Type1diabetes
Conditions
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.
Interventions
BEHAVIORALPositive Psychology Intervention
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)
BEHAVIORALEducation
Health Behavior Contract - Baseline visit Education Packet - Baseline visit
Sponsors
Vanderbilt University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
13 Years to 17 Years
Healthy volunteers
No
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
\-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Glycemic Control (A1C) | 3 months | A1C is the percentage of glycosylated hemoglobin and represents an average of glycemic control over the previous 2-3 months. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Frequency of Blood Glucose Monitoring | 3 months | Glucometer download to determine frequency of blood glucose checks per day. Higher numbers indicates more frequent blood glucose checks. |
| Diabetes Family Conflict Scale | 3 months | 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 | 3 months | 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. |
| Positive Affect | 3 months | 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. |
| Secondary Control Coping | 3 months | 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 | 3 months | 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 | 3 months | 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. |
| Primary Control Coping | 3 months | 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). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Experimental: Positive Psychology Intervention 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. SelfAffirmation). 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. | 24 |
| Active Comparator: Education Group The education group will be given developmentally appropriate diabetes education material at the time of enrollment. | 24 |
| Total | 48 |
Baseline characteristics
| Characteristic | Active Comparator: Education Group | Total | Experimental: Positive Psychology Intervention |
|---|---|---|---|
| Age, Categorical <=18 years | 24 Participants | 48 Participants | 24 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 14.4 years STANDARD_DEVIATION 1.2 | 14.7 years STANDARD_DEVIATION 1.3 | 15.0 years STANDARD_DEVIATION 1.3 |
| Diabetes Family Conflict Scale Parent | 30 score on a scale STANDARD_DEVIATION 9.1 | 27.2 score on a scale STANDARD_DEVIATION 7.8 | 24.1 score on a scale STANDARD_DEVIATION 4.3 |
| Diabetes Family Conflict Scale Teen | 33 score on a scale STANDARD_DEVIATION 12 | 32 score on a scale STANDARD_DEVIATION 12 | 30 score on a scale STANDARD_DEVIATION 12 |
| Disengagement Coping | .15 ratio score STANDARD_DEVIATION 0.03 | .15 ratio score STANDARD_DEVIATION 0.03 | .15 ratio score STANDARD_DEVIATION 0.03 |
| Frequency of Blood Glucose Monitoring | 3.2 number of blood glucose checks STANDARD_DEVIATION 1.4 | 3.2 number of blood glucose checks STANDARD_DEVIATION 1.4 | 3.5 number of blood glucose checks STANDARD_DEVIATION 1.4 |
| Glycemic Control (A1C) | 9.00 percentage of glycosylated hemoglobin STANDARD_DEVIATION 1.07 | 8.81 percentage of glycosylated hemoglobin STANDARD_DEVIATION 0.99 | 8.60 percentage of glycosylated hemoglobin STANDARD_DEVIATION 0.86 |
| Positive Affect | 41.2 score on a scale STANDARD_DEVIATION 9 | 40.8 score on a scale STANDARD_DEVIATION 8.4 | 40.3 score on a scale STANDARD_DEVIATION 7.9 |
| Primary Control Coping | .18 ratio score STANDARD_DEVIATION 0.04 | .18 ratio score STANDARD_DEVIATION 0.04 | .17 ratio score STANDARD_DEVIATION 0.04 |
| Quality of Life | 72 score on a scale STANDARD_DEVIATION 11 | 71 score on a scale STANDARD_DEVIATION 12 | 70 score on a scale STANDARD_DEVIATION 13 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 5 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) White | 19 Participants | 41 Participants | 22 Participants |
| Region of Enrollment United States | 24 participants | 48 participants | 24 participants |
| Secondary Control Coping | .27 ratio score STANDARD_DEVIATION 0.05 | .27 ratio score STANDARD_DEVIATION 0.05 | .26 ratio score STANDARD_DEVIATION 0.05 |
| Self Care Inventory Parent | 24.5 score on a scale STANDARD_DEVIATION 4.6 | 24.7 score on a scale STANDARD_DEVIATION 4.4 | 24.8 score on a scale STANDARD_DEVIATION 4.2 |
| Self Care Inventory Teen | 25.0 score on a scale STANDARD_DEVIATION 5.1 | 24.9 score on a scale STANDARD_DEVIATION 5.1 | 24.8 score on a scale STANDARD_DEVIATION 5.2 |
| Sex: Female, Male Female | 11 Participants | 25 Participants | 14 Participants |
| Sex: Female, Male Male | 13 Participants | 23 Participants | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 24 | 0 / 24 |
| other Total, other adverse events | 0 / 24 | 0 / 24 |
| serious Total, serious adverse events | 0 / 24 | 0 / 24 |
Outcome results
Primary
Glycemic Control (A1C)
A1C is the percentage of glycosylated hemoglobin and represents an average of glycemic control over the previous 2-3 months.
Time frame: 3 months
Population: One participant in the Active Comparator group did not return for a clinic visit and therefore did not have an A1C value at follow-up.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental: Positive Psychology Intervention | Glycemic Control (A1C) | 8.60 percentage of glycosylated hemoglobin | Standard Deviation 1.49 |
| Active Comparator: Education Group | Glycemic Control (A1C) | 9.35 percentage of glycosylated hemoglobin | Standard Deviation 1.39 |
p-value: 0.59395% CI: [-0.81, 0.47]Multiple linear regression
Secondary
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.
Time frame: 3 months
Population: One teen participant in the Experimental group did not complete follow-up survey data. All parents completed the follow-up surveys.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Experimental: Positive Psychology Intervention | Diabetes Family Conflict Scale | Diabetes Family Conflict - Teen | 30 score on a scale | Standard Deviation 12 |
| Experimental: Positive Psychology Intervention | Diabetes Family Conflict Scale | Diabetes Family Conflict - Parent | 23.8 score on a scale | Standard Deviation 5.7 |
| Active Comparator: Education Group | Diabetes Family Conflict Scale | Diabetes Family Conflict - Teen | 36 score on a scale | Standard Deviation 12 |
| Active Comparator: Education Group | Diabetes Family Conflict Scale | Diabetes Family Conflict - Parent | 30.4 score on a scale | Standard Deviation 9.6 |
Comparison: Child-reported family conflictp-value: 0.51195% CI: [-10.11, 5.13]Multiple linear regression
Comparison: Parent-reported family conflictp-value: 0.1995% CI: [-8.44, 1.73]Multiple linear regression
Secondary
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.
Time frame: 3 months
Population: One teen participant in the Experimental group did not complete follow-up survey data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental: Positive Psychology Intervention | Diabetes-Specific Quality of Life | 71 score on a scale | Standard Deviation 14 |
| Active Comparator: Education Group | Diabetes-Specific Quality of Life | 71 score on a scale | Standard Deviation 11 |
p-value: 0.87395% CI: [-4.57, 5.36]Multiple linear regression
Secondary
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).
Time frame: 3 months
Population: One teen participant in the Experimental group did not complete follow-up survey data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental: Positive Psychology Intervention | Disengagement Coping | .14 ratio score | Standard Deviation 0.03 |
| Active Comparator: Education Group | Disengagement Coping | .14 ratio score | Standard Deviation 0.03 |
Secondary
Frequency of Blood Glucose Monitoring
Glucometer download to determine frequency of blood glucose checks per day. Higher numbers indicates more frequent blood glucose checks.
Time frame: 3 months
Population: Three participants in the Experimental group and five participants in the Active Comparator group did not bring their glucometers to clinic visits and therefore frequency of blood glucose monitoring could not be obtained.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental: Positive Psychology Intervention | Frequency of Blood Glucose Monitoring | 3.8 blood glucose checks per day | Standard Deviation 1.3 |
| Active Comparator: Education Group | Frequency of Blood Glucose Monitoring | 3.2 blood glucose checks per day | Standard Deviation 1.5 |
p-value: 0.20695% CI: [-1.52, 0.34]Multiple linear regression
Secondary
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.
Time frame: 3 months
Population: One teen participant in the Experimental group did not complete follow-up survey data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental: Positive Psychology Intervention | Positive Affect | 40.6 score on a scale | Standard Deviation 7.1 |
| Active Comparator: Education Group | Positive Affect | 42.8 score on a scale | Standard Deviation 9.2 |
p-value: 0.58195% CI: [-5.27, 2.99]Multiple linear regression
Secondary
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).
Time frame: 3 months
Population: One teen participant in the Experimental group did not complete follow-up survey data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental: Positive Psychology Intervention | Primary Control Coping | .18 ratio score | Standard Deviation 0.03 |
| Active Comparator: Education Group | Primary Control Coping | .20 ratio score | Standard Deviation 0.04 |
p-value: 0.60395% CI: [-8.57, 14.56]Multiple linear regression
Secondary
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).
Time frame: 3 months
Population: One teen participant in the Experimental group did not complete follow-up survey data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental: Positive Psychology Intervention | Secondary Control Coping | .27 ratio score | Standard Deviation 0.05 |
| Active Comparator: Education Group | Secondary Control Coping | .28 ratio score | Standard Deviation 0.04 |
Secondary
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.
Time frame: 3 months
Population: One teen participant in the Experimental group did not complete follow-up survey data. All parents completed the follow-up surveys.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Experimental: Positive Psychology Intervention | Self Care Inventory | Self Care Inventory - Parent | 26.6 score on a scale | Standard Deviation 3.9 |
| Experimental: Positive Psychology Intervention | Self Care Inventory | Self Care Inventory - Teen | 25.2 score on a scale | Standard Deviation 5.1 |
| Active Comparator: Education Group | Self Care Inventory | Self Care Inventory - Parent | 25.9 score on a scale | Standard Deviation 5.2 |
| Active Comparator: Education Group | Self Care Inventory | Self Care Inventory - Teen | 26.0 score on a scale | Standard Deviation 5.3 |