Ignite Creation Date:
2024-05-05 @ 4:58 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00358059
Status:
COMPLETED
Last Update Posted:
2006-07-28
First Post:
2006-07-26
Brief Title:
Behavior Therapy for Families of Diabetic Adolescents
Sponsor:
Nemours Childrens Clinic
Organization:
Nemours Childrens Clinic
Study Overview
Official Title:
Behavior Therapy for Families of Diabetic Adolescents
Status:
COMPLETED
Status Verified Date:
2005-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Effective adaptation to type 1 diabetes mellitus requires adolescents and their families to work together effectively to solve problems and resolve disagreements in order to achieve acceptable diabetic control and treatment adherence Many studies show that problematic family communication insufficient parental involvement in care and parent-adolescent conflict are associated with poor adherence and poor diabetic control This study tests a family communication and problem solving intervention by randomizing families of adolescent with type 1 diabetes to 6 months treatment either with the experimental intervention continuation in standard medical care for diabetes or participation in a multifamily educational support group Families are then followed for an additional 12 months to examine the longer-term effects of the interventions on the targeted diabetes outcomes
Detailed Description:
Adolescents with Type 1 diabetes mellitus often struggle to maintain adequate treatment adherence and diabetic control leading to preventable hospitalizations and emergency room visits Numerous cross-sectional and prospective studies show that family communication and conflict resolution skills are important influences on adolescents diabetic control treatment adherence and psychological adjustment Empirical validation of psychological interventions targeting these processes could reduce excess health care costs and risks of diabetic complications In the parent grant we showed that Behavioral Family Systems Therapy BFST Robin Foster 1989 yielded improvements in family communication skills and parent-adolescent relationships but it had weaker and less durable effects on treatment adherence and diabetic control In this competing continuation application we have relied on extensive preliminary data our clinical experience with BFST and the results of others investigations to formulate refinements to BFST that are designed to maximize its impact on diabetes treatment adherence and metabolic control These include required targeting of behavioral barriers to adherence and diabetic control for every family lengthening treatment from 3 to 6 months and incorporation of several treatment components that were shown to be effective in other studies We propose a randomized controlled trial of this refined BFST intervention compared with standard medical therapy or participation in a diabetes educational support group on measures of family communication parent-adolescent relationships adolescent psychological adjustment treatment adherence diabetic control and health care use We will analyze predictors of treatment outcome and evaluate the clinical significance social validity and maintenance of treatment effects over 6month and 12-month follow-up intervals The results could influence the clinical practice of diabetes management and health care policy regarding adolescents with diabetes and other chronic diseases
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None