Family & Caregiver Engagement Checklist & Resources

*Please Note: The information on this page is still being developed. To submit comments, resources, or to join the working group, please contact us!

Supporting families and caregivers in mental health research

We are proud to introduce a new module in the STARR Site Certification program focused on caregiver engagement, developed in collaboration with the National Federation of Families (NFF). This module helps equip staff with the understanding and tools to help involve families and caregivers effectively in mental health research.

We recognize the vital role that families and caregivers play in mental health research and treatment. This resource page is designed to encourage and support clinicians and research site staff in engaging families and caregivers effectively, helping to improve communication and collaboration.

The active involvement of families and caregivers can have an enormous impact on mental health clinical research. Caregivers are not only integral to the daily lives of participants but can also significantly influence the success of clinical studies. Here’s why their engagement is indispensable:

1. Enhancing Participant Support and Compliance

Mental health conditions often impact an individual’s ability to fully comprehend or adhere to complex study protocols. Families and caregivers serve as an essential support system, helping participants remember appointments, adhere to medication schedules, and follow study guidelines. Their involvement reduces the risk of dropout and ensures higher data integrity by promoting consistency in participation.

2. Providing Valuable Insights

Families and caregivers offer unique perspectives on participants’ behaviors, challenges, and progress that researchers may not observe during study visits. Their observations can provide context to clinical data, helping researchers better understand the real-world implications of mental health interventions. This holistic view ensures that studies capture not only clinical outcomes but also the day-to-day realities of living with mental health conditions.

3. Improving Communication and Trust

Engaging families and caregivers fosters open communication and builds trust between researchers and the communities they serve. Mental health conditions are often accompanied by stigma, making participants and their families wary of research. By involving caregivers, researchers can address concerns, clarify misconceptions, and demonstrate their commitment to the well-being of participants, thus enhancing overall trust in the research process.

4. Reducing Stigma and Isolation

When caregivers are actively involved in research, they become part of a broader network of support. This can reduce feelings of isolation and stigma that often accompany caregiving roles. Moreover, it emphasizes the societal value of their role, empowering families to advocate for better mental health care and research outcomes.

5. Supporting Long-Term Impact

The ultimate goal of mental health research is to improve treatment options. By engaging families and caregivers, researchers can better understand how interventions affect not just the individual but their entire support system. This long-term perspective ensures that research translates into practical, sustainable improvements in mental health care.

6. Advancing Ethical Research Practices

Involving families and caregivers aligns with ethical principles of research, emphasizing respect for participants and their communities. It ensures that participants’ support systems are acknowledged and valued, and that the research process considers the broader context of participants’ lives.

Engagement Checklist

We have created a tool to assess your SOPs and help identify any gaps for involving families and caregivers. There are two versions of the checklist: a short version for a quick assessment and a long version for a more comprehensive evaluation.  See the sidebar for links to the Checklists.

Contact

If you have any questions or need assistance in any way, please contact us.  We would be happy to work with you to include the Family & Caregiver Engagement exercise into your training program or curriculum.

Family and caregiver engagement is not merely a complementary aspect of mental health clinical research; it is a cornerstone of its success. By involving these key stakeholders, researchers can enhance study outcomes, foster trust, and ensure that mental health interventions are effective and applicable in real-world settings. As the field of mental health research evolves, embracing the voices of families and caregivers will remain essential to driving meaningful progress.

Engagement Checklist

Use this checklist to identify gaps and assess your strategies for involving families and caregivers. Choose between the short version for a quick assessment or the long version for a more comprehensive evaluation.

Short Checklist – 10 Items

Long Checklist is coming soon! We are working on a comprehensive version of the checklist for those who want a deeper dive into family and caregiver engagement best practices.

 

Additional Resources:

 

Additional Notes:

  • When working with patients with SMIs, it’s wise to actively engage a caregiver, even when its not required by the protocol. At the very least, you could get a secondary or emergency contact.
    • Create a caregiver form for all patients as part of their registration at the site. This does not give the right to disclose PHA unless specifically indicated by the study volunteer.
    • Patient does not have to give the name of a caregiver/family member if they do not wish.
  • When meeting with patients and their caregivers, you can offer validation, empathy, and compassion, HOWEVER researchers must be extremely careful with interactions so as to not create study bias. Educate as much as possible and be open about medications’ side effects, etc., but too much empathy or validation could come across as persuasion, which we absolutely steer away from.
  • Informed Consent Forms (ICF) are created by sponsors and approved by the IRB and do a great job of avoiding jargon. For study specific documents, you must have IRB approval, and they ensure clear language. Site staff should read through all information with the patient and their caregiver (if required/allowed) and answer any questions and ensure understanding.
  • If a family member reaches out, you must get consent from the patient to give them information, similar to a hospital. This may take longer than 48 hours depending on the patient.
  • Create a form to collect family and/or caregiver info.  In addition to asking about patient resources being shared, ask the caregiver if resources have been provided to family / caregivers
    • thinking specifically local NAMI Family Support Groups and NAMI Family-to-Family Education classes, DBSA caregiver support groups, etc, as well as Alzheimer’s Association Caregiver Support Groups.
  • sometimes the caregiver is a good candidate for other studies on-site with other indications – like memory loss, vaccines, etc. Maybe have a question where you ask if they have shared other opportunities at the site for the entire family?

 

Workgroup:

Dana LaBranche, NFF (Co-Chair)
Mallory Witham, Pillar
Rachel Barber, CenExel GA
Tamara Nelson, NTXCT
Erica Moore, The STARR Coalition