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Follow up Treatment of Children With Attention Deficit Hyperactivity Disorder (ADHD)

27. srpna 2018 aktualizováno: 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:

  1. standard community follow up
  2. 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.

Přehled studie

Postavení

Neznámý

Podmínky

Intervence / Léčba

Typ studie

Intervenční

Zápis (Očekávaný)

326

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

  • Kanada
    • Quebec
      • Montreal, Quebec, Kanada, H4H 1R3
        • Douglas Mental Health University Institute
      • Montreal, Quebec, Kanada, H4A 3J1
        • Montreal Children's Hospital

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

6 let až 12 let (Dítě)

Přijímá zdravé dobrovolníky

Ano

Pohlaví způsobilá ke studiu

Všechno

Popis

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.

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Žádné (otevřený štítek)

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: 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).
Behaviorální: Academic and Organization skills
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.
Behaviorální: Parent Training
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.
Behaviorální: Social Skills Training
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.
Lék: Long-acting stimulant
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.
Ostatní jména:
  • Koncert
  • Vyvanse
  • Adderall
  • Ritalin
  • Strattera
  • Dexedrin
  • Biphentin
Lék: Long-acting stimulant
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.
Ostatní jména:
  • Koncert
  • Vyvanse
  • Adderall
  • Ritalin
  • Strattera
  • Dexedrin
  • Biphentin
Aktivní komparátor: 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.
Behaviorální: Academic and Organization skills
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.
Behaviorální: Parent Training
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.
Behaviorální: Social Skills Training
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.
Lék: Long-acting stimulant
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.
Ostatní jména:
  • Koncert
  • Vyvanse
  • Adderall
  • Ritalin
  • Strattera
  • Dexedrin
  • Biphentin
Lék: Long-acting stimulant
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.
Ostatní jména:
  • Koncert
  • Vyvanse
  • Adderall
  • Ritalin
  • Strattera
  • Dexedrin
  • Biphentin

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Časové okno
Attention Deficit Hyperactivity Disorder (ADHD) symptomatology (measured via Conners' Global Index - Parent and Teacher Version)
Časové okno: At baseline - no medication
At baseline - no medication
Attention Deficit Hyperactivity Disorder (ADHD) symptomatology (measured via Conners' Global Index - Parent and Teacher Version)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: Twenty-four months after tailored treatment has ended - on medication
Twenty-four months after tailored treatment has ended - on medication

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Social skills (measured via Parent and Teacher Social Skills Rating Scale)
Časové okno: At baseline - no medication
At baseline - no medication
Academic achievement (measured via Wechsler Individual Achievement Test (WIAT))
Časové okno: At baseline - no medication
At baseline - no medication
Emotional and symptomatic functioning (measured via the Achenbach Child Behavior Check List (CBCL))
Časové okno: At baseline - no medication
At baseline - no medication
Overall functioning (measured via the Weiss Functional Impairment Scale (WFIRS))
Časové okno: At baseline - no medication
At baseline - no medication
Overall functioning (measured via the Clinical Global Impression Scale (CGI))
Časové okno: Assessed at baseline
Assessed at baseline
Social skills (measured via Parent and Teacher Social Skills Rating Scale)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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))
Časové okno: 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))
Časové okno: 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))
Časové okno: 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))
Časové okno: 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))
Časové okno: 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))
Časové okno: 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))
Časové okno: 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))
Časové okno: 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))
Časové okno: 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))
Časové okno: 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))
Časové okno: 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))
Časové okno: 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))
Časové okno: 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))
Časové okno: 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))
Časové okno: 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))
Časové okno: 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))
Časové okno: 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))
Časové okno: 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))
Časové okno: 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))
Časové okno: 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))
Časové okno: 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

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

McGill University Health Centre/Research Institute of the McGill University Health Centre

Spolupracovníci

Canadian Institutes of Health Research (CIHR)

Vyšetřovatelé

  • Vrchní vyšetřovatel: Ridha Joober, MD, PhD, Douglas Mental Health University Institute
  • Vrchní vyšetřovatel: Natalie Grizenko, MD, FRCPC, Douglas Mental Health University Institute
  • Vrchní vyšetřovatel: Lily Hechtman, MD, FRCPC, McGill University Health Centre/Research Institute of the McGill University Health Centre

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia

1. prosince 2012

Primární dokončení (Očekávaný)

1. února 2019

Dokončení studie (Očekávaný)

1. února 2019

Termíny zápisu do studia

První předloženo

14. května 2014

První předloženo, které splnilo kritéria kontroly kvality

16. května 2014

První zveřejněno (Odhad)

20. května 2014

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

28. srpna 2018

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

27. srpna 2018

Naposledy ověřeno

1. srpna 2018

Více informací

Termíny související s touto studií

Klíčová slova

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Další identifikační čísla studie

  • MOP 123412

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