Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT03151187 |
| Other study ID # |
15/163X |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
May 5, 2017 |
| Last updated |
January 29, 2018 |
| Start date |
August 1, 2017 |
| Est. completion date |
May 31, 2018 |
Study information
| Verified date |
January 2018 |
| Source |
Children's Hospital of Eastern Ontario |
| Contact |
Asif Doja, MD |
| Phone |
613-737-7600 |
| Email |
adoja[@]cheo.on.ca |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The investigators have initiated an education program for residents on the diagnosis and
management of disruptive behavior disorders in children. These will be presented as two
2-hour modules to be delivered at an academic half-day for pediatric trainees across Canada.
We plan to evaluate the effectiveness of the curriculum by administering a pre and post test.
Pediatric residents in Canada all participate in a practical assessment of their skills (an
Observed Structured Clinical Examination or OSCE). The investigators plan to develop on OSCE
station which assesses the curriculum and randomize programs to do the curriculum either
before or after the OSCE. This will help us determine how effective the curriculum is at
teaching about disruptive behaviours.
Description:
Background Information Children with disruptive behaviour include those with Attention
Deficit Hyperactivity Disorder (ADHD), Oppositional Defiant Disorder (ODD), Conduct Disorder
(CD) and Disruptive Mood Dysregulation Disorder (DMDD). Disruptive behaviour disorders in
children are common, with 4.1% of Canadian school-age children diagnosed with ADHD, 1-6% of
children with ODD, and 0.2-2% with CD. Population-based data from the 1999 British Child
Mental Health Survey has shown that of children diagnosed with ADHD, the rate of comorbid ODD
is approximately 30%, and of CD approximately 31%. Oppositional behaviour, conduct problems,
and aggression in children with disruptive behaviour disorders (DBDs) are major risk factors
for the development of criminality in adolescence and adulthood, and negatively influence
quality of life for children and their families. Providing effective and safe treatments for
aggression and disruptive behaviour is of extreme importance. While the Diagnostic and
Statistical Manual of Mental Disorders, Version 5 has re-organized the categorization of
DBDs, we will refer to ADHD, ODD, CD and DMDD collectively as the DBDs for ease of language
and because behavioural outcomes are similar.
Current Health Problem Four Canadian pharmacoepidemiologic studies conducted over the past 2
years have found an alarming increase in the use of antipsychotics in children. Prescribers
of these medications for children include psychiatrists, paediatricians, and family
physicians, with at least 50% of prescriptions from family physicians. A major concern
regarding the use of antipsychotics is their propensity to cause metabolic, hormonal, and
extrapyramidal side effects, which can have negative long-term health consequences. Metabolic
side effects include weight gain, increase in body mass index, increase in waist
circumference, and abnormalities in cholesterol, triglycerides, glucose, insulin, and liver
enzymes. Hormonal side effects include elevated prolactin and thyroid hormone abnormalities.
Extrapyramidal side effects include akathisia, drug-induced parkinsonism, tardive dyskinesia
and tardive dystonia. While there are several randomized controlled trials demonstrating
efficacy of risperidone for aggression in DBDs, these trials are of short duration (typically
6 weeks or less). Placebo discontinuation studies suggest that long-term treatment is of
limited benefit in the majority of children. Thus, when antipsychotic medications are used to
address aggression in children with disruptive behaviour, they should be a short-term
treatment strategy while behavioural and psychosocial approaches are being initiated.
Longitudinal data suggest, however, that they are being prescribed for longer-term
maintenance therapy, with the median duration of use being 180 days in Canadian school age
children. Currently, there are no studies longer than 6 months in children treated with
antipsychotics for DBDs, raising concerns regarding potential long-term negative effects on
child development.
In response to these research findings, Canadian guidelines on monitoring of adverse effects
of antipsychotic medications in youth - the Canadian Alliance for Monitoring Safety and
Effectiveness of Antipsychotic Medications in Children (CAMESA) guidelines - were published
in 2011 and have been endorsed by the Canadian Paediatric Society and the Canadian Academy of
Child and Adolescent Psychiatry. They provide recommendations on how to monitor children
started on antipsychotic medications, and how to address metabolic abnormalities and
extrapyramidal side effects when they occur. These guidelines were based on a systematic
review of the literature on antipsychotic medication side effects, with engagement of
multiple stakeholders, including psychiatrists, paediatricians, family physicians, and
parents of children with mental illness. Specific evidence-based recommendations are provided
on monitoring procedures which should be followed in children who are prescribed
antipsychotic medications, including the timing of these procedures.
Strong evidence supports the efficacy of psychosocial interventions and behavioural
modification programs for the management of aggression. Recently, clinical practice
guidelines on the assessment, management, and treatment of maladaptive aggression in youth
Center for Education and Research on Mental Health Therapeutics (CERT) guidelines - have been
published in the United States on behalf of the American Academy of Pediatrics and the Agency
for Healthcare Research and Quality. These guidelines provide recommendations for family
engagement, assessment, and diagnosis of maladaptive aggression, as well as psychosocial and
pharmacological treatment. The guidelines are divided into two parts: 1) Engagement,
Assessment and Management, and 2) Treatments and Ongoing Management. In part one, nine
recommendations for family engagement, assessment and diagnosis are described as key
prerequisites for treatment selection and initiation. The recommendations stress the
importance of recognizing the family and social context in which aggressive symptoms arise,
and understanding the underlying psychiatric conditions that are associated with aggression.
In part two, eleven recommendations are provided for ongoing management of aggression. Key
treatment principles include considering psychosocial interventions, such as evidence-based
parent and child skills training, as the first line of treatment; avoiding the use of
multiple psychotropic medications simultaneously; careful monitoring of treatment response
using structured rating scales; and close medical monitoring for side effects.
Rationale The investigators' aim is to specifically target the assessment and treatment of
oppositional behaviour, conduct problems, and aggressive behaviour in children with DBDs due
to the problems with current management strategies we have identified. The present study
seeks to evaluate the effectiveness of this educational intervention by assessing knowledge
and skills of trainees in the management of disruptive behavior disorders in children. This
will be done by examining test scores on a knowledge assessment test given before and after
the intervention. Knowledge and skills will also be assessed using an OSCE (observed
structured clinical examination) station to be designed to specifically to assess how
trainees address disruptive behavior disorders in children.
The investigators have received funding to initiate an education program for residents on the
diagnosis and management of disruptive behavior disorders in children. These will be
presented as two 2-hour modules to be delivered at an academic half-day for pediatric
trainees across Canada.
Study Objectives Primary objective: to determine if differences exist between OSCE scores
from groups who have had the educational intervention on disruptive behavior disorders in
children and those who have not had the intervention.
Secondary Objective: to determine if differences exist between knowledge test scores
Study Design The examination of knowledge of disruptive behavior disorders in children
consists of a written test pre and post the teaching intervention. The evaluation of
knowledge of skills of trainees in disruptive behavior disorders in children is a cluster
randomized trial.
Expected Duration of Subject Participation Participants will have minimal time commitment to
the study in which they will be asked to if they would like to have their anonymized scores
sent to the researchers.
Study Procedures/Evaluations Subjects will be approached for the study 4 weeks prior to the
OSCE by a person known to them, but not involved in the study (i.e., the Program
Administrator for their Pediatrics program). Interested candidates will then be emailed an
introductory email instructions on how to access the e-consent form in REDCap. \.
Participants will be provided with the study team's contact information should they have any
questions prior to signing the e-consent form. Consent forms will be "signed" using the
e-consent feature in REDCap for securely obtaining participant consent from an off-site
location. Electronic records in REDCap (i.e., e-consent forms) will be stored in the REDCap
database, with user rights only permitted to Dr. Doja and his research team.
Knowledge Test:
Subsequent to development of the educational curriculum, a multiple choice test will be sent
to all participating sites This will be pilot tested at the Children's Hospital of Eastern
Ontario (CHEO) on individuals who have recently completed their pediatrics training and will
be revised based on feedback given. The test will then be administered by Program Directors
at their respective institutions before and after the educational intervention. The tests
will be photocopied and copies of the tests from all participating trainees will be sent to
the study PI at CHEO via courier. Prior to being mailed, all copies will be de-identified,
apart from PGY year, and will be assigned a unique study number by the Program Director at
the site.
OSCE:
Subsequent to development of the educational curriculum, an OSCE station and scoring sheet
will be developed and will be pilot tested at the Children's Hospital of Eastern Ontario on
individuals who have recently completed their pediatrics training. The OSCE station will be
revised based on feedback from pilot participants.
All programs in Canada utilize a joint OSCE where trainees in all programs do the same OSCE
stations twice a year. This allows programs to compare their trainees with the performance of
trainees at other centres. This OSCE's typically occur in the Spring and Fall of every year.
Our OSCE station will be used as a station in one of these joint OSCE's.
In this study, the timing of the educational intervention will randomized; we will utilize a
cluster randomization method by grouping sites by the size of their training program. Sites
in each group will then be randomized to have trainees complete the educational intervention
either before or after doing the OSCE station we have developed.
The OSCE will be administered locally at each site and will be scored by evaluators at each
site using the scoring sheet. The scoring sheets will be photocopied and copies from all
participating trainees will be sent to the PI at CHEO via courier. Prior to being sent, all
copies will be de-identified by the Program Director, apart from PGY year, and will be
assigned a unique study number. These scoring sheets will not be linked to the knowledge
tests and will use a different study number.
