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Cognitive-Function Informed Outpatient Child and Youth Mental Healthcare (CFIC)

2026年9月21日 更新者:Children's Hospital of Eastern Ontario

Cognitive-Function Informed Outpatient Child and Youth Mental Healthcare: A Hybrid Type II Randomized Controlled Trial

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.

研究概览

详细说明

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 .

研究类型

介入性

注册 (估计的)

215

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

  • 姓名:Phillippe Robaey, MD PhD
  • 电话号码:3916 613-737-7600
  • 邮箱:probaey@cheo.on.ca

研究联系人备份

  • 姓名:Angelica Blais, PhD
  • 电话号码:613-769-2881
  • 邮箱:ablais@cheo.on.ca

学习地点

    • Ontario
      • Ottawa、Ontario、加拿大、K1H 8L1
        • 招聘中
        • Children's Hospital of Eastern Ontario
        • 接触:
        • 副研究员:
          • Kathleen Pajer, MD

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

7年 至 17年 (孩子)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:其他
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的:Intervention

Participants will receive a neuropsychological assessment before treatment. Results from this assessment will be interpreted and applied to their treatment plan.

CFIC consists of three components: 1) Stepped Neuropsychological Assessment for every child or youth, which adapts to the individual's cognitive function needs and is recommended when integrating neuropsychological assessments into an existing practice ; 2) Brief Neuropsychological Testing Report completed by a neuropsychologist in the electronic health record (EHR) - these reports are concise and intended to highlight how the cognitive profile can be used to improve treatment, school and home function; 3) A meeting between the neuropsychologist and mental health provider to discuss and tailor treatment, summarized and documented in the EHR.

Following the stepped neuropsychological assessment, there are two ways that CFIC can tailor treatment for an individual. First is an adjustment to the type of psychotherapy planned. The second is by is by optimizing the provider-patient communication and relationship, using information about learning/communication styles.

有源比较器: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.

Participants will meet with their mental health provider as planned. Treatment will be delivered in accordance with standard practice. Neuropsychological assessment results will not be shared with the mental health provider.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Changes in Overall Function and Mental Health Symptoms
大体时间: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.

From enrollment to the end of treatment, in 6 months or less.
CFIC Implementation
大体时间: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.

From enrollment until 6-8 months after beginning their partnership appointment, unless discharged from treatment sooner.

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年7月31日

初级完成 (估计的)

2028年7月31日

研究完成 (估计的)

2028年9月1日

研究注册日期

首次提交

2026年9月21日

首先提交符合 QC 标准的

2026年9月21日

首次发布 (实际的)

2026年9月25日

研究记录更新

最后更新发布 (实际的)

2026年9月25日

上次提交的符合 QC 标准的更新

2026年9月21日

最后验证

2026年9月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

是的

IPD 计划说明

Researchers outside of this specific study may request access to the coded data for new research purposes. Data shared will depend on the request. No personally identifiable information will be shared.

IPD 共享支持信息类型

  • 研究方案
  • 树液
  • 国际碳纤维联合会

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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