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

Not Applicable

Completed

• Conditions: Type 1 Diabetes Mellitus
• Interventions: Behavioral: Education; Behavioral: Positive Affect

• Registration Number: NCT02746627
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-01
• Primary Completion: 2016-02
• Study Completion: 2016-02
• Study First Submitted: 2016-04-05
• Study First Submitted QC: 2016-04-20
• Study First Posted: 2016-04-21
• Results First Submitted: 2018-01-04
• Results First Submitted QC: 2018-09-18
• Status Verified: 2019-02
• Results First Posted: 2019-02-11
• Last Update Submitted: 2019-02-20
• Last Update Posted: 2019-03-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• Diagnosed with type 1 diabetes for at least 6 months
• HbA1c between 8-12%
• Speak and read English
• Caregiver living with child

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Exclusion Criteria

• Other uncontrolled health conditions

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Education	Education	Participants receive educational materials in the mail every 2 weeks for 8 weeks.
Positive Affect - Text	Education	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.
Positive Affect - Phone	Positive Affect	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.
Positive Affect - Text	Positive Affect	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.
Positive Affect - Phone	Education	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.

Primary Outcome Measures

Name	Time	Method
Glycemic Control (HbA1c)	6 months	HbA1c measured as part of diabetes clinic visit. The target for children and adolescents is \<7.5%.

Secondary Outcome Measures

Name	Time	Method
Family Conflict	6 months	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.
Diabetes-Related Quality of Life	6 months	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.
Positive Affect	6 months	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.
Coping	6 months	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.
Frequency of Blood Glucose Monitoring	6 months	Glucometer download to determine blood glucose checks per day.

Trial Locations

Locations (1)

Vanderbilt University Medical Center; 🇺🇸 Nashville, Tennessee, United States