Skip to main content
OpenTrials
Completed

NCT Number: NCT02746627

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

13 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Positive affect

Behavioral

Positive psychology intervention to improve motivation for diabetes management.

Education

Behavioral

Educational materials on diabetes management

Primary outcomes

  1. Glycemic Control (HbA1c)

    Time frame: 6 months

    HbA1c measured as part of diabetes clinic visit. The target for children and adolescents is <7.5%.

Secondary outcomes

  1. Frequency of Blood Glucose Monitoring

    Time frame: 6 months

    Glucometer download to determine blood glucose checks per day.

  2. Diabetes-Related Quality of Life

    Time frame: 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.

  3. Family Conflict

    Time frame: 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.

  4. Positive Affect

    Time frame: 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.

  5. Coping

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Vanderbilt University Medical Center

Other

Registry information

Official study title

Positive Psychology to Improve Adherence in Adolescents With Type 1 Diabetes

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Apr 21, 2016
Registry last updated
Mar 13, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.