Sibling Caregiver CMC Pilot Study
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age10-17
SponsorThe Hospital for Sick Children
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
None
Trial design
Design model
Single group
Treatments tested in this trial
Mental health assessment and diagnosis, psychotherapy, and treatment
BehavioralMental 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).
Treatment groups
63 Participants
are divided into 1 treatment groupGroup A: Mental Health ScreeningExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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 upSecondary outcomes
1
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 up2
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 up3
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 up4
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 upLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
The Hospital for Sick Children
Lead sponsor
Women's College Hospital
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: