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Clinical Trials/NCT00439985
NCT00439985
Terminated
Not Applicable

Improving Metabolic Control in Diabetic Young Children

Icahn School of Medicine at Mount Sinai1 site in 1 country23 target enrollmentSeptember 2006

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Type 1 Diabetes Mellitus
Sponsor
Icahn School of Medicine at Mount Sinai
Enrollment
23
Locations
1
Primary Endpoint
adherence
Status
Terminated
Last Updated
14 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 2006
End Date
July 2009
Last Updated
14 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Eligibility Criteria

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).

Outcomes

Primary Outcomes

adherence

Time Frame: at 9 months

quality of life

Time Frame: at 9 months

Secondary Outcomes

  • optimism(at 9 months)
  • self-efficacy(at 9 months)
  • parent-child collaboration(at 9 months)

Study Sites (1)

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