Positive Psychology to Improve Adherence in Adolescents With Type 1 Diabetes

Check It! Positive Psychology Intervention to Improve Adherence in Adolescents With T1D

Sponsors

Lead sponsor: Vanderbilt University Medical Center

Source Vanderbilt University Medical Center
Brief Summary

Problems with diabetes management in adolescents with type 1 diabetes are common - occurring at rates as high as 93% - and have serious health consequences, including poor blood sugar control and risk for later complications. Therefore, the investigators proposed to test a positive psychology intervention for adolescents with type 1 diabetes aimed at increasing motivation for diabetes management; specifically, to increase the frequency of blood glucose monitoring. This intervention will boost positive mood in adolescents (age 13-17) through tailored exercises in gratitude, self-affirmation, small gifts, and parent affirmation as a way to improve motivation for diabetes management. In addition, this study will explore the use of technology, by comparing telephone-administered vs. automated text-messaging versions of the intervention, to determine which mode of delivery is more appealing, convenient, and beneficial for adolescents in managing their diabetes.

Participants and parents will complete questionnaires on mood and diabetes management during a routine clinic visits at baseline, 3 months, and 6 months. Clinical measures of diabetes management will be collected from participants' electronic medical records.

Overall Status Completed
Start Date January 2014
Completion Date February 2016
Primary Completion Date February 2016
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Glycemic Control (HbA1c) 6 months
Secondary Outcome
Measure Time Frame
Frequency of Blood Glucose Monitoring 6 months
Diabetes-Related Quality of Life 6 months
Family Conflict 6 months
Positive Affect 6 months
Coping 6 months
Enrollment 120
Condition
Intervention

Intervention type: Behavioral

Intervention name: Positive Affect

Description: Positive psychology intervention to improve motivation for diabetes management.

Intervention type: Behavioral

Intervention name: Education

Description: Educational materials on diabetes management

Eligibility

Criteria:

Inclusion Criteria:

- Diagnosed with type 1 diabetes for at least 6 months

- HbA1c between 8-12%

- Speak and read English

- Caregiver living with child

Exclusion Criteria:

- Other uncontrolled health conditions

Gender: All

Minimum age: 13 Years

Maximum age: 17 Years

Healthy volunteers: No

Location
facility Vanderbilt University Medical Center
Location Countries

United States

Verification Date

February 2019

Responsible Party

Responsible party type: Principal Investigator

Investigator affiliation: Vanderbilt University Medical Center

Investigator full name: Sarah Jaser

Investigator title: Assistant Professor

Has Expanded Access No
Condition Browse
Number Of Arms 3
Arm Group

Arm group label: Education

Arm group type: Active Comparator

Description: Participants receive educational materials in the mail every 2 weeks for 8 weeks.

Arm group label: Positive Affect - Text

Arm group type: Experimental

Description: Participants receive positive affect intervention (weekly reminders to use gratitude, self-affirmations, parental affirmations, and gift cards) by SMS. Participants also receive educational materials in the mail every 2 weeks for 8 weeks.

Arm group label: Positive Affect - Phone

Arm group type: Experimental

Description: Participants receive positive affect intervention (weekly reminders to use gratitude, self-affirmations, parental affirmations) by phone. Participants receive small gifts in the mail every 2 weeks for 8 weeks. educational materials in the mail every 2 weeks for 8 weeks.

Patient Data No
Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

Intervention model description: Participants were assigned to Positive Affect - Phone, Positive Affect - Text, or Education groups for the duration of the study.

Primary purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov