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

Primary Purpose

Type1diabetes

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Positive Psychology Intervention
Education
Sponsored by
Vanderbilt University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type1diabetes

Eligibility Criteria

13 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Adolescents will be eligible if they are:

  1. between the ages of 13-17;
  2. have been diagnosed with type 1 diabetes for at least 1 year;
  3. have no other major health problems;
  4. are not currently participating in any other intervention studies;
  5. have a glycosylated hemoglobin level between 7.5 - 12% on date of enrollment;
  6. are patients of the Eskind Diabetes Clinic
  7. must read and write in English
  8. and must live the caregiver that is participating in the study with them

Exclusion Criteria:

-

Sites / Locations

  • Vanderbilt University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Positive Psychology Intervention

Education Group

Arm Description

The text message group will receive the intervention components via text message. They will be instructed to think about things that make them feel good when they are struggling with diabetes management (i.e. gratitude). Also they will be instructed to think about a positive value when they are in a situation that makes it hard to check their blood sugar (i.e. Self-Affirmation). Additionally, to induce positive mood they will be texted gift cards codes valued at $5.00. Further, caregivers will be asked to provide weekly positive affirmations to their adolescents, focused on non-diabetes strengths. All adolescents will be given developmentally-appropriate diabetes education material at the time of enrollment.

The education group will be given developmentally-appropriate diabetes education material at the time of enrollment.

Outcomes

Primary Outcome Measures

Glycemic Control (A1C)
A1C is the percentage of glycosylated hemoglobin and represents an average of glycemic control over the previous 2-3 months.

Secondary Outcome Measures

Positive Affect
Positive affect measured using the Positive and Negative Affect Scale for children (PANAS-C). The positive affect scale consists of 15 items, which are summed for a total score, ranging from 15-60. Higher scores indicate higher levels of positive affect.
Frequency of Blood Glucose Monitoring
Glucometer download to determine frequency of blood glucose checks per day. Higher numbers indicates more frequent blood glucose checks.
Diabetes Family Conflict Scale
Diabetes-specific family conflict was measured with the Revised Diabetes Family Conflict Scale (DRCS), which consists of 19 items regarding how much adolescents and parents argue about diabetes management tasks. Scores range from 19 to 57, and higher scores indicate greater family conflict.
Diabetes-Specific Quality of Life
Pediatric Quality of Life Diabetes-Specific Module (PedsQL) measures quality of life. A mean scaled score is calculated, ranging from 0-100, with higher values indicating better quality of life.
Primary Control Coping
Responses to Stress Questionnaire measures coping with diabetes-related stress. Three factors of coping are measured: primary control coping, secondary control coping,and disengagement coping. A ratio score is calculated to determine the ratio of each type of coping in relation to total coping, ranging from 0.00 to 1.00. Higher scores indicate greater relative use of primary control coping (e.g., problem solving, emotional modulation).
Secondary Control Coping
Responses to Stress Questionnaire measures coping with diabetes-related stress. Three factors of coping are measured: primary control coping, secondary control coping,and disengagement coping. A ratio score is calculated to determine the ratio of each type of coping in relation to total coping, ranging from 0.00 to 1.00. Higher levels indicate greater relative use of secondary control coping (e.g., acceptance, distraction, positive thinking).
Disengagement Coping
Responses to Stress Questionnaire measures coping with diabetes-related stress. Three factors of coping are measured: primary control coping, secondary control coping,and disengagement coping. A ratio score is calculated to determine the ratio of each type of coping in relation to total coping, ranging from 0.00 to 1.00. Higher levels indicate greater relative use of disengagement control coping (e.g., avoidance, denial).
Self Care Inventory
The Self Care Inventory measures adherence to the recommended diabetes treatment regimen. Adolescents and parents report on the adolescents' self-care behaviors. Items are summed for a total score, ranging from 7-35. Higher scores indicate higher levels of adherence.

Full Information

First Posted
November 30, 2016
Last Updated
April 22, 2019
Sponsor
Vanderbilt University
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1. Study Identification

Unique Protocol Identification Number
NCT02984709
Brief Title
Check It! 2.0: Positive Psychology Intervention for Adolescents With Type 1 Diabetes
Official Title
Check It! 2.0: Pilot Test of a Positive Psychology Intervention for Adolescents With Type 1 Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
October 2016 (undefined)
Primary Completion Date
February 24, 2017 (Actual)
Study Completion Date
August 10, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vanderbilt University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type1diabetes

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
48 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Positive Psychology Intervention
Arm Type
Experimental
Arm Description
The text message group will receive the intervention components via text message. They will be instructed to think about things that make them feel good when they are struggling with diabetes management (i.e. gratitude). Also they will be instructed to think about a positive value when they are in a situation that makes it hard to check their blood sugar (i.e. Self-Affirmation). Additionally, to induce positive mood they will be texted gift cards codes valued at $5.00. Further, caregivers will be asked to provide weekly positive affirmations to their adolescents, focused on non-diabetes strengths. All adolescents will be given developmentally-appropriate diabetes education material at the time of enrollment.
Arm Title
Education Group
Arm Type
Active Comparator
Arm Description
The education group will be given developmentally-appropriate diabetes education material at the time of enrollment.
Intervention Type
Behavioral
Intervention Name(s)
Positive Psychology Intervention
Other Intervention Name(s)
Check It 2.0
Intervention Description
Health 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)
Intervention Type
Behavioral
Intervention Name(s)
Education
Intervention Description
Health Behavior Contract - Baseline visit Education Packet - Baseline visit
Primary Outcome Measure Information:
Title
Glycemic Control (A1C)
Description
A1C is the percentage of glycosylated hemoglobin and represents an average of glycemic control over the previous 2-3 months.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Positive Affect
Description
Positive affect measured using the Positive and Negative Affect Scale for children (PANAS-C). The positive affect scale consists of 15 items, which are summed for a total score, ranging from 15-60. Higher scores indicate higher levels of positive affect.
Time Frame
3 months
Title
Frequency of Blood Glucose Monitoring
Description
Glucometer download to determine frequency of blood glucose checks per day. Higher numbers indicates more frequent blood glucose checks.
Time Frame
3 months
Title
Diabetes Family Conflict Scale
Description
Diabetes-specific family conflict was measured with the Revised Diabetes Family Conflict Scale (DRCS), which consists of 19 items regarding how much adolescents and parents argue about diabetes management tasks. Scores range from 19 to 57, and higher scores indicate greater family conflict.
Time Frame
3 months
Title
Diabetes-Specific Quality of Life
Description
Pediatric Quality of Life Diabetes-Specific Module (PedsQL) measures quality of life. A mean scaled score is calculated, ranging from 0-100, with higher values indicating better quality of life.
Time Frame
3 months
Title
Primary Control Coping
Description
Responses to Stress Questionnaire measures coping with diabetes-related stress. Three factors of coping are measured: primary control coping, secondary control coping,and disengagement coping. A ratio score is calculated to determine the ratio of each type of coping in relation to total coping, ranging from 0.00 to 1.00. Higher scores indicate greater relative use of primary control coping (e.g., problem solving, emotional modulation).
Time Frame
3 months
Title
Secondary Control Coping
Description
Responses to Stress Questionnaire measures coping with diabetes-related stress. Three factors of coping are measured: primary control coping, secondary control coping,and disengagement coping. A ratio score is calculated to determine the ratio of each type of coping in relation to total coping, ranging from 0.00 to 1.00. Higher levels indicate greater relative use of secondary control coping (e.g., acceptance, distraction, positive thinking).
Time Frame
3 months
Title
Disengagement Coping
Description
Responses to Stress Questionnaire measures coping with diabetes-related stress. Three factors of coping are measured: primary control coping, secondary control coping,and disengagement coping. A ratio score is calculated to determine the ratio of each type of coping in relation to total coping, ranging from 0.00 to 1.00. Higher levels indicate greater relative use of disengagement control coping (e.g., avoidance, denial).
Time Frame
3 months
Title
Self Care Inventory
Description
The Self Care Inventory measures adherence to the recommended diabetes treatment regimen. Adolescents and parents report on the adolescents' self-care behaviors. Items are summed for a total score, ranging from 7-35. Higher scores indicate higher levels of adherence.
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adolescents will be eligible if they are: between the ages of 13-17; have been diagnosed with type 1 diabetes for at least 1 year; have no other major health problems; are not currently participating in any other intervention studies; have a glycosylated hemoglobin level between 7.5 - 12% on date of enrollment; are patients of the Eskind Diabetes Clinic must read and write in English and must live the caregiver that is participating in the study with them Exclusion Criteria: -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sarah Jaser, PhD
Organizational Affiliation
Vanderbilt University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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