Check It! 2.0: Pilot Test of a Positive Psychology Intervention for Adolescents With Type 1 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Glycemic Control (A1C)
研究概览
简要总结
The treatment regimen for type 1 diabetes is complex and demanding, and many adolescents have problems with adherence. The proposed study will pilot test a positive psychology intervention for adolescents with type 1 diabetes aimed at improving adherence to treatment based on feedback from the first iteration of the intervention. The potential benefits include helping adolescents achieve better glycemic control, thereby reducing the health risks and complications associated with diabetes.
详细描述
The proposed study has the potential to improve adherence to the diabetes regimen in adolescents with type 1 diabetes without compromising their quality of life. The potential benefits include helping adolescents achieve better glycemic control, thereby reducing the health risks and complications associated with diabetes.
The investigators will use a positive psychology framework, which emphasizes positive emotions and strengths rather than problems, to promote adherence.
Positive affect, defined as feelings that reflect pleasurable engagement with the environment (e.g., happy, cheerful,proud), have been linked with favorable health outcomes and increased adherence to medical regimens. Further, positive affect has been shown to increase people's ability to use complex coping strategies. Randomized controlled trials of positive psychology interventions have been shown to successfully increase adults' adherence to medication and physical activity recommendations. However, no studies have examined the effects of positive psychology interventions on adherence behaviors in pediatric populations. Our ongoing work suggests that positive affect in adolescents with type 1 diabetes is related to greater use of adaptive coping strategies, lower levels of family conflict, and fewer depressive symptoms, and demonstrates that a positive psychology intervention has the potential to induce positive affect in adolescents. The investigators propose to pilot test a positive psychology intervention for adolescents with type 1 diabetes. This low-cost, innovative intervention is designed to induce positive affect in adolescents (age 13-17) through tailored exercises in gratitude and self-affirmation. The investigators will also promote positive parental involvement by asking caregivers to provide positive affirmation statements to adolescents. Finally, the investigators will explore the use of technology by delivering the intervention to adolescents and sending reminders to caregivers via text message using the Twilio/REDCap system.
Blood glucose monitoring is one of the best indicators of adherence to the recommended treatment regimen for type 1 diabetes, and frequency of blood glucose monitoring is strongly related to glycemic control. Further, frequency of blood glucose monitoring has been shown to decrease with age in adolescents, and parental reminders to check blood glucose are often a source of conflict between adolescents and their parents. Therefore, blood glucose monitoring represents a specific behavior that may be the best target for adherence interventions in adolescents with type 1 diabetes.
Thus, the specific aims are as follows:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 13 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adolescents will be eligible if they are:
- •between the ages of 13-17;
- •have been diagnosed with type 1 diabetes for at least 1 year;
- •have no other major health problems;
- •are not currently participating in any other intervention studies;
- •have a glycosylated hemoglobin level between 7.5 - 12% on date of enrollment;
- •are patients of the Eskind Diabetes Clinic
- •must read and write in English
- •and must live the caregiver that is participating in the study with them
排除标准
- 未提供
研究组 & 干预措施
Education Group
The education group will be given developmentally-appropriate diabetes education material at the time of enrollment.
干预措施: Education (Behavioral)
Positive Psychology Intervention
The text message group will receive the intervention components via text message. They will be instructed to think about things that make them feel good when they are struggling with diabetes management (i.e. gratitude). Also they will be instructed to think about a positive value when they are in a situation that makes it hard to check their blood sugar (i.e. Self-Affirmation). Additionally, to induce positive mood they will be texted gift cards codes valued at $5.00. Further, caregivers will be asked to provide weekly positive affirmations to their adolescents, focused on non-diabetes strengths. All adolescents will be given developmentally-appropriate diabetes education material at the time of enrollment.
干预措施: Positive Psychology Intervention (Behavioral)
结局指标
主要结局
Glycemic Control (A1C)
时间窗: 3 months
A1C is the percentage of glycosylated hemoglobin and represents an average of glycemic control over the previous 2-3 months.
次要结局
- Positive Affect(3 months)
- Frequency of Blood Glucose Monitoring(3 months)
- Diabetes Family Conflict Scale(3 months)
- Secondary Control Coping(3 months)
- Disengagement Coping(3 months)
- Diabetes-Specific Quality of Life(3 months)
- Primary Control Coping(3 months)
- Self Care Inventory(3 months)
研究者
Sarah Jaser
Assistant Professor
Vanderbilt University