<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/NCT04467320</url>
  </required_header>
  <id_info>
    <org_study_id>274914</org_study_id>
    <nct_id>NCT04467320</nct_id>
  </id_info>
  <brief_title>Recovery Learning for Adolescents After Traumatic Experiences</brief_title>
  <acronym>RELATE</acronym>
  <official_title>Addressing Elevated PTSD Symptoms in Young People in Care: A Randomised Feasibility Trial Across Social-care and Mental Health Services.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Bath</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute for Health Research, United Kingdom</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of East Anglia</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>King's College London</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Edinburgh</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Bristol</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Avon and Wiltshire Mental Health Partnership NHS Trust</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Bath</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>
      Most children who have been removed from their family home and placed under the care of a&#xD;
      Local Authority have been exposed to many frightening experiences, including witnessing&#xD;
      violence, not being fed or cared for, or being abused. These experiences can lead to&#xD;
      significant emotional difficulties. One such difficulty is posttraumatic stress disorder&#xD;
      (PTSD), which can involve symptoms like having constant &quot;flashbacks&quot; of scary experiences,&#xD;
      and a constant feeling of being in danger. This can have a big effect on children's lives.&#xD;
      Yet, it is still not clear how to help young people in care who are experiencing high PTSD&#xD;
      symptoms.&#xD;
&#xD;
      One idea the researchers have is to use a group-based online programme which has successfully&#xD;
      helped other young people who have been exposed to different kinds of stressful experiences&#xD;
      (for example, war). To test whether this programme could help children in care too, the&#xD;
      researchers first need to see whether social workers have the time to check in with a child&#xD;
      about PTSD symptoms; whether young people and their carers are willing to be involved in a&#xD;
      research project which will test out the treatment programme; and whether mental health&#xD;
      workers might face any problems when delivering the programme. This project aims to answer&#xD;
      these questions.&#xD;
&#xD;
      The researchers will train social workers to complete an 8-question interview with 10-17 year&#xD;
      olds in care, which will measure symptoms of PTSD. If the young person is experiencing high&#xD;
      symptoms, they will be invited to take part in a research project. If they would like to join&#xD;
      the project, children will be randomly selected to take part in the online group programme,&#xD;
      or be given care-as-usual. The group programme involves the young person taking part in five&#xD;
      weekly meetings held online, where they will learn skills to reduce their distress, and be&#xD;
      supported to work through their difficult memories. Their carers will also take part in two&#xD;
      online meetings which will teach them how to support their young person.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">August 1, 2020</start_date>
  <completion_date type="Anticipated">December 1, 2021</completion_date>
  <primary_completion_date type="Anticipated">August 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>
    <intervention_model_description>Participants will be randomised to either the online intervention group (Teaching Recovery Techniques) or the care-as-usual group. Any young people entering into the trial who live in the same household will be randomised together. If randomised to the TRT condition, each child will be offered participation in the next age-appropriate group.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Child and Adolescent Trauma Screen (CATS)</measure>
    <time_frame>6 months</time_frame>
    <description>Self-report DSM-5 post-traumatic stress disorder (PTSD) symptom measure. Scores range from 0-60, with greater scores indicating greater symptom severity.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Child Revised Impact of Events Scale (CRIES-8)</measure>
    <time_frame>6 months</time_frame>
    <description>Self-report post-traumatic stress disorder (PTSD) symptom screening tool. Symptom scores range from 0-40, with higher scores indicating greater symptom severity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Child PTSD Symptom Scale (CPSS-5) Interview Schedule</measure>
    <time_frame>6 months</time_frame>
    <description>DSM-5 PTSD diagnostic interview. Symptoms range from 0-80, with higher scores indicating greater symptom severity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Inventory of Parent and Peer Attachment (IPPA)</measure>
    <time_frame>6 months</time_frame>
    <description>Self-report measure of young person's perception of their relationship with their carer. Scores range from 28-140, with lower scores indicating greater relationship difficulties.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Strengths and Difficulties Questionnaire (SDQ)</measure>
    <time_frame>6 months</time_frame>
    <description>Self-report and carer-report measure of internalising and externalising difficulties. There are 5 subscales each with scores ranging from 0-10. The total difficulties score is calculated by summing 4 of the sub-scales to give a score between 0-40. The greater the total score, the greater the difficulties experienced.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Short Mood and Feelings Questionnaire (SMFQ)</measure>
    <time_frame>6 months</time_frame>
    <description>Self-report and carer-report depression questionnaire. Scores range from 0-26, with higher scores indicating more depressive symptoms.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Child Health Utility 9D (CHU9D)</measure>
    <time_frame>6 months</time_frame>
    <description>Self-report measure of health-related quality of life. Scores range from 9-45, with higher scores indicating greater difficulties.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Parent Trauma Response Questionnaire - support style subscale (PTRQ)</measure>
    <time_frame>6 months</time_frame>
    <description>Carer-report measure of their support style. Scores range from 0-30, with higher scores indicating greater difficulties.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Child and Adolescent Trauma Screen (carer report)</measure>
    <time_frame>6 months</time_frame>
    <description>Carer-report young person PTSD symptom scale. Symptom scores range from 0-60, with higher scores indicating greater symptom severity.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Focus groups and 1:1 semi-structured interviews</measure>
    <time_frame>2 months</time_frame>
    <description>Qualitative measures carried out with young people, carers and service providers</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Posttraumatic Stress Disorder</condition>
  <arm_group>
    <arm_group_label>Intervention Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Receiving the Teaching Recovery Techniques intervention (delivered online).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Care-As-Usual Group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Receiving care-as-usual.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Teaching Recovery Techniques</intervention_name>
    <description>Teaching Recovery Techniques is a 7-session group programme, with 5-sessions for the young person and 2-sessions for the carer. All sessions will be held online. The carer sessions are focused on psychoeducation around trauma and PTSD, as well as skills for supporting a young person through the intervention and with PTSD symptoms more broadly. The young person sessions are primarily focused on skill building and include: psychoeducation and understanding intrusive memories; intrusive images, worries and dreams; arousal, emotions, relaxation and coping; avoidance and triggers; and, memories.</description>
    <arm_group_label>Intervention Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Care as usual</intervention_name>
    <description>In the care as usual arm, social workers will follow their standard care protocol for young people experiencing psychological distress. A typical response may include a referral to either the specialist local CAMHS or general CAMHS.</description>
    <arm_group_label>Care-As-Usual Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Experiencing elevated PTSS (using a standard cut-off score of =/&gt; 17 on the 8-item&#xD;
             Child Revised Impact of Events Scale; CRIES-8).&#xD;
&#xD;
          -  Living in any care residence (with the exception of those living with a biological&#xD;
             parent).&#xD;
&#xD;
          -  Access to appropriate technology to engage in the online sessions and can do so in a&#xD;
             quiet and private space.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  A diagnosis of psychosis.&#xD;
&#xD;
          -  Current and active serious suicidal ideations.&#xD;
&#xD;
          -  A moderate to severe learning disability.&#xD;
&#xD;
          -  Currently receiving direct therapeutic mental health support.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>10 Years</minimum_age>
    <maximum_age>17 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Rebecca Davis</last_name>
    <phone>07929827482</phone>
    <email>rsd52@bath.ac.uk</email>
  </overall_contact>
  <location>
    <facility>
      <name>University of Bath</name>
      <address>
        <city>Bath</city>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Rachel Hiller</last_name>
      <phone>01225 383794</phone>
      <email>rmbh20@bath.ac.uk</email>
    </contact>
    <contact_backup>
      <last_name>Rebecca Davis</last_name>
      <phone>01225 383794</phone>
      <email>rsd52@bath.ac.uk</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>March 2021</verification_date>
  <study_first_submitted>June 23, 2020</study_first_submitted>
  <study_first_submitted_qc>July 8, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 13, 2020</study_first_posted>
  <last_update_submitted>March 16, 2021</last_update_submitted>
  <last_update_submitted_qc>March 16, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">March 18, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Bath</investigator_affiliation>
    <investigator_full_name>Sarah Halligan</investigator_full_name>
    <investigator_title>Professor of Child and Family Mental Health</investigator_title>
  </responsible_party>
  <keyword>Post Traumatic Stress Disorder</keyword>
  <keyword>PTSD</keyword>
  <keyword>Trauma</keyword>
  <keyword>Foster care</keyword>
  <keyword>RCT</keyword>
  <keyword>group</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stress Disorders, Traumatic</mesh_term>
    <mesh_term>Stress Disorders, Post-Traumatic</mesh_term>
  </condition_browse>
  <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/NCT04467320
org study id: 274914
nct id: NCT04467320
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Most children who have been removed from their family home and placed under the care of a
      Local Authority have been exposed to many frightening experiences, including witnessing
      violence, not being fed or cared for, or being abused. These experiences can lead to
      significant emotional difficulties. One such difficulty is posttraumatic stress disorder
      (PTSD), which can involve symptoms like having constant "flashbacks" of scary experiences,
      and a constant feeling of being in danger. This can have a big effect on children's lives.
      Yet, it is still not clear how to help young people in care who are experiencing high PTSD
      symptoms.

      One idea the researchers have is to use a group-based online programme which has successfully
      helped other young people who have been exposed to different kinds of stressful experiences
      (for example, war). To test whether this programme could help children in care too, the
      researchers first need to see whether social workers have the time to check in with a child
      about PTSD symptoms; whether young people and their carers are willing to be involved in a
      research project which will test out the treatment programme; and whether mental health
      workers might face any problems when delivering the programme. This project aims to answer
      these questions.

      The researchers will train social workers to complete an 8-question interview with 10-17 year
      olds in care, which will measure symptoms of PTSD. If the young person is experiencing high
      symptoms, they will be invited to take part in a research project. If they would like to join
      the project, children will be randomly selected to take part in the online group programme,
      or be given care-as-usual. The group programme involves the young person taking part in five
      weekly meetings held online, where they will learn skills to reduce their distress, and be
      supported to work through their difficult memories. Their carers will also take part in two
      online meetings which will teach them how to support their young person.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Participants will be randomised to either the online intervention group (Teaching Recovery Techniques) or the care-as-usual group. Any young people entering into the trial who live in the same household will be randomised together. If randomised to the TRT condition, each child will be offered participation in the next age-appropriate group.
primary purpose: Treatment
masking: None (Open Label)
measure: Child and Adolescent Trauma Screen (CATS)
time frame: 6 months
description: Self-report DSM-5 post-traumatic stress disorder (PTSD) symptom measure. Scores range from 0-60, with greater scores indicating greater symptom severity.
measure: Child Revised Impact of Events Scale (CRIES-8)
time frame: 6 months
description: Self-report post-traumatic stress disorder (PTSD) symptom screening tool. Symptom scores range from 0-40, with higher scores indicating greater symptom severity.
measure: Child PTSD Symptom Scale (CPSS-5) Interview Schedule
time frame: 6 months
description: DSM-5 PTSD diagnostic interview. Symptoms range from 0-80, with higher scores indicating greater symptom severity.
measure: Inventory of Parent and Peer Attachment (IPPA)
time frame: 6 months
description: Self-report measure of young person's perception of their relationship with their carer. Scores range from 28-140, with lower scores indicating greater relationship difficulties.
measure: Strengths and Difficulties Questionnaire (SDQ)
time frame: 6 months
description: Self-report and carer-report measure of internalising and externalising difficulties. There are 5 subscales each with scores ranging from 0-10. The total difficulties score is calculated by summing 4 of the sub-scales to give a score between 0-40. The greater the total score, the greater the difficulties experienced.
measure: Short Mood and Feelings Questionnaire (SMFQ)
time frame: 6 months
description: Self-report and carer-report depression questionnaire. Scores range from 0-26, with higher scores indicating more depressive symptoms.
measure: Child Health Utility 9D (CHU9D)
time frame: 6 months
description: Self-report measure of health-related quality of life. Scores range from 9-45, with higher scores indicating greater difficulties.
measure: Parent Trauma Response Questionnaire - support style subscale (PTRQ)
time frame: 6 months
description: Carer-report measure of their support style. Scores range from 0-30, with higher scores indicating greater difficulties.
measure: Child and Adolescent Trauma Screen (carer report)
time frame: 6 months
description: Carer-report young person PTSD symptom scale. Symptom scores range from 0-60, with higher scores indicating greater symptom severity.
measure: Focus groups and 1:1 semi-structured interviews
time frame: 2 months
description: Qualitative measures carried out with young people, carers and service providers
arm group label: Intervention Group
arm group type: Experimental
description: Receiving the Teaching Recovery Techniques intervention (delivered online).
arm group label: Care-As-Usual Group
arm group type: Active Comparator
description: Receiving care-as-usual.
intervention type: Behavioral
intervention name: Teaching Recovery Techniques
description: Teaching Recovery Techniques is a 7-session group programme, with 5-sessions for the young person and 2-sessions for the carer. All sessions will be held online. The carer sessions are focused on psychoeducation around trauma and PTSD, as well as skills for supporting a young person through the intervention and with PTSD symptoms more broadly. The young person sessions are primarily focused on skill building and include: psychoeducation and understanding intrusive memories; intrusive images, worries and dreams; arousal, emotions, relaxation and coping; avoidance and triggers; and, memories.
arm group label: Intervention Group
intervention type: Behavioral
intervention name: Care as usual
description: In the care as usual arm, social workers will follow their standard care protocol for young people experiencing psychological distress. A typical response may include a referral to either the specialist local CAMHS or general CAMHS.
arm group label: Care-As-Usual Group
criteria: 
gender: All
minimum age: 10 Years
maximum age: 17 Years
healthy volunteers: No
last name: Rebecca Davis
phone: 07929827482
email: rsd52@bath.ac.uk
facility: 
status: Recruiting
contact: 
contact backup: 
country: United Kingdom
responsible party type: Principal Investigator
investigator affiliation: University of Bath
investigator full name: Sarah Halligan
investigator title: Professor of Child and Family Mental Health
mesh term: Stress Disorders, Traumatic
mesh term: Stress Disorders, Post-Traumatic
sharing ipd: No