Computerized Intervention of Parental Involvement in Diabetes Care of Their Child
- Conditions
- Diabetes
- Interventions
- Behavioral: Parent Computer-Delivered Motivational InterventionBehavioral: Parent & Child Computer-Delivered Motivational InterventionBehavioral: Computer-Delivered Information
- Registration Number
- NCT01515930
- Lead Sponsor
- Wayne State University
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 145
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Active Caregiver and Child Education Parent 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. Active Caregiver and Active Child Parent & Child Computer-Delivered Motivational Intervention 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. Education Caregiver/Education Child Computer-Delivered Information 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.
- Primary Outcome Measures
Name Time Method Diabetes Management Scale Each of 3 intervention session, 3-4 month apart 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.
- Secondary Outcome Measures
Name Time Method Parental Monitoring of Diabetes Care Each of 3 intervention session, 3-4 month apart 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.
Treatment Regulation Questionnaire Each of 3 intervention session, 3-4 month apart 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.
Readiness Ruler Each of 3 intervention session, 3-4 month apart 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.
HbA1C Blood Test Each of 3 intervention session, 3-4 month apart 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.
Twenty-four Hour Recall Interview Each of 3 intervention session, 3-4 month apart 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.
Blood Glucose Testing Frequency Each of 3 intervention session, 3-4 month apart 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.
Trial Locations
- Locations (1)
Wayne State University
🇺🇸Detroit, Michigan, United States