Improving Metabolic Control in Diabetic Young Children

Not Applicable

Terminated

• Conditions: Type 1 Diabetes Mellitus
• Interventions: Behavioral: Cognitive Behavioral Therapy

• Registration Number: NCT00439985
• Lead Sponsor: Icahn School of Medicine at Mount Sinai

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-09
• Study First Submitted: 2007-02-23
• Study First Submitted QC: 2007-02-23
• Study First Posted: 2007-02-26
• Primary Completion: 2009-07
• Study Completion: 2009-07
• Status Verified: 2011-06
• Last Update Submitted: 2011-06-06
• Last Update Posted: 2011-06-08

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 23

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Behavioral: Cognitive Behavior Therapy	Cognitive Behavioral Therapy	-

Primary Outcome Measures

Name	Time	Method
adherence	at 9 months
quality of life	at 9 months

Secondary Outcome Measures

Name	Time	Method
optimism	at 9 months
self-efficacy	at 9 months
parent-child collaboration	at 9 months

Trial Locations

Locations (1)

Mount Sinai School of Medicine; 🇺🇸 New York, New York, United States