Skype for Youth With Poorly Controlled Diabetes

Phase 4

Completed

• Conditions: Type 1 Diabetes
• Interventions: Behavioral: BFST

• Registration Number: NCT02274103
• Lead Sponsor: Oregon Health and Science University

Brief Summary

Compared family-based skills training (aka, Behavioral Family Systems Therapy) to youth with poorly controlled type 1 diabetes and their parents either face-to-face or over SkypeTM. Examined the differential impact on the youth's adherence to the diabetes medical regimen and the youth's blood sugar control.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2010-03
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Status Verified: 2014-10
• Study First Submitted: 2014-10-21
• Study First Submitted QC: 2014-10-23
• Last Update Submitted: 2014-10-23
• Study First Posted: 2014-10-24
• Last Update Posted: 2014-10-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 92

Inclusion Criteria

• Youth between the ages of 12 and 18 with type 1 diabetes characterized by an HbA1c value great than 9%
• Caregivers willing to participate
• Family members reading English at 5th grade level
• Willing to be randomized.

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Exclusion Criteria

• Youth with intellectual disability
• Parent or youth who doesn't speak English

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Clinic	BFST	BFST delivered to youth with poorly controlled diabetes and their families in the clinic, face-to-face.
Skype	BFST	BFST delivered to youth with poorly controlled diabetes and their families using Skype.

Primary Outcome Measures

Name	Time	Method
HbA1c	Change from Baseline to 3 months and from 3 months to 6 months	HbA1c values for both intervention groups improved from baseline to 3 months and from 3 months to 6 months.

Secondary Outcome Measures

Name	Time	Method
Adherence to diabetes treatment using the Diabetes Self Management Profile (DSMP) (Harris et al, 2001).	Change from Baseline to 3 months and from 3 months to 6 months	DSMP scores for both intervention groups improved from baseline to 3 months and from 3 months to 6 months.