An interventional study of Mental health assessment and diagnosis, psychotherapy, and treatment in Children With Medical Complexity (CMC), Siblings and Mental Health, sponsored by The Hospital for Sick Children. Recruiting at 1 site in Canada. Open to participants aged 10 Years to 17 Years. Per ClinicalTrials.gov, last updated 2026-11-02.
Sponsored by The Hospital for Sick Children · Not applicable, Interventional, and Screening
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.
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.
2,193 studies on the registry are indexed under Psychological Well-Being; 728 are open to participants now.
This study's planned enrollment of 63 is below the median of 110 across 1,796 interventional studies indexed under Psychological Well-Being.
Browse Psychological Well-Being studies →The Hospital for Sick Children is the lead sponsor of 578 studies on the registry; 83 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 1 (14%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
- Siblings who do not meet the three inclusion criteria
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.
Behavioral: Mental health assessment and diagnosis, psychotherapy, and treatment
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).
Feasibility of recruitment
Recruitment rate (how many participants were enrolled VS how many were invited to participate)
Time frame: From enrollment to 12-month follow up
Feasibility Outcomes - Retention Rate
Retention rate is measured through how many participants exited the study before the 12-month time point.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: From enrollment to 12-month follow up
Plan to share: No
No publications or documents are linked to this record.
Started Sep 2026 (actual). Primary completion is estimated for Sep 2028, 24 months after the start.
Of 1,259 non-industry interventional studies with no phase under Psychological Well-Being, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 34. This study's planned 24 months is above that.
Counting every sponsor, half of 1,302 studies reached it within 16 months; a quarter within 7 and three quarters within 34.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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