FL3X Study: An Adaptive Intervention to Improve Outcomes for Youth With Type 1 Diabetes (FL3X)
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      The purpose of this study is to see if a behavioral intervention for adolescents with type 1
      diabetes will improve adherence to T1D self-management activities and improve diabetes
      outcomes. We expect the intervention to improve diabetes outcomes when compared to usual
      care.
    

Detailed description: 
      The FL3X Adaptive Intervention is designed to increase adherence to T1D self-management
      including medical management (blood sugar testing and insulin dosing), diet, and physical
      activity. FL3X relies on MI, and problem-solving skills training (PSST) as the basis for the
      counseling strategy, and creates a coherent integration across three key components of 1)
      behavior family systems therapy focused on family communications and teamwork; 2)
      individualized diabetes education in response to knowledge gaps relevant to behavioral goal
      attainment; and 3) use of currently available communications technology to support behavioral
      goal attainment through participant-defined reminders and motivational boosters, and/or peer
      support.

      All FL3X intervention participants will receive "FL3X-Basic", which is the initial 3-month
      intervention that includes 4 sessions (40-60 min), supplemented with short additional
      contacts (via text, email, or web-based communication) as needed. Thereafter, applying
      principles of adaptive interventions, based on a decision rule using A1c values measured at
      defined intervals, participants are iteratively assigned to "FL3X-Check-in" or
      "FL3X-Regular", both of which continue with MI and PSST for the underlying counseling
      strategy. In FL3X-Check-in, participants who are doing well ("responders") will receive
      minimal ongoing support to reinforce successful strategies through brief monthly "touch-base"
      contacts. In FL3X-Regular, those who are "Regular-responders" will have a minimum of 3-4
      in-person full-length sessions (40-60 min) over each 6-month interval, with additional brief
      contacts as needed (e.g., text, voice, or internet). FL3X participants randomized to the
      control group will receive usual care.
    

Intervention name(s): FL3X: Flexible Lifestyle Empowering Change
Intervention type(s): Behavioral
Intervention description(s): The FL3X Adaptive Intervention is designed to increase adherence to T1D self-management including medical management (blood sugar testing and insulin dosing), diet, and physical activity. FL3X relies on MI, and problem-solving skills training (PSST) as the basis for the counseling strategy, and creates a coherent integration across three key components of 1) behavior family systems therapy focused on family communications and teamwork; 2) individualized diabetes education in response to knowledge gaps relevant to behavioral goal attainment; and 3) use of currently available communications technology to support behavioral goal attainment through participant-defined reminders and motivational boosters, and/or peer support.
Other intervention name(s): FL3X
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: motivational interviewing; problem solving skills training; family communication; social support; adolescents