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/NCT05981690</url>
    </required_header>
    <id_info>
      <org_study_id>UREC 21/27</org_study_id>
      <nct_id>NCT05981690</nct_id>
    </id_info>
    <brief_title>Therapist Guided, Parent-led, Cognitive Behavioural Therapy (CBT) for Preadolescent Children With Obsessive Compulsive Disorder (OCD)</brief_title>
    <official_title>Therapist Guided, Parent-led, Cognitive Behavioural Therapy (CBT) for Preadolescent Children With Obsessive Compulsive Disorder (OCD)</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Reading</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University of Reading</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>
        This preliminary study aims to examine the outcomes from a therapist guided, parent-led, CBT&#xD;
        treatment for preadolescent children (aged 5 to 12 years old) with OCD.&#xD;
  &#xD;
        Specifically, this study aims to:&#xD;
  &#xD;
          1. Examine outcomes for children who receive the therapist guided, parent-led, CBT&#xD;
             treatment for preadolescent children with OCD.&#xD;
  &#xD;
          2. Examine parents' experiences and views about the acceptability of the treatment&#xD;
             approach.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This study adapted an existing therapist guided, parent-led CBT intervention for children&#xD;
        with anxiety difficulties, to ensure suitability for preadolescent children with OCD.&#xD;
  &#xD;
        This preliminary study aims to examine the outcomes from a therapist guided, parent-led, CBT&#xD;
        treatment for preadolescent children (aged 5 to 12 years old) with OCD.&#xD;
  &#xD;
        Specifically, this study aims to:&#xD;
  &#xD;
          1. Examine outcomes for children who receive the therapist guided, parent-led, CBT&#xD;
             treatment for preadolescent children with OCD.&#xD;
  &#xD;
          2. Examine parents' experiences and views about the acceptability of the treatment&#xD;
             approach.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">June 6, 2021</start_date>
    <completion_date type="Actual">March 28, 2022</completion_date>
    <primary_completion_date type="Actual">March 3, 2022</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <intervention_model_description>Non concurrent multiple baseline design</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Children's Yale Brown Obsessive Compulsive Scale (CY-BOCS)</measure>
      <time_frame>Change from pre-baseline phase, within one-week post-treatment, one-month follow-up</time_frame>
      <description>Diagnostic interview. Higher scores indicate higher severity of OCD</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Anxiety Disorder Interview Schedule - Parent Report (ADIS-P)</measure>
      <time_frame>Change from pre-baseline phase, within one-week post-treatment, one-month follow-up</time_frame>
      <description>Diagnostic interview. Indicates presence/absence of anxiety, OCD, and externalising difficulties. Higher severity scores indicate greater severity of difficulties.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Children's Obsessional Compulsive Inventory - Revised - Parent Report (ChOCI-R-P)</measure>
      <time_frame>Weekly during baseline and intervention phase; one month follow up</time_frame>
      <description>Symptom measure. Higher scores indicate greater OCD symptoms and impairment.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Family Accommodation Scale - FAS</measure>
      <time_frame>Weekly during baseline and intervention phase; one month follow up</time_frame>
      <description>Symptom measure. Higher scores indicate greater levels of family accommodation of OCD.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Goal Based Outcomes - GBOs</measure>
      <time_frame>Weekly during intervention phase; one month follow up</time_frame>
      <description>Families identify up to 3 personalised goals to work towards during the intervention. Goals are rated weekly by the parent form 0 (no goal progress) to 10 (goal achieved)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Session Rating Scale- SRS</measure>
      <time_frame>Weekly during intervention phase; one month follow-up</time_frame>
      <description>Therapeutic alliance/treatment acceptability. Higher scores indicate greater acceptability.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Treatment acceptability questions</measure>
      <time_frame>one month follow-up</time_frame>
      <description>Treatment acceptability. 6 questionnaire items on a Likert scale from strongly disagree to strongly agree. 4 open ended questions regarding treatment acceptability.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Items assessing parent knowledge of OCD, how to help their child, and confidence to help child</measure>
      <time_frame>Weekly during baseline and intervention phase; one month follow up</time_frame>
      <description>3 questionnaire items devised by study authors to assess parents' report of their knowledge and confidence to help their child to overcome OCD. Items scored from 0 (no new learning) to 5 (learned a lot)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Items assessing how much children have learned new information about their fears/ability to cope in feared situations</measure>
      <time_frame>Weekly during intervention phase; one month follow up</time_frame>
      <description>2 questionnaire items devised by study authors to assess parents' perceptions of whether their child had learned new information about their fears and their ability to cope in feared situations, without performing their compulsions. Items scored from 0 (no new learning) to 5 (learned a lot)</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Actual">10</enrollment>
    <condition>OCD</condition>
    <arm_group>
      <arm_group_label>Therapist guided, parent-led CBT for preadolescent children with OCD</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>6 to 8 sessions of therapist guided, parent-led CBT for preadolescent children with OCD</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Therapist guided, parent-led CBT for preadolescent children with OCD</intervention_name>
      <description>This treatment was adapted from an existing evidence based therapist guided parent-led CBT intervention for preadolescent children with anxiety difficulties. It consists of 6 to 8 treatment individual treatment sessions where parents learn CBT techniques to apply at home with their child</description>
      <arm_group_label>Therapist guided, parent-led CBT for preadolescent children with OCD</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          Children&#xD;
  &#xD;
          Inclusion criteria:&#xD;
  &#xD;
            1. Aged 5 to 12 years old (when parents/carers complete the baseline questionnaires).&#xD;
  &#xD;
            2. Diagnosis of OCD (identified from the ADIS-P).&#xD;
  &#xD;
            3. UK-resident. Parents&#xD;
  &#xD;
          Inclusion criteria:&#xD;
  &#xD;
            1. Parent/legal guardian of the child.&#xD;
  &#xD;
            2. UK resident.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          Children&#xD;
  &#xD;
          Exclusion criteria:&#xD;
  &#xD;
            1. Comorbid condition, which is likely to interfere with treatment delivery, for example:&#xD;
  &#xD;
                 1. Established Autism Spectrum Condition (ASC).&#xD;
  &#xD;
                 2. Suspected ASC (indicated by exceeding the threshold of 15 on the Social&#xD;
                    Communication Questionnaire and where a diagnosis of ASC has not been ruled out&#xD;
                    by a medical professional).&#xD;
  &#xD;
                 3. Profound learning difficulty (evidenced by attending a specialist school).&#xD;
  &#xD;
            2. Risk and/or safeguarding concerns, which are paramount and would interfere with&#xD;
               treatment delivery, for example:&#xD;
  &#xD;
                 1. Suicidal intent.&#xD;
  &#xD;
                 2. Recurrent or potentially life limiting self-harm.&#xD;
  &#xD;
                 3. Significant safeguarding concerns (i.e., if the child has a child protection plan&#xD;
                    and/or is on the child protection register, and/or the research team consider the&#xD;
                    child to be suffering, or likely to suffer, significant harm).&#xD;
  &#xD;
            3. If children have been prescribed psychotropic medication, the dosage must have been&#xD;
               stable for two months.&#xD;
  &#xD;
            4. Children who are currently receiving other psychological support/interventions&#xD;
               delivered by a mental health professional.&#xD;
  &#xD;
          Parents&#xD;
  &#xD;
          Exclusion criteria:&#xD;
  &#xD;
            1. Significant intellectual impairment that is likely to interfere with treatment&#xD;
               delivery.&#xD;
  &#xD;
            2. Unable to access or understand written English language materials needed for the&#xD;
               intervention.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>5 Years</minimum_age>
      <maximum_age>12 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Kate N Harvey, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>University of Reading</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>University of Reading</name>
        <address>
          <city>Reading</city>
          <state>UK</state>
          <zip>RG6 6BZ</zip>
          <country>United Kingdom</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>United Kingdom</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 18, 2023</study_first_submitted>
    <study_first_submitted_qc>July 31, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 8, 2023</study_first_posted>
    <last_update_submitted>July 31, 2023</last_update_submitted>
    <last_update_submitted_qc>July 31, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 8, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>University of Reading</investigator_affiliation>
      <investigator_full_name>Kate Harvey</investigator_full_name>
      <investigator_title>Professor Kate Harvey</investigator_title>
    </responsible_party>
    <keyword>OCD</keyword>
    <keyword>CBT</keyword>
    <keyword>parent</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Compulsive Personality Disorder</mesh_term>
      <mesh_term>Obsessive-Compulsive Disorder</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>We are not able to make individual participant data available to other researchers.</ipd_description>
    </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/NCT05981690
  org study id: UREC 21/27
  nct id: NCT05981690
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This preliminary study aims to examine the outcomes from a therapist guided, parent-led, CBT
        treatment for preadolescent children (aged 5 to 12 years old) with OCD.
  
        Specifically, this study aims to:
  
          1. Examine outcomes for children who receive the therapist guided, parent-led, CBT
             treatment for preadolescent children with OCD.
  
          2. Examine parents' experiences and views about the acceptability of the treatment
             approach.
  This study adapted an existing therapist guided, parent-led CBT intervention for children
        with anxiety difficulties, to ensure suitability for preadolescent children with OCD.
  
        This preliminary study aims to examine the outcomes from a therapist guided, parent-led, CBT
        treatment for preadolescent children (aged 5 to 12 years old) with OCD.
  
        Specifically, this study aims to:
  
          1. Examine outcomes for children who receive the therapist guided, parent-led, CBT
             treatment for preadolescent children with OCD.
  
          2. Examine parents' experiences and views about the acceptability of the treatment
             approach.
  allocation: N/A
  intervention model: Single Group Assignment
  intervention model description: Non concurrent multiple baseline design
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Children's Yale Brown Obsessive Compulsive Scale (CY-BOCS)
  time frame: Change from pre-baseline phase, within one-week post-treatment, one-month follow-up
  description: Diagnostic interview. Higher scores indicate higher severity of OCD
  measure: Anxiety Disorder Interview Schedule - Parent Report (ADIS-P)
  time frame: Change from pre-baseline phase, within one-week post-treatment, one-month follow-up
  description: Diagnostic interview. Indicates presence/absence of anxiety, OCD, and externalising difficulties. Higher severity scores indicate greater severity of difficulties.
  measure: Children's Obsessional Compulsive Inventory - Revised - Parent Report (ChOCI-R-P)
  time frame: Weekly during baseline and intervention phase; one month follow up
  description: Symptom measure. Higher scores indicate greater OCD symptoms and impairment.
  measure: Family Accommodation Scale - FAS
  time frame: Weekly during baseline and intervention phase; one month follow up
  description: Symptom measure. Higher scores indicate greater levels of family accommodation of OCD.
  measure: Goal Based Outcomes - GBOs
  time frame: Weekly during intervention phase; one month follow up
  description: Families identify up to 3 personalised goals to work towards during the intervention. Goals are rated weekly by the parent form 0 (no goal progress) to 10 (goal achieved)
  measure: Session Rating Scale- SRS
  time frame: Weekly during intervention phase; one month follow-up
  description: Therapeutic alliance/treatment acceptability. Higher scores indicate greater acceptability.
  measure: Treatment acceptability questions
  time frame: one month follow-up
  description: Treatment acceptability. 6 questionnaire items on a Likert scale from strongly disagree to strongly agree. 4 open ended questions regarding treatment acceptability.
  measure: Items assessing parent knowledge of OCD, how to help their child, and confidence to help child
  time frame: Weekly during baseline and intervention phase; one month follow up
  description: 3 questionnaire items devised by study authors to assess parents' report of their knowledge and confidence to help their child to overcome OCD. Items scored from 0 (no new learning) to 5 (learned a lot)
  measure: Items assessing how much children have learned new information about their fears/ability to cope in feared situations
  time frame: Weekly during intervention phase; one month follow up
  description: 2 questionnaire items devised by study authors to assess parents' perceptions of whether their child had learned new information about their fears and their ability to cope in feared situations, without performing their compulsions. Items scored from 0 (no new learning) to 5 (learned a lot)
  arm group label: Therapist guided, parent-led CBT for preadolescent children with OCD
  arm group type: Experimental
  description: 6 to 8 sessions of therapist guided, parent-led CBT for preadolescent children with OCD
  intervention type: Behavioral
  intervention name: Therapist guided, parent-led CBT for preadolescent children with OCD
  description: This treatment was adapted from an existing evidence based therapist guided parent-led CBT intervention for preadolescent children with anxiety difficulties. It consists of 6 to 8 treatment individual treatment sessions where parents learn CBT techniques to apply at home with their child
  arm group label: Therapist guided, parent-led CBT for preadolescent children with OCD
  criteria: 
  gender: All
  minimum age: 5 Years
  maximum age: 12 Years
  healthy volunteers: No
  last name: Kate N Harvey, PhD
  role: Principal Investigator
  affiliation: University of Reading
  facility: 
  country: United Kingdom
  responsible party type: Principal Investigator
  investigator affiliation: University of Reading
  investigator full name: Kate Harvey
  investigator title: Professor Kate Harvey
  mesh term: Compulsive Personality Disorder
  mesh term: Obsessive-Compulsive Disorder
  sharing ipd: No
  ipd description: We are not able to make individual participant data available to other researchers.