RecruitingNot ApplicableNCT06275412

Family Intervention for Black Teens With Type 1 Diabetes

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

Sponsor

Wayne State University

Enrollment

216 participants

Start Date

Sep 16, 2024

Study Type

INTERVENTIONAL

Conditions

Family Relations 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).

Eligibility

Min Age: 10 YearsMax Age: 14 Years

Inclusion Criteria7

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 Criteria4

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

Interventions

BEHAVIORALThe 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.

BEHAVIORALEducational 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.