Computerized Intervention of Parental Involvement in Diabetes Care of Their Child

Wayne State University

Status: Completed

Conditions: Diabetes

Treatments: Behavioral: Parent & Child Computer-Delivered Motivational Intervention; Behavioral: Parent Computer-Delivered Motivational Intervention; Behavioral: Computer-Delivered Information

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01515930

3M's Diabetes Study

R21DK089238 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 145 patients

Sex: All

Ages: 10 to 13 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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145 participants in 3 patient groups

Active Caregiver and Active Child

Active Comparator group

Description:

Parent \& 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.

Treatment:

Behavioral: Parent & Child Computer-Delivered Motivational Intervention

Active Caregiver and Child Education

Experimental group

Description:

Parent 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.

Treatment:

Behavioral: Parent Computer-Delivered Motivational Intervention

Education Caregiver/Education Child

Active Comparator group

Description:

Participants will receive computer-delivered information. A brief computer delivered information session about diabetes related topics for both the caregiver and the child with diabetes.

Treatment:

Behavioral: Computer-Delivered Information