Clinical trial NCT04412499: Study of the Link Between Psychosocial Treatments and the Need of Pharmacological Treatments in Children With Attention Deficit Hyperactivity Disorder
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Attention Deficit Hyperactivity Disorder
Youths
Keywords: ADHD
treatment with methylphenidate
behavioral parent training
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2020-06-02
Enrollment: 110
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children diagnosed with ADHD, treated by methylphenidate, from primary care and community sample.

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Daily dose of methylphenidate (mg/kg) depending on participation in a parent-training programme
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Uhmontpellier
Study officials:
affiliation: UH Montpellier
name: Chrys Amiel, MD, PharmD, MSc
role: PRINCIPAL_INVESTIGATOR
References: