- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving 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.
Studieoversikt
Status
Studietype
Registrering (Faktiske)
Kontakter og plasseringer
Studiesteder
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Montpellier, Frankrike, 34295
- UHMontpellier
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
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 studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / 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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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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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Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Chrys Amiel, MD, PharmD, MSc, UH Montpellier
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- RECHMPL20_0275
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
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Kliniske studier på Attention Deficit Hyperactivity Disorder
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King's College LondonAktiv, ikke rekrutterendeAttention-Deficit Hyperactivity Disorder | Attention-Deficit Hyperactivity Disorder SymptomerStorbritannia
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Central South UniversityRekrutteringAttention-Deficit/Hyperactivity DisorderKina
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NYU Langone HealthRekrutteringAttention-deficit/Hyperactivity DisorderForente stater
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Florida International UniversityFullførtAttention-deficit/Hyperactivity DisorderForente stater
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National Taiwan University HospitalFullførtAttention-deficit/Hyperactivity DisorderTaiwan
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Eli Lilly and CompanyFullførtAttention-Deficit/Hyperactivity DisorderForente stater
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University of Texas at AustinRekrutteringAttention Deficit Hyperactivity DisorderForente stater
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Rutgers, The State University of New JerseyNational Institute of Mental Health (NIMH); Louisiana State University...Rekruttering