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

NCT06014879 | Recruiting DMC

• 1 other identifier: H-51765
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Type 1 Diabetes

Keywords

type 1 diabetes; youth; adolescent; child; positive psychology; mhealth; ehealth

Outcome Measures

Primary Outcomes (5)

• Demographic and Medical Information Questionnaire

  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).

  Baseline

• Glycemic Control - HbA1c

  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.

  Baseline, 6 months, 12 months

• Glycemic Control - time-in-range

  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.

  Baseline, 3 months, 6 months, and 12 months

• Adherence - Self-Care Inventory 2 (SCI-2)

  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.

  Baseline, 3 months, 6 months, and 12 months

• Health-Related Quality of Life (HRQOL)

  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.

  Baseline, 3 months, 6 months, and 12 months

Secondary Outcomes (8)

• Diabetes Distress

  Baseline, 3 months, 6 months, and 12 months

• Diabetes Strength

  Baseline, 3 months, 6 months, and 12 months

• Positivity Scale

  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

Study Arms (2)

Type 1 Doing Well (T1DW) Program

EXPERIMENTAL

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.

Behavioral: Type 1 Doing Well (T1DW) Program

Diabetes-Related Information and Resources Program (Enhanced Usual Care; EUC)

ACTIVE COMPARATOR

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.

Other: Diabetes-Related Information and Resources Program

Interventions

Type 1 Doing Well (T1DW) Program BEHAVIORAL

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 conversation with the youth's diabetes care provider at a regularly scheduled diabetes appointment at participating hospital sites.

Type 1 Doing Well (T1DW) Program

Diabetes-Related Information and Resources Program OTHER

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.

Also known as: Enhanced Usual Care (EUC) Program

Diabetes-Related Information and Resources Program (Enhanced Usual Care; EUC)

Eligibility Criteria

• Age: 10 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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:
• self-reported type 1 diabetes diagnosis for ≥ 1 year,

Sponsors & Collaborators

• Baylor College of Medicine: lead
• Children's National Research Institute: collaborator

Study Sites (1)

Baylor College of Medicine

Houston, Texas, 77030, United States

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Marisa Hilliard, PhD

  Baylor College of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marisa Hilliard, PhD

CONTACT

832-824-7209; marisa.hilliard@bcm.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: For the first phase of this project, all teen participants (up to 40 total) will create videos about living well with type 1 diabetes. The videos will be used in the upcoming randomized clinical trial of the new intervention. For the randomized control trial, a parallel two group design will be used to evaluate the intervention among n=250 parents and youth dyads assigned to the Type 1 Doing Well intervention condition or the enhanced usual care condition (1:1). All parent and youth dyads are randomized to either the Type 1 Doing Well intervention condition or the enhanced usual care condition. Parents and youth dyads will be in the the study for approximately 12 months. Providers (up to 20 per site, 40 total) will also be enrolled as participants to deliver the provider conversation intervention to parent and youth dyads randomized to the intervention condition, and to provide data about their experiences.

Study Record Dates

• First Submitted: August 16, 2023
• First Posted: August 28, 2023
• Study Start: October 22, 2024
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: March 18, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)