Sibling Caregiver CMC Pilot Study

NCT07756502 | Not Yet Recruiting

• 1 other identifier: 3875
• Study Type: interventional
• Target: 63
• Locations: 0 countries
• Sites: N/A

Brief 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. 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. Our goal is to understand how to best support the mental health of siblings of children with medical complexity. We created 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. 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, we 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 we 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. We 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, we have already conducted a similar study where we tested this model on parents of children with medical complexity. We found parents used the model and were linked to supports quickly.

Conditions

Children With Medical Complexity (CMC); Siblings; Mental Health

Keywords

children with medical complexity; siblings; mental health

Outcome Measures

Primary Outcomes (1)

• Feasibility of recruitment

  Recruitment rate (how many participants were enrolled VS how many were invited to participate)

  From enrollment to 12-month follow up

Secondary Outcomes (10)

• Feasibility Outcomes - Retention Rate

  From enrollment to 12-month follow up

• Feasibility Outcomes - Rate of Positive Screens

  From enrollment to 12-month follow up

• Sibling Mental Health - Depression and Anxiety Symptoms

  From enrollment to 12-month follow up

• Sibling Mental Health - Proportions of Unmet Mental Health Needs

  From enrollment to 12-month follow up

• Quality of Life Measure

  From enrollment to 12-month follow up

Study Arms (1)

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.

Behavioral: Mental health assessment and diagnosis, psychotherapy, and treatment

Interventions

Mental health assessment and diagnosis, psychotherapy, and treatment BEHAVIORAL

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).

Mental Health Screening

Eligibility Criteria

• Age: 10 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

Sponsors & Collaborators

• The Hospital for Sick Children: lead
• Women's College Hospital: collaborator

MeSH Terms

Conditions

Psychological Well-Being

Interventions

Psychotherapy; Therapeutics

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior

Intervention Hierarchy (Ancestors)

Behavioral Disciplines and Activities

Central Study Contacts

Julia Orkin

CONTACT

416-813-7654; julia.orkin@sickkids.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Scientist

Study Record Dates

• First Submitted: July 31, 2026
• First Posted: August 10, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): September 1, 2028
• Last Updated: August 10, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share