Effectiveness of an Integrated Care Pathway for Adolescent Depression: A Quasi-experimental, Multi-site, Cluster Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- The Mood and Feelings Questionnaire (MFQ) child, long version
研究概览
简要总结
This is a quasi-experimental, multi-site cluster controlled clinical trial design with two intervention arms--Treatment As Usual (TAU) and an Integrated Care Pathway (ICP). Eligible participants are between the ages of 13 and 18, who present to community mental health agencies with depressive symptoms as the primary concern. The primary clinical outcome of interest is the difference between treatment groups in the rate of change of depressive symptoms from baseline to 24-week endpoint as measured by the Mood and Feelings Questionnaire. The secondary outcomes include rate of change of functional improvement, as measured by the Childhood Anxiety and Depression Life Interference Scale, and caregiver-rated internalizing symptoms as rated by the Childhood Behaviour Checklist. This study will also be examining implementation outcomes such as feasibility, fidelity cost and acceptability.
详细描述
Background: Depression is the leading cause of disability in adolescents and a potent risk factor for suicide. Evidence-based treatments are available; however, many clinics do not provide guidelines-based treatments. Integrated Care Pathways (ICPs) are treatment algorithms based on the highest quality practice guidelines intended to facilitate the delivery of evidence-based treatment at the clinic level. Our group has already tested the feasibility of ICP for adolescent depression at an academic setting. There is still uncertainty regarding whether ICPs lead to improved outcomes in depression in adolescents in community settings relative to typical care.
Objective: The current study aim is to test the effectiveness of an ICP for depression in adolescence, called the CARIBOU-2 intervention, versus treatment-as-usual (TAU) in community settings. This study will also examine important implementation outcomes.
Method: The primary participants are adolescents (Up to N=150), between the ages of 13 to 18 with depressive symptoms, presenting to one of the participating sites. Through a quasi-experimental, multi-site cluster controlled clinical trial design, sites began in the TAU condition and transitioned to the ICP condition once local enrollment to TAU has reached up to 25 participants. The primary clinical outcome of interest is the difference between treatment groups in the rate of change of depressive symptoms from baseline to 24-week endpoint as measured by the Mood and Feelings Questionnaire. Secondary outcomes include rate of change of functional improvement, as measured by the Childhood Anxiety and Depression Life Interference Scale, and caregiver-rated internalizing symptoms as rated by the Childhood Behaviour Checklist. This study will also be examining the following implementation outcomes: feasibility, fidelity cost and acceptability. Implementation will also be assessed at three additional sites through a light-touch evaluation conducted several months after training and implementation of the pathway, focusing on clinicians' perspectives and experiences.
Statistical Analyses:
Descriptive data analysis will be first conducted to examine distribution of collected measures and evaluate whether there are significant differences across arms of assigned sites. Generalized linear mixed-effects model will be the primary analytic tool for evaluating whether the CARIBOU-2 intervention is more effective than TAU for adolescents with depression presenting to care with regards to improvement of depressive symptoms, self-reported functioning, caregiver-reported internalizing psychopathology, and suicidal ideation and behaviours. Time, treatment assignment and their interactions will serve as the primary predictors for the analyses. As an example, if we let Y_ijt to denote a continuous outcome of the j-th participant of the i-th site measured at time t, a linear model for Y_ijt will look like the following:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None (Outcomes Assessor)
盲法说明
The evaluator of the primary outcome will be blind to treatment arm as well as blind to the stepped wedge design.
Edited March 7th, 2024: The evaluator of the primary outcome will be blind to treatment arm as well as blind to the quasi-experimental cluster controlled design.
入排标准
- 年龄范围
- 13 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Youth is aged 13 to 18 years, inclusive.
- •Youth and/or their caregiver is expressing that 'depression" (or some synonym) is a concern.
- •Clinician agrees that depressive symptoms are a treatment target.
- •Mood and Feelings Questionnaire score is ≥22 at two sequential visits (screening and baseline assessment).
- •Youth must be new to the site (in past 3 months) or have a period of no treatment for 3 months
排除标准
- •Known or highly suspected presentations of psychotic symptoms that are persistent, affect functioning, and have observable effects on behaviour.
- •Severe substance use disorder, bipolar disorder, autism spectrum disorder or intellectual disability, severe eating disorder, imminent risk of suicide requiring hospitalization as per judgment of the assessing clinician.
- •Inability to provide informed consent to the study for any reason
- •Youth currently in Day Treatment
研究组 & 干预措施
CARIBOU-2
After the CARIBOU-1 pilot study, the Principal Investigator revised the ICP to render it more applicable to community settings as well as offer a second-line psychotherapy ("Brief Psychosocial Intervention") for youth who do not engage with, or respond to, cognitive-behavioural therapy. The revised version is called the CARIBOU-2 intervention. The current iteration of the pathway involves a series of steps: (1) structured assessment, including safety assessment; (2) education on depression, sleep, exercise, and diet; (3) psychotherapy (with 1st line Cognitive Behavioural Therapy, 2nd line "Brief Psychosocial Intervention"); (4) a caregiver structured support group; (5) medication options (1st line fluoxetine, 2nd line sertraline); (6) "team reviews" every four weeks, (meeting with the youth and involved clinicians to review measures and discuss treatment changes); and, (7) discharge and follow-up planning.
干预措施: CARIBOU-2 (Other)
Treatment as Usual
Study involvement for all sites will begin in the TAU condition, which is the typical treatment at the participating community mental health agency. A range of treatments observed in our previous survey of sites will be on offer in these agencies, depending on the preferences and context of the local agency. In typical TAU in community mental health agencies, depressive symptoms and function are not systematically monitored via standardized rating scales. TAU may or may not include referral to psychotherapy and/or parent support. There are no prompts to prescribe specific medications, and/or internal and external referrals to treatment and other services, guided by local service standards.
干预措施: Treatment As Usual (Other)
结局指标
主要结局
The Mood and Feelings Questionnaire (MFQ) child, long version
时间窗: Change from baseline to 24 weeks
The MFQ is a 33-item self-report measure for youth regarding depressive symptoms experienced over the prior 2 weeks. It was specifically recommended in the NICE guideline, given its strong psychometric properties; namely, it has high discriminatory ability in adolescents, good internal consistency (α=0.92-0.94) and good test-retest reliability (Pearson's r=0.78). It has also been used in a large trial of psychotherapy with adolescents where it was sensitive to change.
次要结局
- Ontario Perception of Care Tool for Mental Health and Addictions(Change from baseline to 24 weeks)
- Youth Quality of Life Scale Research Version(Change from baseline to 24 weeks)
- Health and Social Service Utilization(Change from baseline to 24 weeks)
- The Child Behaviour Checklist (CBCL) - Parent Report Form(Baseline to 24-weeks)
- Clinical Global Impression Scale - both the Improvement Subscale (CGI-I) and Severity Subscale (CGI-S)(Baseline to 24-weeks)
- CollaboRATE(Change from baseline to 24 weeks)
- Adolescent Alcohol and Drug Involvement Scale Grid(Change from baseline to 24 weeks)
- Cognitive Behavioural Therapy Skills Questionnaire(Change from baseline to 24 weeks)
- Columbia Suicide Severity Rating Scale(Change from baseline to 24 weeks)
- Depression Rating Scale(Change from baseline to 24 weeks)
- Nonsuicidal Self-Injury(Change from baseline to 24 weeks)