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Improving Metabolic Control in Diabetic Young Children

This study has been terminated.
(decreased enrollment. (there are no data results for this study))
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by:
Mount Sinai School of Medicine
ClinicalTrials.gov Identifier:
NCT00439985
First received: February 23, 2007
Last updated: June 6, 2011
Last verified: June 2011
History of Changes

February 23, 2007
June 6, 2011
September 2006
July 2009   (final data collection date for primary outcome measure)
  • adherence [ Time Frame: at baseline ] [ Designated as safety issue: No ]
  • adherence [ Time Frame: at 3 months ] [ Designated as safety issue: No ]
  • adherence [ Time Frame: at 6 months ] [ Designated as safety issue: No ]
  • adherence [ Time Frame: at 9 months ] [ Designated as safety issue: No ]
  • quality of life [ Time Frame: at baseline ] [ Designated as safety issue: No ]
  • quality of life [ Time Frame: at 3 months ] [ Designated as safety issue: No ]
  • quality of life [ Time Frame: at 6 months ] [ Designated as safety issue: No ]
  • quality of life [ Time Frame: at 9 months ] [ Designated as safety issue: No ]
  • adherence
  • metabolic control
  • quality of life
Complete list of historical versions of study NCT00439985 on ClinicalTrials.gov Archive Site
  • optimism [ Time Frame: at baseline ] [ Designated as safety issue: No ]
  • optimism [ Time Frame: at 3 months ] [ Designated as safety issue: No ]
  • optimism [ Time Frame: at 6 months ] [ Designated as safety issue: No ]
  • optimism [ Time Frame: at 9 months ] [ Designated as safety issue: No ]
  • self-efficacy [ Time Frame: at baseline ] [ Designated as safety issue: No ]
  • self-efficacy [ Time Frame: at 3 months ] [ Designated as safety issue: No ]
  • self-efficacy [ Time Frame: at 6 months ] [ Designated as safety issue: No ]
  • self-efficacy [ Time Frame: at 9 months ] [ Designated as safety issue: No ]
  • parent-child collaboration [ Time Frame: at baseline ] [ Designated as safety issue: No ]
  • parent-child collaboration [ Time Frame: at 3 months ] [ Designated as safety issue: No ]
  • parent-child collaboration [ Time Frame: at 6 months ] [ Designated as safety issue: No ]
  • parent-child collaboration [ Time Frame: at 9 months ] [ Designated as safety issue: No ]
  • optimism
  • self-efficacy
  • parent-child collaboration
Not Provided
Not Provided
 
Improving Metabolic Control in Diabetic Young Children
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.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Type 1 Diabetes Mellitus
Behavioral: Cognitive Behavioral Therapy
The treatment which incorporates cognitive restructuring and skill training, was designed to help children with diabetes and their families develop particular skills and optimistic/positive thinking style in order to facilitate better coping with the enduring demands and stress of diabetes management. The goal of the intervention was to improve the child's diabetes management both medically and psychologically by promoting optimism (positive outlook), mastery (problem-solving) and child-parent collaboration (team-work).
Behavioral: Cognitive Behavior Therapy
Intervention: Behavioral: Cognitive Behavioral Therapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
23
July 2009
July 2009   (final data collection date for primary outcome measure)

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 information is only displayed when the study is recruiting subjects
United States
 
NCT00439985
DK074580, 05-0667
No
Claude Chemtob, Ph.D., Mount Sinai School of Medicine
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
June 2011

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