<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/NCT03263156</url>
  </required_header>
  <id_info>
    <org_study_id>30160604</org_study_id>
    <nct_id>NCT03263156</nct_id>
  </id_info>
  <brief_title>A Brief Parent-based Sleep Intervention for ADHD Children</brief_title>
  <official_title>Effects of a Brief Parent-based Sleep Intervention for Children With Attention Deficit Hyperactivity Disorder</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The University of Hong Kong</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Chinese University of Hong Kong</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>The University of Hong Kong</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>
      Sleep problems are very common in children with ADHD, with a prevalence rate as high as 73%,&#xD;
      and often pose significant challenges and stress to the families. Sleep problems in ADHD&#xD;
      children are strongly associated with the exacerbation of daytime symptoms, impaired physical&#xD;
      health, and poor parental mental health. The present study is a randomised controlled trial&#xD;
      to compare the effects of a parent-based sleep intervention for children with ADHD (aged&#xD;
      6-12). Eligible participants will be randomised to either intervention (two face-to-face&#xD;
      consultation sessions and one follow-up phone call) or waiting-list control condition.&#xD;
      Assessments will be conducted at pre-treatment (baseline), one-week after the intervention&#xD;
      (post-treatment), and 3 months after the intervention.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">April 1, 2017</start_date>
  <completion_date type="Anticipated">December 31, 2021</completion_date>
  <primary_completion_date type="Anticipated">December 31, 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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Child: Change of child's sleep</measure>
    <time_frame>Baseline, 1-week and 3-month posttreatment</time_frame>
    <description>Change of the child's sleep measured by the Children's Sleep Habits Questionnaire (CSHQ), and sleep problems rated by parent (none, mild, moderate, severe)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Child: Change of daytime sleepiness</measure>
    <time_frame>Baseline, 1-week and 3-month posttreatment</time_frame>
    <description>Pediatric Daytime Sleepiness Scale (PDSS) - parent report</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Child: Change of other sleep measures</measure>
    <time_frame>Baseline, 1-week and 3-month posttreatment</time_frame>
    <description>Daily sleep diary and actigraphic assessment for consecutive seven days</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Child: Change of ADHD symptoms</measure>
    <time_frame>Baseline, 1-week and 3-month posttreatment</time_frame>
    <description>Strengths and Weaknesses of ADHD Symptoms (SWAN) - parent report</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Child: Change of child's behaviour &amp; other clinical symptoms</measure>
    <time_frame>Baseline, 1-week and 3-month posttreatment</time_frame>
    <description>Strengths and Difficulties Questionnaire - parent report; Child Behavior Checklist (CBCL) - parent report</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Child: Change of quality of life</measure>
    <time_frame>Baseline, 1-week and 3-month posttreatment</time_frame>
    <description>Pediatric Quality of Life Inventory 4.0 - parent proxy report (PedsQL) - parent report</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Child: Change of cognitive performance (sustained attention)</measure>
    <time_frame>Baseline, 1-week and 3-month posttreatment</time_frame>
    <description>Continuous Performance Test (CPT)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Child: Change of cognitive performance (auditory attention span)</measure>
    <time_frame>Baseline, 1-week and 3-month posttreatment</time_frame>
    <description>Digit Span</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Child: Change of cognitive performance (working memory)</measure>
    <time_frame>Baseline, 1-week and 3-month posttreatment</time_frame>
    <description>N-back</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Child: Change of cognitive performance (cognitive processing)</measure>
    <time_frame>Baseline, 1-week and 3-month posttreatment</time_frame>
    <description>Letter-digit substitution task</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Child: Change of cognitive performance (cognitive flexibility)</measure>
    <time_frame>Baseline, 1-week and 3-month posttreatment</time_frame>
    <description>Bergs Card Sorting Test (BCST)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Child: Change of cognitive performance (planning skills)</measure>
    <time_frame>Baseline, 1-week and 3-month posttreatment</time_frame>
    <description>Tower of London (TOL)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of parental self-reported sleep quality</measure>
    <time_frame>Baseline, 1-week and 3-month posttreatment</time_frame>
    <description>Pittsburgh Sleep Quality Index (PSQI)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of parental insomnia symptoms</measure>
    <time_frame>Baseline, 1-week and 3-month posttreatment</time_frame>
    <description>Insomnia Severity Index (ISI)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of parental daytime sleepiness</measure>
    <time_frame>Baseline, 1-week and 3-month posttreatment</time_frame>
    <description>Epworth Sleepiness Questionnaire (ESS)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of parental sleep parameters as measured by actigraphy</measure>
    <time_frame>Baseline, 1-week and 3-month posttreatment</time_frame>
    <description>Actigraphic sleep parameters</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of parental sleep hygiene practice</measure>
    <time_frame>Baseline, 1-week and 3-month posttreatment</time_frame>
    <description>Sleep Hygiene Index (SHI)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of parental stress</measure>
    <time_frame>Baseline, 1-week and 3-month posttreatment</time_frame>
    <description>Parental Stress Index - Short Form (PSI-SF)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of parental mood symptoms</measure>
    <time_frame>Baseline, 1-week and 3-month posttreatment</time_frame>
    <description>Depression Anxiety Stress Scales - 21 item (DASS-21)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of parental daytime fatigue</measure>
    <time_frame>Baseline, 1-week and 3-month posttreatment</time_frame>
    <description>Multidimensional Fatigue Inventory (MFI)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Parent's satisfaction to the treatment</measure>
    <time_frame>Baseline, 1-week and 3-month posttreatment</time_frame>
    <description>Treatment satisfaction rating scale</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>ADHD</condition>
  <condition>Insomnia</condition>
  <arm_group>
    <arm_group_label>Intervention group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The intervention will involve two face-to-face consultation sessions and one follow-up phone call with parents to help them learn sleep hygiene practices and specific behavioural strategies to improve their child's sleep and follow up on the progress.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Waiting-list control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Children in the waiting-list control group will receive usual clinical care.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Sleep hygiene practices and behavioural intervention</intervention_name>
    <description>The first session will involve the provision of sleep-related psycho-education (e.g. sleep hygiene practices) and specific strategies to tackle problematic sleep-related behaviours, as well as collaborative goal setting and development of management plan tailored to the child's sleep problem for the next two weeks. The second session will involve a review of the sleep diary and a reinforcement of learned strategies, and focus on problem-solving to tackle any issues that have emerged from implementing the behavioural strategies at home. A follow-up phone call will be made two weeks later to provide parents with an opportunity to ask any further questions and to consolidate learned strategies and further troubleshoot.</description>
    <arm_group_label>Intervention group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Aged 6-12 years old;&#xD;
&#xD;
          -  With a clinical diagnosis of ADHD (any subtype), as confirmed by the Diagnostic&#xD;
             Interview Schedule for Children-version-IV (DISC-IV);&#xD;
&#xD;
          -  With parent-reported insomnia (difficulty initiating sleep and/or maintaining sleep).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Children with a serious medical condition (e.g. severe cerebral palsy) or intellectual&#xD;
             disability (IQ&lt;70);&#xD;
&#xD;
          -  Children with a neurological and/or medical condition that may lead to disordered&#xD;
             sleep;&#xD;
&#xD;
          -  Suspected clinical sleep disorders (e.g. obstructive sleep apnea, OSA) that may&#xD;
             potentially contribute to a disruption in sleep continuity and quality, as assessed by&#xD;
             the Children's Sleep Habits Questionnaire (CSHQ). If the child is suspected of a&#xD;
             clinical sleep disorder, he/she will be referred to appropriate services;&#xD;
&#xD;
          -  Children who are already receiving specialised help (behavioural intervention) for&#xD;
             their sleep from a psychologist or at a specialized sleep clinic.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Years</minimum_age>
    <maximum_age>12 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Shirley Xin Li, PhD,DClinPsy</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Psychology, The University of Hong Kong</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Shirley Xin Li, PhD,DClinPsy</last_name>
    <phone>852-39177035</phone>
    <email>shirley.li@hku.hk</email>
  </overall_contact>
  <location>
    <facility>
      <name>Child and Adolescent Psychiatric Service Clinic, New Territories East Cluster (NTEC), Hospital Authority</name>
      <address>
        <city>Hong Kong</city>
        <country>Hong Kong</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Kelly YC Lai, MRCPsych,FHKAM(Psych)</last_name>
      <phone>(852)26076025</phone>
      <email>kellylai@cuhk.edu.hk</email>
    </contact>
    <contact_backup>
      <last_name>Ka Sin Caroline Shea, FHKCPsy</last_name>
      <phone>(852)26076724</phone>
      <email>carolinesks@gmail.com</email>
    </contact_backup>
  </location>
  <location>
    <facility>
      <name>Sleep Research Clinic &amp; Laboratory, Department of Psychology, The University of Hong Kong</name>
      <address>
        <city>Hong Kong</city>
        <country>Hong Kong</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Shirley Xin Li, PhD,DClinPsy</last_name>
      <phone>852-39177035</phone>
      <email>shirley.li@hku.hk</email>
    </contact>
  </location>
  <location_countries>
    <country>Hong Kong</country>
  </location_countries>
  <verification_date>April 2021</verification_date>
  <study_first_submitted>August 23, 2017</study_first_submitted>
  <study_first_submitted_qc>August 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 28, 2017</study_first_posted>
  <last_update_submitted>April 24, 2021</last_update_submitted>
  <last_update_submitted_qc>April 24, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">April 27, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>The University of Hong Kong</investigator_affiliation>
    <investigator_full_name>Dr. Shirley Xin Li</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>sleep</keyword>
  <keyword>ADHD</keyword>
  <keyword>behavioural intervention</keyword>
  <keyword>insomnia</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sleep Initiation and Maintenance Disorders</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>September 29, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/56/NCT03263156/Prot_001.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT03263156
org study id: 30160604
nct id: NCT03263156
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Sleep problems are very common in children with ADHD, with a prevalence rate as high as 73%,
      and often pose significant challenges and stress to the families. Sleep problems in ADHD
      children are strongly associated with the exacerbation of daytime symptoms, impaired physical
      health, and poor parental mental health. The present study is a randomised controlled trial
      to compare the effects of a parent-based sleep intervention for children with ADHD (aged
      6-12). Eligible participants will be randomised to either intervention (two face-to-face
      consultation sessions and one follow-up phone call) or waiting-list control condition.
      Assessments will be conducted at pre-treatment (baseline), one-week after the intervention
      (post-treatment), and 3 months after the intervention.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Child: Change of child's sleep
time frame: Baseline, 1-week and 3-month posttreatment
description: Change of the child's sleep measured by the Children's Sleep Habits Questionnaire (CSHQ), and sleep problems rated by parent (none, mild, moderate, severe)
measure: Child: Change of daytime sleepiness
time frame: Baseline, 1-week and 3-month posttreatment
description: Pediatric Daytime Sleepiness Scale (PDSS) - parent report
measure: Child: Change of other sleep measures
time frame: Baseline, 1-week and 3-month posttreatment
description: Daily sleep diary and actigraphic assessment for consecutive seven days
measure: Child: Change of ADHD symptoms
time frame: Baseline, 1-week and 3-month posttreatment
description: Strengths and Weaknesses of ADHD Symptoms (SWAN) - parent report
measure: Child: Change of child's behaviour & other clinical symptoms
time frame: Baseline, 1-week and 3-month posttreatment
description: Strengths and Difficulties Questionnaire - parent report; Child Behavior Checklist (CBCL) - parent report
measure: Child: Change of quality of life
time frame: Baseline, 1-week and 3-month posttreatment
description: Pediatric Quality of Life Inventory 4.0 - parent proxy report (PedsQL) - parent report
measure: Child: Change of cognitive performance (sustained attention)
time frame: Baseline, 1-week and 3-month posttreatment
description: Continuous Performance Test (CPT)
measure: Child: Change of cognitive performance (auditory attention span)
time frame: Baseline, 1-week and 3-month posttreatment
description: Digit Span
measure: Child: Change of cognitive performance (working memory)
time frame: Baseline, 1-week and 3-month posttreatment
description: N-back
measure: Child: Change of cognitive performance (cognitive processing)
time frame: Baseline, 1-week and 3-month posttreatment
description: Letter-digit substitution task
measure: Child: Change of cognitive performance (cognitive flexibility)
time frame: Baseline, 1-week and 3-month posttreatment
description: Bergs Card Sorting Test (BCST)
measure: Child: Change of cognitive performance (planning skills)
time frame: Baseline, 1-week and 3-month posttreatment
description: Tower of London (TOL)
measure: Change of parental self-reported sleep quality
time frame: Baseline, 1-week and 3-month posttreatment
description: Pittsburgh Sleep Quality Index (PSQI)
measure: Change of parental insomnia symptoms
time frame: Baseline, 1-week and 3-month posttreatment
description: Insomnia Severity Index (ISI)
measure: Change of parental daytime sleepiness
time frame: Baseline, 1-week and 3-month posttreatment
description: Epworth Sleepiness Questionnaire (ESS)
measure: Change of parental sleep parameters as measured by actigraphy
time frame: Baseline, 1-week and 3-month posttreatment
description: Actigraphic sleep parameters
measure: Change of parental sleep hygiene practice
time frame: Baseline, 1-week and 3-month posttreatment
description: Sleep Hygiene Index (SHI)
measure: Change of parental stress
time frame: Baseline, 1-week and 3-month posttreatment
description: Parental Stress Index - Short Form (PSI-SF)
measure: Change of parental mood symptoms
time frame: Baseline, 1-week and 3-month posttreatment
description: Depression Anxiety Stress Scales - 21 item (DASS-21)
measure: Change of parental daytime fatigue
time frame: Baseline, 1-week and 3-month posttreatment
description: Multidimensional Fatigue Inventory (MFI)
measure: Parent's satisfaction to the treatment
time frame: Baseline, 1-week and 3-month posttreatment
description: Treatment satisfaction rating scale
arm group label: Intervention group
arm group type: Experimental
description: The intervention will involve two face-to-face consultation sessions and one follow-up phone call with parents to help them learn sleep hygiene practices and specific behavioural strategies to improve their child's sleep and follow up on the progress.
arm group label: Waiting-list control
arm group type: No Intervention
description: Children in the waiting-list control group will receive usual clinical care.
intervention type: Behavioral
intervention name: Sleep hygiene practices and behavioural intervention
description: The first session will involve the provision of sleep-related psycho-education (e.g. sleep hygiene practices) and specific strategies to tackle problematic sleep-related behaviours, as well as collaborative goal setting and development of management plan tailored to the child's sleep problem for the next two weeks. The second session will involve a review of the sleep diary and a reinforcement of learned strategies, and focus on problem-solving to tackle any issues that have emerged from implementing the behavioural strategies at home. A follow-up phone call will be made two weeks later to provide parents with an opportunity to ask any further questions and to consolidate learned strategies and further troubleshoot.
arm group label: Intervention group
criteria: 
gender: All
minimum age: 6 Years
maximum age: 12 Years
healthy volunteers: No
last name: Shirley Xin Li, PhD,DClinPsy
role: Principal Investigator
affiliation: Department of Psychology, The University of Hong Kong
last name: Shirley Xin Li, PhD,DClinPsy
phone: 852-39177035
email: shirley.li@hku.hk
facility: 
status: Recruiting
contact: 
contact backup: 
facility: 
status: Recruiting
contact: 
country: Hong Kong
responsible party type: Principal Investigator
investigator affiliation: The University of Hong Kong
investigator full name: Dr. Shirley Xin Li
investigator title: Assistant Professor
mesh term: Sleep Initiation and Maintenance Disorders
sharing ipd: No
provided document: 