Computerized Intervention of Parental Involvement in Diabetes Care of Their Child
Computer-Delivered Motivational Intervention to Improve Teen Diabetes Management
2 other identifiers
interventional
145
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable diabetes
Started Apr 2011
Typical duration for not_applicable diabetes
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2011
CompletedFirst Submitted
Initial submission to the registry
January 18, 2012
CompletedFirst Posted
Study publicly available on registry
January 24, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 3, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
September 9, 2014
CompletedJune 2, 2017
June 1, 2017
2.9 years
January 18, 2012
June 1, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (6)
Treatment Regulation Questionnaire
Each of 3 intervention session, 3-4 month apart
Readiness Ruler
Each of 3 intervention session, 3-4 month apart
HbA1C Blood Test
Each of 3 intervention session, 3-4 month apart
Parental Monitoring of Diabetes Care
Each of 3 intervention session, 3-4 month apart
Twenty-four Hour Recall Interview
Each of 3 intervention session, 3-4 month apart
- +1 more secondary outcomes
Study Arms (3)
Active Caregiver and Active Child
ACTIVE COMPARATORParent \& 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.
Active Caregiver and Child Education
EXPERIMENTALParent 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.
Education Caregiver/Education Child
ACTIVE COMPARATORParticipants will receive computer-delivered information. A brief computer delivered information session about diabetes related topics for both the caregiver and the child with diabetes.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Wayne State University
Detroit, Michigan, 48201, United States
Related Publications (1)
Idalski Carcone A, Ellis DA, Naar S, Ondersma SJ, Moltz K, Dekelbab B, Joseph CL. Enhancing parental motivation to monitor african american adolescents' diabetes care: development and Beta test of a brief computer-delivered intervention. JMIR Res Protoc. 2014 Sep 18;3(3):e43. doi: 10.2196/resprot.3220.
PMID: 25236503DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Deborah A Ellis, Ph.D.
Wayne State University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
January 18, 2012
First Posted
January 24, 2012
Study Start
April 1, 2011
Primary Completion
March 3, 2014
Study Completion
September 9, 2014
Last Updated
June 2, 2017
Record last verified: 2017-06
Data Sharing
- IPD Sharing
- Will not share