EMPoWER Study - Strengths-based Behavioral Intervention for Youth With Type 1 Diabetes
NCT ID: NCT06014879
Last Updated: 2025-04-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
250 participants
INTERVENTIONAL
2024-10-22
2027-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
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.
TREATMENT
NONE
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.
Study Groups
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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.
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 conversation with the youth's diabetes care provider at a regularly scheduled diabetes appointment at participating hospital sites.
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.
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.
Interventions
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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 conversation with the youth's diabetes care provider at a regularly scheduled diabetes appointment at participating hospital sites.
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.
Other Intervention Names
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Eligibility Criteria
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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 ≥ 8 % (percent) within the past 12 months
* 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
* self-reported type 1 diabetes diagnosis for ≥ 1 year,
* age 14-17 at consent,
* English fluency,
* living in the United States
\- Provider at one of the sites' diabetes care centers
Exclusion Criteria
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:
* 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
10 Years
99 Years
ALL
No
Sponsors
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Children's National Research Institute
OTHER
Baylor College of Medicine
OTHER
Responsible Party
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Marisa Hilliard
Associate Professor
Principal Investigators
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Marisa Hilliard, PhD
Role: PRINCIPAL_INVESTIGATOR
Baylor College of Medicine
Locations
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Baylor College of Medicine
Houston, Texas, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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H-51765
Identifier Type: -
Identifier Source: org_study_id
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