Effect of Behavioral Family Therapy on Glycemic Control in Children With Type One Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 75
- 试验地点
- 2
- 主要终点
- Change in HbA1c Level
研究概览
简要总结
Behavioral family therapy, specifically focused on insuring support for the primary caregiver of a child with type one diabetes mellitus and healthy family dynamics, may improve the child's glycemic control as measured by hemoglobin A1c level (HbA1c).
详细描述
The success or failure of type 1 diabetes mellitus (T1D) management in children depends not only on access to care, diabetes technologies and diabetes education, but also on the abilities of the patient and his/her family to carry out complex demands. Recent data show that family dynamics play a critical role in determining glycemic control in pediatric patients with T1D. The investigators prior work (Loomba-Albrecht and Glaser, unpublished data) suggests that the strongest determinants of glycemic control are factors related to the primary caregiver's involvement in supportive relationships with others, either a spouse or other family members. This provides a potential therapeutic target to improve outcomes for children with T1D.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Outcomes Assessor)
盲法说明
The outcomes assessor will be masked to the participant's assignment. Others (participant, care provider, investigator) cannot be masked to assignment because one group will be receiving the behavioral health intervention and the other will not be receiving anything additional.
入排标准
- 年龄范围
- 2 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age 2 to 17 years
- •newly diagnosed (within the past 12 weeks) with T1D
- •seeking care at UC Davis
排除标准
- •Families will be excluded if the child has severe underlying psychiatric, behavioral or medical conditions which could independently affect parental marital stress
结局指标
主要结局
Change in HbA1c Level
时间窗: 6, 12, 18, and 24 months
The main outcome variable will be the change in glycemic control measured as the mean HbA1c level over the two years following study enrollment.
次要结局
- Child Perception of Interparental Conflict (CPIC)(At enrollment and approximately 3 months after enrollment)
- FoH-C Frequency of Help(At enrollment and approximately 3 months after enrollment)
- Behavioral Affect Rating(At enrollment and approximately 3 months after enrollment)
- Family Assessment Device-General Functioning Subscale(At enrollment and approximately 3 months after enrollment)
- Patient-Reported Outcomes Information System- Short Forms (PROMIS)(At enrollment and approximately 3 months after enrollment)