Type 1 Diabetes Mellitus
Conditions
Brief summary
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
Detailed description
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.
Interventions
BEHAVIORALPositive Affect + 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.
BEHAVIORALEducation
Adolescents will complete a health behavior contract and receive an educational packet with information about diabetes management.
Sponsors
Children's National Research Institute
Vanderbilt University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
13 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
* Age 13-17 * Diagnosed with type 1 diabetes for at least 12 months * Speak and read English * Report at least moderate diabetes distress on the Problem Areas in Diabetes Scale - Teen version
Exclusion criteria
\- Other serious health conditions
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hemoglobin A1c | 3 months | 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%. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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). |
| 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 coping (e.g., avoidance, denial). |
| Diabetes Distress | 3 months | 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. |
| Diabetes Self-Care Behavior | 3 months | 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. |
| Diabetes-Related Quality of Life | 3 months | 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. |
| 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. |
Countries
United States
Participant flow
Recruitment details
Recruited from pediatric diabetes clinics at Vanderbilt University Medical Center and Children's National Hospital.
Pre-assignment details
Caregiver-adolescent dyads were enrolled and randomized. Protocol Enrollment, Number Started, and Completed reflect participants. Two dyads were enrolled but not randomized: * One caregiver-adolescent dyad gave informed consent but did not finish baseline data and did not respond to the study team. * One caregiver-adolescent dyad gave informed consent and completed baseline data but were found to be ineligible because the teen did not have access to a cell phone.
Participants by arm
| Arm | Count |
|---|---|
| Education Participants in the Education group will complete a behavioral health contract and will receive an educational packet.
Education: Adolescents will complete a health behavior contract and receive an educational packet with information about diabetes management. | 198 |
| PA + 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.
Positive Affect + 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.
Education: Adolescents will complete a health behavior contract and receive an educational packet with information about diabetes management. | 198 |
| Total | 396 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| 12-month Data Collection | Withdrawal by Subject | 0 | 2 |
| 6-month Data Collection | Withdrawal by Subject | 0 | 2 |
| Baseline Through Intervention | Withdrawal by Subject | 4 | 0 |
Baseline characteristics
| Characteristic | Education | PA + Education | Total |
|---|---|---|---|
| Age, Continuous Adolescent Age | 15.4 years STANDARD_DEVIATION 1.4 | 15.3 years STANDARD_DEVIATION 1.4 | 15.3 years STANDARD_DEVIATION 1.4 |
| Age, Continuous Caregiver Age | 46.1 years STANDARD_DEVIATION 7.1 | 45.3 years STANDARD_DEVIATION 7.6 | 45.7 years STANDARD_DEVIATION 7.3 |
| Diabetes Distress (PAID-T) | 48.4 score on a scale STANDARD_DEVIATION 10.3 | 48.3 score on a scale STANDARD_DEVIATION 10.7 | 48.4 score on a scale STANDARD_DEVIATION 10.5 |
| Ethnicity (NIH/OMB) Adolescent Ethnicity Hispanic or Latino | 7 Participants | 2 Participants | 9 Participants |
| Ethnicity (NIH/OMB) Adolescent Ethnicity Not Hispanic or Latino | 92 Participants | 97 Participants | 189 Participants |
| Ethnicity (NIH/OMB) Adolescent Ethnicity Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Caregiver Ethnicity Hispanic or Latino | 5 Participants | 2 Participants | 7 Participants |
| Ethnicity (NIH/OMB) Caregiver Ethnicity Not Hispanic or Latino | 93 Participants | 95 Participants | 188 Participants |
| Ethnicity (NIH/OMB) Caregiver Ethnicity Unknown or Not Reported | 1 Participants | 2 Participants | 3 Participants |
| HbA1c | 9.4 percentage of glycated hemoglobin STANDARD_DEVIATION 2 | 8.9 percentage of glycated hemoglobin STANDARD_DEVIATION 2.3 | 9.1 percentage of glycated hemoglobin STANDARD_DEVIATION 2.1 |
| Race (NIH/OMB) Adolescent Race American Indian or Alaska Native | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Adolescent Race Asian | 3 Participants | 5 Participants | 8 Participants |
| Race (NIH/OMB) Adolescent Race Black or African American | 23 Participants | 24 Participants | 47 Participants |
| Race (NIH/OMB) Adolescent Race More than one race | 8 Participants | 8 Participants | 16 Participants |
| Race (NIH/OMB) Adolescent Race Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Adolescent Race Unknown or Not Reported | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Adolescent Race White | 63 Participants | 60 Participants | 123 Participants |
| Race (NIH/OMB) Caregiver Race American Indian or Alaska Native | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Caregiver Race Asian | 3 Participants | 6 Participants | 9 Participants |
| Race (NIH/OMB) Caregiver Race Black or African American | 21 Participants | 20 Participants | 41 Participants |
| Race (NIH/OMB) Caregiver Race More than one race | 2 Participants | 3 Participants | 5 Participants |
| Race (NIH/OMB) Caregiver Race Native Hawaiian or Other Pacific Islander | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Caregiver Race Unknown or Not Reported | 2 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) Caregiver Race White | 70 Participants | 67 Participants | 137 Participants |
| Region of Enrollment United States | 99 participants | 99 participants | 198 participants |
| Sex: Female, Male Adolescent Sex Female | 57 Participants | 58 Participants | 115 Participants |
| Sex: Female, Male Adolescent Sex Male | 42 Participants | 41 Participants | 83 Participants |
| Sex: Female, Male Caregiver Sex Female | 84 Participants | 85 Participants | 169 Participants |
| Sex: Female, Male Caregiver Sex Male | 14 Participants | 14 Participants | 28 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 99 | 0 / 99 |
| other Total, other adverse events | 0 / 99 | 0 / 99 |
| serious Total, serious adverse events | 0 / 99 | 0 / 99 |
Outcome results
Primary
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
Population: A1c only collected from adolescents participants (not caregivers), since adolescents had type 1 diabetes. A1c was not available for all participants, due to COVID-related disruptions to diabetes clinic visits.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Education | Hemoglobin A1c | 9.0 Percentage of glycated hemoglobin | Standard Deviation 2 |
| PA + Education | Hemoglobin A1c | 9.0 Percentage of glycated hemoglobin | Standard Deviation 2.4 |
Secondary
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
Population: Only adolescent participants completed this measure. Data were not collected from all participants at the 3-month time point due to COVID-related disruptions to diabetes clinic.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Education | Diabetes Distress | 43 score on a scale | Standard Deviation 16 |
| PA + Education | Diabetes Distress | 45 score on a scale | Standard Deviation 14 |
Secondary
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
Population: Only adolescent participants completed this measure. Data were not collected from all participants at the 3-month time point due to COVID-related disruptions to diabetes clinic.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Education | Diabetes-Related Quality of Life | 52 score on a scale | Standard Deviation 14 |
| PA + Education | Diabetes-Related Quality of Life | 52 score on a scale | Standard Deviation 14 |
Secondary
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
Population: Data were not collected from all participants at the 3-month time point due to COVID-related disruptions to diabetes clinic.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Education | Diabetes Self-Care Behavior | 3.74 score on a scale | Standard Deviation 0.65 |
| PA + Education | Diabetes Self-Care Behavior | 3.72 score on a scale | Standard Deviation 0.68 |
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 coping (e.g., avoidance, denial).
Time frame: 3 months
Population: Only adolescent participants completed this measure. Data were not collected from all participants at the 3-month time point due to COVID-related disruptions to diabetes clinic.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Education | Disengagement Coping | .16 ratio score |
| PA + Education | Disengagement Coping | .16 ratio score |
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: Only adolescent participants completed this measure. Data were not collected from all participants at the 3-month time point due to COVID-related disruptions to diabetes clinic.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Education | Positive Affect | 41 score on a scale | Standard Deviation 11 |
| PA + Education | Positive Affect | 44 score on a scale | Standard Deviation 11 |
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: Only adolescent participants completed this measure. Data were not collected from all participants at the 3-month time point due to COVID-related disruptions to diabetes clinic.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Education | Primary Control Coping | .16 ratio score |
| PA + Education | Primary Control Coping | .16 ratio score |
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: Only adolescent participants completed this measure. Data were not collected from all participants at the 3-month time point due to COVID-related disruptions to diabetes clinic.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Education | Secondary Control Coping | .24 ratio score |
| PA + Education | Secondary Control Coping | .23 ratio score |