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

27. August 2018 aktualisiert von: 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.

Studienübersicht

Status

Unbekannt

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Voraussichtlich)

326

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

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

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

6 Jahre bis 12 Jahre (Kind)

Akzeptiert gesunde Freiwillige

Ja

Studienberechtigte Geschlechter

Alle

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: 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).
Verhalten: 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.
Verhalten: 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.
Verhalten: 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.
Arzneimittel: 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:
  • Konzert
  • Wyvanse
  • Adderall
  • Ritalin
  • Strattera
  • Dexedrin
  • Biphentin
Arzneimittel: 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:
  • Konzert
  • Wyvanse
  • Adderall
  • Ritalin
  • Strattera
  • Dexedrin
  • Biphentin
Aktiver 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.
Verhalten: 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.
Verhalten: 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.
Verhalten: 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.
Arzneimittel: 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:
  • Konzert
  • Wyvanse
  • Adderall
  • Ritalin
  • Strattera
  • Dexedrin
  • Biphentin
Arzneimittel: 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:
  • Konzert
  • Wyvanse
  • Adderall
  • Ritalin
  • Strattera
  • Dexedrin
  • Biphentin

Was misst die Studie?

Primäre Ergebnismessungen

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

Sekundäre Ergebnismessungen

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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

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

Mitarbeiter

Canadian Institutes of Health Research (CIHR)

Ermittler

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

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn

1. Dezember 2012

Primärer Abschluss (Voraussichtlich)

1. Februar 2019

Studienabschluss (Voraussichtlich)

1. Februar 2019

Studienanmeldedaten

Zuerst eingereicht

14. Mai 2014

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

16. Mai 2014

Zuerst gepostet (Schätzen)

20. Mai 2014

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

28. August 2018

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

27. August 2018

Zuletzt verifiziert

1. August 2018

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • MOP 123412

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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