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

Description

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

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Type 1 Diabetes
Intervention / Treatment

-

Contacts and Locations

Houston

Baylor College of Medicine, Houston, Texas, United States, 77030

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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
  • * 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
  • * 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

Ages Eligible for Study

10 Years to 99 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Baylor College of Medicine,

Marisa Hilliard, PhD, PRINCIPAL_INVESTIGATOR, Baylor College of Medicine

Study Record Dates

2027-12-31