Clinical trial NCT01515930: Computerized Intervention of Parental Involvement in Diabetes Care of Their Child
Official title: Computer-Delivered Motivational Intervention to Improve Teen Diabetes Management
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Keywords: Parenting
Parental Monitoring
Diabetes
Care
Lead sponsor: Wayne State University
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2012-01-24
Enrollment: 145
Sex: ALL
Minimum age (years): 10
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Diabetes Management Scale
timeFrame: Each of 3 intervention session, 3-4 month apart
Secondary outcomes:
measure: Treatment Regulation Questionnaire
timeFrame: Each of 3 intervention session, 3-4 month apart
measure: Readiness Ruler
timeFrame: Each of 3 intervention session, 3-4 month apart
measure: HbA1C Blood Test
timeFrame: Each of 3 intervention session, 3-4 month apart
measure: Parental Monitoring of Diabetes Care
timeFrame: Each of 3 intervention session, 3-4 month apart
measure: Twenty-four Hour Recall Interview
timeFrame: Each of 3 intervention session, 3-4 month apart
measure: Blood Glucose Testing Frequency
timeFrame: Each of 3 intervention session, 3-4 month apart
Other outcomes:
Locations:
city: Detroit
country: United States
facility: Wayne State University
state: Michigan
Study officials:
affiliation: Wayne State University
name: Deborah A Ellis, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.