Actively Recruiting

Phase Not Applicable
Age: 10Years - 99Years
All Genders
NCT06014879

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

Led by Baylor College of Medicine · Updated on 2026-03-18

250

Participants Needed

1

Research Sites

166 weeks

Total Duration

On this page

Sponsors

B

Baylor College of Medicine

Lead Sponsor

C

Children's National Research Institute

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 10Years - 99Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Youth aged 10 to 13 years with type 1 diabetes diagnosed at least 6 months ago
  • Youth with at least one hemoglobin A1c value of 7.5% or higher within the past 12 months
  • Youth fluent in English or Spanish
  • Youth receiving care at a participating study site
  • Parent or legal guardian aged 18 years or older
  • Parent or legal guardian fluent in English or Spanish
  • Parent or legal guardian with consistent access to a mobile phone with texting and internet-enabled device
Not Eligible

You will not qualify if you...

  • Youth being treated for a major serious or acute medical condition or comorbidity such as cancer or cystic fibrosis
  • Youth being treated for a major serious psychological or psychiatric condition
  • Youth with a major serious developmental condition interfering with participation or outcomes
  • Parent or legal guardian being treated for a major serious or acute medical condition or comorbidity such as cancer or cystic fibrosis
  • Parent or legal guardian being treated for a major serious psychological or psychiatric condition
  • Parent or legal guardian with a major serious developmental condition interfering with participation or outcomes
  • Plans to move diabetes care out of participating hospital site within 6 months
  • Legal guardianship of the youth is unclear at screening or recruitment
  • Involvement with the legal system discovered during screening or recruitment
  • Adolescents creating videos must have type 1 diabetes for at least 1 year, be aged 14 to 17, fluent in English, and living in the United States
  • Adolescents and parents with major psychiatric, developmental disorders, or major medical comorbidities that interfere with participation or outcomes
  • Diabetes care providers must be affiliated with one of the participating study sites

AI-Screening

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Trial Site Locations

Total: 1 location

1

Baylor College of Medicine

Houston, Texas, United States, 77030

Actively Recruiting

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Research Team

M

Marisa Hilliard, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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