD;
          -  fostercare placement&#xD;
&#xD;
          -  placement in a participating municipality&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  persuasive developmental disorders&#xD;
&#xD;
          -  special education students&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Years</minimum_age>
    <maximum_age>13 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Misja Eiberg, Ph.d. fellow</last_name>
    <role>Principal Investigator</role>
    <affiliation>SFI - The Danish National Centre for Social Research</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Misja Eiberg</last_name>
    <phone>+45 33480819</phone>
    <email>mei@sfi.dk</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Helle Hansen</last_name>
    <phone>+45 33480927</phone>
    <email>heh@sfi.dk</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>SFI - The Danish National Centre for Social Research</name>
      <address>
        <city>Copenhagen</city>
        <zip>1052</zip>
        <country>Denmark</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Misja Eiberg</last_name>
      <phone>33480819</phone>
      <email>mei@sfi.dk</email>
    </contact>
    <contact_backup>
      <last_name>Helle Hansen</last_name>
      <phone>+45 33480927</phone>
      <email>heh@sfi.dk</email>
    </contact_backup>
    <investigator>
      <last_name>Misja Eiberg, Ph.d. fellow</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>August 2014</verification_date>
  <study_first_submitted>July 28, 2014</study_first_submitted>
  <study_first_submitted_qc>August 13, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 15, 2014</study_first_posted>
  <last_update_submitted>August 13, 2014</last_update_submitted>
  <last_update_submitted_qc>August 13, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 15, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>academic performance</keyword>
  <keyword>cognitive development</keyword>
  <keyword>children in care</keyword>
  <keyword>prevention of school failure</keyword>
  <!-- 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/NCT02217072
org study id: SFI 2691
nct id: NCT02217072
lead sponsor: 
collaborator: 
has dmc: Yes
A Randomized controlled study of two different educational support interventions developed
      for children in foster care (age 6-13).
A Randomized controlled study of two different educational support interventions developed
      for children in foster care (age 6-13). One intervention is school-based and involves a team
      of professionals at the child's school, and the other is a home-based tutoring intervention
      provided by the foster parents. The participants in the study are assigned to three groups
      (the two intervention groups and control group). Based on power calculation we aim to recruit
      approximately 180-200 foster children, their foster parents and public schools to participate
      in the study.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Academic performance
time frame: 17 months after intervention start
description: Reading test and mathematical test
measure: Cognitive functions
time frame: 17 months after intervention start
description: Wechsler Intelligence Scale for Children IV and Contingency Naming Test
measure: well-being
time frame: 17 months after intervention start
description: The Strengths and Difficulties Questionnaire
arm group label: Control
arm group type: No Intervention
description: Control
arm group label: Parents as Tutors
arm group type: Experimental
description: Educational support intervention
arm group label: school intervention
arm group type: Experimental
description: Educational support intervention
intervention type: Behavioral
intervention name: School intervention
description: A school-based intervention that builds on the promising Swedish programme SkolFam, but is adapted to a Danish school context. The two main components of the programme are a) comprehensive assessment of the child, involving testing of the child's cognitive and academic abilities and difficulties as well as an evaluation of the child's behaviour, school-related social relations and well-being, and b) a systematic and individually targeted intervention plan, made in collaboration between a psychologist, the teachers, and a special educational teacher at the school (e.g., the reading counsellor).
arm group label: school intervention
intervention type: Behavioral
intervention name: Parents as Tutors
description: A home-based intervention, comprising a structured tutoring programme that allows foster parents to systematically support the foster child's school performance. Foster parents will attend an introductory tutor training seminar at which they will be introduced to relevant theory on learning and counselled on tutoring practice. The intervention itself is designed to provide approximately three hours per week of individual home-based tutoring for a period of 40 weeks.
arm group label: Parents as Tutors
criteria: 
gender: All
minimum age: 6 Years
maximum age: 13 Years
healthy volunteers: No
last name: Misja Eiberg, Ph.d. fellow
role: Principal Investigator
affiliation: SFI - The Danish National Centre for Social Research
last name: Misja Eiberg
phone: +45 33480819
email: mei@sfi.dk
last name: Helle Hansen
phone: +45 33480927
email: heh@sfi.dk
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
country: Denmark
responsible party type: Sponsor