Computer-Delivered Motivational Intervention to Improve Teen Diabetes Management
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 145
- 试验地点
- 2
- 主要终点
- Diabetes Management Scale
研究概览
简要总结
The purpose of this study is to develop an intervention to increase parental motivation for supervision and monitoring youth diabetes care behavior. The intervention will be tested in three brief session in conjunction with regularly scheduled diabetes clinic visits and delivered through a computer program based in the principles of Motivational Interviewing.
详细描述
The study includes a development phase (Phase 1: development of the intervention followed by feasibility testing with 10 youth and 10 parents) and a pilot validation phase [Phase 2: pilot randomized clinical trial (RCT)] using a sample of 90 African American youth transitioning to independent diabetes care and their parents. In this phase, families will be randomly assigned to one of three study arms: parent motivation for monitoring and youth motivation for diabetes care (arm 1), parent motivation for monitoring and youth information (arm 2) or parent and youth information (arm 3). In phase 1 (development), youth and their caregivers will complete a one-time research visit where they use the program and provide feedback via a semi-structured interview regarding the usefulness of the content, its user-friendliness and make suggestions for changes to enhance acceptability. In phase 2 ( RCT), families will complete three intervention plus data collection visits and one additional data collection only visit. Research visits will be scheduled to coincide with appointments in the diabetes clinic to maximize convenience for families.
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
- Single (Participant)
入排标准
- 年龄范围
- 10 Years 至 13 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •African American race/ethnicity
- •Age: 10 years 0 months - 12 years, 11 months
- •Type 1 diabetes mellitus
- •Diagnosed at least 6 months
- •Patient of Children's Hospital of Michigan Diabetes Clinics
- •English fluency, both verbal and written
排除标准
- •Psychiatry/psychological diagnoses including cognitive impairment that would prevent the participant from understanding the data collection measures, (i.e. moderate or severe mental retardation) or the following psychiatric diagnoses: autism and schizophrenia. Youth with current suicidal intent are not enrolled until psychiatrically stable.
- •Medical diagnoses that would result in atypical diabetes management i.e. cystic fibrosis. Other medical conditions that would not affect diabetes management, such as asthma, do not exclude the participant from study participation.
结局指标
主要结局
Diabetes Management Scale
时间窗: Each of 3 intervention session, 3-4 month apart
The Diabetes Management Scale (DMS) (Frey, Ellis, Naar-King et al., 2004) is a self-report questionnaire used to measure a broad range of diabetes management behaviors, such as insulin management, dietary management, blood glucose monitoring, symptom response, and parent assistance/supervision.
次要结局
- Parental Monitoring of Diabetes Care(Each of 3 intervention session, 3-4 month apart)
- Treatment Regulation Questionnaire(Each of 3 intervention session, 3-4 month apart)
- Readiness Ruler(Each of 3 intervention session, 3-4 month apart)
- HbA1C Blood Test(Each of 3 intervention session, 3-4 month apart)
- Twenty-four Hour Recall Interview(Each of 3 intervention session, 3-4 month apart)
- Blood Glucose Testing Frequency(Each of 3 intervention session, 3-4 month apart)
研究者
Deborah Ellis, Ph.D.
Associate Professor
Wayne State University