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Problems with diabetes management in adolescents with type 1 diabetes are common - occurring at rates as high as 93% - and have serious health consequences, including poor blood sugar control and risk for later complications. Therefore, the investigators proposed to test a positive psychology intervention for adolescents with type 1 diabetes aimed at increasing motivation for diabetes management; specifically, to increase the frequency of blood glucose monitoring. This intervention will boost positive mood in adolescents (age 13-17) through tailored exercises in gratitude, self-affirmation, small gifts, and parent affirmation as a way to improve motivation for diabetes management. In addition, this study will explore the use of technology, by comparing telephone-administered vs. automated text-messaging versions of the intervention, to determine which mode of delivery is more appealing, convenient, and beneficial for adolescents in managing their diabetes.
Participants and parents will complete questionnaires on mood and diabetes management during a routine clinic visits at baseline, 3 months, and 6 months. Clinical measures of diabetes management will be collected from participants' electronic medical records.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Education | Active Comparator | Participants receive educational materials in the mail every 2 weeks for 8 weeks. |
|
| Positive Affect - Text | Experimental | Participants receive positive affect intervention (weekly reminders to use gratitude, self-affirmations, parental affirmations, and gift cards) by SMS. Participants also receive educational materials in the mail every 2 weeks for 8 weeks. |
|
| Positive Affect - Phone | Experimental | Participants receive positive affect intervention (weekly reminders to use gratitude, self-affirmations, parental affirmations) by phone. Participants receive small gifts in the mail every 2 weeks for 8 weeks. educational materials in the mail every 2 weeks for 8 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Positive Affect | Behavioral | Positive psychology intervention to improve motivation for diabetes management. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Glycemic Control (HbA1c) | HbA1c measured as part of diabetes clinic visit. The target for children and adolescents is <7.5%. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of Blood Glucose Monitoring | Glucometer download to determine blood glucose checks per day. | 6 months |
| Diabetes-Related Quality of Life | The Pediatric Quality of Life (PedsQL) Diabetes-Specific Module assesses adolescents' self-reported quality of life. Scaled scores range from 0-100, with higher scores indicating better quality of life. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29543490 | Derived | Savin KL, Hamburger ER, Monzon AD, Patel NJ, Perez KM, Lord JH, Jaser SS. Diabetes-specific family conflict: Informant discrepancies and the impact of parental factors. J Fam Psychol. 2018 Feb;32(1):157-163. doi: 10.1037/fam0000364. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Education | Participants receive educational materials in the mail every 2 weeks for 8 weeks. Education: Educational materials on diabetes management |
| FG001 | Positive Affect - Text | Participants receive positive affect intervention (weekly reminders to use gratitude, self-affirmations, parental affirmations, and gift cards) by SMS. Participants also receive educational materials in the mail every 2 weeks for 8 weeks. Positive Affect: Positive psychology intervention to improve motivation for diabetes management. Education: Educational materials on diabetes management |
| FG002 | Positive Affect - Phone | Participants receive positive affect intervention (weekly reminders to use gratitude, self-affirmations, parental affirmations) by phone. Participants receive small gifts in the mail every 2 weeks for 8 weeks. educational materials in the mail every 2 weeks for 8 weeks. Positive Affect: Positive psychology intervention to improve motivation for diabetes management. Education: Educational materials on diabetes management |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Education | Participants receive educational materials in the mail every 2 weeks for 8 weeks. Education: Educational materials on diabetes management |
| BG001 | Positive Affect - Text |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Glycemic Control (HbA1c) | HbA1c measured as part of diabetes clinic visit. The target for children and adolescents is <7.5%. | Posted | Median | Inter-Quartile Range | percentage of glycated hemoglobin | 6 months |
|
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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 receive educational materials in the mail every 2 weeks for 8 weeks. Education: Educational materials on diabetes management |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sarah Jaser, PhD | Vanderbilt University Medical Center | 615-343-6775 | sarah.jaser@vanderbilt.edu |
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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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Participants were assigned to Positive Affect - Phone, Positive Affect - Text, or Education groups for the duration of the study.
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| Education | Behavioral | Educational materials on diabetes management |
|
| 6 months |
| Family Conflict | Diabetes-specific family conflict was measured with the Revised Diabetes Family Conflict Scale, which consists of 19 items regarding how much adolescents and parents argue about diabetes management tasks. Scores range from 19-57, and higher scores indicate greater conflict. | 6 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. Scores range from 15-75, and higher scores indicate higher levels of positive affect. | 6 months |
| Coping | Responses to Stress Questionnaire measures coping strategies used in response to diabetes-related stress. Scores range from 57-228, and higher scores indicate more responses to stress. | 6 months |
Participants receive positive affect intervention (weekly reminders to use gratitude, self-affirmations, parental affirmations, and gift cards) by SMS. Participants also receive educational materials in the mail every 2 weeks for 8 weeks.
Positive Affect: Positive psychology intervention to improve motivation for diabetes management.
Education: Educational materials on diabetes management
| BG002 | Positive Affect - Phone | Participants receive positive affect intervention (weekly reminders to use gratitude, self-affirmations, parental affirmations) by phone. Participants receive small gifts in the mail every 2 weeks for 8 weeks. educational materials in the mail every 2 weeks for 8 weeks. Positive Affect: Positive psychology intervention to improve motivation for diabetes management. Education: Educational materials on diabetes management |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG002 | Positive Affect - Phone | Participants receive positive affect intervention (weekly reminders to use gratitude, self-affirmations, parental affirmations) by phone. Participants receive small gifts in the mail every 2 weeks for 8 weeks. educational materials in the mail every 2 weeks for 8 weeks. Positive Affect: Positive psychology intervention to improve motivation for diabetes management. Education: Educational materials on diabetes management |
|
|
| Secondary | Frequency of Blood Glucose Monitoring | Glucometer download to determine blood glucose checks per day. | Posted | Median | Inter-Quartile Range | blood glucose checks per day | 6 months |
|
|
|
| Secondary | Diabetes-Related Quality of Life | The Pediatric Quality of Life (PedsQL) Diabetes-Specific Module assesses adolescents' self-reported quality of life. Scaled scores range from 0-100, with higher scores indicating better quality of life. | Posted | Median | Inter-Quartile Range | score on a scale | 6 months |
|
|
|
| Secondary | Family Conflict | Diabetes-specific family conflict was measured with the Revised Diabetes Family Conflict Scale, which consists of 19 items regarding how much adolescents and parents argue about diabetes management tasks. Scores range from 19-57, and higher scores indicate greater conflict. | Posted | Median | Inter-Quartile Range | score on a scale | 6 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. Scores range from 15-75, and higher scores indicate higher levels of positive affect. | Posted | Median | Inter-Quartile Range | score on a scale | 6 months |
|
|
|
| Secondary | Coping | Responses to Stress Questionnaire measures coping strategies used in response to diabetes-related stress. Scores range from 57-228, and higher scores indicate more responses to stress. | Posted | Median | Inter-Quartile Range | score on a scale | 6 months |
|
|
|
| 0 |
| 60 |
| 0 |
| 60 |
| EG001 | Positive Affect - Text | Participants receive positive affect intervention (weekly reminders to use gratitude, self-affirmations, parental affirmations, and gift cards) by SMS. Participants also receive educational materials in the mail every 2 weeks for 8 weeks. Positive Affect: Positive psychology intervention to improve motivation for diabetes management. Education: Educational materials on diabetes management | 0 | 30 | 0 | 30 |
| EG002 | Positive Affect - Phone | Participants receive positive affect intervention (weekly reminders to use gratitude, self-affirmations, parental affirmations) by phone. Participants receive small gifts in the mail every 2 weeks for 8 weeks. educational materials in the mail every 2 weeks for 8 weeks. Positive Affect: Positive psychology intervention to improve motivation for diabetes management. Education: Educational materials on diabetes management | 0 | 30 | 0 | 30 |
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| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
|