Improving Metabolic Control in Diabetic Young Children

Type 1 Diabetes Mellitus Clinical Trial

Official title:

Improving Metabolic Control in Diabetic Young Children

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00439985
• Other study ID #: DK074580
• Secondary ID: 05-0667
• Status: Terminated
• Phase: N/A
• First received: February 23, 2007
• Last updated: June 6, 2011
• Start date: September 2006
• Est. completion date: July 2009

Study information

• Verified date: June 2011
• Source: Icahn School of Medicine at Mount Sinai
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 23
• Est. completion date: July 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 7 Years to 11 Years

Eligibility

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).

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes Mellitus

Intervention

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).

Locations

Country	Name	City	State
United States	Mount Sinai School of Medicine	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Icahn School of Medicine at Mount Sinai	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	adherence		at baseline	No
Primary	adherence		at 3 months	No
Primary	adherence		at 6 months	No
Primary	adherence		at 9 months	No
Primary	quality of life		at baseline	No
Primary	quality of life		at 3 months	No
Primary	quality of life		at 6 months	No
Primary	quality of life		at 9 months	No
Secondary	optimism		at baseline	No
Secondary	optimism		at 3 months	No
Secondary	optimism		at 6 months	No
Secondary	optimism		at 9 months	No
Secondary	self-efficacy		at baseline	No
Secondary	self-efficacy		at 3 months	No
Secondary	self-efficacy		at 6 months	No
Secondary	self-efficacy		at 9 months	No
Secondary	parent-child collaboration		at baseline	No
Secondary	parent-child collaboration		at 3 months	No
Secondary	parent-child collaboration		at 6 months	No
Secondary	parent-child collaboration		at 9 months	No