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| Name | Class |
|---|---|
| Children's National Research Institute | OTHER |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Education | Active Comparator | Participants in the Education group will complete a behavioral health contract and will receive an educational packet. |
|
| PA + Education | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Positive Affect + Education | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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%. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 3 months |
| Primary Control Coping |
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Inclusion Criteria:
Exclusion Criteria:
- Other serious health conditions
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's National | Washington D.C. | District of Columbia | 20010 | United States | ||
| Vanderbilt University Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39014980 | Derived | Straton E, Anifowoshe K, Moore H, Streisand R, Jaser SS. Associations of Coping Strategies With Glycemic and Psychosocial Outcomes Among Adolescents With Type 1 Diabetes Experiencing Diabetes Distress. Ann Behav Med. 2024 Aug 7;58(9):628-633. doi: 10.1093/abm/kaae028. |
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Caregiver-adolescent dyads were enrolled and randomized. Protocol Enrollment, Number Started, and Completed reflect participants.
Two dyads were enrolled but not randomized:
Recruited from pediatric diabetes clinics at Vanderbilt University Medical Center and Children's National Hospital.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline Through Intervention |
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| 3-month Data Collection |
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| 6-month Data Collection |
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| 12-month Data Collection |
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Participants were caregiver-adolescent dyads.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | PA + Education |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Caregiver age analyzed separately from adolescent age. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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%. | 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. | Posted | Mean | Standard Deviation | Percentage of glycated hemoglobin | 3 months |
|
Adverse event data were collected for the active study period (4 years).
Adverse events were self-reported by adolescent participants. We did not collect adverse events from caregivers.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sarah Jaser, PhD | Vanderbilt University Medical Center | 6153436775 | sarah.jaser@vumc.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 11, 2023 | Jul 29, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D004522 | Educational Status |
| ID | Term |
|---|---|
| D012959 | Socioeconomic Factors |
| D011154 | Population Characteristics |
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|
| Education | Behavioral | Adolescents will complete a health behavior contract and receive an educational packet with information about diabetes management. |
|
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). |
| 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). | 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). | 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. | 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. | 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. | 3 months |
| Nashville |
| Tennessee |
| 37232 |
| United States |
| Adolescents |
|
| COMPLETED |
|
| NOT COMPLETED |
|
| Adolescents |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Adolescents |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
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. |
| BG002 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | Caregiver sex analyzed separately from adolescent sex. 1 caregiver did not report sex. | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Caregiver ethnicity analyzed separately from adolescent ethnicity. | Count of Participants | Participants |
|
| Race (NIH/OMB) | Caregiver race analyzed separately from adolescent race. | Count of Participants | Participants |
|
| Region of Enrollment | Caregiver Region of Enrollment | Caregiver region of enrollment. | Number | participants |
|
| Region of Enrollment | Adolescent region of enrollment | Adolescent region of enrollment | Number | participants |
|
| Diabetes Distress (PAID-T) | Problem Area in Diabetes - Teen (PAID-T) consists of 14 items measuring adolescents' diabetes distress. Scores range from 14-84, and higher scores indicate greater distress. A score of 44 or higher indicates clinically significant distress. | Diabetes distress was collected from adolescent participants (not caregivers). | Mean | Standard Deviation | score on a scale |
|
| HbA1c | Hemoglobin A1c measured as part of clinic visit indicates the amount of glucose attached to hemoglobin. | HbA1c values not available for all adolescent participants due to COVID-related disruptions to clinical care. | Mean | Standard Deviation | percentage of glycated hemoglobin |
|
| 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. |
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | 3 months |
|
|
|
| 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). | 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. | Posted | Median | Inter-Quartile Range | ratio score | 3 months |
|
|
|
| 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). | 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. | Posted | Median | Inter-Quartile Range | ratio score | 3 months |
|
|
|
| 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). | 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. | Posted | Median | Inter-Quartile Range | ratio score | 3 months |
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | 3 months |
|
|
|
| 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. | Data were not collected from all participants at the 3-month time point due to COVID-related disruptions to diabetes clinic. | Posted | Mean | Standard Deviation | score on a scale | 3 months |
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | 3 months |
|
|
|
| 0 |
| 99 |
| 0 |
| 99 |
| 0 |
| 99 |
| EG001 | 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. | 0 | 99 | 0 | 99 | 0 | 99 |
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| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| Male |
|
| Unknown or Not Reported |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|