Family Intervention for Black Teens With Type 1 Diabetes

Part of paid clinical trials in Washington D.C., District of Columbia.

Sponsor
Wayne State University
Study ID
NCT06275412
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
10 Years - 14 Years
Healthy Volunteers
Not accepted

Interventions

  • The 3Ms 2.0 Intervention — BEHAVIORAL
    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.
  • Educational Attention Control (EAC) — BEHAVIORAL
    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.

Study Details

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).

Key Dates

Start date
Sep 16, 2024
Status verified
Jul 2025
Primary completion
Apr 30, 2028
Completion
Apr 30, 2028

Study Design

Enrollment
216 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Educational Attention Control (EAC) + Standard Medical Care
  • Experimental: The 3Ms 2.0 Intervention + Standard Medical Care

Primary Outcome Measure

Glycemic Control [ Time Frame: Baseline, 3 months, 6 months, and 12 months ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
Children's National HospitalWashington D.C.District of Columbia20010
Angelica Eddington, Ph.D., ABPP
[email protected]
202-476-2342
Angelica Eddington, Ph.D., ABPP (SUB_INVESTIGATOR)
Wayne PediatricsDetroitMichigan48201
Jillian Sjostrom
[email protected]
3135776997
Deborah A Ellis, Ph.D. (PRINCIPAL_INVESTIGATOR)
LeBonheur Children's HospitalMemphisTennessee38103
Kristoffer S Berlin, Ph.D.
[email protected]
Kathryn Sumpter, MD (SUB_INVESTIGATOR)
Kristoffer S Berlin, Ph.D. (SUB_INVESTIGATOR)
University of Tennessee Health Science Center-MemphisMemphisTennessee38163
Kristoffer S Berlin, Ph.D.
[email protected]
Kathryn Sumpter, MD (SUB_INVESTIGATOR)
Kristoffer S Berlin, Ph.D. (SUB_INVESTIGATOR)

Find similar trials in Washington D.C., DC

By condition
Type 1 diabetes
By specialty
Endocrinology
By research site
Children's National Hospital· Washington D.C., DCWayne Pediatrics· Detroit, MILeBonheur Children's Hospital· Memphis, TNUniversity of Tennessee Health Science Center-Memphis· Memphis, TN

Related Studies