Family Intervention for Black Teens With Type 1 Diabetes
3Ms
Family mHealth Intervention to Improve Health Outcomes in Black Youth With Type 1 Diabetes
2 other identifiers
interventional
216
1 country
4
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2024
Longer than P75 for not_applicable
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 8, 2024
CompletedFirst Posted
Study publicly available on registry
February 23, 2024
CompletedStudy Start
First participant enrolled
September 16, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 30, 2028
July 15, 2025
July 1, 2025
3.6 years
February 8, 2024
July 14, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Glycemic Control
Hemoglobin A1c (HbA1c)
Baseline, 3 months, 6 months, and 12 months
Secondary Outcomes (4)
Caregiver Diabetes Distress
Baseline, 3 months, 6 months, and 12 months
Diabetes-Specific Family Conflict
Baseline, 3 months, 6 months, and 12 months
Diabetes-Specific Parental Monitoring
Baseline, 3 months, 6 months and 12 months
Diabetes-Specific Family Support
Baseline, 3 months, 6 months and 12 months
Other Outcomes (2)
Illness Management
Baseline, 3 months, 6 months, and 12 months
Intervention Satisfaction
6 months
Study Arms (2)
Educational Attention Control (EAC) + Standard Medical Care
ACTIVE COMPARATORThe 3Ms 2.0 Intervention + Standard Medical Care
EXPERIMENTALInterventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Children's National Hospital
Washington D.C., 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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Deborah A Ellis, Ph.D.
Wayne State University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- CARE PROVIDER
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Deborah Ellis, Ph.D., Professor of Family Medicine and Public Health Sciences Wayne State University School of Medicine
Study Record Dates
First Submitted
February 8, 2024
First Posted
February 23, 2024
Study Start
September 16, 2024
Primary Completion (Estimated)
April 30, 2028
Study Completion (Estimated)
April 30, 2028
Last Updated
July 15, 2025
Record last verified: 2025-07
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- June 2029
- Access Criteria
- Given the sensitive nature of the health data contained in the data set, as well as the participation of children, the data and associated documentation will be available to users under a specific data-sharing agreement that provides for: (1) a commitment to using the data only for research purposes and not to identify any individual participant; (2) a commitment to securing the data using appropriate technology; and (3) a commitment to destroying the data after analyses are completed.
Identifiers will be removed from the data prior to any release of the dataset. The final data set will include data obtained from medical records, data obtained directly from participants on diabetes health status, behavioral data, and intervention data. Participants in the trial will be recruited through two children's hospitals. Even though the final dataset will not contain identifiers, given the relatively small sample size and focus on Black youth, there remains the possibility of deductive identification of subjects with unusual characteristics (i.e. high number hospital admissions).