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/NCT06003582</url>
    </required_header>
    <id_info>
      <org_study_id>316250</org_study_id>
      <nct_id>NCT06003582</nct_id>
    </id_info>
    <brief_title>Co-production and Feasibility RCT of Intervention to Improve the Mental Health of Children With a Social Worker</brief_title>
    <official_title>Partnership for Change - Co-production and Feasibility Randomised Controlled Trial of an Intervention to Improve the Mental Health of Children With a Social Worker</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Glasgow</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>NSPCC</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Glasgow City Council</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>London Borough of Bromley</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>University of Nottingham</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Queen Mary University of London</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>University of Glasgow</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>
        Feasibility RCT to ask: Can the investigators coproduce, with parent collaborators, a new&#xD;
        service, Infant Parent Support (IPS), to improve the mental health of children with a social&#xD;
        worker? Can the investigators test the feasibility of an RCT of IPS compared with services as&#xD;
        usual?&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Questions addressed: Can the investigators coproduce, with parent collaborators, a new&#xD;
        service, Infant Parent Support (IPS), to improve the mental health of children with a social&#xD;
        worker? Can the investigators test the feasibility of an RCT of IPS compared with services as&#xD;
        usual?&#xD;
  &#xD;
        Considered for entry: Parents of children aged 0-5 who have mental health concerns, social&#xD;
        workers, and a multi-agency support plan.&#xD;
  &#xD;
        Inclusion criteria: Any family in the Glasgow or Bromley trial sites with a child aged 0-5&#xD;
        years with mental health concerns, a social worker, and a multi-agency support plan.&#xD;
  &#xD;
        Exclusion criteria: At the outset of the Trial there were no exclusion criteria.&#xD;
  &#xD;
        Over the course of Phase 1, the following exclusion criteria have emerged:&#xD;
  &#xD;
          -  If the child has a Child Protection Plan or is on the Child Protection Register&#xD;
  &#xD;
          -  If the family are in the process of 'stepping down' from a CPP or CPR&#xD;
  &#xD;
          -  If the child is currently engaged in therapeutic work.&#xD;
  &#xD;
        Intervention: Infant Parent Support (a multidisciplinary infant mental health team aiming to&#xD;
        improve the mental health of children aged 0-5 with a social worker).&#xD;
  &#xD;
        Primary Outcomes Phase 1: Coproduction, with parents of children who have a social worker, of&#xD;
        the IPS intervention.&#xD;
  &#xD;
        Phase 2: Recruitment and retention (at 3 and 6 months) to a feasibility RCT.&#xD;
  &#xD;
        Secondary Outcomes&#xD;
  &#xD;
        Phase 1: preliminary mapping of service context.&#xD;
  &#xD;
        Phase 2:&#xD;
  &#xD;
          -  Improvement in the organisation, access, and quality of services, for children with a&#xD;
             social worker and mental health issues.&#xD;
  &#xD;
          -  Examination of putative primary and secondary outcomes for a future definitive RCT of&#xD;
             IPS (see below)&#xD;
  &#xD;
          -  Development of a parent-supported outcome measure and a parent-supported experience&#xD;
             measure for use in a future definitive RCT&#xD;
  &#xD;
          -  Exploration of whether it is possible to expand into new sites to conduct a successful&#xD;
             Phase III trial.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">May 18, 2023</start_date>
    <completion_date type="Anticipated">November 2023</completion_date>
    <primary_completion_date type="Anticipated">November 2023</primary_completion_date>
    <phase>Phase 1/Phase 2</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>
      <intervention_model_description>Infant mental health service</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Single (Investigator)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Recruitment rates to a feasibility RCT</measure>
      <time_frame>6 months</time_frame>
      <description>The recruitment of 30 families to the Trial and the 15 families randomised to the new therapeutic intervention will be measured by recruitment rates.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Retention rates to a feasibility RCT</measure>
      <time_frame>1 year</time_frame>
      <description>The proportion of the 15 families randomised to the new intervention who continue through the Trial will be measured by retention rates.</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">30</enrollment>
    <condition>Parent-Child Relations</condition>
    <condition>Child Mental Disorder</condition>
    <condition>Child Maltreatment</condition>
    <arm_group>
      <arm_group_label>Infant Parent Support</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Families engage with the new therapeutic intervention, Infant Parent Support.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Services As Usual</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>Families randomised to Services As Usual, engage with already existing services.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Infant Parent Support</intervention_name>
      <description>Therapeutic Intervention</description>
      <arm_group_label>Infant Parent Support</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Any family in the Glasgow or Bromley trial sites with a child aged 0-5 years with&#xD;
               mental health concerns, a social worker, and a multi-agency support plan.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          At the outset of the Trial there were no exclusion criteria. Over the course of Phase 1,&#xD;
          the following exclusion criteria have emerged:&#xD;
  &#xD;
            -  If the child has a Child Protection Plan or is on the Child Protection Register&#xD;
  &#xD;
            -  If the family are in the process of 'stepping down' from a CPP or CPR&#xD;
  &#xD;
            -  If the child is currently engaged in therapeutic work.&#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>Helen Minnis, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>University of Glasgow</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Helen Minnis, PhD</last_name>
      <phone>+44 0141 201 9239</phone>
      <email>Helen.Minnis@glasgow.ac.uk</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Judith Fisher, MSc</last_name>
      <phone>+44 0141 201 9239</phone>
      <email>Judith.Fisher@glasgow.ac.uk</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>London Borough of Bromley</name>
        <address>
          <city>London</city>
          <country>United Kingdom</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Carol Whiting</last_name>
      </contact>
    </location>
    <location_countries>
      <country>United Kingdom</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>May 11, 2023</study_first_submitted>
    <study_first_submitted_qc>August 14, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 22, 2023</study_first_posted>
    <last_update_submitted>August 14, 2023</last_update_submitted>
    <last_update_submitted_qc>August 14, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 22, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>University of Glasgow</investigator_affiliation>
      <investigator_full_name>Helen Minnis</investigator_full_name>
      <investigator_title>Professor Helen Minnis</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Mental Disorders</mesh_term>
      <mesh_term>Neurodevelopmental Disorders</mesh_term>
    </condition_browse>
    <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/NCT06003582
  org study id: 316250
  nct id: NCT06003582
  lead sponsor: 
  collaborator: 
  collaborator: 
  collaborator: 
  collaborator: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Feasibility RCT to ask: Can the investigators coproduce, with parent collaborators, a new
        service, Infant Parent Support (IPS), to improve the mental health of children with a social
        worker? Can the investigators test the feasibility of an RCT of IPS compared with services as
        usual?
  Questions addressed: Can the investigators coproduce, with parent collaborators, a new
        service, Infant Parent Support (IPS), to improve the mental health of children with a social
        worker? Can the investigators test the feasibility of an RCT of IPS compared with services as
        usual?
  
        Considered for entry: Parents of children aged 0-5 who have mental health concerns, social
        workers, and a multi-agency support plan.
  
        Inclusion criteria: Any family in the Glasgow or Bromley trial sites with a child aged 0-5
        years with mental health concerns, a social worker, and a multi-agency support plan.
  
        Exclusion criteria: At the outset of the Trial there were no exclusion criteria.
  
        Over the course of Phase 1, the following exclusion criteria have emerged:
  
          -  If the child has a Child Protection Plan or is on the Child Protection Register
  
          -  If the family are in the process of 'stepping down' from a CPP or CPR
  
          -  If the child is currently engaged in therapeutic work.
  
        Intervention: Infant Parent Support (a multidisciplinary infant mental health team aiming to
        improve the mental health of children aged 0-5 with a social worker).
  
        Primary Outcomes Phase 1: Coproduction, with parents of children who have a social worker, of
        the IPS intervention.
  
        Phase 2: Recruitment and retention (at 3 and 6 months) to a feasibility RCT.
  
        Secondary Outcomes
  
        Phase 1: preliminary mapping of service context.
  
        Phase 2:
  
          -  Improvement in the organisation, access, and quality of services, for children with a
             social worker and mental health issues.
  
          -  Examination of putative primary and secondary outcomes for a future definitive RCT of
             IPS (see below)
  
          -  Development of a parent-supported outcome measure and a parent-supported experience
             measure for use in a future definitive RCT
  
          -  Exploration of whether it is possible to expand into new sites to conduct a successful
             Phase III trial.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Infant mental health service
  primary purpose: Treatment
  masking: Single (Investigator)
  measure: Recruitment rates to a feasibility RCT
  time frame: 6 months
  description: The recruitment of 30 families to the Trial and the 15 families randomised to the new therapeutic intervention will be measured by recruitment rates.
  measure: Retention rates to a feasibility RCT
  time frame: 1 year
  description: The proportion of the 15 families randomised to the new intervention who continue through the Trial will be measured by retention rates.
  arm group label: Infant Parent Support
  arm group type: Experimental
  description: Families engage with the new therapeutic intervention, Infant Parent Support.
  arm group label: Services As Usual
  arm group type: No Intervention
  description: Families randomised to Services As Usual, engage with already existing services.
  intervention type: Other
  intervention name: Infant Parent Support
  description: Therapeutic Intervention
  arm group label: Infant Parent Support
  criteria: 
  gender: All
  minimum age: N/A
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Helen Minnis, PhD
  role: Principal Investigator
  affiliation: University of Glasgow
  last name: Helen Minnis, PhD
  phone: +44 0141 201 9239
  email: Helen.Minnis@glasgow.ac.uk
  last name: Judith Fisher, MSc
  phone: +44 0141 201 9239
  email: Judith.Fisher@glasgow.ac.uk
  facility: 
  status: Recruiting
  contact: 
  country: United Kingdom
  responsible party type: Principal Investigator
  investigator affiliation: University of Glasgow
  investigator full name: Helen Minnis
  investigator title: Professor Helen Minnis
  mesh term: Mental Disorders
  mesh term: Neurodevelopmental Disorders
  sharing ipd: No