- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg 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.
Studieoversigt
Status
Betingelser
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
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Montpellier, Frankrig, 34295
- Uhmontpellier
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
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
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
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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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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Daily dose of methylphenidate (mg/kg) depending on participation in a parent-training programme
Tidsramme: 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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Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Chrys Amiel, MD, PharmD, MSc, UH Montpellier
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- RECHMPL20_0275
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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Kliniske forsøg med Attention Deficit Hyperactivity Disorder
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King's College LondonAktiv, ikke rekrutterendeAttention-Deficit Hyperactivity Disorder | Attention-Deficit Hyperactivity Disorder SymptomerDet Forenede Kongerige
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Children's National Research InstituteRekrutteringADHD | Attention Deficit Hyperactivity Disorder | Attention-Deficit Hyperactivity Disorder | Attention Deficit Disorder | TILFØJE | ADHD Overvejende uopmærksom type | ADHD - kombineret type | ADHD, overvejende hyperaktiv - impulsiv | Attention-Deficit Disorder i ungdomsårene | Attention-Deficit Hyperactivity...Forenede Stater
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Central South UniversityRekrutteringAttention-Deficit/Hyperactivity DisorderKina
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NYU Langone HealthRekrutteringAttention-deficit/Hyperactivity DisorderForenede Stater
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University of California, Los AngelesNational Institute of Mental Health (NIMH)AfsluttetAttention-Deficit Hyperactivity DisorderForenede Stater
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Ironshore Pharmaceuticals and Development, IncAfsluttetAttention-Deficit Hyperactivity DisorderForenede Stater
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Florida International UniversityAfsluttetAttention-deficit/Hyperactivity DisorderForenede Stater
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National Taiwan University HospitalUkendtAttention Deficit/Hyperactivity DisorderTaiwan
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National Taiwan University HospitalAfsluttetAttention-deficit/Hyperactivity DisorderTaiwan
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University of Texas at AustinRekrutteringAttention Deficit Hyperactivity DisorderForenede Stater