Improving Metabolic Control in Diabetic Young Children
Primary Purpose
Type 1 Diabetes Mellitus
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cognitive Behavioral Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Type 1 Diabetes Mellitus focused on measuring Type 1 Diabetes Mellitus (T1DM), Metabolic Control, Adherence, Optimism, Parent-Child Collaboration, Prevention
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).
Sites / Locations
- Mount Sinai School of Medicine
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Behavioral: Cognitive Behavior Therapy
Arm Description
Outcomes
Primary Outcome Measures
adherence
adherence
adherence
adherence
quality of life
quality of life
quality of life
quality of life
Secondary Outcome Measures
optimism
optimism
optimism
optimism
self-efficacy
self-efficacy
self-efficacy
self-efficacy
parent-child collaboration
parent-child collaboration
parent-child collaboration
parent-child collaboration
Full Information
NCT ID
NCT00439985
First Posted
February 23, 2007
Last Updated
June 6, 2011
Sponsor
Icahn School of Medicine at Mount Sinai
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
1. Study Identification
Unique Protocol Identification Number
NCT00439985
Brief Title
Improving Metabolic Control in Diabetic Young Children
Official Title
Improving Metabolic Control in Diabetic Young Children
Study Type
Interventional
2. Study Status
Record Verification Date
June 2011
Overall Recruitment Status
Terminated
Why Stopped
decreased enrollment. (there are no data results for this study)
Study Start Date
September 2006 (undefined)
Primary Completion Date
July 2009 (Actual)
Study Completion Date
July 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Icahn School of Medicine at Mount Sinai
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes Mellitus
Keywords
Type 1 Diabetes Mellitus (T1DM), Metabolic Control, Adherence, Optimism, Parent-Child Collaboration, Prevention
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
23 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Behavioral: Cognitive Behavior Therapy
Arm Type
Other
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Behavioral Therapy
Intervention Description
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).
Primary Outcome Measure Information:
Title
adherence
Time Frame
at baseline
Title
adherence
Time Frame
at 3 months
Title
adherence
Time Frame
at 6 months
Title
adherence
Time Frame
at 9 months
Title
quality of life
Time Frame
at baseline
Title
quality of life
Time Frame
at 3 months
Title
quality of life
Time Frame
at 6 months
Title
quality of life
Time Frame
at 9 months
Secondary Outcome Measure Information:
Title
optimism
Time Frame
at baseline
Title
optimism
Time Frame
at 3 months
Title
optimism
Time Frame
at 6 months
Title
optimism
Time Frame
at 9 months
Title
self-efficacy
Time Frame
at baseline
Title
self-efficacy
Time Frame
at 3 months
Title
self-efficacy
Time Frame
at 6 months
Title
self-efficacy
Time Frame
at 9 months
Title
parent-child collaboration
Time Frame
at baseline
Title
parent-child collaboration
Time Frame
at 3 months
Title
parent-child collaboration
Time Frame
at 6 months
Title
parent-child collaboration
Time Frame
at 9 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
No
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Claude Chemtob, Ph.D.
Organizational Affiliation
Icahn School of Medicine at Mount Sinai
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mount Sinai School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10029-6574
Country
United States
12. IPD Sharing Statement
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Improving Metabolic Control in Diabetic Young Children
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