EMPoWER Study - Strengths-based Behavioral Intervention for Youth With Type 1 Diabetes

Официальное название

Strengths-Based Multi-Level Behavioral Intervention to Promote Resilience and Self-Management in Youth With Type 1 Diabetes

Обзор

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.

Подробное описание

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:

1. 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. 2. 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.

Diabetes care providers at each of the sites will also be enrolled in the study. Provider participants will receive a brief training to deliver the strength-based conversation with parent-youth dyads in the T1DW Program arm, and they will complete study-related questionnaires about their experiences delivering the strengths-based conversation component of the intervention.

Вмешательства

• Поведенческое Type 1 Doing Well (T1DW) Program
  Parent and youth will each have access to a version of the app. The study app activities include parents and youth: * noticing what the youth does well for diabetes; * setting and tracking a family diabetes goal in the app; and * having a weekly meeting to review what the youth is doing well with diabetes and progress on the family diabetes goal. Parents and youth will also have access to age-appropriate libraries of videos with diabetes-specific content. Parents and youth will also have a co
• Другое Diabetes-Related Information and Resources Program
  Parent and youth will receive diabetes-related information and resources in the form of electronic handouts. They will receive one handout per month by email during the 6-month intervention period. These handouts include a variety of diabetes-related topics curated by the study team. Handouts will not include any specific information about the youth's health.

Первичные конечные точки

• Demographic and Medical Information Questionnaire [Срок оценки: Baseline]
• Glycemic Control - HbA1c [Срок оценки: Baseline, 6 months, 12 months]
• Glycemic Control - time-in-range [Срок оценки: Baseline, 3 months, 6 months, and 12 months]
• Adherence - Self-Care Inventory 2 (SCI-2) [Срок оценки: Baseline, 3 months, 6 months, and 12 months]
• Health-Related Quality of Life (HRQOL) [Срок оценки: Baseline, 3 months, 6 months, and 12 months]

Вторичные конечные точки (8)

• Diabetes Distress [Срок оценки: Baseline, 3 months, 6 months, and 12 months]
• Diabetes Strength [Срок оценки: Baseline, 3 months, 6 months, and 12 months]
• Positivity Scale [Срок оценки: Baseline, 3 months, 6 months, and 12 months]
• Role Overload [Срок оценки: Baseline, 3 months, 6 months, and 12 months]
• Family Conflict - Diabetes Family Conflict Scale - Revised (DFCS) [Срок оценки: Baseline, 3 months, 6 months, and 12 months]
• Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form Positive Affect 15a Items [Срок оценки: Baseline, 3 months, 6 months, and 12 months]
• PROMIS Short Form Family Relationships 4a Items [Срок оценки: Baseline, 3 months, 6 months, and 12 months]
• Satisfaction Questionnaire [Срок оценки: 3 months, 6 months, and 12 months]

Критерии участия

For Trial Participants -

Критерии включения

Youth

• 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

Критерии исключения

Youth

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:

Критерии включения

• self-reported type 1 diabetes diagnosis for ≥ 1 year,
• age 14-17 at consent,
• English fluency,
• living in the United States

Критерии исключения

• 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

Критерии включения

\- Provider at one of the sites' diabetes care centers

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Baylor College of Medicine — Houston

Идентификаторы

NCT: NCT06014879 · H-51765

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗