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

Attention Deficit Hyperactivity Disorder (ADHD) Clinical Trial

Official title:

Efficacy of Careful Medication and Tailored Case Management Follow up Treatment for Children With Attention Deficit Hyperactivity Disorder

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02142140
• Other study ID #: MOP 123412
• Status: Active, not recruiting
• Phase: N/A
• Start date: December 2012
• Est. completion date: February 2019

Study information

• Verified date: August 2018
• Source: McGill University Health Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 326
• Est. completion date: February 2019
• Est. primary completion date: February 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 12 Years

Eligibility

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.

Related Conditions & MeSH terms

• Attention Deficit Disorder with Hyperactivity
• Attention Deficit Hyperactivity Disorder (ADHD)
• Disease
• Hyperkinesis

Intervention

Behavioral:
• 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.
• 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.
• 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.

Drug:
• 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.
• 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.

Locations

Country	Name	City	State
Canada	Douglas Mental Health University Institute	Montreal	Quebec
Canada	Montreal Children's Hospital	Montreal	Quebec

Sponsors (2)

Lead Sponsor	Collaborator
McGill University Health Center	Canadian Institutes of Health Research (CIHR)

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Attention Deficit Hyperactivity Disorder (ADHD) symptomatology (measured via Conners' Global Index - Parent and Teacher Version)		At baseline - no medication
Primary	Attention Deficit Hyperactivity Disorder (ADHD) symptomatology (measured via Conners' Global Index - Parent and Teacher Version)		Following 3 months of tailored treatment (including medication)
Primary	Attention Deficit Hyperactivity Disorder (ADHD) symptomatology (measured via Conners' Global Index - Parent and Teacher Version)		Six months after tailored treatment ends - on medication
Primary	Attention Deficit Hyperactivity Disorder (ADHD) symptomatology (measured via Conners' Global Index - Parent and Teacher Version)		Twelve months after tailored treatment has ended - on medication
Primary	Attention Deficit Hyperactivity Disorder (ADHD) symptomatology (measured via Conners' Global Index - Parent and Teacher Version)		Eighteen months after tailored treatment has ended - on medication
Primary	Attention Deficit Hyperactivity Disorder (ADHD) symptomatology (measured via Conners' Global Index - Parent and Teacher Version)		Twenty-four months after tailored treatment has ended - on medication
Secondary	Social skills (measured via Parent and Teacher Social Skills Rating Scale)		At baseline - no medication
Secondary	Academic achievement (measured via Wechsler Individual Achievement Test (WIAT))		At baseline - no medication
Secondary	Emotional and symptomatic functioning (measured via the Achenbach Child Behavior Check List (CBCL))		At baseline - no medication
Secondary	Overall functioning (measured via the Weiss Functional Impairment Scale (WFIRS))		At baseline - no medication
Secondary	Overall functioning (measured via the Clinical Global Impression Scale (CGI))		Assessed at baseline
Secondary	Social skills (measured via Parent and Teacher Social Skills Rating Scale)		Following 3 months of tailored treatment (including medication)
Secondary	Social skills (measured via Parent and Teacher Social Skills Rating Scale)		Six months after tailored treatment ends - on medication
Secondary	Social skills (measured via Parent and Teacher Social Skills Rating Scale)		Twelve months after tailored treatment has ended - on medication
Secondary	Social skills (measured via Parent and Teacher Social Skills Rating Scale)		Eighteen months after tailored treatment has ended - on medication
Secondary	Social skills (measured via Parent and Teacher Social Skills Rating Scale)		Twenty-four months after tailored treatment has ended - on medication
Secondary	Academic achievement (measured via Wechsler Individual Achievement Test (WIAT))		Twelve month after tailored treatment has ended - on medication
Secondary	Academic achievement (measured via Wechsler Individual Achievement Test (WIAT))		Twenty-four months after tailored treatment has ended
Secondary	Emotional and symptomatic functioning (measured via the Achenbach Child Behavior Check List (CBCL))		Following 3 months of tailored treatment (including medication)
Secondary	Emotional and symptomatic functioning (measured via the Achenbach Child Behavior Check List (CBCL))		Six months after tailored treatment ends - on medication
Secondary	Emotional and symptomatic functioning (measured via the Achenbach Child Behavior Check List (CBCL))		Twelve months after tailored treatment has ended - on medication
Secondary	Emotional and symptomatic functioning (measured via the Achenbach Child Behavior Check List (CBCL))		Eighteen months after tailored treatment has ended - on medication
Secondary	Emotional and symptomatic functioning (measured via the Achenbach Child Behavior Check List (CBCL))		Twenty-four months after tailored treatment has ended - on medication
Secondary	Overall functioning (measured via the Weiss Functional Impairment Scale (WFIRS))		Following 3 months of tailored treatment (including medication)
Secondary	Overall functioning (measured via the Weiss Functional Impairment Scale (WFIRS))		Six months after tailored treatment ends - on medication
Secondary	Overall functioning (measured via the Weiss Functional Impairment Scale (WFIRS))		Twelve months after tailored treatment has ended - on medication
Secondary	Overall functioning (measured via the Weiss Functional Impairment Scale (WFIRS))		Eighteen months after tailored treatment has ended - on medication
Secondary	Overall functioning (measured via the Weiss Functional Impairment Scale (WFIRS))		Twenty-four months after tailored treatment has ended - on medication
Secondary	Overall functioning (measured via the Clinical Global Impression Scale (CGI))		Following 3 months of tailored treatment (including medication)
Secondary	Overall functioning (measured via the Clinical Global Impression Scale (CGI))	For participants randomized to the medication monitoring and tailored case management follow-up group.	Three months after tailored treatment ends - on medication
Secondary	Overall functioning (measured via the Clinical Global Impression Scale (CGI))	For participants randomized to the medication monitoring and tailored case management follow-up group.	Six months after tailored treatment ends - on medication
Secondary	Overall functioning (measured via the Clinical Global Impression Scale (CGI))	For participants randomized to the medication monitoring and tailored case management follow-up group.	Nine months after tailored treatment ends - on medication
Secondary	Overall functioning (measured via the Clinical Global Impression Scale (CGI))	For participants randomized to the medication monitoring and tailored case management follow-up group.	Twelve months after tailored treatment ends - on medication
Secondary	Overall functioning (measured via the Clinical Global Impression Scale (CGI))	For participants randomized to the medication monitoring and tailored case management follow-up group.	Fifteen months after tailored treatment ends - on medication
Secondary	Overall functioning (measured via the Clinical Global Impression Scale (CGI))	For participants randomized to the medication monitoring and tailored case management follow-up group.	Eighteen months after tailored treatment ends - on medication
Secondary	Overall functioning (measured via the Clinical Global Impression Scale (CGI))	For participants randomized to the medication monitoring and tailored case management follow-up group.	Twenty-one months after tailored treatment ends - on medication
Secondary	Overall functioning (measured via the Clinical Global Impression Scale (CGI))	For participants randomized to the medication monitoring and tailored case management follow-up group.	Twenty-four months after tailored treatment ends - on medication