Mental Health CareCFICNCT07842952
Cognitive-Function Informed Outpatient Child and Youth Mental Healthcare
A study testing Cognitive Function Informed Care (CFIC) in people with Mental Health Care and Mental Health in Elementary School Children, run by Children's Hospital of Eastern Ontario at 1 site in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 7 to 17 years
- Conditions the study is for
- Mental Health Care, Mental Health in Elementary School Children, Mental Health Conditions
- What is being tested?
- Cognitive Function Informed Care (CFIC)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 215 participants
- Where
- 1 siteCanada
- Study dates
- 31 Jul 2026to 1 Sep 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Children's Hospital of Eastern Ontario
Ottawa, Ontario, K1H 8L1
Dasa Farthing, 613-737-7600, dfarthing@cheo.on.ca
Kathleen Pajer, MD
About this study
Official title: 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.
Read the 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 .
- Conditions
- Mental Health Care, Mental Health in Elementary School Children, Mental Health Conditions, Mental Health Difficulties, Mental Health Disorders in Adolescents, Mental Health Issues
- Being tested
- Cognitive Function Informed Care (CFIC), Standard Care (in control arm)
- Keywords
- Hybrid Type 2, Neuropsychology, Cognitive Function
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Function Informed Care (CFIC)Other
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.
Standard Care (in control arm)Other
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Participants will receive a neuropsychological assessment before treatment. Results from this assessment will be interpreted and applied to their treatment plan. Receives: Other: Cognitive Function Informed Care (CFIC) |
| Treatment as Usual (TAU) | Active comparator | 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. Receives: Other: Standard Care (in control arm) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Overall Function and Mental Health Symptoms
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.
Measured: From enrollment to the end of treatment, in 6 months or less.
CFIC Implementation
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.
Measured: From enrollment until 6-8 months after beginning their partnership appointment, unless discharged from treatment sooner.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2026
- Study start31 Jul 2026
- Primary completion31 Jul 2028 (estimated)
- Study completion1 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mental Health CareStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 1:1 Randomized Control Trial
- Masking
- None (open label)
- Enrolment
- 215 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Eastern Ontario
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07842952
- Sponsor's protocol ID
- CHEOREB#26/62X
- Acronym
- CFIC
- Status last verified
- Sep 2026
- First submitted
- 21 Sep 2026
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
Blais A, Holahan AL, Helleman A, Pajer K, Honeywell C, Salehi R, Anderson P, Vasserman M. Using Neuropsychological Profiling to Tailor Mental Health Care for Children and Youth: a Quality Improvement Project to Measure Feasibility. Arch Clin Neuropsychol. 2025 Apr 27;40(3):394-408. doi: 10.1093/arclin/acae087.
PubMed 39348851
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive-Function Informed Outpatient Child and Youth Mental Healthcare: A Hybrid Type II Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07842952
- Acronym / sponsor ID
- CFIC / CHEOREB#26/62X
- Conditions
- Mental Health Care, Mental Health in Elementary School Children, Mental Health Conditions, Mental Health Difficulties, Mental Health Disorders in Adolescents, Mental Health Issues
- Keywords
- Hybrid Type 2, Neuropsychology, Cognitive Function
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 215 participants (estimated)
- Lead sponsor
- Children's Hospital of Eastern OntarioUniversity, hospital or other
- Study start
- 31 Jul 2026 (actual)
- Primary completion
- 31 Jul 2028 (estimated)
- Study completion
- 1 Sep 2028 (estimated)
- First posted
- 25 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 1:1 Randomized Control Trial
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Cognitive Function Informed Care (CFIC)Participants will receive a neuropsychological assessment before treatment. Results from this assessment will be interpreted and applied to their treatment plan. |
| Treatment as Usual (TAU) | Active comparator | Other: Standard Care (in control arm)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. |
Who may qualify
- Ages
- 7 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 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).
- The parent/guardian/caregiver of a child or youth meeting the above criteria
- 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.
Key exclusion criteria (8 listed)
- 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.
- The adults responsible for any child or youth in the situations described above.
- Does not understand English or French.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive Function Informed Care (CFIC)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. | Other | Intervention |
| Standard Care (in control arm)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. | Other | Treatment as Usual (TAU) |
Primary outcome
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
- Background: PubMed 39348851Blais A, Holahan AL, Helleman A, Pajer K, Honeywell C, Salehi R, Anderson P, Vasserman M. Using Neuropsychological Profiling to Tailor Mental Health Care for Children and Youth: a Quality Improvement Project to Measure Feasibility. Arch Clin Neuropsychol. 2025 Apr 27;40(3):394-408. doi: 10.1093/arclin/acae087.
- Individual participant dataSharing planned: Yes. 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.
Related trials for Mental Health Care
Not yet recruiting
Be Body Brave: Digital Written Exposure Therapy for Eating Disorders
Eating Disorders
Not yet recruiting
The Effectiveness of Comic-based Learning Materials on Nursing Students' Knowledge, Attitudes, and Confidence in Dementia Care
Dementia Care Education, Students, Nursing
Active, not recruiting
Economic Empowerment and Health Promotion of Uganda Grandmother-caregivers.
Financial Burden, Health Behavior
Not yet recruiting
Hand in Hand: Feasibility of a Compassion-Focused App to Support Parents of Children With Mental Health Problems
Physiological Conditions, Distress, Emotional
Active, not recruiting
Bringing Health Home
Mental Disorders, Severe
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Function Informed Care (CFIC) in people with Mental Health Care and Mental Health in Elementary School Children, run by Children's Hospital of Eastern Ontario at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Phillippe Robaey, MD PhD (613-737-7600 ext. 3916, probaey@cheo.on.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Overall Function and Mental Health Symptoms (time frame: From enrollment to the end of treatment, in 6 months or less.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07842952, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2026.