Trials / Completed
CompletedNCT01515930
Computerized Intervention of Parental Involvement in Diabetes Care of Their Child
Computer-Delivered Motivational Intervention to Improve Teen Diabetes Management
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 145 (actual)
- Sponsor
- Wayne State University · Academic / Other
- Sex
- All
- Age
- 10 Years – 13 Years
- Healthy volunteers
- Not accepted
Summary
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.
Detailed description
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BEHAVIORAL | Parent Computer-Delivered Motivational Intervention | Motivational Interviewing (MI) is a client-centered, directive method for enhancing intrinsic motivation to change by exploring \& resolving ambivalence, with a strong evidence for improving adolescent \& adult health behaviors. Three motivational sessions will be provided by an animated character who delivers the intervention with high fidelity to MI principles. Small amounts of psychoeducation about potential improvements illness management that can result from parental monitoring of diabetes care will be integrated with more purely motivational elements. Mailings will be sent to participants to remind them of the reasons they gave as motivation \& goals they set regarding monitoring diabetes care. |
| BEHAVIORAL | Parent & Child Computer-Delivered Motivational Intervention | Motivational Interviewing (MI) is a client-centered, directive method for enhancing intrinsic motivation to change by exploring \& resolving ambivalence, with a strong evidence for improving adolescent \& adult health behaviors. Three motivational sessions will be provided by an animated character who delivers the intervention with high fidelity to MI principles. Small amounts of psychoeducation about potential improvements illness management that can result from monitoring/completing diabetes care will be integrated with more purely motivational elements. Mailings will be sent to participants to remind them of the reasons they gave as motivation \& goals they set regarding diabetes care. |
| BEHAVIORAL | Computer-Delivered Information | Computer-Delivered Information about issues related to living with diabetes that do not directly impact completing diabetes care. |
Timeline
- Start date
- 2011-04-01
- Primary completion
- 2014-03-03
- Completion
- 2014-09-09
- First posted
- 2012-01-24
- Last updated
- 2017-06-02
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT01515930. Inclusion in this directory is not an endorsement.