Clinical trial NCT00847327: Parental Management of Young Children's Diabetes
Official title: Parenting and Control Among Young Children With Type 1 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 1 Diabetes
Keywords: Type 1 Diabetes
Parenting
Young Children
Lead sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Sponsor class: NIH
Collaborators: name: Children's National Research Institute
name: Virginia Commonwealth University
First posted: 2009-02-19
Enrollment: 134
Sex: ALL
Minimum age (years): 1
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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. If Type 1 diabetes is not properly controlled, it can lead to a host of devastating disease-related complications later in life. Therefore, achieving proper diabetes control during childhood is an important public health issue.

To achieve proper diabetes control, it is necessary to conform or adhere one's behavior to a physician-prescribed diabetes self-care regimen consisting of multiple insulin administrations and blood glucose (BG) checks daily, as well as pay careful attention to diet and exercise. 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.

It is not surprising that the experience of managing a child's diabetes can be demanding, overwhelming, and stressful for some parents, and may even significantly impair parental psychosocial well being. Further, difficulties achieving proper diabetes control have been reported to occur among parents of children of all ages, including parents of those who are very young.

Operationally, these psychosocial well being and diabetes outcomes can be examined by assessing: (1) parental symptoms of depression, anxiety, diabetes parenting stress, and perceived social support, and (2) metabolic control, which may be measured with the quarterly HbA1C counts.

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 due to the aforementioned difficulties (on the part of their parents), more research is needed to understand and treat the leading contributors to diabetes-related parental distress (depression, anxiety, stress, social support) and medical outcomes among this growing subgroup.

Recent findings indicate that responsibility for diabetes management falls heavily on mothers, who report performing 79% of their children's injections and 70% of blood glucose checks (Mednick, 2005). 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.

Evaluating this intervention is a first step in the long-term goal of improving diabetes health outcomes for young children. Understanding the usefulness of this intervention can help us to further refine intervention programs for parents of young children with Type 1 diabetes that best meet their unique needs and risks.

Eligibility criteria: 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

Primary outcomes:
measure: Glycemic variability
timeFrame: baseline, 1, 6, and 12 months post intervention
Secondary outcomes:
measure: Parent Quality of Life
timeFrame: baseline, 1, 6, and 12 months post intervention
measure: Child Quality of Life
timeFrame: baseline, 1, 6, and 12 months post intervention
measure: Hemoglobin A1C
timeFrame: 6 months post intervention
Other outcomes:
Locations:
city: Washington
country: United States
facility: Children's National Medical Center
state: District of Columbia
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
Study officials:
affiliation: Children's National Research Institute
name: Randi Streisand, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: