Recruiting

Family Intervention

Sponsor:

Wayne State University

Code:

NCT06275412

Conditions

Type 1 Diabetes

Family Relations

Eligibility Criteria

Sex: All

Age: 10 - 14

Healthy Volunteers: Not accepted

Interventions

The 3Ms 2.0 Intervention

Educational Attention Control (EAC)

Study Details

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).

Conditions

Type 1 Diabetes

Family Relations

Study ID

NCT06275412

Start date

Sep 16, 2024

Status verified date

Aug, 2026

Completion date

Apr 30, 2028

Anticipated

Primary completion date

Apr 30, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 10 - 14

Healthy Volunteers: Not accepted

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 Design

Enrollment

216 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Educational Attention Control (EAC) + Standard Medical Care

experimental: The 3Ms 2.0 Intervention + Standard Medical Care

Interventions

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.

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.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Deborah A Ellis, Ph.D.

313-577-1055dellis@med.wayne.edu

Jillian T Sjostrom, B.S.

313-577-6997jrhind@med.wayne.edu

Locations

Children's National Hospital

Recruiting

Washington D.C., District of Columbia, United States, 20010

Contacts

Angelica Eddington, Ph.D., ABPP

202-476-2342aeddington@childrensnational.org

Wayne Pediatrics

Recruiting

Detroit, Michigan, United States, 48201

Contacts

Jillian Sjostrom

3135776997jrhind@med.wayne.edu

Principal Investigator:

Deborah A Ellis, Ph.D.

LeBonheur Children's Hospital

Recruiting

Memphis, Tennessee, United States, 38103

Contacts

Kristoffer S Berlin, Ph.D.

ksberlin@memphis.edu

University of Tennessee Health Science Center-Memphis

Recruiting

Memphis, Tennessee, United States, 38163

Contacts

Kristoffer S Berlin, Ph.D.

ksberlin@memphis.edu

More Information

Sponsor

Wayne State University

Last update posted

Aug 27, 2026

Last verified

Aug, 2026

Keywords

  • Type 1 Diabetes
  • mobile health
  • Family-based intervention

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-08. This information was provided to ClinicalTrials.gov by Wayne State University on 2026-08-27. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.