An interventional study of Parent Computer-Delivered Motivational Intervention and Parent & Child Computer-Delivered Motivational Intervention in Diabetes, sponsored by Wayne State University. Completed at 1 site in United States. Open to participants aged 10 Years to 13 Years. Per ClinicalTrials.gov, last updated 2017-06-02.
Sponsored by Wayne State University · Not applicable, Interventional, and Treatment
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.
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.
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This study's enrollment of 145 is above the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.
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Exclusion Criteria:
Parent \& Child Computer-Delivered Motivational Intervention will be delivered to participants. A brief computer delivered behavior change counseling intervention for parents of children with diabetes to improve monitoring of diabetes care and a brief computer delivered behavior change counseling intervention for children with diabetes to improve completion of daily diabetes care.
Behavioral: Parent & Child Computer-Delivered Motivational Intervention
Parent Computer-Delivered Motivational Intervention will be delivered to the parents only. A brief computer delivered behavior change counseling intervention for parents of children with diabetes to improve monitoring of diabetes care and a brief computer delivered informational session about diabetes related topics for their child with diabetes.
Behavioral: Parent Computer-Delivered Motivational Intervention
Participants will receive computer-delivered information. A brief computer delivered information session about diabetes related topics for both the caregiver and the child with diabetes.
Behavioral: Computer-Delivered Information
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.
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.
Computer-Delivered Information about issues related to living with diabetes that do not directly impact completing diabetes care.
Diabetes Management Scale
The Diabetes Management Scale (DMS) (Frey, Ellis, Naar-King et al., 2004) is a self-report questionnaire used to measure a broad range of diabetes management behaviors, such as insulin management, dietary management, blood glucose monitoring, symptom response, and parent assistance/supervision.
Time frame: Each of 3 intervention session, 3-4 month apart
Treatment Regulation Questionnaire
Parental motivation to monitor the youth is measured by the Treatment Self-Regulation Questionnaire (TSRQ; Ryan \& Connell (1989). The TSRQ evaluates why people engage in a health-relevant behavior and assesses the degree to which one's motivation for a particular behavior or set of behaviors is relatively autonomous or self-determined as compared to derived from external pressures or constraints.
Time frame: Each of 3 intervention session, 3-4 month apart
Readiness Ruler
Parent motivation to monitor the youth is also measured by the Readiness Ruler (Stott, Rollnick, \& Pill, 1995). Since readiness to change behaviors is behavior specific, the items will be tailored to assess the behaviors most critical to parental monitoring of diabetes management. The response format is a visual analog scale (VAS) 10 mm in length. Written cues anchor the ends and middle of the scale. Respondents mark their "readiness" on the scale and the position on the line is measured in millimeters.
Time frame: Each of 3 intervention session, 3-4 month apart
HbA1C Blood Test
Metabolic control will be measured via hemoglobin A1c (HbA1c). HbA1c is an indirect and retrospective measure of average blood glucose levels over the previous two to three month period.
Time frame: Each of 3 intervention session, 3-4 month apart
Parental Monitoring of Diabetes Care
The Parental Monitoring of Diabetes Care scale (PMDC) is an 18 item, investigator-developed questionnaire that measures the frequency of parental monitoring and direct supervision of diabetes care tasks such as insulin administration, blood glucose testing, and dietary management.
Time frame: Each of 3 intervention session, 3-4 month apart
Twenty-four Hour Recall Interview
The Twenty-four Hour Recall Interview, developed by Johnson and colleagues (Freund, Johnson, Silverstein et al., 1991), has been used extensively in pediatric diabetes research for the assessment of illness management.
Time frame: Each of 3 intervention session, 3-4 month apart
Blood Glucose Testing Frequency
Objective data on mean daily frequency of blood glucose testing during the 14-day period prior to data collection will be obtained directly from blood glucose meters.
Time frame: Each of 3 intervention session, 3-4 month apart
Plan to share: No
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Wayne State University