Effectiveness Trial of an E-Health Intervention To Support Diabetes Care in Minority Youth (3Ms)

The study will be conducted at one clinic in the Detroit area (Children's Hospital of
Michigan; CHM) and 3 clinics in the Chicago area. Wayne State University (WSU) will function
as the coordinating center for the trial and will be responsible for overseeing the adequacy
all aspects of trial management, including recruitment, retention, data collection, data
management and statistical analyses. 212 African American (AA) adolescents with type 1
diabetes and their primary caregivers will be enrolled across all sites (half will be
enrolled at WSU/CHM and half at the three Chicago sites). Families will be randomized to one
of two arms: The 3Ms intervention (parental motivation for supervision of adolescent DSM) or
standard educational control. In the 3Ms condition, parents will receive a brief (10-20
minute) computer delivered intervention at three consecutive routine diabetes clinic visits
that is designed to increase parental motivation to supervise adolescent diabetes management.
In the control condition, parents will receive computer-delivered education materials
regarding type 1 diabetes. Data collection will be completed in the diabetes clinic at
baseline and then at 6, 12 and 18 months after baseline in the families' home. Data
collection is completed by the adolescent and caregiver on a tablet computer and includes
questionnaires to assess adolescent diabetes management, parental supervision of diabetes
management, family relationships and youth quality of life. Blood will also be collected to
measure HbA1c (mean blood glucose level). Medical record data will also be collected. The
data analyses will be intent-to-treat, meaning that all randomized participants are included
regardless of the intervention dose received. Trial data will analyzed using the linear mixed
effect model (LME) for repeated measures.

In addition to the clinical trial, 20 diabetes clinic staff members (5 at WSU from the CHM
clinic; 15 from the Chicago clinics) will also be recruited to participate in qualitative
interviews upon completion of the trial. The purpose of the interview is to identify barriers
and facilitators of use of the 3Ms intervention at the level of the individual clinician, the
diabetes clinic and the organization (hospital). Interviews will be audiotaped and
subsequently transcribed for coding.

Inclusion Criteria:

- Age: 10 years 0 months - 15 years, 11 months

- Diagnosed with Type 1 diabetes

- Diagnosed for at least 6 months

- African American

- Residence within 30 miles of a recruitment site (Children's Hospital of Michigan, Ann
and Robert H. Lurie Children's Hospital of Chicago, Children's Hospital University of
Illinois, or La Rabida Children's Hospital of Chicago)

- Primary caregiver willing to participate

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