Clinical Trials Directory

Trials / Completed

CompletedNCT02984709

Check It! 2.0: Positive Psychology Intervention for Adolescents With Type 1 Diabetes

Check It! 2.0: Pilot Test of a Positive Psychology Intervention for Adolescents With Type 1 Diabetes

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
48 (actual)
Sponsor
Vanderbilt University · Academic / Other
Sex
All
Age
13 Years – 17 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALPositive Psychology InterventionHealth Behavior Contract - Baseline visit Education Packet - Baseline visit Positive psychology training for teen and parents - baseline visit Parent praise reminder (text message) - one time per week (over 8 week intervention period) Teen gratitude message (text message) - every Monday (over 8 week intervention period) Teen positive value message (text message) - every Wednesday (over 8 week intervention period) Teen mood booster (text message) - every Thursday and Saturday and alternative Sundays (over 8 week intervention period) Small gift ($5 gift card code sent every 2 weeks for 8 weeks)
BEHAVIORALEducationHealth Behavior Contract - Baseline visit Education Packet - Baseline visit

Timeline

Start date
2016-10-01
Primary completion
2017-02-24
Completion
2017-08-10
First posted
2016-12-07
Last updated
2019-04-24
Results posted
2019-04-24

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT02984709. Inclusion in this directory is not an endorsement.