<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/NCT03040895</url>
  </required_header>
  <id_info>
    <org_study_id>Public 360-nr. 16/13557</org_study_id>
    <nct_id>NCT03040895</nct_id>
  </id_info>
  <brief_title>Effect Evaluation of The International Child Development Programme (ICDP)</brief_title>
  <acronym>ICDP RCT</acronym>
  <official_title>Effect Evaluation of The International Child Development Programme (ICDP)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Norwegian Institute of Public Health</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Norwegian Directorate for Children, Youth and Family Affairs</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Norwegian Institute of Public Health</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study evaluate if a parental guidance programme based on the International Child&#xD;
      Development Programme (ICDP) offered to the general Norwegian population, has an effect on&#xD;
      caregivers, the relationship between caregiver and child, and on children's Development.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The International Child Development Programme (ICDP) is a psychosocial preventive programme&#xD;
      offered to parents and other caregivers. The programme aims to improve parenting practices&#xD;
      and thereby child development and well-being. The ICDP is designed to influence and improve&#xD;
      the quality of contact and relation between the caregivers, usually parents, and their&#xD;
      children through the practical application of eight themes or guidelines for positive&#xD;
      interaction. ICDP courses are implemented in a group format and include group discussions,&#xD;
      caregiver assignments, and report back through a sequence of eight meetings. The caregiver&#xD;
      groups are led by facilitators trained in the ICDP, and with the competence to lead such&#xD;
      groups.&#xD;
&#xD;
      The aim of this study is to evaluate if ICDP has an effect on caregiver's positive&#xD;
      involvement and sensitivity to childrens emotions, and on parental self-efficacy. The study&#xD;
      will also evaluate the effect of ICDP on caregiver-child relationships, and the children's&#xD;
      development and well-being.&#xD;
&#xD;
      The study will use a stratified cluster randomized control design, and will be implemented in&#xD;
      regular clinical practice in Norway.&#xD;
&#xD;
      More knowledge within this field is important for practitioners as well as policy makers in&#xD;
      planning preventive interventions for caregivers ant their children.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 10, 2016</start_date>
  <completion_date type="Actual">May 1, 2021</completion_date>
  <primary_completion_date type="Actual">May 1, 2021</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>Change in parents' reactions to children's emotions. Measurement: Coping With Toddlers'/Children's Negative Emotions Scale (CTNES/CCNES)</measure>
    <time_frame>Assessment points: Baseline (just before the intervention), 10-12 weeks after baseline (immediately after the intervention), and 6 months after baseline</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in positive Involvement with children. Measurement used: Alabama Parenting Questionnaire (APQ)</measure>
    <time_frame>Assessment points: Baseline (just before the intervention), 10-12 weeks after baseline (immediately after the intervention), and 6 months after baseline</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Parenting self-efficacy. Measurement: Tool to measure Parenting Self Efficacy (TOPSE)</measure>
    <time_frame>Assessment points: Baseline (just before the intervention), 10-12 weeks after baseline (immediately after the intervention), and 6 months after baseline</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in inter-parental conflict over child rearing issues. Measurement: Parenting Problem Checklist (PPC)</measure>
    <time_frame>Assessment points: Baseline (just before the intervention), 10-12 weeks after baseline (immediately after the intervention), and 6 months after baseline</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in the parent- child relationship. Measurement: Child-parent relationship scale (CPRS)</measure>
    <time_frame>Assessment points: Baseline (just before the intervention), 10-12 weeks after baseline (immediately after the intervention), and 6 months after baseline</time_frame>
    <description>Closeness and conflicts</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in the child's psychosocial functioning. Measurement:Strength and Difficulties Questionnaire (SDQ)</measure>
    <time_frame>Assessment points: Baseline (just before the intervention), 10-12 weeks after baseline (immediately after the intervention), and 6 months after baseline</time_frame>
    <description>Emotional symptoms, hyperactivity, conduct problems, peer problems, prosocial behavior</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in the child's quality of life. Measurement: KINDer und Jugendliche zur Erfassung der gesundheitsbezogenen Lebensqualität (KINDL)</measure>
    <time_frame>Assessment points: Baseline (just before the intervention), 10-12 weeks after baseline (immediately after the intervention), and 6 months after baseline</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">666</enrollment>
  <condition>Parenting</condition>
  <condition>Parent-Child Relations</condition>
  <condition>Child Development</condition>
  <arm_group>
    <arm_group_label>ICDP-intervention for caregivers</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Group-based ICDP-intervention for caregivers through a sequence of eight meetings. The groups are led by facilitators trained in the ICDP.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Treatment as usual</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Participants may use other health services (GP, other interventions) as usual through the data Collection period (6 months). Afther this period, they will have the opportunity to join an ICDP-Group if they still want.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Group-based ICDP-intervention</intervention_name>
    <description>Group-based ICDP-intervention for caregivers through a sequence of eight meetings</description>
    <arm_group_label>ICDP-intervention for caregivers</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Treatment as usual</intervention_name>
    <description>Treatment as usual through the data collection period (6 months)</description>
    <arm_group_label>Treatment as usual</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Caregivers with children between the age of 0-18 years, from the general Norwegian&#xD;
             population&#xD;
&#xD;
          -  Participants must be able to speak and write adequately Norwegian&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Not having children between 0-18 years&#xD;
&#xD;
          -  Insufficient Norwegian language skills&#xD;
&#xD;
          -  ICDP imposed by resolution in the Fylkesnemnda&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Gun-Mette B. Røsand, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Norwegian Institute of Public Health</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Norwegian Institute of Public Health</name>
      <address>
        <city>Oslo</city>
        <zip>PO Box 4404, N-0403 Oslo</zip>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Norway</country>
  </location_countries>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>January 30, 2017</study_first_submitted>
  <study_first_submitted_qc>January 31, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 2, 2017</study_first_posted>
  <last_update_submitted>March 24, 2023</last_update_submitted>
  <last_update_submitted_qc>March 24, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 28, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Parenting practices</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/NCT03040895
org study id: Public 360-nr. 16/13557
nct id: NCT03040895
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
This study evaluate if a parental guidance programme based on the International Child
      Development Programme (ICDP) offered to the general Norwegian population, has an effect on
      caregivers, the relationship between caregiver and child, and on children's Development.
The International Child Development Programme (ICDP) is a psychosocial preventive programme
      offered to parents and other caregivers. The programme aims to improve parenting practices
      and thereby child development and well-being. The ICDP is designed to influence and improve
      the quality of contact and relation between the caregivers, usually parents, and their
      children through the practical application of eight themes or guidelines for positive
      interaction. ICDP courses are implemented in a group format and include group discussions,
      caregiver assignments, and report back through a sequence of eight meetings. The caregiver
      groups are led by facilitators trained in the ICDP, and with the competence to lead such
      groups.

      The aim of this study is to evaluate if ICDP has an effect on caregiver's positive
      involvement and sensitivity to childrens emotions, and on parental self-efficacy. The study
      will also evaluate the effect of ICDP on caregiver-child relationships, and the children's
      development and well-being.

      The study will use a stratified cluster randomized control design, and will be implemented in
      regular clinical practice in Norway.

      More knowledge within this field is important for practitioners as well as policy makers in
      planning preventive interventions for caregivers ant their children.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Change in parents' reactions to children's emotions. Measurement: Coping With Toddlers'/Children's Negative Emotions Scale (CTNES/CCNES)
time frame: Assessment points: Baseline (just before the intervention), 10-12 weeks after baseline (immediately after the intervention), and 6 months after baseline
measure: Change in positive Involvement with children. Measurement used: Alabama Parenting Questionnaire (APQ)
time frame: Assessment points: Baseline (just before the intervention), 10-12 weeks after baseline (immediately after the intervention), and 6 months after baseline
measure: Change in Parenting self-efficacy. Measurement: Tool to measure Parenting Self Efficacy (TOPSE)
time frame: Assessment points: Baseline (just before the intervention), 10-12 weeks after baseline (immediately after the intervention), and 6 months after baseline
measure: Change in inter-parental conflict over child rearing issues. Measurement: Parenting Problem Checklist (PPC)
time frame: Assessment points: Baseline (just before the intervention), 10-12 weeks after baseline (immediately after the intervention), and 6 months after baseline
measure: Change in the parent- child relationship. Measurement: Child-parent relationship scale (CPRS)
time frame: Assessment points: Baseline (just before the intervention), 10-12 weeks after baseline (immediately after the intervention), and 6 months after baseline
description: Closeness and conflicts
measure: Change in the child's psychosocial functioning. Measurement:Strength and Difficulties Questionnaire (SDQ)
time frame: Assessment points: Baseline (just before the intervention), 10-12 weeks after baseline (immediately after the intervention), and 6 months after baseline
description: Emotional symptoms, hyperactivity, conduct problems, peer problems, prosocial behavior
measure: Change in the child's quality of life. Measurement: KINDer und Jugendliche zur Erfassung der gesundheitsbezogenen Lebensqualität (KINDL)
time frame: Assessment points: Baseline (just before the intervention), 10-12 weeks after baseline (immediately after the intervention), and 6 months after baseline
arm group label: ICDP-intervention for caregivers
arm group type: Experimental
description: Group-based ICDP-intervention for caregivers through a sequence of eight meetings. The groups are led by facilitators trained in the ICDP.
arm group label: Treatment as usual
arm group type: Other
description: Participants may use other health services (GP, other interventions) as usual through the data Collection period (6 months). Afther this period, they will have the opportunity to join an ICDP-Group if they still want.
intervention type: Other
intervention name: Group-based ICDP-intervention
description: Group-based ICDP-intervention for caregivers through a sequence of eight meetings
arm group label: ICDP-intervention for caregivers
intervention type: Other
intervention name: Treatment as usual
description: Treatment as usual through the data collection period (6 months)
arm group label: Treatment as usual
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Gun-Mette B. Røsand, PhD
role: Principal Investigator
affiliation: Norwegian Institute of Public Health
facility: 
country: Norway
responsible party type: Sponsor
sharing ipd: No