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/NCT06033781</url>
    </required_header>
    <id_info>
      <org_study_id>IRB15401</org_study_id>
      <nct_id>NCT06033781</nct_id>
    </id_info>
    <brief_title>Randomized Controlled Trial for a Cognitive-Behavioral Therapy for Children With Nightmares</brief_title>
    <official_title>Can a Brief Therapy Improve Pediatric Nightmares, Mental Health, and Suicidality?</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Oklahoma</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>University of Tulsa</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>University of Oklahoma</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 assess the efficacy of CBT-NC intervention to determine&#xD;
        its impact on mental health and suicidality in children ages 6-17. The main aims are:&#xD;
  &#xD;
        Aim 1: Examine CBT-NC efficacy for improving nightmare distress and frequency in youth with&#xD;
        chronic nightmares by comparing the treatment and waitlist group.&#xD;
  &#xD;
        Aim 2: Examine whether improvements in nightmares relate to fewer mental health problems for&#xD;
        youth by determining by comparing the treatment and waitlist group.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Chronic nightmares in youth put them at risk for mental health problems including suicidal&#xD;
        ideation and attempts. Left untreated, chronic childhood nightmares can persist, resulting in&#xD;
        myriad mental health problems. An international consortium of nightmare experts urged the&#xD;
        medical community to prevent mental health problems in youth through early detection and&#xD;
        treatment of chronic nightmares. There are several well-established, brief, and&#xD;
        cost-effective nightmare treatments for adults but research with youth is lagging. To date,&#xD;
        several small case series have investigated nightmare treatments for youth and there is a&#xD;
        need for clinical trials. The proposed study will evaluate the efficacy of Cognitive&#xD;
        Behavioral Therapy for Nightmares in Children (CBT-NC), a brief five-session manualized&#xD;
        therapy designed to treat children ages 6-17. This randomized controlled trial with treatment&#xD;
        and waitlist arms will assess the efficacy of the intervention and determine if the&#xD;
        intervention has any impact on mental health problems and suicidality at follow-up.&#xD;
  &#xD;
        This study will be the first randomized controlled trial to assess the efficacy of Cognitive&#xD;
        behavioral therapy for nightmares in children (CBT-NC), compared to a waitlist group. Our&#xD;
        goal is to determine whether CBT-NC can be an effective treatment strategy for reducing&#xD;
        nightmares in youth, which are linked to suicidality.&#xD;
  &#xD;
        First, this study will address the need for efficacious and cost-effective treatment for&#xD;
        improving nightmare distress and frequency in youth with chronic nightmares. Second, this&#xD;
        study will determine if improvements in nightmares reduce risk for youth mental health&#xD;
        problems including suicidal ideation.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 7, 2023</start_date>
    <completion_date type="Anticipated">January 1, 2026</completion_date>
    <primary_completion_date type="Anticipated">January 1, 2026</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>Treatment</primary_purpose>
      <masking>Single (Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Changes in reports on Sleep Journal</measure>
      <time_frame>Participants complete this daily from consent to baseline assessment (Week 0), during treatment, and before post-assessments, up to 20 weeks. They also complete a weekly version for 4 weeks following post-assessments (Weeks 10-14).</time_frame>
      <description>The sleep journal is a 3 question self report regarding nightmares.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in Nightmare Disorder Diagnoses from Structure Clinical Interview for Sleep Disorders in Children (SCISD-Kid)</measure>
      <time_frame>Participants will be assessed at baseline (Week 0) and at post-assessments, up to 20 weeks.</time_frame>
      <description>The SCISD-Kid is a structured clinical interview that assesses for sleep disorders. The main module interest is the nightmare disorder module.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change on the Columbia Suicide Severity Rating Scale (C-SSRS)</measure>
      <time_frame>Participants will be assessed at baseline (Week 0), at post-assessments, up to 20 weeks, and weekly following their post-assessment for 4 weeks.</time_frame>
      <description>The C-SSRS is a yes/no questionnaire to assess for suicidal ideations and behaviors. For this study, we will be looking at the 5 suicidal ideation questions.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change on the Strengths and Difficulties Questionnaire (SDQ) - Caregiver Version</measure>
      <time_frame>Participants' caregivers will be assessed at baseline (Week 0) and at post-assessments, up to 20 weeks.</time_frame>
      <description>The SDQ is a 25-item brief behavioral screening questionnaire for detecting mental health problems in general populations people aged 2-17. IT assesses three scales for internalizing problems (10 items), externalizing problems (10 items), and prosocial behavior (5 items).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change on the Patient Health-Questionnaire-9 (PHQ-9)</measure>
      <time_frame>Participants will be assessed at baseline (Week 0) and at post-assessments, up to 20 weeks.</time_frame>
      <description>The PHQ-9 is a 9-question Likert scale questionnaire to assess for depression.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Change on the Child Adolescent Trauma Screen (CATS) - Child Version</measure>
      <time_frame>Participants will be assessed at baseline (Week 0) and at post-assessments, up to 20 weeks.</time_frame>
      <description>The CATS screens for child trauma history and PTSD symptoms in youth ages 7-17; 15 YES/NO questions; 1 open-ended question</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change on the Patient Health-Questionnaire-2 (PHQ-2)</measure>
      <time_frame>Participants will be assessed at baseline (Week 0), at post-assessments, up to 20 weeks, and weekly following their post-assessment for 4 weeks.</time_frame>
      <description>The PHQ-9 is a 2-question Likert scale questionnaire to screen for depression.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change on the Child Adolescent Trauma Screen (CATS) - Caregiver Version</measure>
      <time_frame>Participants' caregivers will be assessed at baseline (Week 0) and at post-assessments, up to 20 weeks.</time_frame>
      <description>The CATS screens for child trauma history and PTSD symptoms in youth ages 7-17; 15 YES/NO questions; 1 open-ended question</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change on Sleep Locus of Control (SLOC)</measure>
      <time_frame>Participants and caregivers will be assessed at Baseline (Week 0), post-assessments, and weekly during therapy, up to 20 weeks.</time_frame>
      <description>The SLOC is a 6 item self report measure perceived contingencies between sleep behavior and events. This scale is collected as a child self report, and a caregiver report regarding child.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change on Nightmare Locus of Control (NLOC)</measure>
      <time_frame>Participants and caregivers will be assessed at Baseline (Week 0), post-assessments, and weekly during therapy, up to 20 weeks.</time_frame>
      <description>The NLOC is a 6 item self report measure regarding nightmare behavior and events. This scale is collected as a child self report, and a caregiver report regarding child.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">90</enrollment>
    <condition>Nightmare</condition>
    <condition>Suicidal Ideation</condition>
    <condition>Children, Only</condition>
    <arm_group>
      <arm_group_label>Treatment Right-Away</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Child will start the CBT-NC treatment right away.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Waitlist Control</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>Waitlist control group will complete the assessments at the same time as the treatment group, without receiving any treatment. They will be offered treatment after finishing the waitlist.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Cognitive Behavioral Therapy for Nightmares in Children</intervention_name>
      <description>The Cognitive Behavioral Therapy for Nightmares in Children (CBT-NC) is a brief, five-session manualized therapy designed to treat children ages 6-17. The manualized CBT protocol is five session that teach sleep hygiene, relaxation strategies, and addresses nightmares therapeutically through exposure and rescripting.</description>
      <arm_group_label>Treatment Right-Away</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Child must be between ages of 6-17 years 11 months.&#xD;
  &#xD;
            -  Child must report recurrent nightmares that meet Diagnostic and Statistical Manual of&#xD;
               Mental Disorders criteria for nightmare disorder.&#xD;
  &#xD;
            -  Child must speak and understand English at no less than a 6-year-old level.&#xD;
  &#xD;
            -  Children on prescribed psychotropic medications must be stable for 30 days prior to&#xD;
               enrolling.&#xD;
  &#xD;
            -  Child must have a parent or legal guardian attend study visits with them.&#xD;
  &#xD;
            -  Participants must have access to WIFI/phone data in order to participate in this study&#xD;
               and must have an electronic device with a camera enabled.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Children with a diagnosis of sleep apnea which is not adequately treated.&#xD;
  &#xD;
            -  Children whose receptive/expressive language skills are below a 6-year-old level.&#xD;
  &#xD;
            -  If it is determined that a child is actively suicidal and at imminent risk for&#xD;
               self-harm, the family will be notified and referred for immediate care. They will not&#xD;
               be eligible for the study until they are deemed stable.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>6 Years</minimum_age>
      <maximum_age>17 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Lisa Cromer, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>University of Tulsa</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Tara Buck, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>University of Oklahoma</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Lauren Prince, BA</last_name>
      <phone>918-634-3242</phone>
      <email>lauren-prince@ouhsc.edu</email>
    </overall_contact>
    <location>
      <facility>
        <name>University of Tulsa</name>
        <address>
          <city>Tulsa</city>
          <state>Oklahoma</state>
          <zip>74104</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Lisa Cromer, PhD</last_name>
        <phone>918-938-1441</phone>
        <email>lisa-cromer@utulsa.edu</email>
      </contact>
      <investigator>
        <last_name>Lisa Cromer, PhD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>University of Oklahoma School of Community Medicine</name>
        <address>
          <city>Tulsa</city>
          <state>Oklahoma</state>
          <zip>74135</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Michelle Matukewicz, MHR</last_name>
        <phone>918-660-3118</phone>
        <email>michelle-mautekwicz@ouhsc.edu</email>
      </contact>
      <contact_backup>
        <last_name>Tara Buck, MD</last_name>
        <phone>918-660-3507</phone>
        <email>tara-buck@ouhsc.edu</email>
      </contact_backup>
      <investigator>
        <last_name>Tara Buck, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 5, 2023</study_first_submitted>
    <study_first_submitted_qc>September 5, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 13, 2023</study_first_posted>
    <last_update_submitted>September 5, 2023</last_update_submitted>
    <last_update_submitted_qc>September 5, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>CBT</keyword>
    <keyword>Cognitive</keyword>
    <keyword>Behavioral</keyword>
    <keyword>Therapy</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Suicidal Ideation</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/NCT06033781
  org study id: IRB15401
  nct id: NCT06033781
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this clinical trial is to assess the efficacy of CBT-NC intervention to determine
        its impact on mental health and suicidality in children ages 6-17. The main aims are:
  
        Aim 1: Examine CBT-NC efficacy for improving nightmare distress and frequency in youth with
        chronic nightmares by comparing the treatment and waitlist group.
  
        Aim 2: Examine whether improvements in nightmares relate to fewer mental health problems for
        youth by determining by comparing the treatment and waitlist group.
  Chronic nightmares in youth put them at risk for mental health problems including suicidal
        ideation and attempts. Left untreated, chronic childhood nightmares can persist, resulting in
        myriad mental health problems. An international consortium of nightmare experts urged the
        medical community to prevent mental health problems in youth through early detection and
        treatment of chronic nightmares. There are several well-established, brief, and
        cost-effective nightmare treatments for adults but research with youth is lagging. To date,
        several small case series have investigated nightmare treatments for youth and there is a
        need for clinical trials. The proposed study will evaluate the efficacy of Cognitive
        Behavioral Therapy for Nightmares in Children (CBT-NC), a brief five-session manualized
        therapy designed to treat children ages 6-17. This randomized controlled trial with treatment
        and waitlist arms will assess the efficacy of the intervention and determine if the
        intervention has any impact on mental health problems and suicidality at follow-up.
  
        This study will be the first randomized controlled trial to assess the efficacy of Cognitive
        behavioral therapy for nightmares in children (CBT-NC), compared to a waitlist group. Our
        goal is to determine whether CBT-NC can be an effective treatment strategy for reducing
        nightmares in youth, which are linked to suicidality.
  
        First, this study will address the need for efficacious and cost-effective treatment for
        improving nightmare distress and frequency in youth with chronic nightmares. Second, this
        study will determine if improvements in nightmares reduce risk for youth mental health
        problems including suicidal ideation.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Single (Outcomes Assessor)
  measure: Changes in reports on Sleep Journal
  time frame: Participants complete this daily from consent to baseline assessment (Week 0), during treatment, and before post-assessments, up to 20 weeks. They also complete a weekly version for 4 weeks following post-assessments (Weeks 10-14).
  description: The sleep journal is a 3 question self report regarding nightmares.
  measure: Change in Nightmare Disorder Diagnoses from Structure Clinical Interview for Sleep Disorders in Children (SCISD-Kid)
  time frame: Participants will be assessed at baseline (Week 0) and at post-assessments, up to 20 weeks.
  description: The SCISD-Kid is a structured clinical interview that assesses for sleep disorders. The main module interest is the nightmare disorder module.
  measure: Change on the Columbia Suicide Severity Rating Scale (C-SSRS)
  time frame: Participants will be assessed at baseline (Week 0), at post-assessments, up to 20 weeks, and weekly following their post-assessment for 4 weeks.
  description: The C-SSRS is a yes/no questionnaire to assess for suicidal ideations and behaviors. For this study, we will be looking at the 5 suicidal ideation questions.
  measure: Change on the Strengths and Difficulties Questionnaire (SDQ) - Caregiver Version
  time frame: Participants' caregivers will be assessed at baseline (Week 0) and at post-assessments, up to 20 weeks.
  description: The SDQ is a 25-item brief behavioral screening questionnaire for detecting mental health problems in general populations people aged 2-17. IT assesses three scales for internalizing problems (10 items), externalizing problems (10 items), and prosocial behavior (5 items).
  measure: Change on the Patient Health-Questionnaire-9 (PHQ-9)
  time frame: Participants will be assessed at baseline (Week 0) and at post-assessments, up to 20 weeks.
  description: The PHQ-9 is a 9-question Likert scale questionnaire to assess for depression.
  measure: Change on the Child Adolescent Trauma Screen (CATS) - Child Version
  time frame: Participants will be assessed at baseline (Week 0) and at post-assessments, up to 20 weeks.
  description: The CATS screens for child trauma history and PTSD symptoms in youth ages 7-17; 15 YES/NO questions; 1 open-ended question
  measure: Change on the Patient Health-Questionnaire-2 (PHQ-2)
  time frame: Participants will be assessed at baseline (Week 0), at post-assessments, up to 20 weeks, and weekly following their post-assessment for 4 weeks.
  description: The PHQ-9 is a 2-question Likert scale questionnaire to screen for depression.
  measure: Change on the Child Adolescent Trauma Screen (CATS) - Caregiver Version
  time frame: Participants' caregivers will be assessed at baseline (Week 0) and at post-assessments, up to 20 weeks.
  description: The CATS screens for child trauma history and PTSD symptoms in youth ages 7-17; 15 YES/NO questions; 1 open-ended question
  measure: Change on Sleep Locus of Control (SLOC)
  time frame: Participants and caregivers will be assessed at Baseline (Week 0), post-assessments, and weekly during therapy, up to 20 weeks.
  description: The SLOC is a 6 item self report measure perceived contingencies between sleep behavior and events. This scale is collected as a child self report, and a caregiver report regarding child.
  measure: Change on Nightmare Locus of Control (NLOC)
  time frame: Participants and caregivers will be assessed at Baseline (Week 0), post-assessments, and weekly during therapy, up to 20 weeks.
  description: The NLOC is a 6 item self report measure regarding nightmare behavior and events. This scale is collected as a child self report, and a caregiver report regarding child.
  arm group label: Treatment Right-Away
  arm group type: Experimental
  description: Child will start the CBT-NC treatment right away.
  arm group label: Waitlist Control
  arm group type: No Intervention
  description: Waitlist control group will complete the assessments at the same time as the treatment group, without receiving any treatment. They will be offered treatment after finishing the waitlist.
  intervention type: Behavioral
  intervention name: Cognitive Behavioral Therapy for Nightmares in Children
  description: The Cognitive Behavioral Therapy for Nightmares in Children (CBT-NC) is a brief, five-session manualized therapy designed to treat children ages 6-17. The manualized CBT protocol is five session that teach sleep hygiene, relaxation strategies, and addresses nightmares therapeutically through exposure and rescripting.
  arm group label: Treatment Right-Away
  criteria: 
  gender: All
  minimum age: 6 Years
  maximum age: 17 Years
  healthy volunteers: No
  last name: Lisa Cromer, PhD
  role: Principal Investigator
  affiliation: University of Tulsa
  last name: Tara Buck, MD
  role: Principal Investigator
  affiliation: University of Oklahoma
  last name: Lauren Prince, BA
  phone: 918-634-3242
  email: lauren-prince@ouhsc.edu
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  investigator: 
  country: United States
  responsible party type: Sponsor
  mesh term: Suicidal Ideation
  sharing ipd: No