Family Routines - Healthy Families

Study Overview
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Brief Summary
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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
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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.

Official Title
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Family Routine - Healthy Families

Conditions
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Diabetes Mellitus, Type 1

Intervention / Treatment
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* Behavioral: Parenting classes


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 5 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Families attending parenting classes<br>Families attended 6 parenting sessions, filled out daily glucose screens, & questionnaires | Behavioral: Parenting classes<br>* Parenting Classes:The Incredible Years curriculum<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | After 6 weeks of classes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Pre intervention to 3 months post intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetes