- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT04412499
Study of the Link Between Psychosocial Treatments and the Need of Pharmacological Treatments in Children With Attention Deficit Hyperactivity Disorder (OPTIME-TDAH)
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
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.
Studieöversikt
Status
Betingelser
Studietyp
Inskrivning (Faktisk)
Kontakter och platser
Studieorter
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-
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Montpellier, Frankrike, 34295
- UHMontpellier
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Beskrivning
Inclusion criteria:
- Children 6-18 years of age, diagnosed with ADHD, treated with methylphenidate for at least 6 months. Parents' online response between may and june 2020.
Exclusion criteria:
- Exclusion of respondants not caring for the child , refusal to participate
Studieplan
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
|---|
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Methylphenidate + parent-training programm
Methylphenidate and participation in a parent-training programme
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Methylphenidate alone
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Daily dose of methylphenidate (mg/kg) depending on participation in a parent-training programme
Tidsram: 1 day
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Daily dose of methylphenidate (mg/kg) depending on participation in a parent-training programme
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1 day
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Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Chrys Amiel, MD, PharmD, MSc, UH Montpellier
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- RECHMPL20_0275
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
IPD-planbeskrivning
Läkemedels- och apparatinformation, studiedokument
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Kliniska prövningar på Attention Deficit Hyperactivity Disorder
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NYU Langone HealthRekryteringAttention-deficit/Hyperactivity DisorderFörenta staterna
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University of California, Los AngelesNational Institute of Mental Health (NIMH)AvslutadAttention-Deficit Hyperactivity DisorderFörenta staterna
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Ironshore Pharmaceuticals and Development, IncAvslutadAttention-Deficit Hyperactivity DisorderFörenta staterna
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Florida International UniversityAvslutadAttention-deficit/Hyperactivity DisorderFörenta staterna
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National Taiwan University HospitalOkändAttention Deficit/Hyperactivity DisorderTaiwan
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National Taiwan University HospitalAvslutadAttention-deficit/Hyperactivity DisorderTaiwan
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Central South UniversityRekryteringAttention-Deficit/Hyperactivity DisorderKina
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Corium, Inc.Worldwide Clinical Trials; Almac; Prometrika, LLC; Premier ResearchAvslutadAttention Deficit/Hyperactivity DisorderFörenta staterna
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University of Texas at AustinRekryteringAttention Deficit Hyperactivity DisorderFörenta staterna
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Rutgers, The State University of New JerseyNational Institute of Mental Health (NIMH); Louisiana State University...Rekrytering