Improving Self-management in Childhood Diabetes - Feasibility and Preliminary Effects of a CBT-based Intervention for Parents
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 17
- 试验地点
- 2
- 主要终点
- Diabetes Treatment Satisfaction Questionnaire - parent report
研究概览
简要总结
This study investigates feasibility and preliminary effects of a new behavioral parent intervention that aims to support and improve pediatric diabetes self-management
详细描述
Diabetes self-management is extensive, complex and places high demands on the affected individual and his/her family. Today, half of Swedish children and adolescents with type 1 diabetes (T1D) do not reach target levels of glycemic control. Among the various factors that influence glycemic control, family function is of great importance. Parent-child conflicts surrounding self-management tasks have been shown to predict glycemic control deterioration over time. This study will explore feasibility and preliminary effects of a new behavioral parent intervention that aims to strengthen parent-child cooperation and facilitate diabetes routines in every-day-life. The results of the feasibility study will guide further refinement of the intervention, and the design of a future RCT.
Through digital ads and posters at the diabetes clinics in Stockholm, we will recruit parents of children aged 9-14 with T1D experiencing problems in getting diabetes self-management routines to work in every-day-life. The intervention is held at the hospital and includes six weekly group sessions and a booster session one month later. At the end of each session, parents plan to use a new behavioral strategy at home during the upcoming week. This feasibility study will explore participant satisfaction and attendance combined with qualitative assessments of their experiences. Preliminary effects are investigated through repeated assessments of a set of digitalized questionnaires, data from the national diabetes registry and online blood glucose data during the intervention phase, post intervention and at 3- months follow up.
This intervention is believed to be an effective way to target and prevent T1D self-management problems and may come to serve as an important complement to standard diabetes treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Parents/guardians of children aged 9-14 with type 1 diabetes.
- •The child has had type 1 diabetes for at least one year.
- •The parent experience difficulties in managing daily life and/or the parent-child collaboration around self-management routines.
- •The perceived difficulties should not solely be due to perceived problems in the medical aspects of the diabetes treatment, such as a perceived need for more support in insulin dosing, more diabetes education, or technical/medical support. This criterion is based solely on the subjective judgement of the parent him-/herself.
- •The child receives diabetes care at one of the three diabetes clinics in the Stockholm Region.
- •The parent speaks, understands, and can read Swedish.
- •The parent claims to be motivated and has the practical possibility to participate in the study and attend group meetings.
排除标准
- •The parent reports current and severe psychiatric conditions in themselves or the child that need to be prioritized, such as severe depression, suicidal thoughts/self-harm, psychosis, or mania.
- •The parent is involved in another psychological treatment of a behavior-changing nature that is in an active phase, either concerning themselves or a child.
- •Major planned changes in diabetes treatment that require learning and behavioral changes, such as transitioning from pen to pump, and that are expected to occur during the first 3.5 months of the study (active intervention phase).
结局指标
主要结局
Diabetes Treatment Satisfaction Questionnaire - parent report
时间窗: Weekly from baseline to 14 weeks
This is a 14 item questionnaire that aim to measure parental satisfaction with the diabetes treatment. Parents are asked to rate their satisfaction on a likert scale from 0 = very unsatisfied, to 6 = very satisfied about a range of diabetes treatment domains. The questionnaire is based on the adult version of DTSQ and adapted to pediatric type 1 diabetes. Translated to Swedish and validated in a Swedish cohort.
次要结局
- Glycaemic control(From baseline until 15 weeks.)
- DISABKIDS (child QoL) - parent report(From baseline until 15 weeks.)
- Days of physical activity(From baseline until 15 weeks.)
- PedsQL - Family Impact Measure (parent QoL)(From baseline until 15 weeks.)
- Me As Parent(From baseline until 15 weeks.)
- Getting Self-Management Routines Done(Weekly from baseline to 14 weeks)
- Parental Challenges in Diabetes Self-Management(Weekly from baseline to 14 weeks.)
- General Anxiety Disorder -7(Weekly from baseline to 14 weeks.)
- Diabetes Family Conflict Scale - parent(From baseline until 15 weeks.)
- Perceived Stress Scale 10(From baseline until 15 weeks.)
- Parenting Practices Scale(From baseline until 15 weeks.)
- Time in Target (TiT)(From baseline until 15 weeks.)
- Mean glucose level(From baseline until 15 weeks.)
- Blood glucose variation(From baseline until 15 weeks.)
- Time with low blood glucose(From baseline until 15 weeks.)
- Ketoacidosis(From baseline until 15 weeks.)
- Severe hypoglycemia(From baseline until 15 weeks.)
- Visits at the diabetes clinic(From baseline until 15 weeks.)
- Client Satisfaction Questionnaire - 8(15 weeks after baseline)
- DISABKIDS (child QoL) generic + diabetes module - child report(From baseline until 15 weeks.)
- Diabetes Family Conflict Scale - youth report(From baseline until 15 weeks.)
- Time with high blood glucose(From baseline until 26 weeks.)
- Short Engagement Questionnaire(Weekly from baseline until 14 weeks.)
- Time with high blood glucose (repeated measures)(Every second week from baseline until 14 weeks.)
- Blood glucose variation (repeated measures)(Every second week from baseline until 14 weeks.)
- Mean glucose level (repeated measures)(Every second week from baseline until 14 weeks.)
- Time in Target (TiT) (repeated measures)(Every second week from baseline until 14 weeks.)
- Time with low blood glucose (repeated measures)(Every second week from baseline until 14 weeks.)
研究者
Brjann Ljotsson
Professor, licensed psychologist
Karolinska Institutet