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

27 augustus 2018 bijgewerkt door: 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.

Studie Overzicht

Toestand

Onbekend

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Verwacht)

326

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

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

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

6 jaar tot 12 jaar (Kind)

Accepteert gezonde vrijwilligers

Ja

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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).
Gedragsmatig: 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.
Gedragsmatig: 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.
Gedragsmatig: 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.
Geneesmiddel: 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.
Andere namen:
  • Concerta
  • Vyvanse
  • Adderall
  • Ritalin
  • Stratera
  • Dexedrine
  • Biphentin
Geneesmiddel: 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.
Andere namen:
  • Concerta
  • Vyvanse
  • Adderall
  • Ritalin
  • Stratera
  • Dexedrine
  • Biphentin
Actieve vergelijker: 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.
Gedragsmatig: 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.
Gedragsmatig: 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.
Gedragsmatig: 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.
Geneesmiddel: 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.
Andere namen:
  • Concerta
  • Vyvanse
  • Adderall
  • Ritalin
  • Stratera
  • Dexedrine
  • Biphentin
Geneesmiddel: 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.
Andere namen:
  • Concerta
  • Vyvanse
  • Adderall
  • Ritalin
  • Stratera
  • Dexedrine
  • Biphentin

Wat meet het onderzoek?

Primaire uitkomstmaten

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

Secundaire uitkomstmaten

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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

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

Medewerkers

Canadian Institutes of Health Research (CIHR)

Onderzoekers

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

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 december 2012

Primaire voltooiing (Verwacht)

1 februari 2019

Studie voltooiing (Verwacht)

1 februari 2019

Studieregistratiedata

Eerst ingediend

14 mei 2014

Eerst ingediend dat voldeed aan de QC-criteria

16 mei 2014

Eerst geplaatst (Schatting)

20 mei 2014

Updates van studierecords

Laatste update geplaatst (Werkelijk)

28 augustus 2018

Laatste update ingediend die voldeed aan QC-criteria

27 augustus 2018

Laatst geverifieerd

1 augustus 2018

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • MOP 123412

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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