<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/NCT02987608</url>
  </required_header>
  <id_info>
    <org_study_id>16/0087</org_study_id>
    <nct_id>NCT02987608</nct_id>
  </id_info>
  <brief_title>A Feasibility Trial of Power Up</brief_title>
  <official_title>A Feasibility Trial of Power Up: A Smartphone App to Support Young People to Make Shared Decisions in Therapy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University College, London</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Anna Freud National Centre for Children and Families</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>MindTech Healthcare Technology Co-operative</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Common Room Consulting Ltd</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Create Marketing</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University College, London</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      There is an increasing demand for digital tools to empower young people with mental health&#xD;
      difficulties (NHS England, 2015). Digital information, advice and mood tracking tools are&#xD;
      increasingly being used to support child mental health. Evidence suggests that young people&#xD;
      want to be active participants in their care and involved in decisions about their treatment.&#xD;
      However, there is a lack of digital shared decision making tools available to support young&#xD;
      people in Child and Adolescent Mental Health Services (CAMHS). This study aims to develop&#xD;
      Power Up, a smartphone app to empower young people in CAMHS to make their voice heard and to&#xD;
      participate more in decisions around their care.&#xD;
&#xD;
      The project will involve two phases:&#xD;
&#xD;
        -  Development Phase -Developing Power Up according to the views and ideas expressed by&#xD;
           young people, their parents/ carers, and clinicians in Patient and Public Involvement&#xD;
           (PPI) sessions. -Conducting interviews and focus groups with 10 young people in CAMHS,&#xD;
           10 parents/ carers and 10 clinicians to review the acceptability of the content and&#xD;
           format of Power Up.&#xD;
&#xD;
        -  Feasibility testing Phase -Conducting a feasibility trial with 120 young people with&#xD;
           emotional difficulties, aged 11-19 years, from three London CAMHS. 60 young people will&#xD;
           receive treatment as usual and 60 will use Power Up alongside treatment as usual.&#xD;
           Participant's ratings of empowerment, activation, and symptoms will be measured soon&#xD;
           after their referral to the service. The same measures plus shared decision making&#xD;
           questionnaires will be administered three months later.&#xD;
&#xD;
      The findings will inform the planning of a prospective cluster controlled trial. More broadly&#xD;
      this trial will contribute an understanding of the feasibility and acceptability of&#xD;
      developing and implementing a shared decision making app into CAMHS.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>September 2016</start_date>
  <completion_date type="Anticipated">September 2017</completion_date>
  <primary_completion_date type="Anticipated">August 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-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>Shared Decision Making Questionnaire - 9 (SDM Q-9)</measure>
    <time_frame>3 months</time_frame>
    <description>This will be completed by young people at time two (three months into therapy). The SDM Q-9 is a nine item patient reported shared decision making questionnaire.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>CollaboRATE</measure>
    <time_frame>3 months</time_frame>
    <description>This will be completed by young people at time two (three months into therapy). CollaboRATE is a three item patient reported shared decision making measure.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Experience of Service Questionnaire (ESQ)</measure>
    <time_frame>3 months</time_frame>
    <description>Four items from this questionnaire will be completed by young people at time two (three months into therapy) as a proxy measure of shared decision making. The ESQ is a self-completion questionnaire that assesses children and young people's views of services with respect to accessibility, humanity of care, organisation of care and environment.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Dyadic OPTION scale</measure>
    <time_frame>3 months</time_frame>
    <description>This will be completed by clinicians at time two (three months into therapy). The Dyadic OPTION scale is a 12- item instrument to measure the extent to which patients have been involved in shared decision making from the viewpoint of the clinician.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Patient Activation Measure - Mental Health (PAM - MH)</measure>
    <time_frame>3 months</time_frame>
    <description>The PAM - MH will be completed by young people at time one (beginning of therapy) and time two (three months into therapy). The PAM - MH is a patient reported tool for measuring engagement in mental healthcare.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Strengths and Difficulties questionnaire (SDQ)</measure>
    <time_frame>3 months</time_frame>
    <description>The SDQ will be completed by young people at time one (beginning of therapy) and time two (three months into therapy). The SDQ is a self-report behavioural screening questionnaire for children and adolescents measuring symptoms and functioning.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Youth Efficacy / Empowerment Scale - Mental Health (YES - MH)</measure>
    <time_frame>3 months</time_frame>
    <description>The YES -MH will be completed by young people at time one (beginning of therapy) and time two (three months into therapy). The YES - MH assesses youth perceptions of efficacy with respect to managing their own mental health condition ('Self'), managing their own services and supports ('Service'), and using their experience and knowledge to help peers and improve service systems ('System').</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Client Receipt of Services Inventory (CSRI) - Children's Version.</measure>
    <time_frame>3 months</time_frame>
    <description>The CSRI will be completed by parents at time one (beginning of therapy) and time two (three months into therapy). The CSRI provides information on service utilisation, as reported by the main carer of the child in the family.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Did Not Attends (DNAs)</measure>
    <time_frame>3 months</time_frame>
    <description>Number of young person DNAs will be reported by the clinician.</description>
  </other_outcome>
  <other_outcome>
    <measure>Number of sessions attended</measure>
    <time_frame>3 months</time_frame>
    <description>The number of sessions attended by the young person will be reported by the clinician.</description>
  </other_outcome>
  <other_outcome>
    <measure>Type of therapy / intervention received</measure>
    <time_frame>3 months</time_frame>
    <description>The type of therapy / intervention received by the young person will be reported by the clinician.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">120</enrollment>
  <condition>Emotional Difficulties</condition>
  <arm_group>
    <arm_group_label>Control Phase (No Power Up)</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>60 young people will receive CAMHS treatment as usual. Measures of empowerment, activation, and symptoms will be completed by participants soon after their referral to the service. The same measures plus shared decision making questionnaires will be administered three months later.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intervention Phase (Power Up)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>60 young people use Power Up alongside CAMHS treatment as usual. Measures of empowerment, activation, and symptoms will be completed by participants soon after their referral to the service. The same measures plus shared decision making questionnaires and a Power Up feedback form will be administered three months later.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Power Up</intervention_name>
    <description>Smartphone phone app</description>
    <arm_group_label>Intervention Phase (Power Up)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Recently been referred to CAMHS (pre - first appointment)&#xD;
&#xD;
          -  Presenting with emotional difficulties&#xD;
&#xD;
          -  Clinician will have confirmed that the young person does not have any vulnerability&#xD;
             which would make taking part in the study inappropriate to their context&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>11 Years</minimum_age>
    <maximum_age>19 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Miranda Wolpert, Professor</last_name>
    <role>Principal Investigator</role>
    <affiliation>UCL &amp; Anaa Freud National Centre for Children and Families</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Louise N Chapman</last_name>
    <phone>020 7443 2205</phone>
    <email>louise.chapman@annafreud.org</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Julian Edbrooke - Childs</last_name>
    <phone>020 7443 2275</phone>
    <email>julian.edbrooke-childs@annafreud.org</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>East London NHS Foundation Trust</name>
      <address>
        <city>London</city>
        <zip>E1 5NF</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Percy Aggett</last_name>
      <phone>020 7426 2375</phone>
      <phone_ext>2400</phone_ext>
      <email>Percy.Aggett@elft.nhs.uk</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>North East London NHS Foundation Trust</name>
      <address>
        <city>London</city>
        <zip>IG11 7LZ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Vivienne Okoh</last_name>
      <phone>0300 555 1035</phone>
      <phone_ext>53261</phone_ext>
      <email>Vivienne.Okoh@nelft.nhs.uk</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>The Tavistock and Portman NHS Foundation Trust</name>
      <address>
        <city>London</city>
        <zip>NW3 5BA</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Emilios Lemoniatis</last_name>
      <phone>020 8938 2429</phone>
      <email>ELemoniatis@tavi-port.nhs.uk</email>
    </contact>
    <investigator>
      <last_name>Emilios Lemoniatis</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>October 2016</verification_date>
  <study_first_submitted>October 12, 2016</study_first_submitted>
  <study_first_submitted_qc>December 6, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 9, 2016</study_first_posted>
  <last_update_submitted>December 6, 2016</last_update_submitted>
  <last_update_submitted_qc>December 6, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 9, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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/NCT02987608
org study id: 16/0087
nct id: NCT02987608
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
There is an increasing demand for digital tools to empower young people with mental health
      difficulties (NHS England, 2015). Digital information, advice and mood tracking tools are
      increasingly being used to support child mental health. Evidence suggests that young people
      want to be active participants in their care and involved in decisions about their treatment.
      However, there is a lack of digital shared decision making tools available to support young
      people in Child and Adolescent Mental Health Services (CAMHS). This study aims to develop
      Power Up, a smartphone app to empower young people in CAMHS to make their voice heard and to
      participate more in decisions around their care.

      The project will involve two phases:

        -  Development Phase -Developing Power Up according to the views and ideas expressed by
           young people, their parents/ carers, and clinicians in Patient and Public Involvement
           (PPI) sessions. -Conducting interviews and focus groups with 10 young people in CAMHS,
           10 parents/ carers and 10 clinicians to review the acceptability of the content and
           format of Power Up.

        -  Feasibility testing Phase -Conducting a feasibility trial with 120 young people with
           emotional difficulties, aged 11-19 years, from three London CAMHS. 60 young people will
           receive treatment as usual and 60 will use Power Up alongside treatment as usual.
           Participant's ratings of empowerment, activation, and symptoms will be measured soon
           after their referral to the service. The same measures plus shared decision making
           questionnaires will be administered three months later.

      The findings will inform the planning of a prospective cluster controlled trial. More broadly
      this trial will contribute an understanding of the feasibility and acceptability of
      developing and implementing a shared decision making app into CAMHS.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Shared Decision Making Questionnaire - 9 (SDM Q-9)
time frame: 3 months
description: This will be completed by young people at time two (three months into therapy). The SDM Q-9 is a nine item patient reported shared decision making questionnaire.
measure: CollaboRATE
time frame: 3 months
description: This will be completed by young people at time two (three months into therapy). CollaboRATE is a three item patient reported shared decision making measure.
measure: Experience of Service Questionnaire (ESQ)
time frame: 3 months
description: Four items from this questionnaire will be completed by young people at time two (three months into therapy) as a proxy measure of shared decision making. The ESQ is a self-completion questionnaire that assesses children and young people's views of services with respect to accessibility, humanity of care, organisation of care and environment.
measure: Dyadic OPTION scale
time frame: 3 months
description: This will be completed by clinicians at time two (three months into therapy). The Dyadic OPTION scale is a 12- item instrument to measure the extent to which patients have been involved in shared decision making from the viewpoint of the clinician.
measure: Patient Activation Measure - Mental Health (PAM - MH)
time frame: 3 months
description: The PAM - MH will be completed by young people at time one (beginning of therapy) and time two (three months into therapy). The PAM - MH is a patient reported tool for measuring engagement in mental healthcare.
measure: Strengths and Difficulties questionnaire (SDQ)
time frame: 3 months
description: The SDQ will be completed by young people at time one (beginning of therapy) and time two (three months into therapy). The SDQ is a self-report behavioural screening questionnaire for children and adolescents measuring symptoms and functioning.
measure: Youth Efficacy / Empowerment Scale - Mental Health (YES - MH)
time frame: 3 months
description: The YES -MH will be completed by young people at time one (beginning of therapy) and time two (three months into therapy). The YES - MH assesses youth perceptions of efficacy with respect to managing their own mental health condition ('Self'), managing their own services and supports ('Service'), and using their experience and knowledge to help peers and improve service systems ('System').
measure: Client Receipt of Services Inventory (CSRI) - Children's Version.
time frame: 3 months
description: The CSRI will be completed by parents at time one (beginning of therapy) and time two (three months into therapy). The CSRI provides information on service utilisation, as reported by the main carer of the child in the family.
measure: Did Not Attends (DNAs)
time frame: 3 months
description: Number of young person DNAs will be reported by the clinician.
measure: Number of sessions attended
time frame: 3 months
description: The number of sessions attended by the young person will be reported by the clinician.
measure: Type of therapy / intervention received
time frame: 3 months
description: The type of therapy / intervention received by the young person will be reported by the clinician.
arm group label: Control Phase (No Power Up)
arm group type: No Intervention
description: 60 young people will receive CAMHS treatment as usual. Measures of empowerment, activation, and symptoms will be completed by participants soon after their referral to the service. The same measures plus shared decision making questionnaires will be administered three months later.
arm group label: Intervention Phase (Power Up)
arm group type: Experimental
description: 60 young people use Power Up alongside CAMHS treatment as usual. Measures of empowerment, activation, and symptoms will be completed by participants soon after their referral to the service. The same measures plus shared decision making questionnaires and a Power Up feedback form will be administered three months later.
intervention type: Device
intervention name: Power Up
description: Smartphone phone app
arm group label: Intervention Phase (Power Up)
criteria: 
gender: All
minimum age: 11 Years
maximum age: 19 Years
healthy volunteers: No
last name: Miranda Wolpert, Professor
role: Principal Investigator
affiliation: UCL & Anaa Freud National Centre for Children and Families
last name: Louise N Chapman
phone: 020 7443 2205
email: louise.chapman@annafreud.org
last name: Julian Edbrooke - Childs
phone: 020 7443 2275
email: julian.edbrooke-childs@annafreud.org
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
investigator: 
country: United Kingdom
responsible party type: Sponsor
sharing ipd: No