Improving Metabolic Control in Diabetic Young Children

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-09-30

Study Completion Date

2009-07-31

Brief Summary

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: 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.

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Detailed Description

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Conditions

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Type 1 Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Behavioral: Cognitive Behavior Therapy

Group Type OTHER

Cognitive Behavioral Therapy

Intervention Type BEHAVIORAL

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).

Interventions

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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).

Intervention Type BEHAVIORAL

Eligibility Criteria

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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).

Minimum Eligible Age

7 Years

Maximum Eligible Age

11 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No