Assessment of the Impact of a Teaching Curriculum on Disruptive Behavior Disorders in Children and Youth: A Pilot Study
试验速览
- 阶段
- 不适用
- 入组人数
- 278
- 试验地点
- 2
- 主要终点
- OSCE scores
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Other
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •General pediatrics residents enrolled in one of the general pediatrics training programs in Canada. Post-graduate years (PGY) 1-4 will be approached for the study.
排除标准
- •Residents not giving informed consent to have their scores shared with the researchers
研究组 & 干预措施
Curriculum administered prior to OSCE
Programs randomized to this arm will receive the teaching intervention (two 2 hour lectures) prior to the OSCE.
干预措施: Teaching intervention (Other)
Curriculum administered after OSCE
Programs randomized to this arm will receive the teaching intervention (two 2 hour lectures) after the OSCE.
干预措施: Teaching intervention (Other)
结局指标
主要结局
OSCE scores
时间窗: OSCE scores will be obtained either between 1-6 months before or 1-6 months after the teaching intervention
Observed Structured Clinical Encounter Score
次要结局
- Pre and Post test scores(The first test will be done the day of the teaching intervention, 5 minutes prior to the intervention being given. The test will then be re-administered 5 minutes after the conclusion of the intervention.)
研究者
Asif Doja
Associate Professor
Children's Hospital of Eastern Ontario
