First STEPS- Study of Type 1 in Early Childhood and Parenting Support

Summary

The incidence of type 1 diabetes (T1D) in young children (age \<6 years) is rising. Disease management guidelines offered by the ADA and other diabetes care organizations place a high burden of responsibility onto these children's parents and caregivers to check blood sugar, administer insulin, and monitor diet and physical activity to maintain tight glycemic control. Unfortunately, this occurs at a vulnerable time in life when children's behavior is unpredictable, their T1D is difficult to control, parenting stress is elevated, and caregivers are strained by normal child caretaking routines. T1D education and support tends to be highly concentrated at diagnosis/during the inpatient stay, and requires rapid knowledge and skill acquisition on the part of parents. Not all families respond equally well to this teaching model, and many need more guided practice, problem-solving assistance, and behavioral supports than can be offered in a one-size-fits-all patient education approach. Our research will attempt to better meet the needs of individual families through a clinical behavioral stepped care intervention for T1D in parents of young children by using real-time glycemic control and \[parental depression indices\] to intensify management support when indicated. Primary caregivers of young children (\<6 years) newly diagnosed with T1D will be randomized to either a 3-step stepped care (treatment) or usual care (comparison) condition. Stepped care components include: T1D management support delivered by trained lay parent consultants (Step 1), T1D parenting strategies and mealtime behavior management delivered by bachelor's level behavioral assistants (Step 2), and individualized diabetes education/management planning with a certified diabetes nurse educator and \[consultation with a diabetes team clinical psychologist\] (Step 3). Biomedical and psychosocial measurements (including A1c, depressive symptoms, mealtime behavior, parenting stress, quality of life) will occur at baseline and 3-month intervals for up to 15 months post-diagnosis. The results of this work will ultimately lead to a more practical approach to T1D education and management that can be translated more easily into a variety of clinical practice settings to support young children's T1D management.

Conditions

• Diabetes Mellitus, Type 1

Interventions

BEHAVIORAL

Stepped Care

Sponsors & Collaborators

• Baylor College of Medicine

  collaborator OTHER

• National Institutes of Health (NIH)

  collaborator NIH

• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

  collaborator NIH

• Children's National Research Institute

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

21 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-04-30

Primary Completion

2021-07-31

Completion

2021-07-31