NCT02274103

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
92

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Mar 2010

Typical duration for phase_4

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2010

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

October 21, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 24, 2014

Completed
Last Updated

October 24, 2014

Status Verified

October 1, 2014

Enrollment Period

2.8 years

First QC Date

October 21, 2014

Last Update Submit

October 23, 2014

Conditions

Outcome Measures

Primary Outcomes (1)

  • HbA1c

    HbA1c values for both intervention groups improved from baseline to 3 months and from 3 months to 6 months.

    Change from Baseline to 3 months and from 3 months to 6 months

Secondary Outcomes (1)

  • 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

Study Arms (2)

Clinic

ACTIVE COMPARATOR

BFST delivered to youth with poorly controlled diabetes and their families in the clinic, face-to-face.

Behavioral: BFST

Skype

ACTIVE COMPARATOR

BFST delivered to youth with poorly controlled diabetes and their families using Skype.

Behavioral: BFST

Interventions

BFSTBEHAVIORAL

Family-based skills training.

ClinicSkype

Eligibility Criteria

Age12 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • Duke DC, Wagner DV, Ulrich J, Freeman KA, Harris MA. Videoconferencing for Teens With Diabetes: Family Matters. J Diabetes Sci Technol. 2016 Jun 28;10(4):816-23. doi: 10.1177/1932296816642577. Print 2016 Jul.

  • Harris MA, Freeman KA, Duke DC. Seeing Is Believing: Using Skype to Improve Diabetes Outcomes in Youth. Diabetes Care. 2015 Aug;38(8):1427-34. doi: 10.2337/dc14-2469. Epub 2015 Jun 1.

  • Riley AR, Duke DC, Freeman KA, Hood KK, Harris MA. Depressive Symptoms in a Trial Behavioral Family Systems Therapy for Diabetes: A Post Hoc Analysis of Change. Diabetes Care. 2015 Aug;38(8):1435-40. doi: 10.2337/dc14-2519. Epub 2015 May 26.

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, Pediatrics

Study Record Dates

First Submitted

October 21, 2014

First Posted

October 24, 2014

Study Start

March 1, 2010

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

October 24, 2014

Record last verified: 2014-10