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Improving Metabolic Control in Diabetic Young Children

NCT00439985 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2011-06-08

No results posted yet for this study

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.

Conditions

  • Type 1 Diabetes Mellitus

Interventions

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).

Sponsors & Collaborators

Principal Investigators

  • Claude Chemtob, Ph.D. · Icahn School of Medicine at Mount Sinai

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
7 Years
Max Age
11 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-09-30
Primary Completion
2009-07-31
Completion
2009-07-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00439985 on ClinicalTrials.gov