Viewing Study NCT00439985



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Last Modification Date: 2024-10-26 @ 9:31 AM
Study NCT ID: NCT00439985
Status: TERMINATED
Last Update Posted: 2011-06-08
First Post: 2007-02-23

Brief Title: Improving Metabolic Control in Diabetic Young Children
Sponsor: Icahn School of Medicine at Mount Sinai
Organization: Icahn School of Medicine at Mount Sinai

Study Overview

Official Title: Improving Metabolic Control in Diabetic Young Children
Status: TERMINATED
Status Verified Date: 2011-06
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: decreased enrollment there are no data results for this study
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: Although intervention or prevention with young children with T1DM may help ameliorate problems or forestall later problems in metabolic control a number of potential barriers to research have constrained the development of such interventions To assess the feasibility of intervening with young children and their families we propose to conduct an exploratory pilot study of a behavioral intervention for young children ages 7 to 11 newly diagnosed with T1DM The intervention derived from the pediatric prevention work of Seligman and his colleagues seeks to apply positive psychology principles to enhance optimism self-efficacy and parent-child collaboration in diabetes management in order to improve quality of life adherence and metabolic control This exploratory study will allow us to evaluate the feasibility of intervening with young children and their caretakers and to estimate intervention effect sizes in preparation for a randomized controlled clinical trial
Detailed Description: None

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
Secondary IDs
Secondary ID Type Domain Link
05-0667 None None None