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Family Routines - Healthy Families

Primary Purpose

Diabetes Mellitus, Type 1

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Parenting classes
Sponsored by
William Beaumont Hospitals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Diabetes Mellitus, Type 1 focused on measuring Diabetes

Eligibility Criteria

2 Years - 5 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Self identification as primary care giver of child that fits following criteria:

    1. Age 2 - 5 years
    2. Diagnosis of Type 1 diabetes
    3. Most recent Hemoglobin A1c (HbA1c) > 8.0
    4. Child a patient of Pediatric Endocrinology, Beaumont Children's Hospital
  2. English fluency

Exclusion Criteria:

  1. Cognitively impaired
  2. Does not meet inclusion criteria

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Families attending parenting classes

    Arm Description

    Families attended 6 parenting sessions, filled out daily glucose screens, & questionnaires

    Outcomes

    Primary Outcome Measures

    Effect of Intervention on Evening Glucose Control.
    Number of families whose child achieved a decrease overnight between bedtime blood glucose level and morning fasting glucose level following intervention at 6 weeks.

    Secondary Outcome Measures

    Difference Between Child's Pre-intervention and 3 Month Hemoglobin A1c Value
    3-month Hemoglobin A1c value subtracted from pre-intervention Hemoglobin A1c value. Positive numbers indicate an improvement in glucose control with intervention, and negative numbers indicate no improvement in glucose control with intervention.

    Full Information

    First Posted
    August 16, 2017
    Last Updated
    May 29, 2019
    Sponsor
    William Beaumont Hospitals
    Collaborators
    University of Michigan
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03255902
    Brief Title
    Family Routines - Healthy Families
    Official Title
    Family Routine - Healthy Families
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    May 24, 2016 (Actual)
    Primary Completion Date
    March 1, 2017 (Actual)
    Study Completion Date
    January 17, 2019 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    William Beaumont Hospitals
    Collaborators
    University of Michigan

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The purpose of the proposed study, Family Routines - Healthy Families, is to examine the feasibility and acceptability of a parenting/family routine intervention program for parents of young children, ages 2-5, with type 1 diabetes.
    Detailed Description
    The intervention in Family Routines - Healthy Families contains an established and effective parent skills training curriculum called "The Incredible Years," uniquely integrated with a newly developed family evening routine component e.g., family dinner time and evening routine, to promote improved metabolic control. The investigator will assess outcomes during and at one week post intervention. Outcome measures will include family routine, specifically the time between the dinner and bedtime glucose check, parent bedtime decision making, and child overnight glucose control. In addition, parental quality of life and receptiveness to the intervention will be assessed.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Diabetes Mellitus, Type 1
    Keywords
    Diabetes

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Model Description
    This feasibility study will be a mixed methods non-randomized trial to examine the feasibility of combining a parent skill training intervention with a family evening routine intervention. Evidence of feasibility will include attendance, activities completed, and interviews.
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    7 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Families attending parenting classes
    Arm Type
    Experimental
    Arm Description
    Families attended 6 parenting sessions, filled out daily glucose screens, & questionnaires
    Intervention Type
    Behavioral
    Intervention Name(s)
    Parenting classes
    Intervention Description
    Parenting Classes:The Incredible Years curriculum
    Primary Outcome Measure Information:
    Title
    Effect of Intervention on Evening Glucose Control.
    Description
    Number of families whose child achieved a decrease overnight between bedtime blood glucose level and morning fasting glucose level following intervention at 6 weeks.
    Time Frame
    After 6 weeks of classes
    Secondary Outcome Measure Information:
    Title
    Difference Between Child's Pre-intervention and 3 Month Hemoglobin A1c Value
    Description
    3-month Hemoglobin A1c value subtracted from pre-intervention Hemoglobin A1c value. Positive numbers indicate an improvement in glucose control with intervention, and negative numbers indicate no improvement in glucose control with intervention.
    Time Frame
    Pre intervention to 3 months post intervention

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    2 Years
    Maximum Age & Unit of Time
    5 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Self identification as primary care giver of child that fits following criteria: Age 2 - 5 years Diagnosis of Type 1 diabetes Most recent Hemoglobin A1c (HbA1c) > 8.0 Child a patient of Pediatric Endocrinology, Beaumont Children's Hospital English fluency Exclusion Criteria: Cognitively impaired Does not meet inclusion criteria
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Donna Marvicsin, PhD
    Organizational Affiliation
    William Beaumont Children's Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Family Routines - Healthy Families

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