Improving Metabolic Control in Diabetic Young Children
Stopped early · Not applicable
Conditions studied: Type 1 Diabetes Mellitus
In brief
: 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.
Key facts
- Study ID
- NCT00439985
- Run by
- Icahn School of Medicine at Mount Sinai
- People needed
- 23
- Starts
- 2006-09-01
- Expected to finish
- 2009-07-01
- Last updated by the study team
- 2011-06-08
Who can join
Age: 7 and older, up to 11. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Children aged 7 to 11
- Recently diagnosed with T1DM
- Treated at Mount Sinai or at North General Hospital
You may not qualify if…
- 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).
Where it is running
- Mount Sinai School of Medicine — New York, New York, United States
Full record on ClinicalTrials.gov
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