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Improving Metabolic Control in Diabetic Young Children
This study is currently recruiting participants.
Study NCT00439985   Information provided by Mount Sinai School of Medicine
First Received: February 23, 2007   Last Updated: May 23, 2008   History of Changes

February 23, 2007
May 23, 2008
September 2006
 
  • metabolic control
  • adherence
  • quality of life
Same as current
Complete list of historical versions of study NCT00439985 on ClinicalTrials.gov Archive Site
  • optimism
  • self-efficacy
  • parent-child collaboration
Same as current
 
Improving Metabolic Control in Diabetic Young Children
 
  • 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.
 
 
Interventional
Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Efficacy Study
Type 1 Diabetes Mellitus
Behavioral: Cognitive Behavioral Therapy
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
32
July 2008
 

Inclusion Criteria:

  • Children aged 7 to 11
  • Recently diagnosed with T1DM
  • Treated at Mount Sinai or at North General Hospital

Exclusion Criteria:

  • Children below age 7 and above age 11
  • Individual with diminished mental capacity, such that they would not be able to either complete the assessments or comprehend the materials presented in the intervention, will be excluded.
  • Individuals without sufficient command of the English language to permit participation (due to the verbal nature of the intervention and the assessment package, and the linguistic limitations of the study team).
Both
7 Years to 11 Years
No
Contact: Claude Chemtob, Ph.D. 212-987-0030 Claude.Chemtob@mssm.edu
United States
 
NCT00439985
 
DK074580, 05-0667
Mount Sinai School of Medicine
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Principal Investigator: Claude Chemtob, Ph.D. Mount Sinai School of Medicine
Mount Sinai School of Medicine
May 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP