Insul-In This Together Program: Optimizing Family-based Interventions for Adolescents With Type 1 Diabetes and Their Parents
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 366
- 试验地点
- 1
- 主要终点
- Glucose Levels Percent Time in Target Range Based on Glucose Monitoring
研究概览
简要总结
The "Insul-In This Together" intervention is designed for teens with Type 1 Diabetes and their parents. This study seeks to evaluate an evidence-based family intervention for teens with type 1 diabetes and their parents to offset the psychosocial and diabetes self-management risks. This information will provide a more in-depth understanding of family-based program efficacy for teens with adolescents and provide more judicious and streamlined intervention options to be offered in diabetes clinics in the future.
详细描述
This study will collect survey and biomedical data to assess this program in a randomized controlled trial with 165 families (including an adolescent and parent/caregiver) will be enrolled, complete surveys, provide biomedical data via continuous glucose monitors and receive a 6-week psychosocial intervention. The results of this study will inform future intervention redesign to provide more judicious interventions to be disseminated across diabetes care.This study will evaluate the relative efficacy of each of the individual intervention components and also identify the mechanisms of actions (mediators) that are most impacted by these types of interventions as well as most linked to long-term outcomes for adolescents.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Teen subject has a type 1 diabetes (T1D) diagnosis according to ADA criteria for at least 6 months
- •Teen subject is age 12-19 years at time of screening (no age limit for parent participants)
- •Participation of at least one cohabitating parent/caregiver.
排除标准
- •Subject lacks access to a smartphone or Wi-Fi via computer
- •Subject has restricted or no English proficiency
- •Subject has a pervasive developmental, cognitive, or psychiatric limitations that compromise participation in study
研究组 & 干预措施
Intervention Group
The intervention group will participated in the The Insul-In This Together intervention, which consists of 6 weekly 30-minute online family sessions to discuss topics related to diabetes distress and parent-teen communication. Sessions include structured education, discussions, and skill-building activities related to parental involvement, parental monitoring, and parent-adolescent conflict. The intervention will be conducted by the PI or clinically trained research staff via Zoom. Online surveys, and glucose monitoring data will be captured at baseline and 3,6 and 12-month follow-ups. Brief surveys will also be conducted at 2-, 4-, and 6-week follow-ups (after every 2 sessions for the intervention group and later the control group). Participants will be asked to provide A1C test results that will be collected via chart review or from participants sharing their test results at baseline, 6-month, and 12-month follow-up.
干预措施: Insul-In This Together (Behavioral)
Waitlisted Control Group
The waitlisted control group will receive the same intervention as the intervention group, but at the 6-month follow-up mark. The intervention will be conducted by the PI or clinically trained research staff via Zoom. Online surveys, and glucose monitoring data will be captured at baseline and 3,6 and 12-month follow-ups. Brief surveys will also be conducted at 2-, 4-, and 6-week from baseline. Participants will be asked to provide A1C test results that will be collected via chart review or from participants sharing their test results at baseline, 6-month, and 12-month follow-up.
干预措施: Insul-In This Together (Behavioral)
结局指标
主要结局
Glucose Levels Percent Time in Target Range Based on Glucose Monitoring
时间窗: Average percent time in range based on two weeks of glucose monitoring data at baseline, 3-month, and 6-month follow-up (plus or minus 2 weeks around target data collection date)
Adolescent glucose levels percent time in target range (70-180 mg/dL) based on glucose monitoring to measure glycemic control. The clinical recommendation is a percent time-in-range of 70% or more.
Adolescent Quality of Life
时间窗: Baseline, 3-month follow-up, and 6-month follow-up.
Self-report via Type 1 Diabetes and Life (T1DAL) surveys for adolescents to measure the adolescent's quality of life. Possible score range is 0-100 and the higher scores indicated better quality of life. Adolescent quality of life was measured for adolescents only (not parents).
次要结局
- Adolescent Depression(Baseline, 3-month follow-up, and 6-month follow-up.)
- Parenting Stress(Baseline, 3-month follow-up, and 6-month follow-up)
- Parent Depression(Baseline, 3-month follow-up, and 6-month follow-up.)
- Adolescent Diabetes Distress(Baseline, 3-month follow-up, and 6-month follow-up)
- Parent Diabetes Distress(Baseline, 3-month follow-up, and 6-month follow-up.)
- Hemoglobin A1c (HbA1c)(Baseline and 6-month follow-up)
研究者
Korey Hood
Professor, Medicine
Stanford University