xml: <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/NCT06037642</url>
    </required_header>
    <id_info>
      <org_study_id>All children in focus</org_study_id>
      <nct_id>NCT06037642</nct_id>
    </id_info>
    <brief_title>All Children in Focus (ABC) 0-2 Years: A Pilot Study</brief_title>
    <official_title>All Children in Focus (ABC) 0-2 Years: A Pilot Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Ersta Sköndal University College</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Ersta Sköndal University College</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>
        The goal of this clinical trial is to compare parents tools to handle challenges and&#xD;
        strengths as parents. The main questions it aims to answer are:&#xD;
  &#xD;
          -  Do participating parents feel more confident than non partipating parents?&#xD;
  &#xD;
          -  Does the program have positive effects on parenting practices, parents´ well-being, and&#xD;
             social support?&#xD;
  &#xD;
          -  Is the programme more effective for some groups of parents ( e.g., gender, socioeconomis&#xD;
             status)&#xD;
  &#xD;
        Participating parents will attend four 1-hour, manual based sessions followed by a 30-minutes&#xD;
        optional coffe break. In addition parents will be asked to do homework assignments between&#xD;
        the sessions.&#xD;
  &#xD;
        Researchers will compare the intervention group with an equally sized control group that will&#xD;
        receive the program later the same year.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">February 1, 2023</start_date>
    <completion_date type="Actual">June 30, 2023</completion_date>
    <primary_completion_date type="Actual">June 30, 2023</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>Supportive Care</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Parents´self efficacy</measure>
      <time_frame>Four weeks</time_frame>
      <description>Questionnaire</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Parenting practices and parent child relationship</measure>
      <time_frame>Four weeks</time_frame>
      <description>Questionnaire</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Parents´involvement and warmth</measure>
      <time_frame>Four weeks</time_frame>
      <description>Questionnaire</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Parents´ well-being</measure>
      <time_frame>Four weeks</time_frame>
      <description>Questionnaire</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Parents´ social network</measure>
      <time_frame>Four weeks</time_frame>
      <description>Questionnaire</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">300</enrollment>
    <condition>Parent-Child Relations</condition>
    <condition>Parenting</condition>
    <arm_group>
      <arm_group_label>Intervention group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>Control group</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>ABC 0-2 years</intervention_name>
      <description>Four 1 hour meetings and homework</description>
      <arm_group_label>Intervention group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>waiting list</intervention_name>
      <description>Will be put on hold for four weeks</description>
      <arm_group_label>Control group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          Parents to children aged 0-2 years&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          Non fluent in Swedish language&#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>Maria Eriksson, Phd</last_name>
      <role>Study Director</role>
      <affiliation>Ersta Sköndal University College</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>PLUS</name>
        <address>
          <city>Stockholm</city>
          <country>Sweden</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Sweden</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 7, 2023</study_first_submitted>
    <study_first_submitted_qc>September 7, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 14, 2023</study_first_posted>
    <last_update_submitted>September 7, 2023</last_update_submitted>
    <last_update_submitted_qc>September 7, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Ersta Sköndal University College</investigator_affiliation>
      <investigator_full_name>Anders Kassman</investigator_full_name>
      <investigator_title>Associate professor</investigator_title>
    </responsible_party>
    <keyword>Parenting support</keyword>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06037642
  org study id: All children in focus
  nct id: NCT06037642
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this clinical trial is to compare parents tools to handle challenges and
        strengths as parents. The main questions it aims to answer are:
  
          -  Do participating parents feel more confident than non partipating parents?
  
          -  Does the program have positive effects on parenting practices, parents´ well-being, and
             social support?
  
          -  Is the programme more effective for some groups of parents ( e.g., gender, socioeconomis
             status)
  
        Participating parents will attend four 1-hour, manual based sessions followed by a 30-minutes
        optional coffe break. In addition parents will be asked to do homework assignments between
        the sessions.
  
        Researchers will compare the intervention group with an equally sized control group that will
        receive the program later the same year.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Supportive Care
  masking: None (Open Label)
  measure: Parents´self efficacy
  time frame: Four weeks
  description: Questionnaire
  measure: Parenting practices and parent child relationship
  time frame: Four weeks
  description: Questionnaire
  measure: Parents´involvement and warmth
  time frame: Four weeks
  description: Questionnaire
  measure: Parents´ well-being
  time frame: Four weeks
  description: Questionnaire
  measure: Parents´ social network
  time frame: Four weeks
  description: Questionnaire
  arm group label: Intervention group
  arm group type: Experimental
  arm group label: Control group
  arm group type: Active Comparator
  intervention type: Behavioral
  intervention name: ABC 0-2 years
  description: Four 1 hour meetings and homework
  arm group label: Intervention group
  intervention type: Other
  intervention name: waiting list
  description: Will be put on hold for four weeks
  arm group label: Control group
  criteria: 
  gender: All
  minimum age: N/A
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Maria Eriksson, Phd
  role: Study Director
  affiliation: Ersta Sköndal University College
  facility: 
  country: Sweden
  responsible party type: Principal Investigator
  investigator affiliation: Ersta Sköndal University College
  investigator full name: Anders Kassman
  investigator title: Associate professor
  sharing ipd: No