An interventional study of Parenting classes in Diabetes Mellitus, Type 1, sponsored by William Beaumont Hospitals. Completed. Open to participants aged 2 Years to 5 Years. Per ClinicalTrials.gov, last updated 2019-07-26.
Sponsored by William Beaumont Hospitals · Not applicable, Interventional, and Supportive care
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.
Self identification as primary care giver of child that fits following criteria:
Exclusion Criteria:
Families attended 6 parenting sessions, filled out daily glucose screens, \& questionnaires
Behavioral: Parenting classes
Parenting Classes:The Incredible Years curriculum
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.
Time frame: After 6 weeks of classes
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.
Time frame: Pre intervention to 3 months post intervention
| Milestone | Families Attending Parenting Classes |
|---|---|
| Started | 7 |
| Completed | 5 |
| Not completed | 2 |
Number of families whose child achieved a decrease overnight between bedtime blood glucose level and morning fasting glucose level following intervention at 6 weeks.
| Participants | Families Attending Parenting Classes |
|---|---|
| Effect of Intervention on Evening Glucose Control. | 2 |
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.
| percent of HbA1c | Families Attending Parenting Classes |
|---|---|
| Difference Between Child's Pre-intervention and 3 Month Hemoglobin A1c Value | -0.3 (-1.1 to 0.6) |
Collected over 6 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Families Attending Parenting Class | 0/7 (0%) | 0/7 (0%) | 0/7 (0%) |
7 parents enrolled with children between the ages of 2 to 5 years old, but 2 did not complete.
| Age, Categorical(Participants) | Families Attending Parenting Classes |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 7 |
| >=65 years | 0 |
| Sex: Female, Male(Participants) | Families Attending Parenting Classes |
|---|---|
| Female | 2 |
| Male | 5 |
| Race (NIH/OMB)(Participants) | Families Attending Parenting Classes |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 1 |
| White | 6 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(Participants) | Families Attending Parenting Classes |
|---|---|
| United States | 7 |
No study locations are listed for this record.
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Plan to share: No
This study is completed, as verified in May 2019. You cannot join it, but the record below documents what was studied.
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William Beaumont Hospitals