An interventional study of Positive Affect + Education and Education in Type 1 Diabetes Mellitus, sponsored by Vanderbilt University Medical Center. Completed at 2 sites in United States. Open to participants aged 13 Years to 17 Years. Per ClinicalTrials.gov, last updated 2025-03-21.
Sponsored by Vanderbilt University Medical Center · Not applicable, Interventional, and Treatment
The treatment regimen for type 1 diabetes is complex and demanding, and many adolescents experience diabetes distress related to the daily demands of diabetes care, which can cause problems with diabetes management and glycemic control. The proposed study will conduct a multisite, randomized trial to test the effects of a positive psychology intervention aimed at treating diabetes distress and improving glycemic outcomes. The potential benefits include helping adolescents achieve better glycemic control, improved self-management, and psychosocial outcomes
Adolescents with type 1 diabetes (T1D) struggle to meet treatment goals - only 17% met the target for glycemic control in a recent national study - and many adolescents experience high levels of diabetes distress related to the daily demands of diabetes care. Yet, previous interventions to improve glycemic control in adolescents with type 1 diabetes have only shown modest to moderate effects, and many have been time-intensive and expensive. Thus, there is a need for novel interventions to improve outcomes in adolescents with T1D. Increasing positive affect, or pleasurable engagement with the environment (e.g., feeling happy, cheerful, proud), has been shown to promote the use of more adaptive coping strategies to manage stress. Thus, the proposed study is based on the premise that, by boosting positive affect in teens with diabetes, we will enhance the use of adaptive coping strategies and reduce diabetes distress, thereby improving glycemic control in adolescents. Through an iterative series of pilot studies, our research team adapted a behavioral intervention using a positive psychology framework that we demonstrated to be feasible and acceptable for adolescents with T1D. This intervention is aimed at inducing positive affect in adolescents (age 13-17) through empirically-validated, tailored exercises in gratitude, self-affirmation, and caregiver affirmations. In our pilot studies, the intervention had promising effects on adolescents' quality of life, diabetes-related stress, and family conflict, all of which are closely linked with diabetes distress. We now plan to evaluate the efficacy of the intervention in a multisite, randomized controlled trial. The aims of this study are to 1) evaluate the effects of a positive psychology intervention for adolescents (age 13-17) and their caregivers on glycemic control; 2) evaluate the effects of the intervention on diabetes distress, coping, and self-care behavior; and 3) explore the differential impact of intervention effects across demographic and treatment variables. We plan to randomize 200 adolescent-caregiver dyads to the Positive Affect + Education intervention (n=100) or the Education only intervention (n=100) from two clinical sites (Vanderbilt University Medical Center and Children's National Medical Center). By employing a positive psychology framework, we propose an innovative approach to treat diabetes distress and improve glycemic outcomes. We believe this novel intervention has the potential to improve outcomes in adolescents with T1D, and the use of automated text messaging to deliver the intervention offers possibilities for wide dissemination.
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Exclusion Criteria:
Participants in the Education group will complete a behavioral health contract and will receive an educational packet.
Behavioral: Education
Participants in the Positive Affect + Education group will complete a behavioral health contract and receive an educational packet. In addition, they will receive intervention components aimed at inducing positive affect.
Behavioral: Positive Affect + Education · Behavioral: Education
Adolescents will complete a health behavior contract and receive an educational packet at baseline. Adolescents will complete a positive affect interview at baseline. They will receive automated text messages 5 days/week for 8 weeks. Messages will be tailored to include adolescents' responses to the baseline interview, including reminders to engage in gratitude and 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.
Adolescents will complete a health behavior contract and receive an educational packet with information about diabetes management.
Hemoglobin A1c
Hemoglobin A1c measures the amount of glucose attached to hemoglobin. It is assessed as part of regular diabetes clinic visits. The target is \<7.0%.
Time frame: 3 months
Diabetes Distress
The Problem Area In Diabetes - Teen (PAID-T) measures diabetes distress. Scores range from 14-84, with higher scores indicated greater distress. A total score of 44 or higher is considered clinically significant.
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 coping (e.g., avoidance, denial).
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
Diabetes Self-Care Behavior
The Self Care Inventory measures adherence to the recommended diabetes treatment regimen. Adolescents and parents report on the adolescents' self-care behaviors. A mean score is calcuated, ranging from 1-5. Higher scores indicate higher levels of self-management behaviors.
Time frame: 3 months
Diabetes-Related Quality of Life
Type 1 Diabetes and Life measures adolescents self-reported diabetes-related quality of life. Scores range from 0-100, and higher scores indicate better quality of life.
Time frame: 3 months
Recruited from pediatric diabetes clinics at Vanderbilt University Medical Center and Children's National Hospital.
| Milestone | Education | PA + Education |
|---|---|---|
| Started | 198 | 198 |
| Caregivers | 99 | 99 |
| Adolescents | 99 | 99 |
| Completed | 194 | 198 |
| Not completed | 4 | 0 |
| Withdrew: Withdrawal by subject | 4 | 0 |
| Milestone | Education | PA + Education |
|---|---|---|
| Started | 194 | 198 |
| Caregivers | 97 | 99 |
| Adolescents | 97 | 99 |
| Completed | 194 | 198 |
| Not completed | 0 | 0 |
| Milestone | Education | PA + Education |
|---|---|---|
| Started | 194 | 198 |
| Caregivers | 97 | 99 |
| Adolescents | 97 | 99 |
| Completed | 194 | 196 |
| Not completed | 0 | 2 |
| Withdrew: Withdrawal by subject | 0 | 2 |
| Milestone | Education | PA + Education |
|---|---|---|
| Started | 194 | 196 |
| Caregivers | 97 | 98 |
| Adolescents | 97 | 98 |
| Completed | 194 | 194 |
| Not completed | 0 | 2 |
| Withdrew: Withdrawal by subject | 0 | 2 |
Hemoglobin A1c measures the amount of glucose attached to hemoglobin. It is assessed as part of regular diabetes clinic visits. The target is \<7.0%.
| Percentage of glycated hemoglobin | Education | PA + Education |
|---|---|---|
| Hemoglobin A1c | 9.0 ± 2.0 | 9.0 ± 2.4 |
The Problem Area In Diabetes - Teen (PAID-T) measures diabetes distress. Scores range from 14-84, with higher scores indicated greater distress. A total score of 44 or higher is considered clinically significant.
| score on a scale | Education | PA + Education |
|---|---|---|
| Diabetes Distress | 43 ± 16 | 45 ± 14 |
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 | Education | PA + Education |
|---|---|---|
| Primary Control Coping | .16 (.14 to .18) | .16 (.13 to .18) |
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 | Education | PA + Education |
|---|---|---|
| Secondary Control Coping | .24 (.20 to .27) | .23 (.21 to .26) |
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 coping (e.g., avoidance, denial).
| ratio score | Education | PA + Education |
|---|---|---|
| Disengagement Coping | .16 (.14 to .17) | .16 (.14 to .18) |
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 | Education | PA + Education |
|---|---|---|
| Positive Affect | 41 ± 11 | 44 ± 11 |
The Self Care Inventory measures adherence to the recommended diabetes treatment regimen. Adolescents and parents report on the adolescents' self-care behaviors. A mean score is calcuated, ranging from 1-5. Higher scores indicate higher levels of self-management behaviors.
| score on a scale | Education | PA + Education |
|---|---|---|
| Diabetes Self-Care Behavior | 3.74 ± 0.65 | 3.72 ± 0.68 |
Type 1 Diabetes and Life measures adolescents self-reported diabetes-related quality of life. Scores range from 0-100, and higher scores indicate better quality of life.
| score on a scale | Education | PA + Education |
|---|---|---|
| Diabetes-Related Quality of Life | 52 ± 14 | 52 ± 14 |
Collected over Adverse event data were collected for the active study period (4 years).. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Education | 0/99 (0%) | 0/99 (0%) | 0/99 (0%) |
| PA + Education | 0/99 (0%) | 0/99 (0%) | 0/99 (0%) |
Participants were caregiver-adolescent dyads.
| Age, Continuous(years) | Education | PA + Education | Total |
|---|---|---|---|
| Adolescent Age | 15.4 ± 1.4 | 15.3 ± 1.4 | 15.3 ± 1.4 |
| Caregiver Age | 46.1 ± 7.1 | 45.3 ± 7.6 | 45.7 ± 7.3 |
| Sex: Female, Male(Participants) | Education | PA + Education | Total |
|---|---|---|---|
| Adolescent Sex — Female | 57 | 58 | 115 |
| Adolescent Sex — Male | 42 | 41 | 83 |
| Caregiver Sex — Female | 84 | 85 | 169 |
| Caregiver Sex — Male | 14 | 14 | 28 |
| Ethnicity (NIH/OMB)(Participants) | Education | PA + Education | Total |
|---|---|---|---|
| Adolescent Ethnicity — Hispanic or Latino | 7 | 2 | 9 |
| Adolescent Ethnicity — Not Hispanic or Latino | 92 | 97 | 189 |
| Adolescent Ethnicity — Unknown or Not Reported | 0 | 0 | 0 |
| Caregiver Ethnicity — Hispanic or Latino | 5 | 2 | 7 |
| Caregiver Ethnicity — Not Hispanic or Latino | 93 | 95 | 188 |
| Caregiver Ethnicity — Unknown or Not Reported | 1 | 2 | 3 |
| Race (NIH/OMB)(Participants) | Education | PA + Education | Total |
|---|---|---|---|
| Adolescent Race — American Indian or Alaska Native | 1 | 1 | 2 |
| Adolescent Race — Asian | 3 | 5 | 8 |
| Adolescent Race — Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Adolescent Race — Black or African American | 23 | 24 | 47 |
| Adolescent Race — White | 63 | 60 | 123 |
| Adolescent Race — More than one race | 8 | 8 | 16 |
| Adolescent Race — Unknown or Not Reported | 1 | 1 | 2 |
| Caregiver Race — American Indian or Alaska Native | 1 | 1 | 2 |
| Caregiver Race — Asian | 3 | 6 | 9 |
| Caregiver Race — Native Hawaiian or Other Pacific Islander | 0 | 1 | 1 |
| Caregiver Race — Black or African American | 21 | 20 | 41 |
| Caregiver Race — White | 70 | 67 | 137 |
| Caregiver Race — More than one race | 2 | 3 | 5 |
| Caregiver Race — Unknown or Not Reported | 2 | 1 | 3 |
| Region of Enrollment(participants) | Education | PA + Education | Total |
|---|---|---|---|
| United States | 99 | 99 | 198 |
| Region of Enrollment(participants) | Education | PA + Education | Total |
|---|---|---|---|
| United States | 99 | 99 | 198 |
| Diabetes Distress (PAID-T)(score on a scale) | Education | PA + Education | Total |
|---|---|---|---|
| Mean | 48.4 ± 10.3 | 48.3 ± 10.7 | 48.4 ± 10.5 |
| HbA1c(percentage of glycated hemoglobin) | Education | PA + Education | Total |
|---|---|---|---|
| Mean | 9.4 ± 2.0 | 8.9 ± 2.3 | 9.1 ± 2.1 |
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Vanderbilt University Medical Center