Cognitive-Function Informed Outpatient Child and Youth Mental Healthcare (CFIC)
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.
調査の概要
状態
詳細な説明
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 .
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前:Phillippe Robaey, MD PhD
- 電話番号:3916 613-737-7600
- メール:probaey@cheo.on.ca
研究連絡先のバックアップ
- 名前:Angelica Blais, PhD
- 電話番号:613-769-2881
- メール:ablais@cheo.on.ca
研究場所
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Ontario
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Ottawa、Ontario、カナダ、K1H 8L1
- 募集
- Children's Hospital of Eastern Ontario
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コンタクト:
- Dasa Farthing
- 電話番号:613-737-7600
- メール:dfarthing@cheo.on.ca
-
副調査官:
- Kathleen Pajer, MD
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-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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.
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:他の
- 割り当て:ランダム化
- 介入モデル:並列代入
- マスキング:なし(オープンラベル)
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的: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. |
|
アクティブコンパレータ: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. |
この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Changes in Overall Function and Mental Health Symptoms
時間枠: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
時間枠: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.
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協力者と研究者
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- CHEOREB#26/62X
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
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 共有サポート情報タイプ
- STUDY_PROTOCOL
- SAP
- ICF
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米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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