An Internet Coping Skills Training Program for Teens With Type 1 Diabetes
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 320
- 试验地点
- 8
- 主要终点
- Hemoglobin A1c (HbA1c)
研究概览
简要总结
The purpose of the study is to compare the effects of a 5-week internet-based coping skills training program (TeenCope) with a 5-week internet education program (Managing Diabetes) in youth (age 11-14) with type 1 diabetes on intensive insulin therapy.
详细描述
It is well established that for many youth with type 1 diabetes (T1D), the developmental stage of puberty is characterized by a significant deterioration in metabolic control. Previous research conducted by the Yale School of Nursing demonstrates that providing cognitive-behavioral coping skills training program (CST) as a supplement to intensive medical treatment regimen enhances physiological and psychosocial outcomes - most notably in youth as they approach adolescence. Successful CST programs studied at Yale consist of weekly, in-person group sessions over a 5-week period conducted by a clinical psychologist or social worker.
Rapid advances in technology have made the internet a compelling tool to reach out to youth and significantly broaden the application of CST programs. Investigators at Yale (scientists, NPs, clinical psychologists) have teamed with web specialists (computer programmers, web designers, graphic artists, and illustrators) and youth with T1D and their parents to adapt the successful CST program for use on the internet. In this trial, internet-based CST (TeenCope) will be evaluated by comparing it to an internet-based education program for managing diabetes (Managing Diabetes).
Three hundred (300) youth from 4 different sites within the U.S will take part in the study. Youth will be randomly assigned to complete either the TeenCope or Managing Diabetes program right away, and will be given the opportunity to complete the alternate program after 12 months. Data on psychosocial and disease management parameters will be collected at baseline, 3, 6, 12 and 18 months through youth filling out online questionnaires (lasting approximately 30 minutes). Clinical outcome data (height, weight, HbA1c, episodes of hypoglycemia, DKA, and hospitalization) will be collected from the medical chart throughout the study, and parents will complete a demographic data form.
This study has great potential for working with youth with type 1 diabetes. If proven effective, the investigators are interested in continued dissemination and translation of this intervention beyond their geographical location.
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
- Triple (Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 11 Years 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 11-14
- •English speaking
- •Youth assents and parent consents to participation
- •School grade is appropriate to age within 1 year
- •Type 1 diabetes for a minimum of 6 months
- •Access to high speed internet service for 5 week intervention (will be arranged by study if not presently in the home)
排除标准
- •Other significant chronic health problems requiring intensive self-management
- •Previous exposure to Yale School of Nursing's Coping Skills Training or Managing Diabetes materials
结局指标
主要结局
Hemoglobin A1c (HbA1c)
时间窗: 18 months
Pediatric Quality of Life Inventory (PedsQL)
时间窗: 18 months
次要结局
- Perceived Stress Scale (PSS)(18 months)
- Self-Efficacy for Diabetes Scale(18 months)
- Responses to Stress Questionaire (RSQ)(18 months)
- Self Management of Type 1 Diabetes(18 months)
- Diabetes Conflict(18 months)
- Diabetes Family Behavior Scale(18 months)
- Children's Depression Inventory(18 months)
- Self-Perception Profile for Adolescents(18 months)