Cognitive-Function Informed Outpatient Child and Youth Mental Healthcare: A Hybrid Type II Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 215
- 试验地点
- 1
- 主要终点
- Changes in Overall Function and Mental Health Symptoms
研究概览
简要总结
Cognitive Function Informed Care (CFIC) is a new, add-on type of care for mental health outpatients. To receive this type of care, a child/youth does something called a neuropsychological assessment, which are tests given by a special type of psychologist, called a neuropsychologist. These tests give the neuropsychologist information about how that child/youth's brain works, in a way that is unique to them. This information is called cognitive function, and it is shared with the patient and their family. This information is also shared with their mental health provider, who will work with the neuropsychologist to make sure that their treatment makes sense for their brain.
One main purpose of this research is to see if it is better to receive information about cognitive function to help make treatment decisions (CFIC), or better to receive standard care without this information. To do this, participants will be randomly assigned to either receive CFIC or proceed with standard care. Between groups, we will be comparing any improvement(s) in overall function and symptoms.
The other main purpose of this research is to evaluate how CFIC influences the outpatient mental health service (i.e., implementation). We will be monitoring how the service is delivered, documenting changes as needed, asking patients about their experience(s), surveying staff members and evaluating cost.
详细描述
The purpose of the current project is to examine whether clinical outcomes of the care path, Cognitive Function-Informed Care (CFIC), are better than treatment as usual. However, even if clinical outcomes are better, measuring uptake into clinical care and sustainability of the model are crucial if study results are to have a long-term impact on treating CYMH disorders. Therefore, we will concurrently evaluate implementation of CFIC, including fidelity to the protocol, adaptations needed during implementation, provider adoption of the protocol, reciprocal effects of the context, experiences of patients, families, providers, and administrators, fiscal and time costs, and administrative effects on the CHEO MH Outpatient Clinic, e.g., patient flow while the study is going on. This type of research may be described as a Hybrid Type II Implementation-Effectiveness study.
The primary clinical objective is to determine if CYMH outpatients receiving CFIC will have a more robust response to their treatment plans than those who do not. A "robust response" is defined as a statistically and clinically meaningful pre-post change in quantitative scores of overall function and symptoms of MH disorders. The primary implementation objective is to determine if CFIC was fully implemented.
We have also included some exploratory objectives to look for differential responses to the CFIC intervention. The first is to categorize different profiles of neurocognitive functioning among children and youth seeking outpatient mental health care and then explore whether certain neurocognitive profiles predict treatment outcomes. The second exploratory objective is to investigate whether differentially responding sub-groups can be characterized by baseline participant features, e.g., age, sex/gender, race, past MH history, geographic categorization of the family home (Rurality Index of Ontario (RIO)), school history, and baseline MH symptoms. If the project demonstrates that CFIC produces better clinical outcomes than routine care and is implementable, it will be important to determine if everyone needs CFIC, or if we can predict who may not do well with it. This exploration could lead us to further improve the efficiency of CFIC, as well as modify the intervention if necessary for children and youth marginalized by geographic location (distance from tertiary care centre), sex/gender status, or race, three of the most common causes of MH disparities .
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 7 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children and Youth: At least 7 but no more than 17 years of age at enrollment.
- •Referred by the initial CHEO Outpatient MH clinician (the Choice clinician) to an individual Outpatient MH provider (an Individual Partnership provider).
- •Parents/Caregivers:
- •- The parent/guardian/caregiver of a child or youth meeting the above criteria
- •Mental Health Staff:
- •Partnership-level providers involved in delivering CFIC to children/youth in CHEO's Outpatient MH Service.
- •Administrative leaders (i.e, Medical Lead, Clinical Lead, Manager, MH Program Director, Chief of Psychiatry) for CHEO's Outpatient MH Team.
排除标准
- •Younger than 7 years of age or older than 18 years at initial CHEO Outpatient MH appointment.
- •Referred to any non-individual provider appointment by the initial CHEO Outpatient MH clinician (the Choice clinician); this includes referral to providers administering group or Rapid Response Team care.
- •Does not understand English or French.
- •Parents/Caregivers:
- •The adults responsible for any child or youth in the situations described above.
- •Does not understand English or French.
- •Mental Health Staff:
- •- Providers not involved in delivering CFIC to children/youth as part of CHEO's Outpatient Mental Health Service.
研究组 & 干预措施
Intervention
Participants will receive a neuropsychological assessment before treatment. Results from this assessment will be interpreted and applied to their treatment plan.
干预措施: Cognitive Function Informed Care (CFIC) (Other)
Treatment as Usual (TAU)
The TAU group will proceed with the standard mental health care path. Once post-test measures are complete, these participants will receive a neuropsychological assessment.
干预措施: Standard Care (in control arm) (Other)
结局指标
主要结局
Changes in Overall Function and Mental Health Symptoms
时间窗: From enrollment to the end of treatment, in 6 months or less.
We will measure overall social and psychological function for the Primary Clinical Objective using the Child Global Assessment of Function Scale (CGAS) , one of the most widely used clinician-rated measures of social and psychological functioning for children ages 4-16 years (can be used in youth as old as 17 years). We will evaluate MH diagnoses and symptoms for the Primary Clinical Objective with the Ontario Child Health Study - Emotional Behavioural Scales (OCHS-EBS) , a series of self-report or patient-reported outcomes measures (PROMS) based on the Ontario Child Health Study that assess common child/youth mental health disorders. We will use the original 52-item self-report youth and caregiver versions only.
CFIC Implementation
时间窗: From enrollment until 6-8 months after beginning their partnership appointment, unless discharged from treatment sooner.
The implementation evaluation will include fidelity to the protocol, adaptations needed during implementation, provider adoption of the protocol, reciprocal effects of the context, experiences of patients, families, providers, and administrators, fiscal and time costs, and administrative effects on the CHEO MH Outpatient Clinic, e.g., patient flow. We will evaluate experiences with care using two methods. The first is the Experiences of Service Questionnaire (ESQ) , which will be given to youth and caregivers in both arms at the end of treatment or 6 months after starting their Partnership treatment (post-test). We will want to compare the experience of care between the groups, as significantly more positive or negative experiences in the CFIC group will help inform acceptance of the intervention. The second method of evaluation will be using data from semi-structured interviews with participants and their families about their experience of the CFIC intervention.
次要结局
未报告次要终点