Children With Medical Complexity (CMC)NCT07756502
Sibling Caregiver CMC Pilot Study
A study testing Mental health assessment and diagnosis, psychotherapy, and treatment in people with Children With Medical Complexity (CMC) and Siblings, run by The Hospital for Sick Children.
Trial summary
Children with medical complexity require intense caregiving from their parents and other health care providers, such as family doctors and medical specialists. These children have complex and lifelong medical conditions, and can be dependent on technology to help them breathe, move, or eat. Read more about this study
- Who is it for?
- Ages 10 to 17 years
- Conditions the study is for
- Children With Medical Complexity (CMC), Siblings, Mental Health
- What is being tested?
- Mental health assessment and diagnosis, psychotherapy, and treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2026to 1 Sep 2028
- Phase
- Interventional
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 10 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Have a sibling with medical complexity followed by the SickKids Complex Care program
- Age 10 to 17 (inclusive)
- Capable of completing the study measures independently or with the help of translation services
Who cannot join
- Siblings who do not meet the three inclusion criteria
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Caring for the Mental Health of Sibling Caregivers of Children With Medical Complexity: a Pilot Study
Children with medical complexity require intense caregiving from their parents and other health care providers, such as family doctors and medical specialists. These children have complex and lifelong medical conditions, and can be dependent on technology to help them breathe, move, or eat. From a young age, siblings of children with medical complexity typically assume caregiving roles to support their families. Caregiving may be associated with increased depression and anxiety in siblings, disruptions in routine, parental neglect, and constant changes. There is a gap in research on, and supports for, the mental health of these siblings.
The goal of this study is to understand how to best support the mental health of siblings of children with medical complexity. A new model of support that involves measuring mental health symptoms in siblings age 10-17 through surveys and a mental health assessment conducted by social workers was created. Siblings who need support can be referred to social work and child psychiatry services that are integrated in the health care team the family already has a relationship with. By using screening and built-in supports, the investigators hope to create a pathway for siblings that is easy to access and proactive.
Read more
Social workers can provide talk therapy to help siblings manage difficult emotions. Psychiatrists can provide a medical diagnosis if the sibling meets the criteria for an illness such as depression or anxiety. Psychiatrists can also recommend medications or resources to help siblings manage symptoms.
This is a pilot study, meaning the investigators are exploring a new model and would like to gather more information on whether it is realistic to run this model, whether siblings will use it, and to gather information on sibling mental health patterns. The investigators will also be interviewing siblings so they can share their experiences with caregiving and any challenges with mental health support. Findings from this study can inform a larger, more robust study to measure how effective the model is compared to normal care.
While sibling research is new, the investigators have already conducted a similar study where this model was tested on parents of children with medical complexity. The investigators found parents used the model and were linked to supports quickly.
- Being tested
- Mental health assessment and diagnosis, psychotherapy, and treatment
- Keywords
- children with medical complexity, siblings, mental health
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mental health assessment and diagnosis, psychotherapy, and treatmentBehavioural
Mental health need screenings will be conducted by the social workers, who will escalate cases for those meeting clinical cutoffs or requesting additional support in a stepped care approach. The first intervention level involves social workers who conduct assessment and psychotherapy, and determine appropriateness of referral to psychiatry. The second level involves referral to a child psychiatrist for diagnostic assessment and short term treatment of psychiatric illness (only for those who the social worker deems requiring a psychiatric consultation).
| Study group | Role | What they receive |
|---|---|---|
| Mental Health Screening | Experimental | All siblings of CMC will be screened for mental health symptoms by a social worker and those meeting clinical cutoffs will be referred to social work for intervention and social work may refer to child psychiatry. Receives: Behavioral: Mental health assessment and diagnosis, psychotherapy, and treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of recruitment
Recruitment rate (how many participants were enrolled VS how many were invited to participate)
Measured: From enrollment to 12-month follow up
Secondary outcomes (10)
Feasibility Outcomes - Retention Rate
Retention rate is measured through how many participants exited the study before the 12-month time point.
Measured: From enrollment to 12-month follow up
Feasibility Outcomes - Rate of Positive Screens
Rate of positive screens on the mental health measures is measured through how many participants screen above the clinically significant cutoff on the Revised Children's Anxiety and Depression Scale (RCADS).
Measured: From enrollment to 12-month follow up
Sibling Mental Health - Depression and Anxiety Symptoms
This is measured using the Revised Children's Anxiety and Depression Scale (and Subscales) (RCADS). This questionnaire has 47 items and takes approximately 10 minutes to complete, and screens for symptoms of separation anxiety disorder, social phobia, generalized anxiety disorder, panic disorder, obsessive compulsive disorder, and low mood (major depressive disorder). The measure yields a T-score for each subscale that can be compared to clinical cutoffs. A T-score of above 65 on any subscale indicates the need for further assessment by social work before a referral to child psychiatry is made.
Measured: From enrollment to 12-month follow up
Sibling Mental Health - Proportions of Unmet Mental Health Needs
This is measured through rates of referral to social work and psychiatry services.
Measured: From enrollment to 12-month follow up
Quality of Life Measure
This is measured using the Pediatric Quality of Life Inventory (PedsQL). The questionnaire assesses four different dimensions: physical functioning, emotional functioning, social functioning, and school functioning. It consists of 23 items in total, with scores ranging from 0 to 100. Higher scores indicate better quality of life.
Measured: From enrollment to 12-month follow up
Mental Health Experiences of Siblings
This will be explore through qualitative interviews focusing on caregiving role, impact of caregiving, gaps in mental health support, and barriers to support.
Measured: At 12-month follow up
Social Work Clinical Outcomes - Engagement
This is measured by number of appointments and length of time of follow up with social work if the child is seen by social work beyond the initial assessment. This will be recorded on a form filled out by the social worker.
Measured: From enrollment to 12-month follow up
Social Work Clinical Outcomes - Reason for Referral
If the child is seen by social work beyond the initial assessment, the primary reason for referral will be recorded on a form filled out by the social worker.
Measured: From enrollment to 12-month follow up
Psychiatry Clinical Outcomes - Engagement
This is measured by number of appointments and length of time of follow up with psychiatry. This will be recorded on a form filled out by the psychiatrist.
Measured: From enrollment to 12-month follow up
Psychiatry Clinical Outcomes - Diagnosis
If the child is seen by psychiatry at WCH, any new diagnoses will be recorded on a form filled out by the psychiatrist.
Measured: From enrollment to 12-month follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2026
- Study start1 Sep 2026 (estimated)
- Primary completion1 Sep 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.
- Other trials for Children With Medical Complexity (CMC)Studies 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
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 63 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Collaborators
- Women's College Hospital
- Responsible party
- Principal investigator, Julia Orkin, The Hospital for Sick Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07756502
- Sponsor's protocol ID
- 3875
- Status last verified
- Jul 2026
- First submitted
- 31 Jul 2026
- Last updated
- 12 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No