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Family Intervention for Black Teens With Type 1 Diabetes

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
10 Years to 14 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Questionnaires, Pills

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Data collection is completed by the adolescent and caregiver on a tablet computer and includes questionnaires to assess adolescent diabetes management, parental supervision of diabetes management, family relationships and youth quality of life."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests The 3Ms 2.0, a family program with videos and text messages accessed through a parent's cell phone, against an education-only program. It aims to improve blood sugar control and family relationships around diabetes, and lower caregiver stress about diabetes. It is for Black youth ages 10 to 14 with type 1 diabetes and their main caregivers.

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).

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Age 10 years through 14 years, 11 months.
  • Has had type 1 diabetes for at least 6 months.
  • Is Black.
  • Main caregiver is willing to take part.
  • Lives within 30 miles of a study site.
  • Caregiver owns a device that connects to the internet, such as a phone, computer, or tablet.

Who can't join

  • Has a mental health or developmental condition that could make study results less reliable, such as developmental delay, schizophrenia, psychosis (trouble knowing what is real), or current thoughts of suicide or killing others.
  • Has another medical condition, such as cystic fibrosis, that requires a different approach to diabetes care.
  • Cannot speak or read English.
  • Child is placed in care outside the home.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * Age: 10 years, 0 months - 14 years, 11 months * Diagnosed with Type 1 diabetes * Diagnosed for at least 6 months * Black * Primary caregiver willing to participate * Residence within 30 miles of a recruitment site * Caregiver ownership of an Internet-enabled device (cell phone, laptop or desktop computer, tablet, etc) Exclusion Criteria: * Mental health conditions that might compromise data integrity (e.g., developmental delay, schizophrenia, psychosis, current suicidality, homicidality) * Co-morbid medical condition resulting in atypical diabetes management (e.g., cystic fibrosis) * Inability to speak or read English * Child is in out-of-home placement

Study sites (4)

DC

MI

TN

  • LeBonheur Children's Hospital · Memphis, TN 38103Kristoffer S Berlin, Ph.D. · Study contact · ksberlin@memphis.eduKathryn Sumpter, MD · Sub-investigatorKristoffer S Berlin, Ph.D. · Sub-investigatorMore trials in Memphis
  • University of Tennessee Health Science Center-Memphis · Memphis, TN 38163Kristoffer S Berlin, Ph.D. · Study contact · ksberlin@memphis.eduKathryn Sumpter, MD · Sub-investigatorKristoffer S Berlin, Ph.D. · Sub-investigatorMore trials in Memphis