Follow up Treatment of Children With Attention Deficit Hyperactivity Disorder (ADHD)
27 sierpnia 2018 zaktualizowane przez: Lily Hechtman, McGill University Health Centre/Research Institute of the McGill University Health Centre
Efficacy of Careful Medication and Tailored Case Management Follow up Treatment for Children With Attention Deficit Hyperactivity Disorder
The purpose of the study is to examine how well two types of treatment follow up work compared to one another:
- standard community follow up
- medication monitoring plus tailored case management follow up.
A child's participation will involve 3 months of treatment consisting of medication and psychological, behavioural, and academic interventions tailored to their individual needs.
Following this treatment, the child will be randomly assigned to receive two years of either community follow up or medication monitoring plus tailored case management follow up delivered by the study team. During both types of follow up, at 6 month intervals, the parent and child will be asked to complete interviews with our study personnel and comprehensive assessments pertaining to ADHD symptoms and various other areas of functioning.
Parents will also be asked to obtain information from the child's teacher regarding the child's functioning at 6 month intervals during the school year.
Przegląd badań
Status
Nieznany
Typ studiów
Interwencyjne
Zapisy (Oczekiwany)
326
Faza
- Nie dotyczy
Kontakty i lokalizacje
Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.
Lokalizacje studiów
-
-
Quebec
-
Montreal, Quebec, Kanada, H4H 1R3
- Douglas Mental Health University Institute
-
Montreal, Quebec, Kanada, H4A 3J1
- Montreal Children's Hospital
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-
Kryteria uczestnictwa
Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.
Kryteria kwalifikacji
Wiek uprawniający do nauki
6 lat do 12 lat (Dziecko)
Akceptuje zdrowych ochotników
Tak
Płeć kwalifikująca się do nauki
Wszystko
Opis
Inclusion Criteria:
- age 6 to 12 years
- DSM-IV ADHD diagnosis by a specialist i.e. child psychiatrist or developmental paediatrician (DSM 5 ADHD criteria do not differ dramatically from DSM IV criteria for children)
- Intelligence Quotient (IQ) > 80 as per the Wechsler Intelligence Scale for Children (WISC-IV)
- Proficiency in English or French
Exclusion Criteria:
- History of Autism Spectrum Disorder (ASD) or psychosis
- Significant brain traumas (encephalitis, head injury requiring hospitalization, etc.)
- Major medical conditions or impairments that would interfere with the ability of the child to complete testing or take psychostimulants, e.g., epilepsy, cardiac abnormalities, or renal abnormalities.
Plan studiów
Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
|
Eksperymentalny: Medication Monitoring & Case Management
All children entered into this study will be prescribed medication for their ADHD symptoms (usually a long-acting stimulant).
Based on the individual needs of the child and family, they could receive the following interventions - Academic and organization skills, social skills training and parent training.
Participants randomized to this group will meet with the study clinicians 4 times a year for medication monitoring and adjustment.
This group will also receive a monthly call from a case manager who will explore the child's academic, social and emotional functioning.
Depending on the needs of the child and family, the case manager may offer 1 to 5 intervention sessions with the child (e.g.
social skills, anger management), the family (e.g.
family counselling), and the school (e.g.
consultation with the teacher).
|
This program aims at teaching children organization, time management and stress management skills.
They are also taught academic strategies in reading, writing, and math.
The program consists of six, 90 minute sessions.
The Parent Training Program: The parent training program is designed to increase parental understanding of ADHD; establish attentive, positive interactions, and solve problems collaboratively.
Eight weekly group sessions lasting about 2 hours each will be conducted by trained psychologists, social workers, or clinical nurses.
Homework assignments and detailed summary sheets will be used to promote technique acquisition and generalization.
Social Skills and Anger Management Training: The social skills training program is based on understanding yourself and others, and being able to understand things from the other's perspective.
The program uses direct instruction, modelling, behavioural rehearsal, feedback, and social reinforcement.
The following are covered: joining in, understanding emotions, dealing with anger, using self-control, responding to teasing / bullying, and staying out of fights.
The medication prescribed is usually a long-acting stimulant that is carefully titrated to the child's optimal dose (normally that dose above which further improvement is not seen and side effects are manageable).
Once optimal dose is reached, children are followed at regular once per three month visits for medication monitoring.
In this group the child can be referred for a medication reevaluation and adjustment as many times as is needed.
Inne nazwy:
The medication prescribed is usually a long-acting stimulant that is carefully titrated to the child's optimal dose (normally that dose above which further improvement is not seen and side effects are manageable).
Once optimal dose is reached, children are followed by their pediatrician, with a frequency at his/her discretion.
Inne nazwy:
|
|
Aktywny komparator: Community Follow-up Group
All children entered into this study will be prescribed medication for their ADHD symptoms (usually a long-acting stimulant).
Based on the individual needs of the child and family, they could receive the following interventions - Academic and organization skills, social skills training and parent training.
Families randomized to this group will be referred to their pediatricians or family physicians for medication follow-up and their local Community Health Clinic (CLSC) for other psychosocial interventions that may be required and available.
|
This program aims at teaching children organization, time management and stress management skills.
They are also taught academic strategies in reading, writing, and math.
The program consists of six, 90 minute sessions.
The Parent Training Program: The parent training program is designed to increase parental understanding of ADHD; establish attentive, positive interactions, and solve problems collaboratively.
Eight weekly group sessions lasting about 2 hours each will be conducted by trained psychologists, social workers, or clinical nurses.
Homework assignments and detailed summary sheets will be used to promote technique acquisition and generalization.
Social Skills and Anger Management Training: The social skills training program is based on understanding yourself and others, and being able to understand things from the other's perspective.
The program uses direct instruction, modelling, behavioural rehearsal, feedback, and social reinforcement.
The following are covered: joining in, understanding emotions, dealing with anger, using self-control, responding to teasing / bullying, and staying out of fights.
The medication prescribed is usually a long-acting stimulant that is carefully titrated to the child's optimal dose (normally that dose above which further improvement is not seen and side effects are manageable).
Once optimal dose is reached, children are followed at regular once per three month visits for medication monitoring.
In this group the child can be referred for a medication reevaluation and adjustment as many times as is needed.
Inne nazwy:
The medication prescribed is usually a long-acting stimulant that is carefully titrated to the child's optimal dose (normally that dose above which further improvement is not seen and side effects are manageable).
Once optimal dose is reached, children are followed by their pediatrician, with a frequency at his/her discretion.
Inne nazwy:
|
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Ramy czasowe |
|---|---|
|
Attention Deficit Hyperactivity Disorder (ADHD) symptomatology (measured via Conners' Global Index - Parent and Teacher Version)
Ramy czasowe: At baseline - no medication
|
At baseline - no medication
|
|
Attention Deficit Hyperactivity Disorder (ADHD) symptomatology (measured via Conners' Global Index - Parent and Teacher Version)
Ramy czasowe: Following 3 months of tailored treatment (including medication)
|
Following 3 months of tailored treatment (including medication)
|
|
Attention Deficit Hyperactivity Disorder (ADHD) symptomatology (measured via Conners' Global Index - Parent and Teacher Version)
Ramy czasowe: Six months after tailored treatment ends - on medication
|
Six months after tailored treatment ends - on medication
|
|
Attention Deficit Hyperactivity Disorder (ADHD) symptomatology (measured via Conners' Global Index - Parent and Teacher Version)
Ramy czasowe: Twelve months after tailored treatment has ended - on medication
|
Twelve months after tailored treatment has ended - on medication
|
|
Attention Deficit Hyperactivity Disorder (ADHD) symptomatology (measured via Conners' Global Index - Parent and Teacher Version)
Ramy czasowe: Eighteen months after tailored treatment has ended - on medication
|
Eighteen months after tailored treatment has ended - on medication
|
|
Attention Deficit Hyperactivity Disorder (ADHD) symptomatology (measured via Conners' Global Index - Parent and Teacher Version)
Ramy czasowe: Twenty-four months after tailored treatment has ended - on medication
|
Twenty-four months after tailored treatment has ended - on medication
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Social skills (measured via Parent and Teacher Social Skills Rating Scale)
Ramy czasowe: At baseline - no medication
|
At baseline - no medication
|
|
|
Academic achievement (measured via Wechsler Individual Achievement Test (WIAT))
Ramy czasowe: At baseline - no medication
|
At baseline - no medication
|
|
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Emotional and symptomatic functioning (measured via the Achenbach Child Behavior Check List (CBCL))
Ramy czasowe: At baseline - no medication
|
At baseline - no medication
|
|
|
Overall functioning (measured via the Weiss Functional Impairment Scale (WFIRS))
Ramy czasowe: At baseline - no medication
|
At baseline - no medication
|
|
|
Overall functioning (measured via the Clinical Global Impression Scale (CGI))
Ramy czasowe: Assessed at baseline
|
Assessed at baseline
|
|
|
Social skills (measured via Parent and Teacher Social Skills Rating Scale)
Ramy czasowe: Following 3 months of tailored treatment (including medication)
|
Following 3 months of tailored treatment (including medication)
|
|
|
Social skills (measured via Parent and Teacher Social Skills Rating Scale)
Ramy czasowe: Six months after tailored treatment ends - on medication
|
Six months after tailored treatment ends - on medication
|
|
|
Social skills (measured via Parent and Teacher Social Skills Rating Scale)
Ramy czasowe: Twelve months after tailored treatment has ended - on medication
|
Twelve months after tailored treatment has ended - on medication
|
|
|
Social skills (measured via Parent and Teacher Social Skills Rating Scale)
Ramy czasowe: Eighteen months after tailored treatment has ended - on medication
|
Eighteen months after tailored treatment has ended - on medication
|
|
|
Social skills (measured via Parent and Teacher Social Skills Rating Scale)
Ramy czasowe: Twenty-four months after tailored treatment has ended - on medication
|
Twenty-four months after tailored treatment has ended - on medication
|
|
|
Academic achievement (measured via Wechsler Individual Achievement Test (WIAT))
Ramy czasowe: Twelve month after tailored treatment has ended - on medication
|
Twelve month after tailored treatment has ended - on medication
|
|
|
Academic achievement (measured via Wechsler Individual Achievement Test (WIAT))
Ramy czasowe: Twenty-four months after tailored treatment has ended
|
Twenty-four months after tailored treatment has ended
|
|
|
Emotional and symptomatic functioning (measured via the Achenbach Child Behavior Check List (CBCL))
Ramy czasowe: Following 3 months of tailored treatment (including medication)
|
Following 3 months of tailored treatment (including medication)
|
|
|
Emotional and symptomatic functioning (measured via the Achenbach Child Behavior Check List (CBCL))
Ramy czasowe: Six months after tailored treatment ends - on medication
|
Six months after tailored treatment ends - on medication
|
|
|
Emotional and symptomatic functioning (measured via the Achenbach Child Behavior Check List (CBCL))
Ramy czasowe: Twelve months after tailored treatment has ended - on medication
|
Twelve months after tailored treatment has ended - on medication
|
|
|
Emotional and symptomatic functioning (measured via the Achenbach Child Behavior Check List (CBCL))
Ramy czasowe: Eighteen months after tailored treatment has ended - on medication
|
Eighteen months after tailored treatment has ended - on medication
|
|
|
Emotional and symptomatic functioning (measured via the Achenbach Child Behavior Check List (CBCL))
Ramy czasowe: Twenty-four months after tailored treatment has ended - on medication
|
Twenty-four months after tailored treatment has ended - on medication
|
|
|
Overall functioning (measured via the Weiss Functional Impairment Scale (WFIRS))
Ramy czasowe: Following 3 months of tailored treatment (including medication)
|
Following 3 months of tailored treatment (including medication)
|
|
|
Overall functioning (measured via the Weiss Functional Impairment Scale (WFIRS))
Ramy czasowe: Six months after tailored treatment ends - on medication
|
Six months after tailored treatment ends - on medication
|
|
|
Overall functioning (measured via the Weiss Functional Impairment Scale (WFIRS))
Ramy czasowe: Twelve months after tailored treatment has ended - on medication
|
Twelve months after tailored treatment has ended - on medication
|
|
|
Overall functioning (measured via the Weiss Functional Impairment Scale (WFIRS))
Ramy czasowe: Eighteen months after tailored treatment has ended - on medication
|
Eighteen months after tailored treatment has ended - on medication
|
|
|
Overall functioning (measured via the Weiss Functional Impairment Scale (WFIRS))
Ramy czasowe: Twenty-four months after tailored treatment has ended - on medication
|
Twenty-four months after tailored treatment has ended - on medication
|
|
|
Overall functioning (measured via the Clinical Global Impression Scale (CGI))
Ramy czasowe: Following 3 months of tailored treatment (including medication)
|
Following 3 months of tailored treatment (including medication)
|
|
|
Overall functioning (measured via the Clinical Global Impression Scale (CGI))
Ramy czasowe: Three months after tailored treatment ends - on medication
|
For participants randomized to the medication monitoring and tailored case management follow-up group.
|
Three months after tailored treatment ends - on medication
|
|
Overall functioning (measured via the Clinical Global Impression Scale (CGI))
Ramy czasowe: Six months after tailored treatment ends - on medication
|
For participants randomized to the medication monitoring and tailored case management follow-up group.
|
Six months after tailored treatment ends - on medication
|
|
Overall functioning (measured via the Clinical Global Impression Scale (CGI))
Ramy czasowe: Nine months after tailored treatment ends - on medication
|
For participants randomized to the medication monitoring and tailored case management follow-up group.
|
Nine months after tailored treatment ends - on medication
|
|
Overall functioning (measured via the Clinical Global Impression Scale (CGI))
Ramy czasowe: Twelve months after tailored treatment ends - on medication
|
For participants randomized to the medication monitoring and tailored case management follow-up group.
|
Twelve months after tailored treatment ends - on medication
|
|
Overall functioning (measured via the Clinical Global Impression Scale (CGI))
Ramy czasowe: Fifteen months after tailored treatment ends - on medication
|
For participants randomized to the medication monitoring and tailored case management follow-up group.
|
Fifteen months after tailored treatment ends - on medication
|
|
Overall functioning (measured via the Clinical Global Impression Scale (CGI))
Ramy czasowe: Eighteen months after tailored treatment ends - on medication
|
For participants randomized to the medication monitoring and tailored case management follow-up group.
|
Eighteen months after tailored treatment ends - on medication
|
|
Overall functioning (measured via the Clinical Global Impression Scale (CGI))
Ramy czasowe: Twenty-one months after tailored treatment ends - on medication
|
For participants randomized to the medication monitoring and tailored case management follow-up group.
|
Twenty-one months after tailored treatment ends - on medication
|
|
Overall functioning (measured via the Clinical Global Impression Scale (CGI))
Ramy czasowe: Twenty-four months after tailored treatment ends - on medication
|
For participants randomized to the medication monitoring and tailored case management follow-up group.
|
Twenty-four months after tailored treatment ends - on medication
|
Współpracownicy i badacze
Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.
Współpracownicy
Śledczy
- Główny śledczy: Ridha Joober, MD, PhD, Douglas Mental Health University Institute
- Główny śledczy: Natalie Grizenko, MD, FRCPC, Douglas Mental Health University Institute
- Główny śledczy: Lily Hechtman, MD, FRCPC, McGill University Health Centre/Research Institute of the McGill University Health Centre
Daty zapisu na studia
Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.
Główne daty studiów
Rozpoczęcie studiów
1 grudnia 2012
Zakończenie podstawowe (Oczekiwany)
1 lutego 2019
Ukończenie studiów (Oczekiwany)
1 lutego 2019
Daty rejestracji na studia
Pierwszy przesłany
14 maja 2014
Pierwszy przesłany, który spełnia kryteria kontroli jakości
16 maja 2014
Pierwszy wysłany (Oszacować)
20 maja 2014
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
28 sierpnia 2018
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
27 sierpnia 2018
Ostatnia weryfikacja
1 sierpnia 2018
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
- Zaburzenia psychiczne
- Choroby Układu Nerwowego
- Objawy neurologiczne
- Dyskinezy
- Deficyt uwagi i destrukcyjne zaburzenia zachowania
- Zaburzenia neurorozwojowe
- Zespół deficytu uwagi z nadpobudliwością
- Hiperkineza
- Fizjologiczne skutki leków
- Środki adrenergiczne
- Agentów neuroprzekaźników
- Molekularne mechanizmy działania farmakologicznego
- Inhibitory wychwytu neuroprzekaźników
- Modulatory transportu membranowego
- Agentów dopaminy
- Inhibitory wychwytu dopaminy
- Inhibitory wychwytu adrenergicznego
- Metylofenidat
- Dimezylan lisdeksamfetaminy
- Chlorowodorek atomoksetyny
- Dekstroamfetamina
- Adderall
- Stymulatory ośrodkowego układu nerwowego
Inne numery identyfikacyjne badania
- MOP 123412
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .