RECRUITING

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

Conditions

Type 1 Diabetes youth adolescent child positive psychology mhealth ehealth

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2024-10-22

Study Completion:2027-12-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06014879

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.

Ages Eligible for Study:10 Years to 99 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD, ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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

Inclusion Criteria

Exclusion 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

Contacts and Locations

Study Contact

Marisa Hilliard, PhD

CONTACT

832-824-7209

marisa.hilliard@bcm.edu

Principal Investigator

Marisa Hilliard, PhD

PRINCIPAL_INVESTIGATOR

Baylor College of Medicine

Study Locations (Sites)

Baylor College of Medicine

Houston, Texas, 77030

United States

Collaborators and Investigators

Sponsor: Baylor College of Medicine

Marisa Hilliard, PhD, PRINCIPAL_INVESTIGATOR, Baylor College of Medicine

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-10-22

Study Completion Date2027-12-31

Study Record Updates

Study Start Date2024-10-22

Study Completion Date2027-12-31

Terms related to this study

Keywords Provided by Researchers

type 1 diabetes
youth
adolescent
child
positive psychology
mhealth
ehealth

Additional Relevant MeSH Terms

Type 1 Diabetes