Intensive Care Program for Youth With Diabetes

N/ACompletedNCT00961974

Joslin Diabetes Center154 enrolled

Overview

The purpose of this study was to determine the ability of a family-focused, office-based intervention to improve medical and behavioral outcomes for children and adolescents with type 1 diabetes.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

154

Conditions

Type 1 Diabetes

Interventions

Care Ambassador InterventionBEHAVIORAL

Care Ambassador provides additional monthly outreach (by phone or e-mail) to families between clinic visits.

Psychoeducational InterventionBEHAVIORAL

A psychoeducational intervention module is reviewed with the family by the Care Ambassador at each clinic visit. The intervention focuses on incorporating intensive therapy into the daily routine of the child through positive family support for blood glucose monitoring and healthy eating. The intervention modules review positive family communication, realistic expectations, ways to avoid perfectionism and maintain family involvement, prevention of hypoglycemia, avoidance of diabetes-specific family conflict, and approaches to reducing "diabetes burnout".

Eligibility

Sex: ALLMin age: 8 YearsMax age: 16 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Age 8-16 years * Type 1 diabetes diagnosed by standard American Diabetes Association criteria * Type 1 diabetes duration of at least 6 months * Residence in northeastern U.S. * Established clinic patient * Fluency in English or Spanish Exclusion Criteria: * Major psychiatric disorder (e.g., major depression, severe eating disorder, mental retardation) * Unstable living environment (e.g., Department of Social Services or Department of Youth Services involvement)

Locations (1)

Joslin Diabetes Center

Boston, Massachusetts, United States

Outcomes

Primary Outcomes

Glycemic control, assessed by hemoglobin A1c

Time frame: Every 3 months

Secondary Outcomes

Psychosocial factors (diabetes-specific family conflict, responsibility-sharing for diabetes management tasks, quality of life, affect regarding blood glucose monitoring, disordered eating behaviors)

Time frame: Annually

Weight, assessed by z-BMI (age- and gender-adjusted body mass index)

Time frame: Every 3 months

Frequency of hospitalizations, emergency department visits, and episodes of severe hypoglycemia

Time frame: Every 3 months

Data from ClinicalTrials.gov

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