Baylor College of Medicine and Texas Children's Hospital, Houston, Texas, USA.
Joslin Diabetes Center, Harvard Medical School, Boston, Massachusetts, USA.
Pediatr Diabetes. 2022 Sep;23(6):792-798. doi: 10.1111/pedi.13349. Epub 2022 May 19.
Despite potential glycemic benefits of continuous glucose monitor (CGM) use in young children with type 1 diabetes, psychosocial and behavioral challenges may interfere with sustained use. We developed a 5-session family behavioral intervention (FBI) to support CGM use.
We report on the multi-step development of the FBI, training interventionists, implementation in a 14-site clinical trial, and participant satisfaction.
A multidisciplinary team created the FBI based on mixed-methods (i.e., survey data, qualitative research) preliminary work with parents of young children. Investigators trained non-physician staff to deliver the 5 sessions per an intervention manual. Trial participants received the FBI either during the first (FBI group, n = 50) or second 6-months (Crossover group, n = 44) of the 1-year trial. Investigators listened to session recordings to rate intervention fidelity, and participants rated satisfaction with the FBI.
The complete 5-session FBI was delivered to 89% of participants, in-person (73%) or by telephone (23%). Sessions lasted 23 min on average, and fidelity was high across sessions. Over 80% of participants rated very high satisfaction with all aspects of the FBI and offered few recommendations for improvement.
Having been developed based on experiences and input of families of young children with type 1 diabetes, the FBI represented a novel behavioral approach to enhance sustained CGM use during a challenging developmental period. Evidence of strong feasibility and acceptability supports its potential for implementation in research and clinical care. As diabetes technologies evolve, the FBI may continue to be refined to address parents' most relevant concerns.
尽管连续血糖监测（CGM）在 1 型糖尿病儿童中有潜在的血糖益处，但社会心理和行为挑战可能会干扰其持续使用。我们开发了一个 5 节家庭行为干预（FBI）课程，以支持 CGM 的使用。
我们报告了 FBI 的多步骤开发、培训干预者、在 14 个地点的临床试验中的实施情况以及参与者的满意度。
一个多学科团队根据对幼儿父母的混合方法（即调查数据、定性研究）初步工作制定了 FBI。研究人员根据干预手册培训非医师人员来实施 5 个课程。试验参与者在 1 年试验的前 6 个月（FBI 组，n=50）或后 6 个月（交叉组，n=44）接受 FBI。研究人员听取了课程录音，以评估干预的一致性，参与者对 FBI 的满意度进行了评分。
完整的 5 节 FBI 课程以面对面（73%）或电话（23%）的方式提供给了 89%的参与者。每个课程平均持续 23 分钟，并且各个课程之间的一致性很高。超过 80%的参与者对 FBI 的所有方面都给予了非常高的满意度，并对改进提出了很少的建议。
FBI 是根据 1 型糖尿病幼儿家庭的经验和意见制定的，代表了一种新的行为方法，以增强在具有挑战性的发育期间持续使用 CGM。强有力的可行性和可接受性证据支持了其在研究和临床护理中的实施潜力。随着糖尿病技术的发展，FBI 可能会继续得到改进，以解决父母最相关的问题。
