Attention Deficit Hyperactivity DisorderOPTIME-TDAHNCT04412499
Study of the Link Between Psychosocial Treatments and the Need of Pharmacological Treatments in Children With Attention Deficit Hyperactivity Disorder
An observational study of Attention Deficit Hyperactivity Disorder and Youths, run by University Hospital, Montpellier at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder, Youths
- How many people
- 110 participants
- Where
- 1 siteFrance
- Study dates
- 1 May 2020to 30 Jun 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Children diagnosed with ADHD, treated by methylphenidate, from primary care and community sample.
Who may be able to join
- 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.
Who cannot join
- Exclusion of respondants not caring for the child , refusal to participate
Trial locations and contacts
1 site in 1 country.
About this study
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
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).
Read more
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.
- Conditions
- Attention Deficit Hyperactivity Disorder, Youths
- Keywords
- ADHD, treatment with methylphenidate, behavioral parent training
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Methylphenidate + parent-training programm | Methylphenidate and participation in a parent-training programme | |
| Methylphenidate alone | Methylphenidate alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Daily dose of methylphenidate (mg/kg) depending on participation in a parent-training programme
Daily dose of methylphenidate (mg/kg) depending on participation in a parent-training programme
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2020
- Study start1 May 2020
- Primary completion30 Jun 2020
- Study completion30 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Attention Deficit Hyperactivity DisorderStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chrys Amiel, MD, PharmD, MSc, Principal investigator, UH Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04412499
- Sponsor's protocol ID
- RECHMPL20_0275
- Acronym
- OPTIME-TDAH
- Status last verified
- Jul 2020
- First submitted
- 28 May 2020
- Last updated
- 29 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: NC
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04412499
- Acronym / sponsor ID
- OPTIME-TDAH / RECHMPL20_0275
- Conditions
- Attention Deficit Hyperactivity Disorder, Youths
- Keywords
- ADHD, treatment with methylphenidate, behavioral parent training
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 1 May 2020 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 2 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Methylphenidate + parent-training programm | – | –Methylphenidate and participation in a parent-training programme |
| Methylphenidate alone | – | –Methylphenidate alone |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Children diagnosed with ADHD, treated by methylphenidate, from primary care and community sample.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Exclusion of respondants not caring for the child , refusal to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Daily dose of methylphenidate (mg/kg) depending on participation in a parent-training programme
Time frame: 1 day
Daily dose of methylphenidate (mg/kg) depending on participation in a parent-training programme
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2020.
- Individual participant dataSharing planned: Undecided. NC
Related trials for Attention Deficit Hyperactivity Disorder
Enrolling by invitationPhase 3
An Open-Label Study to Assess the Long-Term Safety of Solriamfetol in Children and Adolescents With ADHD
ADHD
Not yet recruitingPhase 2
Lisdexamfetamine For the Treatment of Conduct Disorder in Children
Conduct Disorder
RecruitingObservational study
Augmenting Parent Management Training for Child Temper Outbursts Using a Digital Tool
Disruptive Behavior Disorders, Conduct Disorder
Recruiting
Micronutrient Supplementation and Chronotherapy in Children With ADHD
Attention Deficit Hyperactivity Disorder (ADHD)
RecruitingPhase 3
Forward Treatment of Attention Deficit and Hyperactivity Using Solriamfetol (FOCUS-2)
ADHD
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chrys Amiel, MD, PharmD, MSc principal investigator
UH Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Attention Deficit Hyperactivity Disorder and Youths, run by University Hospital, Montpellier at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Daily dose of methylphenidate (mg/kg) depending on participation in a parent-training programme (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2020.