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

McGill University

Status: Unknown

Conditions: Attention Deficit Hyperactivity Disorder (ADHD)

Treatments: Behavioral: Social Skills Training; Behavioral: Academic and Organization skills; Drug: Long-acting stimulant; Behavioral: Parent Training

Study type: Interventional

Funder types: Other

Identifiers

NCT02142140

MOP 123412

Details and patient eligibility

About

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.

Enrollment: 326 estimated patients

Sex: All

Ages: 6 to 12 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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326 participants in 2 patient groups

Medication Monitoring & Case Management

Experimental group

Description:

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).

Treatment:

Drug: Long-acting stimulant

Behavioral: Parent Training

Behavioral: Social Skills Training

Behavioral: Academic and Organization skills

Drug: Long-acting stimulant

Community Follow-up Group

Active Comparator group

Description:

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.

Treatment:

Drug: Long-acting stimulant

Behavioral: Parent Training

Behavioral: Social Skills Training

Behavioral: Academic and Organization skills

Drug: Long-acting stimulant