Improving Metabolic Control in Diabetic Young Children

This study has been terminated.
(decreased enrollment. (there are no data results for this study))
Sponsor:
Collaborator:
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
  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: Allocation: Randomized
Endpoint Classification: Efficacy Study
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 Mount Sinai School of Medicine:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

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).

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, New York
Mount Sinai School of Medicine
New York, New York, United States, 10029-6574
Sponsors and Collaborators
Mount Sinai School of Medicine
Investigators
Principal Investigator: Claude Chemtob, Ph.D. Mount Sinai School of Medicine
  More Information

No publications provided

Responsible Party: Claude Chemtob, Ph.D., Mount Sinai School of Medicine
ClinicalTrials.gov Identifier: NCT00439985     History of Changes
Other Study ID Numbers: DK074580, 05-0667
Study First Received: February 23, 2007
Last Updated: June 6, 2011
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:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Autoimmune Diseases
Endocrine System Diseases
Glucose Metabolism Disorders
Immune System Diseases
Metabolic Diseases

ClinicalTrials.gov processed this record on October 22, 2014