<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/NCT04412499</url>
  </required_header>
  <id_info>
    <org_study_id>RECHMPL20_0275</org_study_id>
    <nct_id>NCT04412499</nct_id>
  </id_info>
  <brief_title>Study of the Link Between Psychosocial Treatments and the Need of Pharmacological Treatments in Children With Attention Deficit Hyperactivity Disorder</brief_title>
  <acronym>OPTIME-TDAH</acronym>
  <official_title>Study of the Link Between Psychosocial Treatments and the Need of Pharmacological Treatments in Children With Attention Deficit Hyperactivity Disorder : a Retrospective Online Study for Parents</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Montpellier</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Montpellier</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 Attention Deficit and Hyperactivity Disorder (ADHD) is a frequent disorder in children&#xD;
      and adolescents. The diagnosis is clinical with the input of several informants (child,&#xD;
      family, teachers, …). ADHD is a risk factor for academic difficulties, school dropout, social&#xD;
      isolation, injury, oppositional behaviour. In school-age children and adolescents having&#xD;
      moderate to high or persistent impairment despite psycho-educational support and&#xD;
      environmental modification, the first-line treatment is methylphenidate. Group or individual&#xD;
      cognitive behavioural therapy for parents and/or children and adolescents is recommended for&#xD;
      co-occurring disorders and persistent impairment. In France, the initiation of&#xD;
      methylphenidate requires an annual hospital prescription by a paediatrician or psychiatrist,&#xD;
      and a regular medical supervision (weight, heart rate, blood pressure, …). At least once a&#xD;
      year, the indication of methyphenidate needs to be re-evaluated and confirmed at the&#xD;
      hospital. In case of lack of efficiency and/or poor tolerance, therapeutic alternatives&#xD;
      including non-psychostimulants should be considered.&#xD;
&#xD;
      A randomized controlled trial evaluated the dose of methylphenidate received over a period of&#xD;
      13 months. It was observed that the &quot;combined treatment&quot; group (methylphenidate +&#xD;
      psychosocial treatments) received a lower average dose of methylphenidate than the&#xD;
      &quot;methylphenidate alone&quot; group. These results are difficult to extrapolate to the general&#xD;
      population, due to the study protocol (regular monitoring of ADHD symptoms with the aim of&#xD;
      total remission).&#xD;
&#xD;
      For a global consideration of children's needs, it is important to better understand the&#xD;
      interactions between these two therapeutic approaches.&#xD;
&#xD;
      To participate in the study, parents will have to complete an online questionnaire. This&#xD;
      questionnaire contains anamnestic data collection, questionnaires to assess ADHD symptoms and&#xD;
      parenting practices.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 1, 2020</start_date>
  <completion_date type="Actual">June 30, 2020</completion_date>
  <primary_completion_date type="Actual">June 30, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Daily dose of methylphenidate (mg/kg) depending on participation in a parent-training programme</measure>
    <time_frame>1 day</time_frame>
    <description>Daily dose of methylphenidate (mg/kg) depending on participation in a parent-training programme</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">110</enrollment>
  <condition>Attention Deficit Hyperactivity Disorder</condition>
  <condition>Youths</condition>
  <arm_group>
    <arm_group_label>Methylphenidate + parent-training programm</arm_group_label>
    <description>Methylphenidate and participation in a parent-training programme</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Methylphenidate alone</arm_group_label>
    <description>Methylphenidate alone</description>
  </arm_group>
  <biospec_retention>None Retained</biospec_retention>
  <biospec_descr>
    <textblock>
      NC&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Children diagnosed with ADHD, treated by methylphenidate, from primary care and community&#xD;
        sample.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
        - Children 6-18 years of age, diagnosed with ADHD, treated with methylphenidate for at&#xD;
        least 6 months. Parents' online response between may and june 2020.&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
        - Exclusion of respondants not caring for the child , refusal to participate&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Years</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Chrys Amiel, MD, PharmD, MSc</last_name>
    <role>Principal Investigator</role>
    <affiliation>UH Montpellier</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Uhmontpellier</name>
      <address>
        <city>Montpellier</city>
        <zip>34295</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>May 28, 2020</study_first_submitted>
  <study_first_submitted_qc>May 28, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 2, 2020</study_first_posted>
  <last_update_submitted>July 28, 2020</last_update_submitted>
  <last_update_submitted_qc>July 28, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 29, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>ADHD</keyword>
  <keyword>treatment with methylphenidate</keyword>
  <keyword>behavioral parent training</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hyperkinesis</mesh_term>
    <mesh_term>Attention Deficit Disorder with Hyperactivity</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>NC</ipd_description>
  </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/NCT04412499
org study id: RECHMPL20_0275
nct id: NCT04412499
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The Attention Deficit and Hyperactivity Disorder (ADHD) is a frequent disorder in children
      and adolescents. The diagnosis is clinical with the input of several informants (child,
      family, teachers, …). ADHD is a risk factor for academic difficulties, school dropout, social
      isolation, injury, oppositional behaviour. In school-age children and adolescents having
      moderate to high or persistent impairment despite psycho-educational support and
      environmental modification, the first-line treatment is methylphenidate. Group or individual
      cognitive behavioural therapy for parents and/or children and adolescents is recommended for
      co-occurring disorders and persistent impairment. In France, the initiation of
      methylphenidate requires an annual hospital prescription by a paediatrician or psychiatrist,
      and a regular medical supervision (weight, heart rate, blood pressure, …). At least once a
      year, the indication of methyphenidate needs to be re-evaluated and confirmed at the
      hospital. In case of lack of efficiency and/or poor tolerance, therapeutic alternatives
      including non-psychostimulants should be considered.

      A randomized controlled trial evaluated the dose of methylphenidate received over a period of
      13 months. It was observed that the "combined treatment" group (methylphenidate +
      psychosocial treatments) received a lower average dose of methylphenidate than the
      "methylphenidate alone" group. These results are difficult to extrapolate to the general
      population, due to the study protocol (regular monitoring of ADHD symptoms with the aim of
      total remission).

      For a global consideration of children's needs, it is important to better understand the
      interactions between these two therapeutic approaches.

      To participate in the study, parents will have to complete an online questionnaire. This
      questionnaire contains anamnestic data collection, questionnaires to assess ADHD symptoms and
      parenting practices.
observational model: Case-Control
time perspective: Cross-Sectional
measure: Daily dose of methylphenidate (mg/kg) depending on participation in a parent-training programme
time frame: 1 day
description: Daily dose of methylphenidate (mg/kg) depending on participation in a parent-training programme
arm group label: Methylphenidate + parent-training programm
description: Methylphenidate and participation in a parent-training programme
arm group label: Methylphenidate alone
description: Methylphenidate alone
NC
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 6 Years
maximum age: 18 Years
healthy volunteers: No
last name: Chrys Amiel, MD, PharmD, MSc
role: Principal Investigator
affiliation: UH Montpellier
facility: 
country: France
responsible party type: Sponsor
mesh term: Hyperkinesis
mesh term: Attention Deficit Disorder with Hyperactivity
sharing ipd: Undecided
ipd description: NC