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

Primary Purpose

Type 1 Diabetes

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Teen Videos
Sponsored by
Baylor College of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Type 1 Diabetes

Eligibility Criteria

14 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Baylor College of MedicineRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Teen Videos

Arm Description

All participants in the teen video phase of this project will make brief videos about living well with type 1 diabetes. Guidance will be provided about requirements for the videos. Participants may make up to 4 brief videos. The videos will be used in the upcoming clinical trial of the new behavioral intervention.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Full Information

First Posted
August 16, 2023
Last Updated
August 22, 2023
Sponsor
Baylor College of Medicine
Collaborators
Children's National Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT06014879
Brief Title
EMPoWER Study - Strengths-based Behavioral Intervention for Youth With Type 1 Diabetes
Acronym
EMPoWER
Official Title
Strengths-Based Multi-Level Behavioral Intervention to Promote Resilience and Self-Management in Youth With Type 1 Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 7, 2023 (Actual)
Primary Completion Date
December 31, 2026 (Anticipated)
Study Completion Date
June 30, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Baylor College of Medicine
Collaborators
Children's National Research Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
In preparation for the randomized clinical trial of a new behavioral intervention for preteens with type 1 diabetes and their parents, the study is first 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
For the first phase of this project, all teen participants 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.
Masking
None (Open Label)
Masking Description
All video participants will be in a single group, so there will be no masking.
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Teen Videos
Arm Type
Other
Arm Description
All participants in the teen video phase of this project will make brief videos about living well with type 1 diabetes. Guidance will be provided about requirements for the videos. Participants may make up to 4 brief videos. The videos will be used in the upcoming clinical trial of the new behavioral intervention.
Intervention Type
Behavioral
Intervention Name(s)
Teen Videos
Other Intervention Name(s)
EMPoWER Teen Videos
Intervention Description
All participants in the Teen Videos will create videos about living well with diabetes, which will be used in the upcoming clinical trial of a new behavioral intervention.
Primary Outcome Measure Information:
Title
Demographic and Medical Information Questionnaire
Description
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).
Time Frame
Baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marisa Hilliard, PhD
Phone
832-824-7209
Email
marisa.hilliard@bcm.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marisa Hilliard, PhD
Organizational Affiliation
Baylor College of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Baylor College of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marisa Hilliard, PhD
Phone
832-824-7209
Email
marisa.hilliard@bcm.edu

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Individual participant data will only be available within study team. Participants may be identified by showing face within videos, and participants sign consent form and institutional media release forms.

Learn more about this trial

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

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