- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03255902
Family Routines - Healthy Families
May 29, 2019 updated by: Donna Marvicsin, William Beaumont Hospitals
Family Routine - Healthy Families
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
7
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
2 years to 5 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Families attending parenting classes
Families attended 6 parenting sessions, filled out daily glucose screens, & questionnaires
|
Parenting Classes:The Incredible Years curriculum
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Effect of Intervention on Evening Glucose Control.
Time Frame: After 6 weeks of classes
|
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
Time Frame: Pre intervention to 3 months post intervention
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Donna Marvicsin, PhD, William Beaumont Children's Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 24, 2016
Primary Completion (Actual)
March 1, 2017
Study Completion (Actual)
January 17, 2019
Study Registration Dates
First Submitted
August 16, 2017
First Submitted That Met QC Criteria
August 18, 2017
First Posted (Actual)
August 21, 2017
Study Record Updates
Last Update Posted (Actual)
July 26, 2019
Last Update Submitted That Met QC Criteria
May 29, 2019
Last Verified
May 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2016-154
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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