Clinical trial NCT02984709: Check It! 2.0: Positive Psychology Intervention for Adolescents With Type 1 Diabetes
Official title: Check It! 2.0: Pilot Test of a Positive Psychology Intervention for Adolescents With Type 1 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type1diabetes
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
First posted: 2016-12-07
Enrollment: 48
Sex: ALL
Minimum age (years): 13
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The treatment regimen for type 1 diabetes is complex and demanding, and many adolescents have problems with adherence. The proposed study will pilot test a positive psychology intervention for adolescents with type 1 diabetes aimed at improving adherence to treatment based on feedback from the first iteration of the intervention. The potential benefits include helping adolescents achieve better glycemic control, thereby reducing the health risks and complications associated with diabetes.

Detailed description: The proposed study has the potential to improve adherence to the diabetes regimen in adolescents with type 1 diabetes without compromising their quality of life. The potential benefits include helping adolescents achieve better glycemic control, thereby reducing the health risks and complications associated with diabetes.

The investigators will use a positive psychology framework, which emphasizes positive emotions and strengths rather than problems, to promote adherence.

Positive affect, defined as feelings that reflect pleasurable engagement with the environment (e.g., happy, cheerful,proud), have been linked with favorable health outcomes and increased adherence to medical regimens. Further, positive affect has been shown to increase people's ability to use complex coping strategies. Randomized controlled trials of positive psychology interventions have been shown to successfully increase adults' adherence to medication and physical activity recommendations. However, no studies have examined the effects of positive psychology interventions on adherence behaviors in pediatric populations. Our ongoing work suggests that positive affect in adolescents with type 1 diabetes is related to greater use of adaptive coping strategies, lower levels of family conflict, and fewer depressive symptoms, and demonstrates that a positive psychology intervention has the potential to induce positive affect in adolescents. The investigators propose to pilot test a positive psychology intervention for adolescents with type 1 diabetes. This low-cost, innovative intervention is designed to induce positive affect in adolescents (age 13-17) through tailored exercises in gratitude and self-affirmation. The investigators will also promote positive parental involvement by asking caregivers to provide positive affirmation statements to adolescents. Finally, the investigators will explore the use of technology by delivering the intervention to adolescents and sending reminders to caregivers via text message using the Twilio/REDCap system.

Blood glucose monitoring is one of the best indicators of adherence to the recommended treatment regimen for type 1 diabetes, and frequency of blood glucose monitoring is strongly related to glycemic control. Further, frequency of blood glucose monitoring has been shown to decrease with age in adolescents, and parental reminders to check blood glucose are often a source of conflict between adolescents and their parents. Therefore, blood glucose monitoring represents a specific behavior that may be the best target for adherence interventions in adolescents with type 1 diabetes.

Thus, the specific aims are as follows:

Aim 1: Adapt a positive psychology intervention for adolescents (age 13-17) with type 1 diabetes designed to increase the frequency of blood glucose monitoring. Aim 2: Evaluate the feasibility, acceptability, and preliminary efficacy of a positive psychology intervention for adolescents with type 1 diabetes and their caregivers delivered by text message with the Twilio/REDCap system. The primary outcome is glycemic control, and secondary outcomes include positive affect, coping, adherence (i.e., frequency of blood glucose monitoring), family conflict, and quality of life.

Eligibility criteria: Inclusion Criteria:

Adolescents will be eligible if they are:

1. between the ages of 13-17;
2. have been diagnosed with type 1 diabetes for at least 1 year;
3. have no other major health problems;
4. are not currently participating in any other intervention studies;
5. have a glycosylated hemoglobin level between 7.5 - 12% on date of enrollment;
6. are patients of the Eskind Diabetes Clinic
7. must read and write in English
8. and must live the caregiver that is participating in the study with them

Exclusion Criteria:

-

Primary outcomes:
measure: Glycemic Control (A1C)
timeFrame: 3 months
Secondary outcomes:
measure: Positive Affect
timeFrame: 3 months
measure: Frequency of Blood Glucose Monitoring
timeFrame: 3 months
measure: Diabetes Family Conflict Scale
timeFrame: 3 months
measure: Diabetes-Specific Quality of Life
timeFrame: 3 months
measure: Primary Control Coping
timeFrame: 3 months
measure: Secondary Control Coping
timeFrame: 3 months
measure: Disengagement Coping
timeFrame: 3 months
measure: Self Care Inventory
timeFrame: 3 months
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Vanderbilt University Medical Center
name: Sarah Jaser, PhD
role: PRINCIPAL_INVESTIGATOR
References: