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

Attention Deficit Hyperactivity Disorder (ADHD) research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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.

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Attention Deficit Hyperactivity Disorder (ADHD)

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Behavioral:Academic and Organization skillsThis 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.

Behavioral:Parent TrainingThe 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.

Behavioral:Social Skills TrainingSocial 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 stimulantThe 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.

Drug:Long-acting stimulantThe 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.

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

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).

Community Follow-up GroupAll 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.

Study Status

Active, not recruiting

Start Date: December 2012

Completed Date: February 2019

Phase: N/A

Type: Interventional

Design:

Primary Outcome: Attention Deficit Hyperactivity Disorder (ADHD) symptomatology (measured via Conners' Global Index - Parent and Teacher Version)

Secondary Outcome: Social skills (measured via Parent and Teacher Social Skills Rating Scale)

Study sponsors, principal investigator, and references

Principal Investigator: Lily Hechtman, MD, FRCPC

Lead Sponsor: McGill University Health Center

Collaborator: Canadian Institutes of Health Research (CIHR)

More information:https://clinicaltrials.gov/show/NCT02142140

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