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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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 .
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Phillippe Robaey, MD PhD
- Phone Number: 3916 613-737-7600
- Email: probaey@cheo.on.ca
Study Contact Backup
- Name: Angelica Blais, PhD
- Phone Number: 613-769-2881
- Email: ablais@cheo.on.ca
Study Locations
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Ontario
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Ottawa, Ontario, Canada, K1H 8L1
- Recruiting
- Children's Hospital of Eastern Ontario
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Contact:
- Dasa Farthing
- Phone Number: 613-737-7600
- Email: dfarthing@cheo.on.ca
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Sub-Investigator:
- Kathleen Pajer, MD
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 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. |
|
Active Comparator: 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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Changes in Overall Function and Mental Health Symptoms
Time Frame: 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
Time Frame: 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.
|
Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CHEOREB#26/62X
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
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 Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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