Type 1 Diabetes
Conditions
Keywords
type 1 diabetes, hemoglobin A1c, family, involvement, responsibility, conflict, quality of life, children
Brief summary
The purpose of this study was to determine the ability of a family-focused, office-based intervention to improve medical and behavioral outcomes for children and adolescents with type 1 diabetes.
Interventions
BEHAVIORALCare Ambassador Intervention
Care Ambassador provides additional monthly outreach (by phone or e-mail) to families between clinic visits.
BEHAVIORALPsychoeducational Intervention
A psychoeducational intervention module is reviewed with the family by the Care Ambassador at each clinic visit. The intervention focuses on incorporating intensive therapy into the daily routine of the child through positive family support for blood glucose monitoring and healthy eating. The intervention modules review positive family communication, realistic expectations, ways to avoid perfectionism and maintain family involvement, prevention of hypoglycemia, avoidance of diabetes-specific family conflict, and approaches to reducing diabetes burnout.
Sponsors
Charles H. Hood Foundation
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Joslin Diabetes Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
8 Years to 16 Years
Healthy volunteers
No
Inclusion criteria
* Age 8-16 years * Type 1 diabetes diagnosed by standard American Diabetes Association criteria * Type 1 diabetes duration of at least 6 months * Residence in northeastern U.S. * Established clinic patient * Fluency in English or Spanish
Exclusion criteria
* Major psychiatric disorder (e.g., major depression, severe eating disorder, mental retardation) * Unstable living environment (e.g., Department of Social Services or Department of Youth Services involvement)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Glycemic control, assessed by hemoglobin A1c | Every 3 months |
Secondary
| Measure | Time frame |
|---|---|
| Psychosocial factors (diabetes-specific family conflict, responsibility-sharing for diabetes management tasks, quality of life, affect regarding blood glucose monitoring, disordered eating behaviors) | Annually |
| Weight, assessed by z-BMI (age- and gender-adjusted body mass index) | Every 3 months |
| Frequency of hospitalizations, emergency department visits, and episodes of severe hypoglycemia | Every 3 months |
Countries
United States
Outcome results
None listed