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

NCT02527525 | Completed DMC

• 2 other identifiers: 62701R01DK102561-01A1
• Study Type: interventional
• Target: 158
• Locations: 0 countries
• Sites: N/A

Brief 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

Outcome Measures

Primary Outcomes (3)

• glycemic control

  A1c

  6 months post intervention completion

• parental mood

  parent report on CES-D

  6 months post intervention completion

• glycemic variability

  data from 30 day blood glucose download will be summarized to characterize percent of time above, below, and within target range

  6 months post intervention

Study Arms (2)

Stepped Care

EXPERIMENTAL

150 subjects will be randomized to the stepped care intervention. All 150 participants will be assigned a parent coach after randomization to stepped care condition. At the child's next follow up clinic visit participants who have elevated depression scores OR who's child has not met A1c target will move on to Step 2 of the intervention- 5 sessions with a study interventionist. At the following child's clinic visit, participants can either remain in Step 1, move to Step 2, or if needed, move on to Step 3- using a continuous glucose monitor for 1 week followed by a meeting with a certified diabetes educator and a diabetes team clinical psychologist.

Behavioral: Stepped Care

Usual Care

NO INTERVENTION

Participants randomized to usual care will participate in regular diabetes clinic visits and diabetes education, as they would have done without participation in this study.

Interventions

Stepped Care BEHAVIORAL

Stepped Care

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Primary caregivers for children ages 1-6 newly diagnosed with T1D
• Although we anticipate that the majority (90%) of primary caregivers will be female (e.g., mothers, grandmothers), we will include males who self-identify as the primary caregiver (e.g., fathers).
• Parents of children following all types of medical regimens, with any level of glycemic control, will be invited to participate.
• Parents must be able to adequately understand, speak, and read English to benefit from participation. Parents must have ready and consistent access to a mobile telephone with text messaging capability to participate.

You may not qualify if:

• Parent non-english speaking.
• Parents are the focus of this investigation and, therefore, cannot have serious mental illness (e.g., schizophrenia) or developmental disability that would limit participation. Similarly, children with T1D should not have other life-threatening disease (e.g., cancer, cystic fibrosis) or developmental disability (e.g., autism, mental retardation).

Sponsors & Collaborators

• Children's National Research Institute: lead
• Baylor College of Medicine: collaborator
• National Institutes of Health (NIH): collaborator
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Related Publications (4)

• Hilliard ME, Tully C, Monaghan M, Hildebrandt T, Wang CH, Barber JR, Clary L, Gallagher K, Levy W, Cogen F, Henderson C, Karaviti L, Streisand R. First STEPS: Primary Outcomes of a Randomized, Stepped-Care Behavioral Clinical Trial for Parents of Young Children With New-Onset Type 1 Diabetes. Diabetes Care. 2022 Oct 1;45(10):2238-2246. doi: 10.2337/dc21-2704.

  PMID: 35997261 DERIVED

• Wang CH, Hilliard ME, Carreon SA, Jones J, Rooney K, Barber JR, Tully C, Monaghan M, Streisand R. Predictors of mood, diabetes-specific and COVID-19-specific experiences among parents of early school-age children with type 1 diabetes during initial months of the COVID-19 pandemic. Pediatr Diabetes. 2021 Nov;22(7):1071-1080. doi: 10.1111/pedi.13255. Epub 2021 Aug 30.

  PMID: 34369043 DERIVED

• Sinisterra M, Wang CH, Marks BE, Barber J, Tully C, Monaghan M, Hilliard ME, Streisand R. Patterns of Continuous Glucose Monitor Use in Young Children Throughout the First 18 Months Following Type 1 Diabetes Diagnosis. Diabetes Technol Ther. 2021 Nov;23(11):777-781. doi: 10.1089/dia.2021.0183. Epub 2021 Jul 29.

  PMID: 34252292 DERIVED

• Shneider C, Hilliard ME, Monaghan M, Tully C, Wang CH, Sinisterra M, Jones J, Levy W, Streisand R. Recruiting and retaining parents in behavioral intervention trials: Strategies to consider. Contemp Clin Trials. 2021 Sep;108:106502. doi: 10.1016/j.cct.2021.106502. Epub 2021 Jul 6.

  PMID: 34237457 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 16, 2015
• First Posted: August 19, 2015
• Study Start: April 1, 2016
• Primary Completion: July 1, 2021
• Study Completion: July 1, 2021
• Last Updated: August 6, 2021

Record last verified: 2021-08