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

Type 1 Diabetes Mellitus Clinical Trial

Official title:

Positive Psychology to Improve Adherence in Adolescents With Type 1 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02746627
• Other study ID #: 131384
• Status: Completed
• Phase: N/A
• Start date: January 2014
• Est. completion date: February 2016

Study information

• Verified date: February 2019
• Source: Vanderbilt University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: February 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes Mellitus

Intervention

Behavioral:
• Positive Affect
Positive psychology intervention to improve motivation for diabetes management.
• Education
Educational materials on diabetes management

Locations

Country	Name	City	State
United States	Vanderbilt University Medical Center	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Vanderbilt University Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glycemic Control (HbA1c)	HbA1c measured as part of diabetes clinic visit. The target for children and adolescents is <7.5%.	6 months
Secondary	Frequency of Blood Glucose Monitoring	Glucometer download to determine blood glucose checks per day.	6 months
Secondary	Diabetes-Related Quality of Life	The Pediatric Quality of Life (PedsQL) Diabetes-Specific Module assesses adolescents' self-reported quality of life. Scaled scores range from 0-100, with higher scores indicating better quality of life.	6 months
Secondary	Family Conflict	Diabetes-specific family conflict was measured with the Revised Diabetes Family Conflict Scale, which consists of 19 items regarding how much adolescents and parents argue about diabetes management tasks. Scores range from 19-57, and higher scores indicate greater conflict.	6 months
Secondary	Positive Affect	Positive affect measured using the Positive and Negative Affect Scale for children (PANAS-C). The positive affect scale consists of 15 items. Scores range from 15-75, and higher scores indicate higher levels of positive affect.	6 months
Secondary	Coping	Responses to Stress Questionnaire measures coping strategies used in response to diabetes-related stress. Scores range from 57-228, and higher scores indicate more responses to stress.	6 months