Improving Metabolic Control in Diabetic Young Children

This study is currently recruiting participants.

Verified by Mount Sinai School of Medicine, May 2008

First Received: February 23, 2007 Last Updated: May 23, 2008 History of Changes

Sponsor:	Mount Sinai School of Medicine
Collaborator:	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by:	Mount Sinai School of Medicine
ClinicalTrials.gov Identifier:	NCT00439985

Purpose

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:	Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Efficacy Study

Resource links provided by NLM:

MedlinePlus related topics: Diabetes Diabetes Type 1

U.S. FDA Resources

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

Primary Outcome Measures:

metabolic control
adherence
quality of life

Secondary Outcome Measures:

optimism
self-efficacy
parent-child collaboration

Estimated Enrollment:	32
Study Start Date:	September 2006
Estimated Study Completion Date:	July 2008

Eligibility

Ages Eligible for Study:	7 Years to 11 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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).

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00439985

Contacts

Contact: Claude Chemtob, Ph.D.

212-987-0030

Claude.Chemtob@mssm.edu

Locations

United States, New York
Mount Sinai School of Medicine	Recruiting
New York, New York, United States, 10029-6574
Contact: Claude Chemtob, Ph.D. 212-987-0030 Claude.Chemtob@mssm.edu
Principal Investigator: Claude Chemtob, Ph.D.

Sponsors and Collaborators

Mount Sinai School of Medicine

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Investigators

Principal Investigator:

Claude Chemtob, Ph.D.

Mount Sinai School of Medicine

More Information

No publications provided

Study ID Numbers:	DK074580, 05-0667
Study First Received:	February 23, 2007
Last Updated:	May 23, 2008
ClinicalTrials.gov Identifier:	NCT00439985 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Mount Sinai School of Medicine:

Type 1 Diabetes Mellitus (T1DM)
Metabolic Control
Adherence

Optimism
Parent-Child Collaboration
Prevention

Additional relevant MeSH terms:

Autoimmune Diseases
Metabolic Diseases
Immune System Diseases
Diabetes Mellitus, Type 1

Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on November 20, 2009