- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT02142140
Follow up Treatment of Children With Attention Deficit Hyperactivity Disorder (ADHD)
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.
Panoramica dello studio
Stato
Tipo di studio
Iscrizione (Anticipato)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
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Quebec
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Montreal, Quebec, Canada, H4H 1R3
- Douglas Mental Health University Institute
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Montreal, Quebec, Canada, H4A 3J1
- Montreal Children's Hospital
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
---|---|
Sperimentale: 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.
Altri nomi:
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.
Altri nomi:
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Comparatore attivo: 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.
Altri nomi:
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.
Altri nomi:
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
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Attention Deficit Hyperactivity Disorder (ADHD) symptomatology (measured via Conners' Global Index - Parent and Teacher Version)
Lasso di tempo: At baseline - no medication
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At baseline - no medication
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Attention Deficit Hyperactivity Disorder (ADHD) symptomatology (measured via Conners' Global Index - Parent and Teacher Version)
Lasso di tempo: Following 3 months of tailored treatment (including medication)
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Following 3 months of tailored treatment (including medication)
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Attention Deficit Hyperactivity Disorder (ADHD) symptomatology (measured via Conners' Global Index - Parent and Teacher Version)
Lasso di tempo: Six months after tailored treatment ends - on medication
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Six months after tailored treatment ends - on medication
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Attention Deficit Hyperactivity Disorder (ADHD) symptomatology (measured via Conners' Global Index - Parent and Teacher Version)
Lasso di tempo: Twelve months after tailored treatment has ended - on medication
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Twelve months after tailored treatment has ended - on medication
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Attention Deficit Hyperactivity Disorder (ADHD) symptomatology (measured via Conners' Global Index - Parent and Teacher Version)
Lasso di tempo: Eighteen months after tailored treatment has ended - on medication
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Eighteen months after tailored treatment has ended - on medication
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Attention Deficit Hyperactivity Disorder (ADHD) symptomatology (measured via Conners' Global Index - Parent and Teacher Version)
Lasso di tempo: Twenty-four months after tailored treatment has ended - on medication
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Twenty-four months after tailored treatment has ended - on medication
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Social skills (measured via Parent and Teacher Social Skills Rating Scale)
Lasso di tempo: At baseline - no medication
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At baseline - no medication
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Academic achievement (measured via Wechsler Individual Achievement Test (WIAT))
Lasso di tempo: At baseline - no medication
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At baseline - no medication
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Emotional and symptomatic functioning (measured via the Achenbach Child Behavior Check List (CBCL))
Lasso di tempo: At baseline - no medication
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At baseline - no medication
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Overall functioning (measured via the Weiss Functional Impairment Scale (WFIRS))
Lasso di tempo: At baseline - no medication
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At baseline - no medication
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Overall functioning (measured via the Clinical Global Impression Scale (CGI))
Lasso di tempo: Assessed at baseline
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Assessed at baseline
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Social skills (measured via Parent and Teacher Social Skills Rating Scale)
Lasso di tempo: Following 3 months of tailored treatment (including medication)
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Following 3 months of tailored treatment (including medication)
|
|
Social skills (measured via Parent and Teacher Social Skills Rating Scale)
Lasso di tempo: Six months after tailored treatment ends - on medication
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Six months after tailored treatment ends - on medication
|
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Social skills (measured via Parent and Teacher Social Skills Rating Scale)
Lasso di tempo: 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)
Lasso di tempo: Eighteen months after tailored treatment has ended - on medication
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Eighteen months after tailored treatment has ended - on medication
|
|
Social skills (measured via Parent and Teacher Social Skills Rating Scale)
Lasso di tempo: Twenty-four months after tailored treatment has ended - on medication
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Twenty-four months after tailored treatment has ended - on medication
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Academic achievement (measured via Wechsler Individual Achievement Test (WIAT))
Lasso di tempo: Twelve month after tailored treatment has ended - on medication
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Twelve month after tailored treatment has ended - on medication
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Academic achievement (measured via Wechsler Individual Achievement Test (WIAT))
Lasso di tempo: Twenty-four months after tailored treatment has ended
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Twenty-four months after tailored treatment has ended
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Emotional and symptomatic functioning (measured via the Achenbach Child Behavior Check List (CBCL))
Lasso di tempo: 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))
Lasso di tempo: 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))
Lasso di tempo: 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))
Lasso di tempo: 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))
Lasso di tempo: 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))
Lasso di tempo: Following 3 months of tailored treatment (including medication)
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Following 3 months of tailored treatment (including medication)
|
|
Overall functioning (measured via the Weiss Functional Impairment Scale (WFIRS))
Lasso di tempo: Six months after tailored treatment ends - on medication
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Six months after tailored treatment ends - on medication
|
|
Overall functioning (measured via the Weiss Functional Impairment Scale (WFIRS))
Lasso di tempo: 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))
Lasso di tempo: 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))
Lasso di tempo: 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))
Lasso di tempo: 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))
Lasso di tempo: 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))
Lasso di tempo: 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))
Lasso di tempo: Nine months after tailored treatment ends - on medication
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For participants randomized to the medication monitoring and tailored case management follow-up group.
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Nine months after tailored treatment ends - on medication
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Overall functioning (measured via the Clinical Global Impression Scale (CGI))
Lasso di tempo: 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
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Overall functioning (measured via the Clinical Global Impression Scale (CGI))
Lasso di tempo: Fifteen months after tailored treatment ends - on medication
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For participants randomized to the medication monitoring and tailored case management follow-up group.
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Fifteen months after tailored treatment ends - on medication
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Overall functioning (measured via the Clinical Global Impression Scale (CGI))
Lasso di tempo: 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))
Lasso di tempo: 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))
Lasso di tempo: 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
|
Collaboratori e investigatori
Collaboratori
Investigatori
- Investigatore principale: Ridha Joober, MD, PhD, Douglas Mental Health University Institute
- Investigatore principale: Natalie Grizenko, MD, FRCPC, Douglas Mental Health University Institute
- Investigatore principale: Lily Hechtman, MD, FRCPC, McGill University Health Centre/Research Institute of the McGill University Health Centre
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Anticipato)
Completamento dello studio (Anticipato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
- Disordini mentali
- Malattie del sistema nervoso
- Manifestazioni neurologiche
- Discinesia
- Disturbi da deficit di attenzione e comportamento dirompente
- Disturbi del neurosviluppo
- Disturbo da deficit di attenzione con iperattività
- Ipercinesia
- Effetti fisiologici delle droghe
- Agenti adrenergici
- Agenti neurotrasmettitori
- Meccanismi molecolari dell'azione farmacologica
- Inibitori dell'assorbimento dei neurotrasmettitori
- Modulatori di trasporto a membrana
- Agenti dopaminergici
- Inibitori dell'assorbimento della dopamina
- Inibitori dell'assorbimento adrenergico
- Metilfenidato
- Lisdexamfetamina Dimesylate
- Atomoxetina cloridrato
- Destroanfetamina
- Adderall
- Stimolanti del sistema nervoso centrale
Altri numeri di identificazione dello studio
- MOP 123412
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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