<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/NCT04454008</url>
  </required_header>
  <id_info>
    <org_study_id>XH-20-012</org_study_id>
    <nct_id>NCT04454008</nct_id>
  </id_info>
  <brief_title>RCT of EF Family Training for P ADHD</brief_title>
  <official_title>Executive Functioning Family Training for Preschool Children With Attention Deficit Hyperactivity Disorder - a Randomized Controlled Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Xinhua Hospital, Shanghai Jiao Tong University School of Medicine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Xinhua Hospital, Shanghai Jiao Tong University School of Medicine</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>
      To explore the effect of executive function family training for preschool children with ADHD,&#xD;
      providing early social psychological intervention for aiming the core impairments of ADHD.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      100 preschool children with ADHD will be randomly divided into the intervention group and the&#xD;
      waiting group. The waiting group received regular clinical intervention, while the&#xD;
      intervention group received 12-week training. The intervention program includes executive&#xD;
      function training for ADHD children and parenting guidance for parents by two therapists&#xD;
      respectively, which were carried out in two meeting rooms in Xinhua Hospital. Therapists are&#xD;
      psychiatrists with a background in child psychiatry and psychotherapists with training in&#xD;
      ADHD area. After 12 weeks, the improvement of ADHD core symptoms and executive function was&#xD;
      compared.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">December 6, 2020</start_date>
  <completion_date type="Anticipated">October 30, 2025</completion_date>
  <primary_completion_date type="Anticipated">October 30, 2023</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>
    <masking_description>The evaluator was unaware of the subjects' treatment status</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>ADHD core symptoms</measure>
    <time_frame>12 weeks after baseline</time_frame>
    <description>ADHD core symptoms are assessed by Swanson, Nolan, and Pelham Rating Scale (SNAP), with the score ranged from 0-54 (the higher the socre, the worse the symptoms)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Executive function-Inhibition</measure>
    <time_frame>12 weeks after baseline</time_frame>
    <description>The executive function inhibition is assessed by NEPSY-II task Status (ST) with the higher the score is, the better the function.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Executive function-working memory</measure>
    <time_frame>12 weeks after baseline</time_frame>
    <description>The executive function working memory is assessed by NEPSY-II task memory design (MD) with the higher the score is, the better the function.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>ADHD</condition>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The intervention group will receive 12 sessions of executive function family training, including executive function training for children and parenting guidance for parents.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>waiting</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The waiting group will receive routine clinical intervention, including health education, family support and guidance from outpatient clinic.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>executive function family training</intervention_name>
    <description>Intervention programs include executive function training for children with ADHD and parenting guidance for parents</description>
    <arm_group_label>Intervention</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>treat as usual</intervention_name>
    <description>Outpatient routine health education, behavioral guidance and family support</description>
    <arm_group_label>waiting</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Meet the diagnostic criteria for preschool ADHD, based on the the DSM-5 criteria by&#xD;
             the attending physician or above;&#xD;
&#xD;
          -  Age 4 months 0 to 5 years 11 months;&#xD;
&#xD;
          -  Total IQ is above 80 assessed by WPPSI.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Attention deficit disorders resulting from organic neurological diseases, extensive&#xD;
             developmental disorders, mental retardation, childhood schizophrenia, mood disorders,&#xD;
             epilepsy, and other organic diseases or other primary mental disorders;&#xD;
&#xD;
          -  parent or guardian with a serious mental illness, such as schizophrenia, mood disorder&#xD;
             (onset), etc., and Educational level is lower than junior middle school;&#xD;
&#xD;
          -  Participants who failed to attend more than 80% of the intervention sessions (at least&#xD;
             9 sessions).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>48 Months</minimum_age>
    <maximum_age>71 Months</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jinsong Zhang, Doctor</last_name>
    <role>Study Director</role>
    <affiliation>Director of department of psychology, xinhua hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Jinsong Zhang, Doctor</last_name>
    <phone>008613651601596</phone>
    <email>zhangjinsong@xinhuamed.com.cn</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Lan Shuai, Doctor</last_name>
    <phone>008615000624346</phone>
    <email>shallon@aliyun.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Xinhua Hospital</name>
      <address>
        <city>Shanghai</city>
        <zip>200092</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Lan Shuai, Ph.D</last_name>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>June 27, 2020</study_first_submitted>
  <study_first_submitted_qc>June 27, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 1, 2020</study_first_posted>
  <last_update_submitted>March 19, 2021</last_update_submitted>
  <last_update_submitted_qc>March 19, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">March 22, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>ADHD</keyword>
  <keyword>executive function</keyword>
  <keyword>preschool</keyword>
  <keyword>intervention</keyword>
  <keyword>RCT</keyword>
  <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/NCT04454008
org study id: XH-20-012
nct id: NCT04454008
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
To explore the effect of executive function family training for preschool children with ADHD,
      providing early social psychological intervention for aiming the core impairments of ADHD.
100 preschool children with ADHD will be randomly divided into the intervention group and the
      waiting group. The waiting group received regular clinical intervention, while the
      intervention group received 12-week training. The intervention program includes executive
      function training for ADHD children and parenting guidance for parents by two therapists
      respectively, which were carried out in two meeting rooms in Xinhua Hospital. Therapists are
      psychiatrists with a background in child psychiatry and psychotherapists with training in
      ADHD area. After 12 weeks, the improvement of ADHD core symptoms and executive function was
      compared.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
masking description: The evaluator was unaware of the subjects' treatment status
measure: ADHD core symptoms
time frame: 12 weeks after baseline
description: ADHD core symptoms are assessed by Swanson, Nolan, and Pelham Rating Scale (SNAP), with the score ranged from 0-54 (the higher the socre, the worse the symptoms)
measure: Executive function-Inhibition
time frame: 12 weeks after baseline
description: The executive function inhibition is assessed by NEPSY-II task Status (ST) with the higher the score is, the better the function.
measure: Executive function-working memory
time frame: 12 weeks after baseline
description: The executive function working memory is assessed by NEPSY-II task memory design (MD) with the higher the score is, the better the function.
arm group label: Intervention
arm group type: Experimental
description: The intervention group will receive 12 sessions of executive function family training, including executive function training for children and parenting guidance for parents.
arm group label: waiting
arm group type: Active Comparator
description: The waiting group will receive routine clinical intervention, including health education, family support and guidance from outpatient clinic.
intervention type: Behavioral
intervention name: executive function family training
description: Intervention programs include executive function training for children with ADHD and parenting guidance for parents
arm group label: Intervention
intervention type: Behavioral
intervention name: treat as usual
description: Outpatient routine health education, behavioral guidance and family support
arm group label: waiting
criteria: 
gender: All
minimum age: 48 Months
maximum age: 71 Months
healthy volunteers: No
last name: Jinsong Zhang, Doctor
role: Study Director
affiliation: Director of department of psychology, xinhua hospital
last name: Jinsong Zhang, Doctor
phone: 008613651601596
email: zhangjinsong@xinhuamed.com.cn
last name: Lan Shuai, Doctor
phone: 008615000624346
email: shallon@aliyun.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Sponsor
sharing ipd: No