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DiabetesNCT01515930

Computerized Intervention of Parental Involvement in Diabetes Care of Their Child

A study testing Parent Computer-Delivered Motivational Intervention, Parent & Child Computer-Delivered Motivational Intervention and Computer-Delivered Information in people with Diabetes, run by Wayne State University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 10 to 13 years
Conditions the study is for
Diabetes
What is being tested?
Parent Computer-Delivered Motivational Intervention, Parent & Child Computer-Delivered Motivational Intervention and Computer-Delivered Information
Could I receive a placebo?
No, everyone receives an active treatment
How many people
145 participants
Where
1 siteUnited States
Study dates
Apr 2011to 9 Sep 2014
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 10 to 13 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Wayne State University

    Detroit, Michigan, 48201

Other trials in United States

About this study

Official title: Computer-Delivered Motivational Intervention to Improve Teen Diabetes Management

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.

Read the 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.

Conditions
Diabetes
Being tested
Parent Computer-Delivered Motivational Intervention, Parent & Child Computer-Delivered Motivational Intervention, Computer-Delivered Information
Keywords
Parenting, Parental Monitoring, Diabetes, Care
Medical subject headings
Diabetes Mellitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Parent Computer-Delivered Motivational InterventionBehavioural

    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 InterventionBehavioural

    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 InformationBehavioural

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

Study groups in NCT01515930
Study groupRoleWhat they receive
Active Caregiver and Active ChildActive 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.
Receives: Behavioral: Parent & Child Computer-Delivered Motivational Intervention
Active Caregiver and Child EducationExperimentalParent 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.
Receives: Behavioral: Parent Computer-Delivered Motivational Intervention
Education Caregiver/Education ChildActive 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.
Receives: Behavioral: Computer-Delivered Information

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Each of 3 intervention session, 3-4 month apart

Secondary outcomes (6)

  1. 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.

    Measured: Each of 3 intervention session, 3-4 month apart

  2. 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.

    Measured: Each of 3 intervention session, 3-4 month apart

  3. 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.

    Measured: Each of 3 intervention session, 3-4 month apart

  4. 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.

    Measured: Each of 3 intervention session, 3-4 month apart

  5. 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.

    Measured: Each of 3 intervention session, 3-4 month apart

  6. 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.

    Measured: Each of 3 intervention session, 3-4 month apart

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Jan 2012 (estimated)
  2. Study startApr 2011
  3. Primary completion3 Mar 2014
  4. Study completion9 Sep 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
145 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01515930
Sponsor's protocol ID
3M's Diabetes Study
Other IDs
R21DK089238
Status last verified
Jun 2017
First submitted
18 Jan 2012
Last updated
2 Jun 2017
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 25236503

Questions about this trial

What is this clinical trial studying?

A study testing Parent Computer-Delivered Motivational Intervention, Parent & Child Computer-Delivered Motivational Intervention and Computer-Delivered Information in people with Diabetes, run by Wayne State University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Diabetes Management Scale (time frame: Each of 3 intervention session, 3-4 month apart). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01515930, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2017.

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