RECRUITING

Family Intervention for Black Teens With Type 1 Diabetes

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 purpose of this study is to conduct a multicenter, randomized effectiveness trial of The 3Ms 2.0 compared to an educational control condition for improving adolescent glycemic control and diabetes-related family relationships and reducing primary caregiver diabetes-related distress among Black adolescents with type 1 diabetes (T1D) and their primary caregivers. The proposed study would develop and test The 3Ms 2.0 adapted intervention when delivered using a mobile health approach (accessed via parents' cell phone). The intervention will also include new family intervention content (videoclips and text messages).

Official Title

Family mHealth Intervention to Improve Health Outcomes in Black Youth With Type 1 Diabetes

Quick Facts

Study Start:2024-09-16
Study Completion:2028-04-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06275412

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 14 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. * Age: 10 years, 0 months - 14 years, 11 months
  2. * Diagnosed with Type 1 diabetes
  3. * Diagnosed for at least 6 months
  4. * Black
  5. * Primary caregiver willing to participate
  6. * Residence within 30 miles of a recruitment site
  7. * Caregiver ownership of an Internet-enabled device (cell phone, laptop or desktop computer, tablet, etc)
  1. * Mental health conditions that might compromise data integrity (e.g., developmental delay, schizophrenia, psychosis, current suicidality, homicidality)
  2. * Co-morbid medical condition resulting in atypical diabetes management (e.g., cystic fibrosis)
  3. * Inability to speak or read English
  4. * Child is in out-of-home placement

Contacts and Locations

Study Contact

Deborah A Ellis, Ph.D.
CONTACT
313-577-1055
dellis@med.wayne.edu
Jillian T Sjostrom, B.S.
CONTACT
313-577-6997
jrhind@med.wayne.edu

Principal Investigator

Deborah A Ellis, Ph.D.
PRINCIPAL_INVESTIGATOR
Wayne State University

Study Locations (Sites)

Children's National Hospital
Washington, District of Columbia, 20010
United States
Wayne Pediatrics
Detroit, Michigan, 48201
United States
LeBonheur Children's Hospital
Memphis, Tennessee, 38103
United States
University of Tennessee Health Science Center-Memphis
Memphis, Tennessee, 38163
United States

Collaborators and Investigators

Sponsor: Wayne State University

  • Deborah A Ellis, Ph.D., PRINCIPAL_INVESTIGATOR, Wayne State University

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 Date2024-09-16
Study Completion Date2028-04-30

Study Record Updates

Study Start Date2024-09-16
Study Completion Date2028-04-30

Terms related to this study

Keywords Provided by Researchers

  • Type 1 Diabetes
  • mobile health
  • Family-based intervention

Additional Relevant MeSH Terms

  • Type 1 Diabetes
  • Family Relations