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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))
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by:
Icahn School of Medicine at Mount Sinai Identifier:
First received: February 23, 2007
Last updated: June 6, 2011
Last verified: June 2011
: 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.

Condition Intervention
Type 1 Diabetes Mellitus
Behavioral: Cognitive Behavioral Therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Improving Metabolic Control in Diabetic Young Children

Resource links provided by NLM:

Further study details as provided by Icahn School of Medicine at Mount Sinai:

Primary Outcome Measures:
  • adherence [ Time Frame: at baseline ]
  • adherence [ Time Frame: at 3 months ]
  • adherence [ Time Frame: at 6 months ]
  • adherence [ Time Frame: at 9 months ]
  • quality of life [ Time Frame: at baseline ]
  • quality of life [ Time Frame: at 3 months ]
  • quality of life [ Time Frame: at 6 months ]
  • quality of life [ Time Frame: at 9 months ]

Secondary Outcome Measures:
  • optimism [ Time Frame: at baseline ]
  • optimism [ Time Frame: at 3 months ]
  • optimism [ Time Frame: at 6 months ]
  • optimism [ Time Frame: at 9 months ]
  • self-efficacy [ Time Frame: at baseline ]
  • self-efficacy [ Time Frame: at 3 months ]
  • self-efficacy [ Time Frame: at 6 months ]
  • self-efficacy [ Time Frame: at 9 months ]
  • parent-child collaboration [ Time Frame: at baseline ]
  • parent-child collaboration [ Time Frame: at 3 months ]
  • parent-child collaboration [ Time Frame: at 6 months ]
  • parent-child collaboration [ Time Frame: at 9 months ]

Enrollment: 23
Study Start Date: September 2006
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Behavioral: Cognitive Behavior Therapy 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).


Ages Eligible for Study:   7 Years to 11 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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).
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Please refer to this study by its identifier: NCT00439985

United States, New York
Mount Sinai School of Medicine
New York, New York, United States, 10029-6574
Sponsors and Collaborators
Icahn School of Medicine at Mount Sinai
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Principal Investigator: Claude Chemtob, Ph.D. Icahn School of Medicine at Mount Sinai
  More Information

Responsible Party: Claude Chemtob, Ph.D., Mount Sinai School of Medicine Identifier: NCT00439985     History of Changes
Other Study ID Numbers: DK074580
Study First Received: February 23, 2007
Last Updated: June 6, 2011

Keywords provided by Icahn School of Medicine at Mount Sinai:
Type 1 Diabetes Mellitus (T1DM)
Metabolic Control
Parent-Child Collaboration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases processed this record on May 25, 2017