Cognitive-Function Informed Outpatient Child and Youth Mental Healthcare

NCT07842952 | Recruiting

• 1 other identifier: CHEOREB#26/62X
• Study Type: interventional
• Target: 215
• Locations: 1 country
• Sites: 1

Brief 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. 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.

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

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

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

Study Arms (2)

Intervention

EXPERIMENTAL

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

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.

Other: Standard Care (in control arm)

Interventions

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.

Intervention

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.

Treatment as Usual (TAU)

Eligibility Criteria

• Age: 7 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Children's Hospital of Eastern Ontario: lead

Study Sites (1)

Children's Hospital of Eastern Ontario

Ottawa, Ontario, K1H 8L1, Canada

RECRUITING

Related Publications (1)

• 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.

  PMID: 39348851 BACKGROUND

MeSH Terms

Interventions

Standard of Care

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Central Study Contacts

Phillippe Robaey, MD PhD

CONTACT

613-737-7600; probaey@cheo.on.ca

Angelica Blais, PhD

CONTACT

613-769-2881; ablais@cheo.on.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 1:1 Randomized Control Trial

Study Record Dates

• First Submitted: September 21, 2026
• First Posted: September 25, 2026
• Study Start: July 31, 2026
• Primary Completion (Estimated): July 31, 2028
• Study Completion (Estimated): September 1, 2028
• Last Updated: September 25, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF

Locations

CA (1)