Follow up Treatment of Children With Attention Deficit Hyperactivity Disorder (ADHD)
27 de agosto de 2018 actualizado por: 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:
- 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.
Descripción general del estudio
Estado
Desconocido
Tipo de estudio
Intervencionista
Inscripción (Anticipado)
326
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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-
Quebec
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Montreal, Quebec, Canadá, H4H 1R3
- Douglas Mental Health University Institute
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Montreal, Quebec, Canadá, H4A 3J1
- Montreal Children's Hospital
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-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
6 años a 12 años (Niño)
Acepta Voluntarios Saludables
Sí
Géneros elegibles para el estudio
Todos
Descripción
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.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
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).
|
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.
Otros nombres:
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.
Otros nombres:
|
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Comparador activo: 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.
Otros nombres:
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.
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
Attention Deficit Hyperactivity Disorder (ADHD) symptomatology (measured via Conners' Global Index - Parent and Teacher Version)
Periodo de tiempo: At baseline - no medication
|
At baseline - no medication
|
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Attention Deficit Hyperactivity Disorder (ADHD) symptomatology (measured via Conners' Global Index - Parent and Teacher Version)
Periodo de tiempo: Following 3 months of tailored treatment (including medication)
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Following 3 months of tailored treatment (including medication)
|
|
Attention Deficit Hyperactivity Disorder (ADHD) symptomatology (measured via Conners' Global Index - Parent and Teacher Version)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: Eighteen months after tailored treatment has ended - on medication
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Eighteen months after tailored treatment has ended - on medication
|
|
Attention Deficit Hyperactivity Disorder (ADHD) symptomatology (measured via Conners' Global Index - Parent and Teacher Version)
Periodo de tiempo: Twenty-four months after tailored treatment has ended - on medication
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Twenty-four months after tailored treatment has ended - on medication
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Social skills (measured via Parent and Teacher Social Skills Rating Scale)
Periodo de tiempo: 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))
Periodo de tiempo: 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))
Periodo de tiempo: 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))
Periodo de tiempo: 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))
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: Six months after tailored treatment ends - on medication
|
Six months after tailored treatment ends - on medication
|
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|
Social skills (measured via Parent and Teacher Social Skills Rating Scale)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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))
Periodo de tiempo: Twelve month after tailored treatment has ended - on medication
|
Twelve month after tailored treatment has ended - on medication
|
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Academic achievement (measured via Wechsler Individual Achievement Test (WIAT))
Periodo de tiempo: 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))
Periodo de tiempo: 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))
Periodo de tiempo: 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))
Periodo de tiempo: 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))
Periodo de tiempo: 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))
Periodo de tiempo: 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))
Periodo de tiempo: 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))
Periodo de tiempo: 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))
Periodo de tiempo: 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))
Periodo de tiempo: 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))
Periodo de tiempo: 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))
Periodo de tiempo: 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))
Periodo de tiempo: 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))
Periodo de tiempo: 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))
Periodo de tiempo: 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))
Periodo de tiempo: 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))
Periodo de tiempo: 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))
Periodo de tiempo: 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))
Periodo de tiempo: 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))
Periodo de tiempo: 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
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Ridha Joober, MD, PhD, Douglas Mental Health University Institute
- Investigador principal: Natalie Grizenko, MD, FRCPC, Douglas Mental Health University Institute
- Investigador principal: Lily Hechtman, MD, FRCPC, McGill University Health Centre/Research Institute of the McGill University Health Centre
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio
1 de diciembre de 2012
Finalización primaria (Anticipado)
1 de febrero de 2019
Finalización del estudio (Anticipado)
1 de febrero de 2019
Fechas de registro del estudio
Enviado por primera vez
14 de mayo de 2014
Primero enviado que cumplió con los criterios de control de calidad
16 de mayo de 2014
Publicado por primera vez (Estimar)
20 de mayo de 2014
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
28 de agosto de 2018
Última actualización enviada que cumplió con los criterios de control de calidad
27 de agosto de 2018
Última verificación
1 de agosto de 2018
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Desordenes mentales
- Enfermedades del Sistema Nervioso
- Manifestaciones neurológicas
- Discinesias
- Trastornos por Déficit de Atención y Conducta Disruptiva
- Trastornos del neurodesarrollo
- Trastorno por Déficit de Atención con Hiperactividad
- Hipercinesia
- Efectos fisiológicos de las drogas
- Agentes adrenérgicos
- Agentes neurotransmisores
- Mecanismos moleculares de acción farmacológica
- Inhibidores de la captación de neurotransmisores
- Moduladores de transporte de membrana
- Agentes de dopamina
- Inhibidores de la captación de dopamina
- Inhibidores de la captación adrenérgica
- Metilfenidato
- Dimesilato de lisdexanfetamina
- Clorhidrato de atomoxetina
- Dextroanfetamina
- Adderall
- Estimulantes del Sistema Nervioso Central
Otros números de identificación del estudio
- MOP 123412
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .