Patient Recruitment Case Study: ADHD - Stark / Raving Health
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Patient Recruitment Case Study: ADHD

A clinical trial evaluating the safety and tolerability of Adhansia XR for children aged 4 to 12 with ADHD

THE CLINICAL TRIAL
The primary objective of the Triumph Study was to assess the safety and effectiveness of extended-release capsules in children aged 4 to 12 with attention-deficit/hyperactivity disorder (ADHD). Parents and their children were invited to join the research study if they were either unhappy with their child’s current treatment or if the child was not taking any ADHD medication. The study drug, designed to be taken orally once daily, consisted of multi-layer release beads enclosed within a capsule. The study also aimed to determine the best or optimal dose for each participant.

 

THE PROJECT
The clinical trial faced several challenges, primarily due to stigmas associated with an ADHD diagnosis and enrolling children into a clinical research program. We needed to ensure that the study’s identity didn’t label the children as “problems” due to their ADHD symptoms but still communicated its impact, especially on young children. Therefore, our study materials had to emphasize the child’s individuality and potential to engage them and help site staff empower their parents to make well-informed decisions concerning their child’s treatment.

Patient recruitment adhd clinical study poster branding and content development
Patient recruitment clinical study for ADHD in adolescents
Patient recruitment adhd clinical study reminder cards branding and content development

Study branding that engages parents and potential participants.

The study branding needed to be vibrant and attention-grabbing within a clinical setting and distinguishable as a clinical research trial for children. To achieve this, our in-house design team merged custom illustrations with stock visuals, portraying the children as superhero-like characters, keeping the study materials bright, playful, and engaging. This aesthetic made our branding more relatable to parents or guardians and potential study participants, who could now effortlessly envision themselves as part of the study, putting everyone at ease.

Patient recruitment adhd clinical study reminder cards branding and content development
Patient recruitment adhd clinical study messaging
Patient recruitment clinical study for ADHD in adolescents
Patient recruitment adhd clinical study messaging

Positive messaging that inspires action from parents.

Enrolling children in a clinical research study can present added challenges, especially for studies testing the safety and effectiveness of an experimental medical product or drug. Parents or guardians might hesitate due to the perceived risks associated with a clinical trial. This makes messaging all the more important. With this in mind, we structured our messaging to aid site staff in effectively communicating the potential benefits of enrolling in clinical studies, their rights, protections, and the safeguards in place. This strategy was instrumental in providing parents and guardians with the knowledge needed to make an informed decision when faced with an alternative treatment option for their child’s ADHD.

Equipping sites with study materials to support patient recruitment.

We developed a comprehensive set of study materials supporting site staff in their patient recruitment efforts. The study toolkit provided them with the means to identify potential study participants, educate both parents or guardians and children about the study, and promote the clinical trial across social media platforms. Additionally, we ensured that the toolkit effectively conveyed the parents’ or guardians’ responsibilities for their child’s participation, such as the 12-month treatment period, including weekly visits and overnight stays, and a dose adjustment period. This involved questionnaires to aid their study doctor in determining an optimal dosage of the study drug for their child.

Patient recruitment adhd clinical study social media marketing
Patient recruitment clinical study for ADHD in adolescents

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