Type 1 Diabetes Clinical Trial
— YCPOfficial title:
Parenting and Control Among Young Children With Type 1 Diabetes
Verified date | March 2018 |
Source | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Type 1 diabetes is a lifelong metabolic disorder that affects 1 out of every 400-600 American
children each year, with many children being diagnosed at younger and younger ages.
To achieve proper diabetes control, it is necessary to conform or adhere one's behavior to a
physician-prescribed diabetes self-care regimen. As such, parents of children with Type 1
diabetes must be highly involved in managing their child's disease on a daily basis,
especially parents of affected children who are very young and more highly dependent upon
parental caretaking.
As children diagnosed with Type 1 diabetes at a very young age may be at an increased risk
for the development of long-term behavioral and medical complications, more research is
needed to understand and treat the leading contributors to diabetes-related parental distress
and medical outcomes among this growing subgroup.
Recent findings indicate that responsibility for diabetes management falls heavily on
mothers. The majority of families do not receive outside child care assistance and report
feeling overwhelmed. Parents report high levels of pediatric parenting stress difficulty, as
well as moderate symptoms of anxiety. The current study aims to expand such preliminary
findings and specifically examine the effects of a newly-developed parenting support program
for parents of young children with Type 1 diabetes. The utility of the intervention will be
evaluated. It is hypothesized that parents completing the parent support program will report
lower levels of psychosocial distress and improved quality of life. It is hypothesized that
the children of participating parents will also demonstrate improved quality of life and
metabolic control.
Status | Completed |
Enrollment | 134 |
Est. completion date | August 2013 |
Est. primary completion date | August 2013 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 1 Year to 6 Years |
Eligibility |
Inclusion Criteria: - Type 1 diabetes for at least 6 months prior to enrollment - Seen for diabetes care at Children's National or Virginia Commonwealth - Child ages 1-6 Exclusion Criteria: - Non-English speaking primary caregiver - Child with significant developmental delay |
Country | Name | City | State |
---|---|---|---|
United States | Virginia Commonwealth University | Richmond | Virginia |
United States | Children's National Medical Center | Washington | District of Columbia |
Lead Sponsor | Collaborator |
---|---|
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | Children's Research Institute, Virginia Commonwealth University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Glycemic variability | baseline, 1, 6, and 12 months post intervention | ||
Secondary | Parent Quality of Life | baseline, 1, 6, and 12 months post intervention | ||
Secondary | Child Quality of Life | baseline, 1, 6, and 12 months post intervention | ||
Secondary | Hemoglobin A1C | 6 months post intervention |
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