Computerized Intervention of Parental Involvement in Diabetes Care of Their Child

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2012 by Wayne State University.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Deborah Ellis, Ph.D., Wayne State University
ClinicalTrials.gov Identifier:
NCT01515930
First received: January 18, 2012
Last updated: January 23, 2012
Last verified: January 2012
  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.


Condition Intervention Phase
Diabetes
Behavioral: Parent Computer-Delivered Motivational Intervention
Behavioral: Parent & Child Computer-Delivered Motivational Intervention
Behavioral: Computer-Delivered Information
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Computer-Delivered Motivational Intervention to Improve Teen Diabetes Management

Resource links provided by NLM:


Further study details as provided by Wayne State University:

Primary Outcome Measures:
  • Diabetes Management Scale [ Time Frame: Each of 3 intervention session, 3-4 month apart ] [ Designated as safety issue: No ]
    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.

  • Twenty-four Hour Recall Interview [ Time Frame: Each of 3 intervention session, 3-4 month apart ] [ Designated as safety issue: No ]
    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 [ Time Frame: Each of 3 intervention session, 3-4 month apart ] [ Designated as safety issue: No ]
    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.

  • Parental Monitoring of Diabetes Care [ Time Frame: Each of 3 intervention session, 3-4 month apart ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Treatment Regulation Questionnaire [ Time Frame: Each of 3 intervention session, 3-4 month apart ] [ Designated as safety issue: No ]
    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 [ Time Frame: Each of 3 intervention session, 3-4 month apart ] [ Designated as safety issue: No ]
    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 [ Time Frame: Each of 3 intervention session, 3-4 month apart ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 150
Study Start Date: April 2011
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Active Caregiver and Active Child
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
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. MI seeks to increase motivation & self-efficacy by altering decisional & self-regulatory balances through eliciting verbalizations that are consistent with change. MI is consistent with psychotherapy research, which indicates empathy, optimism, & congruence are strongly related to outcome. 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.
Experimental: Active Caregiver and Child Informational
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
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. MI seeks to increase motivation & self-efficacy by altering decisional & self-regulatory balances through eliciting verbalizations that are consistent with change. MI is consistent with psychotherapy research, which indicates empathy, optimism, & congruence are strongly related to outcome. 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.
Active Comparator: Informational Caregiver/Informational Child
A brief computer delivered information session about diabetes related topics for both the caregiver and the child with diabetes.
Behavioral: Computer-Delivered Information
Computer-Delivered Information about issues related to living with diabetes that do not directly impact completing diabetes care.

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.

  Eligibility

Ages Eligible for Study:   10 Years to 13 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01515930

Contacts
Contact: April Carcone, Ph.D. (313) 966-2065 acarcone@med.wayne.edu

Locations
United States, Michigan
Wayne State University Recruiting
Detroit, Michigan, United States, 48201
Contact: April Carcone, Ph.D.    313-966-2065    acarcone@med.wayne.edu   
Contact: Deborah Ellis, Ph.D.    313-993-7851    dellis@med.wayne.edu   
Sponsors and Collaborators
Wayne State University
  More Information

No publications provided

Responsible Party: Deborah Ellis, Ph.D., Associate Professor, Wayne State University
ClinicalTrials.gov Identifier: NCT01515930     History of Changes
Other Study ID Numbers: 3M's Diabetes Study
Study First Received: January 18, 2012
Last Updated: January 23, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Wayne State University:
Parenting
Parental Monitoring
Diabetes
Care

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on September 30, 2014