Computerized Intervention of Parental Involvement in Diabetes Care of Their Child

Diabetes Clinical Trial

Official title:

Computer-Delivered Motivational Intervention to Improve Teen Diabetes Management

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01515930
• Other study ID #: 3M's Diabetes Study
• Secondary ID: R21DK089238
• Status: Completed
• Phase: N/A
• First received: January 18, 2012
• Last updated: June 1, 2017
• Start date: April 2011
• Est. completion date: September 9, 2014

Study information

• Verified date: June 2017
• Source: Wayne State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 145
• Est. completion date: September 9, 2014
• Est. primary completion date: March 3, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 13 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus

Intervention

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.
• 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.
• Computer-Delivered Information
Computer-Delivered Information about issues related to living with diabetes that do not directly impact completing diabetes care.

Locations

Country	Name	City	State
United States	Wayne State University	Detroit	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
Wayne State University	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Each of 3 intervention session, 3-4 month apart
Secondary	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.	Each of 3 intervention session, 3-4 month apart
Secondary	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.	Each of 3 intervention session, 3-4 month apart
Secondary	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.	Each of 3 intervention session, 3-4 month apart
Secondary	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.	Each of 3 intervention session, 3-4 month apart
Secondary	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.	Each of 3 intervention session, 3-4 month apart
Secondary	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.	Each of 3 intervention session, 3-4 month apart