View Clinical Trial (Medical Research Study)
Computer-Delivered Motivational Intervention to Improve Teen Diabetes Management
| City: |
|
Detroit |
| State: |
|
Michigan |
| Zip Code: |
|
48201 |
| Conditions: |
|
Diabetes |
| Purpose: |
|
The purpose of this study is to develop an intervention to increase parental motivation for
supervision and monitoring youth diabetes care behavior. The intervention will be tested in
three brief session in conjunction with regularly scheduled diabetes clinic visits and
delivered through a computer program based in the principles of Motivational Interviewing.
|
| Study Summary: |
|
The study includes a development phase (Phase 1: development of the intervention followed by
feasibility testing with 10 youth and 10 parents) and a pilot validation phase [Phase 2:
pilot randomized clinical trial (RCT)] using a sample of 90 African American youth
transitioning to independent diabetes care and their parents. In this phase, families will
be randomly assigned to one of three study arms: parent motivation for monitoring and youth
motivation for diabetes care (arm 1), parent motivation for monitoring and youth
information (arm 2) or parent and youth information (arm 3). In phase 1 (development), youth
and their caregivers will complete a one-time research visit where they use the program and
provide feedback via a semi-structured interview regarding the usefulness of the content,
its user-friendliness and make suggestions for changes to enhance acceptability. In phase 2
( RCT), families will complete three intervention plus data collection visits and one
additional data collection only visit. Research visits will be scheduled to coincide with
appointments in the diabetes clinic to maximize convenience for families.
|
| Criteria: |
|
Inclusion Criteria:
- African American race/ethnicity
- Age: 10 years 0 months - 12 years, 11 months
- Type 1 diabetes mellitus
- Diagnosed at least 6 months
- Patient of Children's Hospital of Michigan Diabetes Clinics
- English fluency, both verbal and written
Exclusion Criteria:
- Psychiatry/psychological diagnoses including cognitive impairment that would prevent
the participant from understanding the data collection measures, (i.e. moderate or
severe mental retardation) or the following psychiatric diagnoses: autism and
schizophrenia. Youth with current suicidal intent are not enrolled until
psychiatrically stable.
- Medical diagnoses that would result in atypical diabetes management i.e. cystic
fibrosis. Other medical conditions that would not affect diabetes management, such as
asthma, do not exclude the participant from study participation.
|
| NCT ID: |
|
NCT01515930 |
| Primary Contact: |
|
April Carcone, Ph.D.
Phone: (313) 966-2065
Email: acarcone@med.wayne.edu
|
| Backup Contact: |
|
N/A |
| Location Contact: |
|
Detroit, Michigan 48201
United States
April Carcone, Ph.D.
Phone: 313-966-2065
Email: acarcone@med.wayne.edu
Site Status: Recruiting |
| Data Source: |
|
ClinicalTrials.gov |
| Date Processed: |
|
May 22, 2013 |
| Modifications to this listing: |
|
Only selected fields are shown, please use the link
below to view all information about this clinical trial. |
|
Click to view Full Listing
|