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

Study Overview
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Brief Summary
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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.

Official Title
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Positive Psychology to Improve Adherence in Adolescents With Type 1 Diabetes

Conditions
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Type 1 Diabetes Mellitus

Intervention / Treatment
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* Behavioral: Positive Affect
* Behavioral: Education


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 13 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants were assigned to Positive Affect - Phone, Positive Affect - Text, or Education groups for the duration of the study.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Education<br>Participants receive educational materials in the mail every 2 weeks for 8 weeks. | Behavioral: Education<br>* Educational materials on diabetes management<br>|
| Experimental: Positive Affect - Text<br>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. | Behavioral: Positive Affect<br>* Positive psychology intervention to improve motivation for diabetes management.<br>Behavioral: Education<br>* Educational materials on diabetes management<br>|
| Experimental: Positive Affect - Phone<br>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. | Behavioral: Positive Affect<br>* Positive psychology intervention to improve motivation for diabetes management.<br>Behavioral: Education<br>* Educational materials on diabetes management<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glycemic Control (HbA1c) | HbA1c measured as part of diabetes clinic visit. The target for children and adolescents is <7.5%. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of Blood Glucose Monitoring | Glucometer download to determine blood glucose checks per day. | 6 months | 
| 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 | 
| 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 | 
| 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 | 
| 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 |