Check It! Positive Psychology Intervention to Improve Adherence in Adolescents With T1D
Positive Psychology to Improve Adherence in Adolescents With Type 1 Diabetes
1 other identifier
interventional
120
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2014
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2016
CompletedFirst Submitted
Initial submission to the registry
April 5, 2016
CompletedFirst Posted
Study publicly available on registry
April 21, 2016
CompletedResults Posted
Study results publicly available
February 11, 2019
CompletedMarch 13, 2019
February 1, 2019
2.1 years
April 5, 2016
January 4, 2018
February 20, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Glycemic Control (HbA1c)
HbA1c measured as part of diabetes clinic visit. The target for children and adolescents is \<7.5%.
6 months
Secondary Outcomes (5)
Frequency of Blood Glucose Monitoring
6 months
Diabetes-Related Quality of Life
6 months
Family Conflict
6 months
Positive Affect
6 months
Coping
6 months
Study Arms (3)
Education
ACTIVE COMPARATORParticipants receive educational materials in the mail every 2 weeks for 8 weeks.
Positive Affect - Text
EXPERIMENTALParticipants 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
EXPERIMENTALParticipants 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.
Interventions
Positive psychology intervention to improve motivation for diabetes management.
Educational materials on diabetes management
Eligibility Criteria
You may qualify if:
- Diagnosed with type 1 diabetes for at least 6 months
- HbA1c between 8-12%
- Speak and read English
- Caregiver living with child
You may not qualify if:
- Other uncontrolled health conditions
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Vanderbilt University Medical Center
Nashville, Tennessee, 37232, United States
Related Publications (1)
Savin KL, Hamburger ER, Monzon AD, Patel NJ, Perez KM, Lord JH, Jaser SS. Diabetes-specific family conflict: Informant discrepancies and the impact of parental factors. J Fam Psychol. 2018 Feb;32(1):157-163. doi: 10.1037/fam0000364.
PMID: 29543490DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Sarah Jaser, PhD
- Organization
- Vanderbilt University Medical Center
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
April 5, 2016
First Posted
April 21, 2016
Study Start
January 1, 2014
Primary Completion
February 1, 2016
Study Completion
February 1, 2016
Last Updated
March 13, 2019
Results First Posted
February 11, 2019
Record last verified: 2019-02
Data Sharing
- IPD Sharing
- Will not share