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

27. august 2018 opdateret af: 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.

Studieoversigt

Status

Ukendt

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

326

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

6 år til 12 år (Barn)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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).
Adfærdsmæssigt: 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.
Adfærdsmæssigt: 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.
Adfærdsmæssigt: 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.
Medicin: 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.
Andre navne:
  • Concerta
  • Vyvanse
  • Adderall
  • Ritalin
  • Strattera
  • Dexedrine
  • Biphentin
Medicin: 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.
Andre navne:
  • Concerta
  • Vyvanse
  • Adderall
  • Ritalin
  • Strattera
  • Dexedrine
  • Biphentin
Aktiv 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.
Adfærdsmæssigt: 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.
Adfærdsmæssigt: 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.
Adfærdsmæssigt: 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.
Medicin: 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.
Andre navne:
  • Concerta
  • Vyvanse
  • Adderall
  • Ritalin
  • Strattera
  • Dexedrine
  • Biphentin
Medicin: 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.
Andre navne:
  • Concerta
  • Vyvanse
  • Adderall
  • Ritalin
  • Strattera
  • Dexedrine
  • Biphentin

Hvad måler undersøgelsen?

Primære resultatmål

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

Sekundære resultatmål

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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

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

Samarbejdspartnere

Canadian Institutes of Health Research (CIHR)

Efterforskere

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

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. december 2012

Primær færdiggørelse (Forventet)

1. februar 2019

Studieafslutning (Forventet)

1. februar 2019

Datoer for studieregistrering

Først indsendt

14. maj 2014

Først indsendt, der opfyldte QC-kriterier

16. maj 2014

Først opslået (Skøn)

20. maj 2014

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

28. august 2018

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

27. august 2018

Sidst verificeret

1. august 2018

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • MOP 123412

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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