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| Name | Class |
|---|---|
| University of Michigan | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Families attending parenting classes | Experimental | Families attended 6 parenting sessions, filled out daily glucose screens, & questionnaires |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Parenting classes | Behavioral | Parenting Classes:The Incredible Years curriculum |
|
| 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 |
| 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 |
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Inclusion Criteria:
Self identification as primary care giver of child that fits following criteria:
English fluency
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Donna Marvicsin, PhD | William Beaumont Children's Hospital | Principal Investigator |
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| ID | Title | Description |
|---|---|---|
| FG000 | Families Attending Parenting Classes | Families attended 6 parenting sessions, filled out daily glucose screens, & questionnaires Parenting classes: Parenting Classes:The Incredible Years curriculum |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
7 parents enrolled with children between the ages of 2 to 5 years old, but 2 did not complete.
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| ID | Title | Description |
|---|---|---|
| BG000 | Families Attending Parenting Classes | Families attended 6 parenting sessions, filled out daily glucose screens, & questionnaires Parenting classes: Parenting Classes:The Incredible Years curriculum |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | 2 participants did not complete study | Posted | Count of Participants | Participants | After 6 weeks of classes |
|
|
6 weeks
A questionnaire and survey was used to collect information for this study. Participants were carefully observed for any signs of anxiety or discomfort or any serious adverse events.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Families Attending Parenting Class | Families attended 6 parenting sessions, filled out daily glucose screens, & questionnaires. Parenting Classes: The Incredible Years curriculum |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Donna Marvicsin, Nurse Practitioner, Pediatric Endocrinology | William Beaumont Hospitals | 248-568-6932 | donna.marvicsin@beaumont.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 29, 2016 | Jan 30, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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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.
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| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Participants |
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| Secondary | 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. | 2 participants did not complete study | Posted | Median | Full Range | percent of HbA1c | Pre intervention to 3 months post intervention |
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| 0 |
| 7 |
| 0 |
| 7 |
| 0 |
| 7 |
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| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |