Parental Management of Young Children's Diabetes
YCP
Parenting and Control Among Young Children With Type 1 Diabetes
2 other identifiers
interventional
134
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Apr 2008
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2008
CompletedFirst Submitted
Initial submission to the registry
February 17, 2009
CompletedFirst Posted
Study publicly available on registry
February 19, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2013
CompletedMarch 14, 2018
March 1, 2018
5.3 years
February 17, 2009
March 12, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Glycemic variability
baseline, 1, 6, and 12 months post intervention
Secondary Outcomes (3)
Parent Quality of Life
baseline, 1, 6, and 12 months post intervention
Child Quality of Life
baseline, 1, 6, and 12 months post intervention
Hemoglobin A1C
6 months post intervention
Study Arms (2)
Parental Support
EXPERIMENTALDiabetes Education
ACTIVE COMPARATORInterventions
The intervention utilizes cognitive behavioral strategies. Session 1 uses relaxation and cognitive reframing and explores parents' responses to the challenges of parenting a child with diabetes. Session 2 focuses on the emotional impact of having a child with diabetes and utilizes problem solving techniques. Session 3 focuses on child behavior and strategies for effective parenting. To facilitate support and community, Session 4 is a group session via conference call to discuss issues related to social support. Session 5 focuses on the impact diabetes has on the family and parents are taught cognitive reframing to help with managing diabetes. Parents are invited to participate in an Internet bulletin board moderated by trial personnel.
The education comparison group also participates in 5 sessions across 9 weeks. This group provides educational and resource support that is specific to managing diabetes in young children. Education topics include blood glucose monitoring, nutrition, and physical activity. Print materials are provided to participants and intervention sessions focus on talking points raised in these reading materials.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Non-English speaking primary caregiver
- Child with significant developmental delay
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Children's National Medical Center
Washington D.C., District of Columbia, 20010, United States
Virginia Commonwealth University
Richmond, Virginia, 23284, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Randi Streisand, Ph.D.
Children's National Research Institute
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 17, 2009
First Posted
February 19, 2009
Study Start
April 1, 2008
Primary Completion
August 1, 2013
Study Completion
August 1, 2013
Last Updated
March 14, 2018
Record last verified: 2018-03