Strengths-Based Multi-Level Behavioral Intervention to Promote Resilience and Self-Management in Youth With Type 1 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 250
- 试验地点
- 2
- 主要终点
- Glycemic Control - time-in-range
研究概览
简要总结
The EMPoWER Study randomized clinical trial is a strengths-based behavioral intervention delivered to youth with type 1 diabetes (age 10 to 13) and their parents. The purpose of the intervention is to improve glycemic, behavioral, and psychosocial outcomes in youth with diabetes using a multiple systems approach that engages youth, their parents, and diabetes care providers to identify and build youths' diabetes strengths. The primary aim of this study is to assess the intervention impact on glycemic control, adherence, and health-related quality of life (HRQOL). Secondary aims are to evaluate behavioral mediators of intervention impact and to examine intervention dose as a mediator of intervention impact.
详细描述
The goal of the randomized clinical trial (RCT) is to learn if a brief behavioral intervention targeting multiple systems ("Type 1 Doing Well" Program) can improve glycemic, behavioral, and psychosocial outcomes in youth with type 1 diabetes. Youth, age 10 to 13, will enroll with one parent or legal guardian to participate in the study with them. Researchers will compare the Type 1 Doing Well (T1DW) Program arm to the Enhanced Usual Care (EUC; "Diabetes-Related Information and Resources" Program) arm.
Parent-youth dyads in both study arms will provide data (e.g. questionnaires, A1c, medical chart and diabetes device data) at four timepoints throughout the duration of the study. Following baseline data collection, parent-youth dyads will complete an orientation session with study team members to be randomized to their study arm and review study activities. Parent and youth will also be invited to complete a feedback interview on their experience with the program they received.
The intervention will take place during the 6-month intervention period, and participants will be randomly allocated to 1 of two intervention conditions:
- Parents and youth in the T1DW Program condition (intervention) will use a web-based mobile application to do daily and weekly activities focused on recognizing and reinforcing youths' diabetes strengths. They will also have a conversation with the youth's diabetes provider about what is going well in diabetes care at a routine diabetes appointment.
- Parents and youth in the EUC Program condition will receive and review 6 monthly diabetes-related information and resources in the form of electronic handouts.
In preparation for the randomized clinical trial of a new behavioral intervention for preteens with type 1 diabetes and their parents, the study is also enrolling adolescents with type 1 diabetes to create videos about living well with type 1 diabetes. The videos will be used in the intervention materials for the randomized clinical trial.
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
- None
盲法说明
For the randomized control trial, because of the nature of the behavioral intervention, participants and investigators will be aware of their assignment to the intervention condition or the enhanced usual care condition.
For the teen videos, all video participants will be in a single group, so there will be no masking. For diabetes care professionals, all participants will be in a single group, so there will be no masking. Teen video participants and diabetes care professional participants will not receive interventions.
入排标准
- 年龄范围
- 10 Years 至 99 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •For Trial Participants -
- •Inclusion Criteria:
- •type 1 diabetes diagnosis per ADA criteria for at least 6 months,
- •age 10 to 13 years at consent,
- •English or Spanish fluency,
- •At least one hemoglobin A1c value ≥ 7.5 % (percent) within the past 12 months (changed from ≥8.0% in March 2026)
- •Patient at one of the participating study sites
- •Parent/legal guardian of youth
- •Age at least 18 years old at time of consent,
- •English or Spanish fluency,
- •Consistent access to a mobile phone that has texting capabilities and a device with internet access
排除标准
- •Being treated for:
- •a major serious or acute medical condition or comorbidity (e.g. cancer, cystic fibrosis),
- •a major serious psychological or psychiatric condition,
- •a major serious developmental condition that would interfere with capacity for informed assent or participation or that would confound outcomes
- •Parents/legal guardian of youth participant
- •Being treated for:
- •a major serious or acute medical condition or comorbidity (e.g. cancer, cystic fibrosis),
- •a major serious psychological or psychiatric condition,
- •a major serious developmental condition that would interfere with capacity for informed consent or participation or that would confound outcomes
- •Other Exclusion Criteria
- •Plans to move diabetes care out of participating hospital site within next 6 months,
- •Legal guardianship of the youth with diabetes being unclear at the time of screening or recruitment,
- •Study team learning of other involvement with the legal system during screening or recruitment
- •For the Teen Videos:
- •Inclusion Criteria:
- •self-reported type 1 diabetes diagnosis for ≥ 1 year,
- •age 14-17 at consent,
- •English fluency,
- •living in the United States
- •Exclusion Criteria:
- •major psychiatric or developmental disorders in youth or parents that would interfere with capacity for informed consent or participation,
- •major medical comorbidities that would confound outcomes (e.g., cancer, cystic fibrosis).
- •Diabetes Care Provider Participants
- •Inclusion Criteria:
- •- Provider at one of the sites' diabetes care centers
研究组 & 干预措施
Diabetes-Related Information and Resources Program (Enhanced Usual Care; EUC)
Youth with type 1 diabetes (ages 10-13) and their parents or legal guardians who are receiving care from enrolled diabetes care providers will be randomized to either the T1DW Program or the EUC Program. After being randomized to the EUC Program at the orientation session, parents and youth will receive monthly email handouts with diabetes-related information and resources for 6 months.
干预措施: Diabetes-Related Information and Resources Program (Other)
Type 1 Doing Well (T1DW) Program
Youth with type 1 diabetes (ages 10-13) and their parents or legal guardians who are receiving care from enrolled diabetes care providers will be randomized to either the T1DW Program or the EUC Program. After being randomized to the T1DW Program at the orientation session, parents and youth will receive an overview of the web-based mobile application and intervention activities that they will engage with for 6 months. The app-based intervention activities include brief daily use of the app for parents to recognize and reinforce their child's positive diabetes-related behaviors, brief weekly activities for parents and youth to reflect on and discuss what the child has done well for diabetes, family diabetes goal-setting, and videos for parents and youth about living well with T1D. Parents and youth will also engage in a brief strengths-based conversation with their diabetes care provider at one medical appointment during the study period.
干预措施: Type 1 Doing Well (T1DW) Program (Behavioral)
结局指标
主要结局
Glycemic Control - time-in-range
时间窗: Baseline, 3 months, 6 months, and 12 months
When available for youth who use a continuous glucose monitor (CGM), 14 days' of CGM data will be downloaded at each time point by the study teams to calculate glucose time-in-range as an additional index of glycemic control. Higher time-in-range is an indicator of better glycemic control.
Adherence - Self-Care Inventory 2 (SCI-2)
时间窗: Baseline, 3 months, 6 months, and 12 months
Parents and youth will complete the Self-Care Inventory 2 (SCI-2) Short Form. The form was adapted/shortened by the study team with permission from the original author, with validation paper forthcoming. Higher scores indicate higher adherence/more engagement in diabetes self-management behaviors.
Demographic and Medical Information Questionnaire
时间窗: Baseline
Only demographic information and limited diabetes treatment information will be collected about participants in the teen videos portion of this study. Participants will complete a brief questionnaire developed by the study team, which will request self-reported information about participant demographics (e.g., race, ethnicity, gender) and medical information (e.g., time since diabetes diagnosis, current treatments).
Glycemic Control - HbA1c
时间窗: Baseline, 6 months, 12 months
Point of care HbA1c values documented by the medical team at each clinic visit will be collected from the electronic health record, to assess change in glycemic outcomes. Youth will be asked to complete a home dry blood spot A1c kit at three study timepoints unless an A1c value is documented in the electronic health record within the required timeframe. The study team will mail youth a home kit with instructions, all necessary materials to collect the sample, and a pre-paid mailer to ship it back. Higher HbA1c indicates higher average blood glucose values over the previous 2-3 months, which represents poorer glycemic control.
Health-Related Quality of Life (HRQOL)
时间窗: Baseline, 3 months, 6 months, and 12 months
Parents and youth willcomplete the age- and respondent-appropriate version of the Type 1 Diabetes and Life (T1DAL) measure. Psychometric data regarding the validity and reliability of the pediatric, adult, and parent/partner versions of the T1DAL are published. Total scores are on a 100-point scale, with higher scores indicating better quality of life.
次要结局
- Diabetes Distress(Baseline, 3 months, 6 months, and 12 months)
- Positivity Scale(Baseline, 3 months, 6 months, and 12 months)
- PROMIS Short Form Family Relationships 4a Items(Baseline, 3 months, 6 months, and 12 months)
- Diabetes Strength(Baseline, 3 months, 6 months, and 12 months)
- Role Overload(Baseline, 3 months, 6 months, and 12 months)
- Family Conflict - Diabetes Family Conflict Scale - Revised (DFCS)(Baseline, 3 months, 6 months, and 12 months)
- Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form Positive Affect 15a Items(Baseline, 3 months, 6 months, and 12 months)
- Satisfaction Questionnaire(3 months, 6 months, and 12 months)
研究者
Marisa Hilliard
Professor
Baylor College of Medicine