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

NCT02142140 | Unknown

• 1 other identifier: MOP 123412
• Study Type: interventional
• Target: 326
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of the study is to examine how well two types of treatment follow up work compared to one another:

1. 1.standard community follow up
2. 2.medication monitoring plus tailored case management follow up.

Conditions

Attention Deficit Hyperactivity Disorder (ADHD)

Keywords

Treatment of ADHD; Long-term treatment follow-up

Outcome Measures

Primary Outcomes (6)

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

  At baseline - no medication

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

  Following 3 months of tailored treatment (including medication)

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

  Six months after tailored treatment ends - on medication

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

  Twelve months after tailored treatment has ended - on medication

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

  Eighteen months after tailored treatment has ended - on medication

• 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 Outcomes (31)

• Social skills (measured via Parent and Teacher Social Skills Rating Scale)

  At baseline - no medication

• Academic achievement (measured via Wechsler Individual Achievement Test (WIAT))

  At baseline - no medication

• Emotional and symptomatic functioning (measured via the Achenbach Child Behavior Check List (CBCL))

  At baseline - no medication

• Overall functioning (measured via the Weiss Functional Impairment Scale (WFIRS))

  At baseline - no medication

• Overall functioning (measured via the Clinical Global Impression Scale (CGI))

  Assessed at baseline

Study Arms (2)

Medication Monitoring & Case Management

EXPERIMENTAL

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).

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

Community Follow-up Group

ACTIVE COMPARATOR

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.

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

Interventions

Academic and Organization skills BEHAVIORAL

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.

Community Follow-up Group; Medication Monitoring & Case Management

Parent Training BEHAVIORAL

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.

Community Follow-up Group; Medication Monitoring & Case Management

Social Skills Training BEHAVIORAL

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.

Community Follow-up Group; Medication Monitoring & Case Management

Long-acting stimulant DRUG

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.

Also known as: Biphentin, Strattera, Concerta, Ritalin, Vyvanse, Adderall, Dexedrine

Medication Monitoring & Case Management

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• McGill University Health Centre/Research Institute of the McGill University Health Centre: lead
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (2)

Montreal Children's Hospital

Montreal, Quebec, H4A 3J1, Canada

Location

Douglas Mental Health University Institute

Montreal, Quebec, H4H 1R3, Canada

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Atomoxetine Hydrochloride; Methylphenidate; Lisdexamfetamine Dimesylate; Adderall; Dextroamphetamine

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals; Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Amphetamine; Amphetamines; Phenethylamines; Ethylamines

Study Officials

• Lily Hechtman, MD, FRCPC

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

  PRINCIPAL INVESTIGATOR

• Natalie Grizenko, MD, FRCPC

  Douglas Mental Health University Institute

  PRINCIPAL INVESTIGATOR

• Ridha Joober, MD, PhD

  Douglas Mental Health University Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Psychiatry and Pediatrics; Director of Research - Division of Child Psychiatry

Study Record Dates

• First Submitted: May 14, 2014
• First Posted: May 20, 2014
• Study Start: December 1, 2012
• Primary Completion: February 1, 2019
• Study Completion: February 1, 2019
• Last Updated: August 28, 2018

Record last verified: 2018-08

Locations

CA (2)