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/NCT06007742</url>
    </required_header>
    <id_info>
      <org_study_id>PT_ADHD_AS</org_study_id>
      <nct_id>NCT06007742</nct_id>
    </id_info>
    <brief_title>Parent-administered Pediatric Tuina for Improving Sleep Quality and Appetite in School-aged Children With ADHD</brief_title>
    <official_title>Parent-administered Pediatric Tuina for Improving Sleep Quality and Appetite in School-aged Children With ADHD: a Pilot Randomized Controlled Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>The Hong Kong Polytechnic University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>The Hong Kong Polytechnic University</source>
    <oversight_info>
      <has_dmc>Yes</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>
        Title: Parent-administered pediatric tuina for improving sleep quality and appetite in&#xD;
        school-aged children with ADHD: a pilot randomized controlled trial&#xD;
  &#xD;
        Background: Pediatric tuina has been used and explored by many researchers and clinicians as&#xD;
        a topical complementary and alternative treatment for ADHD, which can compensate for some of&#xD;
        the shortcomings of medications and behavioural therapies, such as the side effects of&#xD;
        medications and the financial stress of long-term behavioural therapies. Pediatric tuina can&#xD;
        also grasp the golden stage of young children and improve their symptoms in time on the basis&#xD;
        of TCM pattern identification and holistic concepts. We once conducted a focus group&#xD;
        interview on 15 parents to understand the effects of parent-administered pediatric tuina on&#xD;
        ADHD symptoms, and all parents reported that parent-administered pediatric tuina&#xD;
        significantly improved the child's sleep quality, eating habits, and parent-child&#xD;
        relationship within a short period of time after receiving the intervention.&#xD;
  &#xD;
        Objective: This study aims to assess the preliminary effects, feasibility, and safety of&#xD;
        parent-administered pediatric tuina for attention deficit hyperactivity disorder (ADHD)&#xD;
        symptoms in school-aged children.&#xD;
  &#xD;
        Methods: This project is a three-arm, parallel, open-label, pilot RCT. Sixty participants&#xD;
        were randomized into three groups at a 1:1:1 ratio. Parents in the parent-administered tuina&#xD;
        group (n = 20) will attend a face-to-face training program on pediatric tuina for ADHD and&#xD;
        conduct this intervention on their children at home. Parents in the parent-child interaction&#xD;
        group (n = 20) will attend face-to-face training about parent-child interactive exercises and&#xD;
        carry them out with their children at home. Both interventions will be carried out every&#xD;
        other day during a two-month intervention period, with each manipulation for at least 25-30&#xD;
        min. Participants in the waitlist group (n=20) will not receive both interventions during the&#xD;
        intervention period. Outcomes will be assessed at baseline, week 4, and week 8. The primary&#xD;
        outcome measure was the Sleep Disturbance Scale for Children; the secondary outcomes included&#xD;
        Children's Eating Behaviour Questionnaire, Conners Parent Rating Scale, and Child Health&#xD;
        Questionnaire. A process evaluation will be embedded within the outcome evaluation.&#xD;
        Descriptive statistics for sociodemographic variables and clinical variables will be&#xD;
        presented. Data will be presented as mean and standard deviation. The feasibility outcomes&#xD;
        will be presented as percentages. The rating scale scores between the intervention groups and&#xD;
        the control group in week 4 and week 8 will be compared using a linear mixed-effects model.&#xD;
        Recorded interviews will be transcribed verbatim and analyzed using content analysis.&#xD;
        Depending on the topic and purpose of the study, the interview was categorized into words or&#xD;
        sentences with the help of the qualitative research tool Nvivo.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 2023</start_date>
    <completion_date type="Anticipated">November 30, 2024</completion_date>
    <primary_completion_date type="Anticipated">September 30, 2024</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>Sleep Disturbance Scale for Children (SDSC) Chinese version</measure>
      <time_frame>Baseline, week 4, and week 8.</time_frame>
      <description>The SDSC is a 26-item scale used to evaluate specific sleep disturbance in children. The scale is divided into 6 dimensions, representing 6 types of sleep disturbance: disorders of initiating and maintaining sleep, sleep breathing disorders, disorders of arousal, sleep-wake transition disorders, disorders of excessive somnolence, and sleep hyperhydrosis. Each item is scored on a 5-point Likert scale from 1-5. The higher the total score, the more serious the sleep disturbance is, and a total score of more than 39 is considered to be a sleep disturbance.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Children's Eating Behaviour Questionnaire (CEBQ) Chinese version</measure>
      <time_frame>Baseline, week 4, and week 8.</time_frame>
      <description>The Child Eating Behavior Questionnaire (CEBQ) is a 35-item parent-report questionnaire assessing eating style in children. Eating style is assessed on eight scales: food responsiveness (4 items), enjoyment of food (4 items), emotional overeating (4 items), desire to drink (3 items), satiety responsiveness (5 items), slowness in eating (4 items), and emotional undereating (4 items), and fussiness (7 items). Informants rate the frequency of their child's behaviors and experiences on a 5-point scale: 1 = never, 2 = rarely, 3 = sometimes, 4 = often, 5 = always.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Conners Parent Rating Scale (CPRS) Chinese version</measure>
      <time_frame>Baseline, week 4, and week 8.</time_frame>
      <description>The CPRS is used to assess ADHD in children aged 3-17 years. It assesses the child's behaviour problems, attention deficit disorder, and hyperactivity through the parent's perspective. The scale identifies behavioural problems, learning problems, psychosomatic problems, impulsivity-hyperactivity, and anxiety problems. Each item is rated on a four-point scale: 0-3. The higher the average score, the more significant the problem, and above 1.5, the more likely ADHD is present.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Child Health Questionnaire (CHQ) Chinese version</measure>
      <time_frame>Baseline, week 4, and week 8.</time_frame>
      <description>The parent-reported CHQ is used to assess the healthy quality of life in children and adolescents aged 5 to 18 years, measuring 14 unique physical and psychological concepts. A 28-item version is used for this study, divided into two subscales: physical and psychosocial, which included 14 basic dimensions.</description>
    </secondary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Anticipated">60</enrollment>
    <condition>ADHD</condition>
    <arm_group>
      <arm_group_label>Intervention group: parent-administered pediatric tuina (n=20)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>Active control group: parent-child interactive exercise (n=20)</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>Control group: usual care (n=20)</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>parent-administered pediatric tuina</intervention_name>
      <description>Parents in intervention group will participate in a pediatric tuina course to improve eating and sleep symptoms of ADHD, followed by an 8-week treatment period for the children. The course will take place at the Hong Kong Polytechnic University campus and will consist of 2 sessions of approximately 2 hours each. The course content will be taught by a registered TCM practitioner.&#xD;
  . Parents assigned to this group will participate in a Parent-Child Exercise for ADHD program, which will complete with their children in the next 8 weeks. The program will take place at the Hong Kong Polytechnic University campus and will consist of 2 sessions of approximately 2 hours each. The content will be taught by a registered physiotherapist.&#xD;
  The two intervention groups are manipulated every other day for 25-30 minutes each. A total number of interventions equal to or greater than 24 is considered a completed intervention.</description>
      <arm_group_label>Active control group: parent-child interactive exercise (n=20)</arm_group_label>
      <arm_group_label>Intervention group: parent-administered pediatric tuina (n=20)</arm_group_label>
      <other_name>parent-child interactive exercise</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Inclusion criteria for the children are the following:&#xD;
  &#xD;
                 1. Children: Aged 6-8 years old by the start of the assessment (according to the&#xD;
                    Hong Kong Education Bureau, 6 years old is considered suitable for primary school&#xD;
                    education)&#xD;
  &#xD;
                 2. Have an internationally recognized diagnosis or documentation of ADHD&#xD;
  &#xD;
                 3. Have a score of more than 39 on the Sleep Disturbance Scale for Children (SDSC)&#xD;
  &#xD;
            -  Inclusion criteria for the parents are the following&#xD;
  &#xD;
                 1. Ability to communicate in Cantonese&#xD;
  &#xD;
                 2. Willingness to learn the knowledge and manipulations of pediatric tuina for ADHD&#xD;
                    symptoms&#xD;
  &#xD;
                 3. Available to visit the Hong Kong Polytechnic University to attend the course as&#xD;
                    scheduled in accordance with the trial process&#xD;
  &#xD;
                 4. Sign the informed consent form&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Exclusion criteria for the children are the following:&#xD;
  &#xD;
                 1. Currently receiving other tuina (or massage) treatments&#xD;
  &#xD;
                 2. Having other developmental disorders (e.g., autism, intellectual disability)&#xD;
  &#xD;
                 3. Having acute infectious diseases (e.g., scarlet fever, chicken pox, etc.),&#xD;
                    hemorrhagic diseases (e.g., bleeding, local places of various kinds of malignant&#xD;
                    tumor), or dermatological problems (e.g., scald, severe skin lesion, skin&#xD;
                    infections)&#xD;
  &#xD;
                 4. Having any severe illness or medical condition (e.g., fractures, paraplegia) that&#xD;
                    are not suitable to receive pediatric tuina&#xD;
  &#xD;
            -  Exclusion criteria for the parents are the following:&#xD;
  &#xD;
                 1. Having any severe psychiatric disorder (e.g., major depression)&#xD;
  &#xD;
                 2. Having difficulties to conduct massage therapy due to physical problems&#xD;
  &#xD;
                 3. Having a score less than 22 on the Montreal Cognitive Assessment (MoCA).&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>6 Years</minimum_age>
      <maximum_age>8 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Cara CHEN</last_name>
      <phone>27661371</phone>
      <email>cara-sc.chen@polyu.edu.hk</email>
    </overall_contact>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 17, 2023</study_first_submitted>
    <study_first_submitted_qc>August 17, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 23, 2023</study_first_posted>
    <last_update_submitted>August 22, 2023</last_update_submitted>
    <last_update_submitted_qc>August 22, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 24, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <!-- 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/NCT06007742
  org study id: PT_ADHD_AS
  nct id: NCT06007742
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  Title: Parent-administered pediatric tuina for improving sleep quality and appetite in
        school-aged children with ADHD: a pilot randomized controlled trial
  
        Background: Pediatric tuina has been used and explored by many researchers and clinicians as
        a topical complementary and alternative treatment for ADHD, which can compensate for some of
        the shortcomings of medications and behavioural therapies, such as the side effects of
        medications and the financial stress of long-term behavioural therapies. Pediatric tuina can
        also grasp the golden stage of young children and improve their symptoms in time on the basis
        of TCM pattern identification and holistic concepts. We once conducted a focus group
        interview on 15 parents to understand the effects of parent-administered pediatric tuina on
        ADHD symptoms, and all parents reported that parent-administered pediatric tuina
        significantly improved the child's sleep quality, eating habits, and parent-child
        relationship within a short period of time after receiving the intervention.
  
        Objective: This study aims to assess the preliminary effects, feasibility, and safety of
        parent-administered pediatric tuina for attention deficit hyperactivity disorder (ADHD)
        symptoms in school-aged children.
  
        Methods: This project is a three-arm, parallel, open-label, pilot RCT. Sixty participants
        were randomized into three groups at a 1:1:1 ratio. Parents in the parent-administered tuina
        group (n = 20) will attend a face-to-face training program on pediatric tuina for ADHD and
        conduct this intervention on their children at home. Parents in the parent-child interaction
        group (n = 20) will attend face-to-face training about parent-child interactive exercises and
        carry them out with their children at home. Both interventions will be carried out every
        other day during a two-month intervention period, with each manipulation for at least 25-30
        min. Participants in the waitlist group (n=20) will not receive both interventions during the
        intervention period. Outcomes will be assessed at baseline, week 4, and week 8. The primary
        outcome measure was the Sleep Disturbance Scale for Children; the secondary outcomes included
        Children's Eating Behaviour Questionnaire, Conners Parent Rating Scale, and Child Health
        Questionnaire. A process evaluation will be embedded within the outcome evaluation.
        Descriptive statistics for sociodemographic variables and clinical variables will be
        presented. Data will be presented as mean and standard deviation. The feasibility outcomes
        will be presented as percentages. The rating scale scores between the intervention groups and
        the control group in week 4 and week 8 will be compared using a linear mixed-effects model.
        Recorded interviews will be transcribed verbatim and analyzed using content analysis.
        Depending on the topic and purpose of the study, the interview was categorized into words or
        sentences with the help of the qualitative research tool Nvivo.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Single (Outcomes Assessor)
  measure: Sleep Disturbance Scale for Children (SDSC) Chinese version
  time frame: Baseline, week 4, and week 8.
  description: The SDSC is a 26-item scale used to evaluate specific sleep disturbance in children. The scale is divided into 6 dimensions, representing 6 types of sleep disturbance: disorders of initiating and maintaining sleep, sleep breathing disorders, disorders of arousal, sleep-wake transition disorders, disorders of excessive somnolence, and sleep hyperhydrosis. Each item is scored on a 5-point Likert scale from 1-5. The higher the total score, the more serious the sleep disturbance is, and a total score of more than 39 is considered to be a sleep disturbance.
  measure: Children's Eating Behaviour Questionnaire (CEBQ) Chinese version
  time frame: Baseline, week 4, and week 8.
  description: The Child Eating Behavior Questionnaire (CEBQ) is a 35-item parent-report questionnaire assessing eating style in children. Eating style is assessed on eight scales: food responsiveness (4 items), enjoyment of food (4 items), emotional overeating (4 items), desire to drink (3 items), satiety responsiveness (5 items), slowness in eating (4 items), and emotional undereating (4 items), and fussiness (7 items). Informants rate the frequency of their child's behaviors and experiences on a 5-point scale: 1 = never, 2 = rarely, 3 = sometimes, 4 = often, 5 = always.
  measure: Conners Parent Rating Scale (CPRS) Chinese version
  time frame: Baseline, week 4, and week 8.
  description: The CPRS is used to assess ADHD in children aged 3-17 years. It assesses the child's behaviour problems, attention deficit disorder, and hyperactivity through the parent's perspective. The scale identifies behavioural problems, learning problems, psychosomatic problems, impulsivity-hyperactivity, and anxiety problems. Each item is rated on a four-point scale: 0-3. The higher the average score, the more significant the problem, and above 1.5, the more likely ADHD is present.
  measure: Child Health Questionnaire (CHQ) Chinese version
  time frame: Baseline, week 4, and week 8.
  description: The parent-reported CHQ is used to assess the healthy quality of life in children and adolescents aged 5 to 18 years, measuring 14 unique physical and psychological concepts. A 28-item version is used for this study, divided into two subscales: physical and psychosocial, which included 14 basic dimensions.
  arm group label: Intervention group: parent-administered pediatric tuina (n=20)
  arm group type: Experimental
  arm group label: Active control group: parent-child interactive exercise (n=20)
  arm group type: Active Comparator
  arm group label: Control group: usual care (n=20)
  arm group type: No Intervention
  intervention type: Other
  intervention name: parent-administered pediatric tuina
  description: Parents in intervention group will participate in a pediatric tuina course to improve eating and sleep symptoms of ADHD, followed by an 8-week treatment period for the children. The course will take place at the Hong Kong Polytechnic University campus and will consist of 2 sessions of approximately 2 hours each. The course content will be taught by a registered TCM practitioner.
  . Parents assigned to this group will participate in a Parent-Child Exercise for ADHD program, which will complete with their children in the next 8 weeks. The program will take place at the Hong Kong Polytechnic University campus and will consist of 2 sessions of approximately 2 hours each. The content will be taught by a registered physiotherapist.
  The two intervention groups are manipulated every other day for 25-30 minutes each. A total number of interventions equal to or greater than 24 is considered a completed intervention.
  arm group label: Active control group: parent-child interactive exercise (n=20)
  arm group label: Intervention group: parent-administered pediatric tuina (n=20)
  other name: parent-child interactive exercise
  criteria: 
  gender: All
  minimum age: 6 Years
  maximum age: 8 Years
  healthy volunteers: No
  last name: Cara CHEN
  phone: 27661371
  email: cara-sc.chen@polyu.edu.hk
  responsible party type: Sponsor