Family Intervention for Black Teens With Type 1 Diabetes

Summary

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).

Conditions

• Type 1 Diabetes
• Family Relations

Interventions

BEHAVIORAL

The 3Ms 2.0 Intervention

The 3Ms is a culturally tailored, mHealth intervention for primary caregivers of Black adolescents with T1D focused on promoting daily parental monitoring of adolescent diabetes care and delivered via an Internet platform, Computer Intervention Authoring System (CIAS). The intervention content is based on the Information-Motivation-Behavioral Skills (IMB) model. Caregivers randomized to The 3Ms receive 3 sessions. The caregiver is guided through each session by an interactive and emotive three-dimensional narrator that reads and speaks aloud. Additional intervention content includes brief videoclips to provide skills demonstrations of supportive parenting practices related to diabetes care and text message reminders. Each session is no more than 20 minutes in length. The intervention is delivered over a three-month window, with the two follow-up sessions available to be accessed by the caregiver at one-month intervals after completion of the initial session.

BEHAVIORAL

Educational Attention Control (EAC)

The EAC intervention consists of three sessions delivered in an mHealth format via the CIAS internet platform over three months, with access for a maximum of six months. EAC provides structured information on topics of interest to caregivers of adolescents with T1D such as travelling with diabetes, or emergency preparedness for persons with diabetes. All participants receive their standard medical care.

Sponsors & Collaborators

• National Institute on Minority Health and Health Disparities (NIMHD)

  collaborator NIH

• Wayne State University

  lead OTHER

Principal Investigators

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

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

10 Years

Max Age

14 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-09-16

Primary Completion

2028-04-30

Completion

2028-04-30

Countries

• United States

Study Locations