An interventional study of Positive Psychology Intervention and Education in Type1diabetes, sponsored by Vanderbilt University. Completed at 1 site in United States. Open to participants aged 13 Years to 17 Years. Per ClinicalTrials.gov, last updated 2019-04-24.
Sponsored by Vanderbilt University · Not applicable, Interventional, and Treatment
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.
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.
Vanderbilt University is the lead sponsor of 520 studies on the registry; 18 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 5 (63%) have results posted.
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Adolescents will be eligible if they are:
Exclusion Criteria:
-
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.
Behavioral: Positive Psychology Intervention
The education group will be given developmentally-appropriate diabetes education material at the time of enrollment.
Behavioral: Education
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)
Also known as: Check It 2.0
Health Behavior Contract - Baseline visit Education Packet - Baseline visit
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
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
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
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
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
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
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
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
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
| Milestone | Experimental: Positive Psychology Intervention | Active Comparator: Education Group |
|---|---|---|
| Started | 24 | 24 |
| Completed | 24 | 24 |
| Not completed | 0 | 0 |
A1C is the percentage of glycosylated hemoglobin and represents an average of glycemic control over the previous 2-3 months.
| percentage of glycosylated hemoglobin | Experimental: Positive Psychology Intervention | Active Comparator: Education Group |
|---|---|---|
| Glycemic Control (A1C) | 8.60 ± 1.49 | 9.35 ± 1.39 |
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.
| score on a scale | Experimental: Positive Psychology Intervention | Active Comparator: Education Group |
|---|---|---|
| Positive Affect | 40.6 ± 7.1 | 42.8 ± 9.2 |
Glucometer download to determine frequency of blood glucose checks per day. Higher numbers indicates more frequent blood glucose checks.
| blood glucose checks per day | Experimental: Positive Psychology Intervention | Active Comparator: Education Group |
|---|---|---|
| Frequency of Blood Glucose Monitoring | 3.8 ± 1.3 | 3.2 ± 1.5 |
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.
| score on a scale | Experimental: Positive Psychology Intervention | Active Comparator: Education Group |
|---|---|---|
| Diabetes Family Conflict - Teen | 30 ± 12 | 36 ± 12 |
| Diabetes Family Conflict - Parent | 23.8 ± 5.7 | 30.4 ± 9.6 |
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.
| score on a scale | Experimental: Positive Psychology Intervention | Active Comparator: Education Group |
|---|---|---|
| Diabetes-Specific Quality of Life | 71 ± 14 | 71 ± 11 |
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).
| ratio score | Experimental: Positive Psychology Intervention | Active Comparator: Education Group |
|---|---|---|
| Primary Control Coping | .18 ± .03 | .20 ± .04 |
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).
| ratio score | Positive Psychology Intervention | Education Group |
|---|---|---|
| Secondary Control Coping | .27 ± .05 | .28 ± .04 |
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).
| ratio score | Positive Psychology Intervention | Education Group |
|---|---|---|
| Disengagement Coping | .14 ± .03 | .14 ± .03 |
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.
| score on a scale | Positive Psychology Intervention | Education Group |
|---|---|---|
| Self Care Inventory - Parent | 26.6 ± 3.9 | 25.9 ± 5.2 |
| Self Care Inventory - Teen | 25.2 ± 5.1 | 26.0 ± 5.3 |
Collected over 1 year. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Experimental: Positive Psychology Intervention | 0/24 (0%) | 0/24 (0%) | 0/24 (0%) |
| Active Comparator: Education Group | 0/24 (0%) | 0/24 (0%) | 0/24 (0%) |
| Age, Categorical(Participants) | Experimental: Positive Psychology Intervention | Active Comparator: Education Group | Total |
|---|---|---|---|
| <=18 years | 24 | 24 | 48 |
| Between 18 and 65 years | 0 | 0 | 0 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | Experimental: Positive Psychology Intervention | Active Comparator: Education Group | Total |
|---|---|---|---|
| Mean | 15.0 ± 1.3 | 14.4 ± 1.2 | 14.7 ± 1.3 |
| Sex: Female, Male(Participants) | Experimental: Positive Psychology Intervention | Active Comparator: Education Group | Total |
|---|---|---|---|
| Female | 14 | 11 | 25 |
| Male | 10 | 13 | 23 |
| Race (NIH/OMB)(Participants) | Experimental: Positive Psychology Intervention | Active Comparator: Education Group | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 2 | 3 | 5 |
| White | 22 | 19 | 41 |
| More than one race | 0 | 1 | 1 |
| Unknown or Not Reported | 0 | 1 | 1 |
| Region of Enrollment(participants) | Experimental: Positive Psychology Intervention | Active Comparator: Education Group | Total |
|---|---|---|---|
| United States | 24 | 24 | 48 |
| Glycemic Control (A1C)(percentage of glycosylated hemoglobin) | Experimental: Positive Psychology Intervention | Active Comparator: Education Group | Total |
|---|---|---|---|
| Mean | 8.60 ± 0.86 | 9.00 ± 1.07 | 8.81 ± 0.99 |
| Positive Affect(score on a scale) | Experimental: Positive Psychology Intervention | Active Comparator: Education Group | Total |
|---|---|---|---|
| Mean | 40.3 ± 7.9 | 41.2 ± 9.0 | 40.8 ± 8.4 |
| Frequency of Blood Glucose Monitoring(number of blood glucose checks) | Experimental: Positive Psychology Intervention | Active Comparator: Education Group | Total |
|---|---|---|---|
| Mean | 3.5 ± 1.4 | 3.2 ± 1.4 | 3.2 ± 1.4 |
6 further baseline measures are reported on the registry.
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