Is an Integrated Care Pathway for Adolescents With Depression More Effective Than Treatment as Usual? A Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 4
- 主要终点
- Change in Childhood Depression Rating Scale-Revised scores
研究概览
简要总结
Major Depressive Disorder in adolescence is prevalent and debilitating. Our group aims to improve treatment response through the use of an Integrated Care Pathway (ICP) based on a high quality Clinical Practice Guideline and measurement-based care (MBC; where periodic symptom scale scores are used to make treatment decisions). We propose a controlled clinical trial comparing ICP to treatment-as-usual (TAU) across two sites.
详细描述
Background: There is a gap between what is known from the evidence about the treatment of adolescent depression and what is practiced. Moreover, while there is evidence that measurement-based care can improve outcomes for adults with various mental health conditions, there is limited information on this framework in adolescent depression.
Objective
Our study aims to enhance the implementation of evidence-based care (using the NICE Clinical Practice Guidelines as a template) combined wtih measurement-based care through the use of an Integrated Care Pathway (ICP) in adolescents with depression.
Hypothesis
As this is a pilot study, our hypotheses centre around feasibility. We hypothesize that: (1) we will recruit at least 30 participants to the ICP treatment arm and 30 participants at the "treatment-as-usual" arm at a different site (2) that baseline measures will be fully completed by 95% of adolescents recruited, (3) that baseline measures will take 2 hours to complete for adolescents and 1 hour to complete for caregivers, (4) that a mean of 90% of the key aspects of the treatment protocol are followed in the ICP group (5) that 80% of participants recruited will complete measures at the end of the 20-week interval and that (6) 90% of the youth, caregivers and clinicians who partake int eh study will attend a focus group to provide qualitative feedback on their experience.
Design: This is a non-randomized controlled clinical trial. Randomizing at the individual level is not possible - the intervention is implemented at the clinic level; so the effect of the intervention on one youth within a clinic would influence the care of other youth at the clinic.
Sampling: Participants are recruited from psychiatric clinics at 2 sites. Each site will recruit to their respective treatment arm.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Participants are not blinded.
入排标准
- 年龄范围
- 14 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Psychiatrist's impression is that depression is a primary psychiatric. concern
- •14-18 years old.
- •DSM-5 criteria for Major Depressive Disorder or Persistent Depressive Disorder as per the Diagnostic Interview for Affective Symptoms for Children (DIAS-C19).
- •Speak, read and write English at a grade 6 level.
排除标准
- •Threshold psychotic symptoms.
- •Bipolar disorder.
- •Moderate-to-severe substance use disorder.
- •Autistic spectrum disorder or intellectual disability.
- •Eating disorder.
- •Suicide-related behaviours requiring acute intervention.
研究组 & 干预措施
Integrate Care Pathway
The intervention is an Integrated Care Pathway with 3 key components.
- Clinical Practice Guidelines (CPG) recommendations: The initial template of the treatment protocol was based on the NICE CPGs for Depression in Children and Young People.
- Provider engagement: The clinicians at CAMH reviewed the template and collaboratively developed a flow chart defining the treatment protocol.
- Measurement-based care: Feedback measures are taken every four weeks and the results are provided to the clinician, patient and family to inform treatment decisions. The feedback measures are the Mood and Feelings Questionnaire, the Columbia Impairment Scale (CIS) and the General Functioning Domain of the McMaster Family Assessment Device (MFAD).
干预措施: Integrated Care Pathway (Behavioral)
Treatment As Usual
Treatment As Usual : Participants at SHSC will receive treatment at could include a psychiatric evaluation, possible medication management and various types of psychotherapy, including cognitive-behavioural therapy, interpersonal psychotherapy, psychodynamic psychotherapy and family therapy. There is no structured protocol and no systematic Measurement Based Care. A research assistant will record the interventions received in either group via chart review.
干预措施: Treatment As Usual (Behavioral)
结局指标
主要结局
Change in Childhood Depression Rating Scale-Revised scores
时间窗: 20 weeks
The CDRS-R is a 17-item measure rated by an evaluator after a semi-structured interview with the adolescent relating to symptoms of depression over the past 2 weeks. Scores range from 0 to 100 with a score of over 55 interpreted as a moderate to severe rating. Lower values represent a better outcome.
次要结局
- Change in WHO Disability Assessment Schedule 2.0 for Children And Youth(20 weeks)
- Change in Childhood Behaviour Checklist(20 weeks)
研究者
Darren Courtney
Principle Investigator
Centre for Addiction and Mental Health