Parent Council for a Pediatric Stroke Rehabilitation Clinical Trial

Clinical trials are critical for determining treatment approaches in health care. Pediatric trials present challenges with recruitment and accrual and complexities of collaboration with families and caregivers.¹  The authors of reviews of pediatric clinical trials have reported that 6% to 20% of trials were discontinued, suspended, or terminated, mostly due to insufficient accrual.^1,2  When researchers partner with families, clinical studies may improve recruitment and retention and prevent failed trials.³  Although partnerships between scientists and community representatives are not new (multiple studies explored improving patient engagement to enrich research),^4–6  in this article, we present the benefits and lessons learned by this Parent Council and how to provide a framework for researchers.

Parent councils can capture issues that families face as they consider or enter a trial, dealing with practicalities like emotional and financial stressors. We have navigated decision-making in the absence of evidence-based research. This motivates us to advocate on behalf of our children and partner with researchers to drive more efficient and effective trials that upgrade the standard of care.⁷  The chance to help families make informed decisions while shaping the first rehabilitation-focused Phase III pediatric clinical trial was enticing.

I-ACQUIRE is a Phase III intensive pediatric rehabilitation clinical trial comparing 2 dosages of a form of constraint-induced movement therapy (CIMT) to usual and customary treatment in children aged 8 to 36 months with perinatal arterial ischemic stroke. We aimed to enroll 240 participants in this trial.

The I-ACQUIRE proposal scoped a Parent Council of 12 (1 per site) and 2 study investigators. Two precursor trials (Baby CHAMP and CHAMP) did not have parent councils because such councils were highly unusual at the time. The study was funded in February 2019, and the Parent Council was formed in April. In May, the Initiation Meeting convened with all I-ACQUIRE study and principal investigators, StrokeNet and NINDS representatives, study coordinators, and the Parent Council co-chairs. The Parent Council co-chairs identified prospective parents to serve, with assistance from site investigators and therapists.

Sharon had conducted National Institutes of Health-funded community-based participatory research in the past. With that experience, we realized that family input was critically important. The I-ACQUIRE intervention is an intensive treatment, and understanding families’ perspectives about participation was crucial in the design and conduct of this Phase III study. A Parent Council was included from the inception of the grant and budget support was provided for ongoing Council input during the trial. The value the Parent Council has brought to I-ACQUIRE affirms the NIH goal of increased community partner engagement in clinical trials. The contributions of the Parent Council to the success of the I-ACQUIRE trial are an example for clinical researchers who are planning future trials, especially those that involve children. For instance, the Council developed a training program to increase the sensitivity of the research team to families’ concerns, which may have improved retention.

We each had a child who participated in 2 precursor trials. While doing so, staff from our respective sites invited us to help formulate the Parent Council for I-ACQUIRE. In retrospect, the Parent Council should have had input from the onset. For example, we were contacted to review a recruitment brochure the night before its submission was due to the institutional review board. We voiced concerns about the wording and offered revisions. We included plain language and removed scientific jargon, but it felt rushed. Amy Darragh [Investigator Liaison] reports, “We were ready to run with the original flier; the Council dramatically improved it.”

Jennifer’s child also partook in previous trials, traveling from the United Kingdom. The investigators valued her international perspective. Mara was recommended by her child’s neurologist at Massachusetts General Hospital when trial sites were being selected. We had both expressed interest in or begun collaborating on rehabilitation support for families affected by pediatric stroke.

Parents were eligible for the Parent Council if they had a child who had a stroke, hemiplegia, cerebral palsy, or any experience with CIMT or clinical trials. Nominated parents attended an initial [hybrid] meeting in June 2019.

The primary goals of the Council, which were designed by the Parent Council co-chairs and investigator liaisons, were to (1) engage as key trial partners to inform scientific approaches by advocating for families and (2) advise researchers, assessors, and therapists on how best to engage with family members, based on our experiences.

As a Parent Council, we determined and allocated our duties. We jointly reviewed recruitment material and methods, the informed consent processes, assessment methods, and dissemination plans. We initially assigned committee leads but shifted to allocating tasks and projects ad hoc. The co-chair positions have changed biennially through open discussion on the basis of personal workloads and commitments.

Parent Council members receive a stipend for their time, which recognizes their efforts and contributions; co-chairs receive 33% more. We agreed to prorate the stipend by meeting attendance and project assignments. This addressed fluctuations in how much time a member was able to devote. Some members declined the stipend.

We needed extensive training from senior members of the executive committee to remain unbiased in relation to the trial and trial recruitment. Multiple discussions determined if and when parents could be balanced spokespersons for the trial in social media contexts.

The Parent Council composition likely reflects selection bias; enlisted parents generally endorsed CIMT and had higher levels of education, income, and flexibility to take time off for intensive trials. Representation from all trial sites was not achieved, so that criterion was removed. Demographically, through active initial outreach, we found modest racial diversity in the fathers and mothers serving, including a single mother. Because of uneven attrition over the years of the trial, the Council became more female and white. With a small council, achieving diversity has been challenging. Some members left the Council. One retiring member found a replacement; otherwise, we proceeded with fewer members. We have struggled with time management. We serve the Parent Council in addition to employment, caregiving, or homeschooling while parenting children with disabilities, resulting in additional demands and stress.⁸  We feel stretched but value the fulfillment of the partnership, contributing to research via hard-earned experience.

We emphasized plain language recruitment materials and later incorporated photos showing racial and ethnic diversity. We trained study personnel to communicate with family members with sensitivity. We drafted a parent survey for the 6-month posttreatment assessment and collaborated with the study team on a 12-month interview. Data collection continues, and results are not yet available. We designed a newsletter to offer a “warm welcome” for families in the trial. We gave assessors feedback about remote assessment protocols and logistics, and we produced a housing document with site-specific tips for traveling families.

We advocated for a social media presence, building proposals to address study investigators’ reservations around privacy and bias. Initially, we tried a private Facebook Group, with access via issued codes to participating families. Because of insufficient uptake, we then created a public I-ACQUIRE Facebook Page to share trial information such as a site map and the results of precursor trials.

The Parent Council helped keep trial recruitment on target in many ways. We shared compelling information from our Facebook Page. We asked advocacy organizations to include trial information in notices of research opportunities via e-mail, websites, and social media. We partnered with study personnel to offer virtual information sessions to prospective parents hosted by a Treatment Implementation Supervisor and attended by Parent Council members.

We used our Facebook Page to promote these sessions and share other resources. We were existing members of several Facebook Groups with wide participation from parents whose children could be eligible for this trial. We could link to vetted information on the I-ACQUIRE Facebook Page when parents asked questions about the trial. We could also escalate problematic comments (such as therapy misconceptions or bias) to study leadership.

Participants often discover trial opportunities through “word-of-mouth” shares on social media. Allowing us to wear our “Parent Council hat” while navigating Facebook has supported trial interest and recruitment. Some prospective parents have reached out directly to Parent Council members.

Since June 2019, the Parent Council has met monthly via Zoom. For 2 years, a doctoral student provided administrative support, including setting up meetings, agendas, note-taking, and assigning actions. In addition, a council member attends the I-ACQUIRE Executive Steering Committee biweekly call, with the Parent Council as a standing agenda point, to communicate Parent Council activities and perspectives on topics. Two investigator liaisons (Amy Darragh and Craig Ramey) attend Parent Council meetings to solidify open communication. These liaisons also provide Parent Council updates at the monthly I-ACQUIRE Principal Investigator/Study Coordinator webinars. A Parent Council representative serves on the I-ACQUIRE Publications Committee. Study personnel have requested Parent Council participation in writing groups for proposed papers. The Parent Council presented its work at several national conferences to further advocate for integrating advisory councils into pediatric clinical trials.^9,10  The budget included travel expenses supporting the dissemination of the parent perspective.

Engaging with research professionals has led to other opportunities. Parent Council members have jointly authored papers, presented at conferences, and contributed to grant proposals. I have changed careers to educate and advocate for families affected by pediatric stroke or brain injury.

We have been guest speakers at pediatric occupational and physical therapy courses at multiple universities, guiding the next generation of clinicians and researchers on family engagement. Jennifer and I assisted researchers with the viability of an adjacent telehealth CIMT trial and enrolled our children as early participants. While on the Council, I left my teaching role to work for the Child Neurology Foundation.

Being on a Parent Council has empowered us further as advocates, gaining confidence, experience, and a sense of wellbeing from being understood, in contrast to the “fight” that parents of children with disabilities often face.

We have been encouraged to voice opinions, feelings, and ideas, no matter how small or “unscientific” they seem. The range of knowledge and perspectives and a desire from all involved to understand the other was refreshingly dynamic in a historically institutionalized and conservative world of research.

Together, our experience suggests several factors that contributed to the success of our functioning as a Parent Council. A key issue was motivation; we are parents who want to improve options for future families with similar diagnoses. We brought legitimacy to our interactions with trial investigators and participants because we could contribute first-hand experience of the challenges faced by parenting children with disabilities. We gained confidence in our roles as we observed buy-in and support from study leadership. Our success was supported by strong communication between council members and trial investigators, utilizing open e-mail communication and regular virtual meetings. Occasional in-person meetings were especially productive and motivating.

The Parent Council has supported the I-ACQUIRE trial greatly, with the benefits considerably outweighing the challenges. We recommend that investigators consider forming community advisory councils for future applicable trials. Pediatric trials such as I-ACQUIRE treat the child but first require recruiting parents or guardians. We recommend forming a council early to assist with trial design and planning. In this way, lived experience informs all aspects of the study, including maintaining on-target recruitment and enrollment procedures, outcome selection, the design of assessment and intervention protocols, and the dissemination of study findings. Having a proactive council also embedded within the communities of parents helped us reach recruitment targets, even in the face of a global pandemic and budget constraints. Engaged advocates become a resource to support ongoing research and translation of research into practice; we not only relish a place to have our voices heard but we feel that it is part of our “journey” as caregivers to help others, and it would be logical for researchers to capitalize on that.

Current and former I-ACQUIRE Parent Council Members, who are not already listed as authors, also contributed to this paper and the projects described here, including Katy Held, Craig Ramey, Sean Ross, Jill Veach, and Nikki Wolcott. Stephanie DeLuca and Steven Wolf provided helpful reviews.

CIMT

constraint-induced movement therapy