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NCT Number: NCT07756502

Sibling Caregiver CMC 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.

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.

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Key information

Conditions

Children With Medical Complexity (CMC) Behavior Mental Health Personal Satisfaction Psychological Well-Being Siblings

Age range

10 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • Siblings who do not meet the three inclusion criteria

Treatment and study plan

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).

Primary outcomes

  1. Feasibility of recruitment

    Time frame: From enrollment to 12-month follow up

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

Secondary outcomes

  1. Feasibility Outcomes - Retention Rate

    Time frame: From enrollment to 12-month follow up

    Retention rate is measured through how many participants exited the study before the 12-month time point.

  2. Feasibility Outcomes - Rate of Positive Screens

    Time frame: From enrollment to 12-month follow up

    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).

  3. Sibling Mental Health - Depression and Anxiety Symptoms

    Time frame: From enrollment to 12-month follow up

    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.

  4. Sibling Mental Health - Proportions of Unmet Mental Health Needs

    Time frame: From enrollment to 12-month follow up

    This is measured through rates of referral to social work and psychiatry services.

  5. Quality of Life Measure

    Time frame: From enrollment to 12-month follow up

    This is measured using the Pediatric Quality of Life Inventory (PedsQL)

  6. Mental Health Experiences of Siblings

    Time frame: At 12-month follow up

    This will be explore through qualitative interviews focusing on caregiving role, impact of caregiving, gaps in mental health support, and barriers to support.

  7. Social Work Clinical Outcomes - Engagement

    Time frame: From enrollment to 12-month follow up

    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.

  8. Social Work Clinical Outcomes - Reason for Referral

    Time frame: From enrollment to 12-month follow up

    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.

  9. Psychiatry Clinical Outcomes - Engagement

    Time frame: From enrollment to 12-month follow up

    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.

  10. Psychiatry Clinical Outcomes - Diagnosis

    Time frame: From enrollment to 12-month follow up

    If the child is seen by psychiatry at WCH, any new diagnoses will be recorded on a form filled out by the psychiatrist.

Study contacts

Contact information is provided by the study sponsor or research team.

Julia Orkin

CONTACT

[email protected]

416-813-7654 ext. 201150

Sponsors and collaborators

Lead sponsor

The Hospital for Sick Children

Other

Collaborators

  • Women's College Hospital

Registry information

Official study title

Caring for the Mental Health of Sibling Caregivers of Children With Medical Complexity: a Pilot Study

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Aug 10, 2026
Registry last updated
Aug 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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