Optimizing Adherence and Glycemia in Youth With New Insulin-dependent Diabetes Mellitus (IDDM)

Study Overview
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Brief Summary
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This 2-year randomized, controlled trial examined the impact of a clinic-based, family teamwork intervention on glycemic control in youth with recently diagnosed type 1 diabetes.

Official Title
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Optimizing Adherence and Glycemia in Youth With New IDDM

Conditions
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Type 1 Diabetes Mellitus

Intervention / Treatment
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* Behavioral: Family Teamwork Intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 8 to 17 years old Duration of type 1 diabetes between 2 months and 6 years Residence in New England or New York At least 1 outpatient visit in the past year Exclusion Criteria: Major co-morbid psychiatric or medical illness in youth Diagnosis of an active major psychiatric disorder in either parent Diagnosis of a life-threatening medical illness in either parent

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Teamwork Group<br>Families randomized to the Teamwork Group received the behavioral family teamwork intervention. | Behavioral: Family Teamwork Intervention<br>* Families in the teamwork group received quarterly psychoeducational interventions at regular clinic visits, focusing on promoting family teamwork and reducing diabetes-specific family conflict and diabetes burnout.<br>|
| No Intervention: Standard Care<br>Families in the Standard Care group received standard diabetes care and equal attention from study staff between visits to schedule appointments and encourage regular diabetes follow-up care. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glycemic control, assessed by hemoglobin A1c | Change in A1c from baseline to 2 years, measured every 3 months | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Youth quality of life, measured using the youth PedsQL survey and the parent-proxy PedsQL survey | Measured at baseline, 1 year, and 2 years | 2 years | 
| Diabetes-specific family conflict, measured using the Diabetes Family Conflict survey (youth and parent versions) | Measured at baseline, 1 year, and 2 years | 2 years | 
| Parent involvement in diabetes management tasks, measured using the Diabetes Family Responsibility Questionnaire (youth and parent versions) | Measured at baseline, 1 year, and 2 years | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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type 1 diabetes, glycemic control, family conflict, quality of life, parental involvement