Trial Outcomes & Findings for Positive Psychology Intervention to Treat Diabetes Distress in Teens With Type 1 Diabetes (NCT NCT03845465)
NCT ID: NCT03845465
Last Updated: 2025-03-21
Results Overview
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%.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
400 participants
Primary outcome timeframe
3 months
Results posted on
2025-03-21
Participant Flow
Recruited from pediatric diabetes clinics at Vanderbilt University Medical Center and Children's National Hospital.
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.
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Baseline Through Intervention
STARTED
|
198
|
198
|
|
Baseline Through Intervention
Caregivers
|
99
|
99
|
|
Baseline Through Intervention
Adolescents
|
99
|
99
|
|
Baseline Through Intervention
COMPLETED
|
194
|
198
|
|
Baseline Through Intervention
NOT COMPLETED
|
4
|
0
|
|
3-month Data Collection
STARTED
|
194
|
198
|
|
3-month Data Collection
Caregivers
|
97
|
99
|
|
3-month Data Collection
Adolescents
|
97
|
99
|
|
3-month Data Collection
COMPLETED
|
194
|
198
|
|
3-month Data Collection
NOT COMPLETED
|
0
|
0
|
|
6-month Data Collection
STARTED
|
194
|
198
|
|
6-month Data Collection
Caregivers
|
97
|
99
|
|
6-month Data Collection
Adolescents
|
97
|
99
|
|
6-month Data Collection
COMPLETED
|
194
|
196
|
|
6-month Data Collection
NOT COMPLETED
|
0
|
2
|
|
12-month Data Collection
STARTED
|
194
|
196
|
|
12-month Data Collection
Caregivers
|
97
|
98
|
|
12-month Data Collection
Adolescents
|
97
|
98
|
|
12-month Data Collection
COMPLETED
|
194
|
194
|
|
12-month Data Collection
NOT COMPLETED
|
0
|
2
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
Baseline Through Intervention
Withdrawal by Subject
|
4
|
0
|
|
6-month Data Collection
Withdrawal by Subject
|
0
|
2
|
|
12-month Data Collection
Withdrawal by Subject
|
0
|
2
|
Baseline Characteristics
Caregiver age analyzed separately from adolescent age.
Baseline characteristics by cohort
| Measure |
Education
n=198 Participants
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.
|
PA + Education
n=198 Participants
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.
|
Total
n=396 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
Adolescent Age
|
15.4 years
STANDARD_DEVIATION 1.4 • n=99 Participants • Caregiver age analyzed separately from adolescent age.
|
15.3 years
STANDARD_DEVIATION 1.4 • n=99 Participants • Caregiver age analyzed separately from adolescent age.
|
15.3 years
STANDARD_DEVIATION 1.4 • n=198 Participants • Caregiver age analyzed separately from adolescent age.
|
|
Age, Continuous
Caregiver Age
|
46.1 years
STANDARD_DEVIATION 7.1 • n=99 Participants • Caregiver age analyzed separately from adolescent age.
|
45.3 years
STANDARD_DEVIATION 7.6 • n=99 Participants • Caregiver age analyzed separately from adolescent age.
|
45.7 years
STANDARD_DEVIATION 7.3 • n=198 Participants • Caregiver age analyzed separately from adolescent age.
|
|
Sex: Female, Male
Adolescent Sex · Female
|
57 Participants
n=99 Participants • Caregiver sex analyzed separately from adolescent sex. 1 caregiver did not report sex.
|
58 Participants
n=99 Participants • Caregiver sex analyzed separately from adolescent sex. 1 caregiver did not report sex.
|
115 Participants
n=198 Participants • Caregiver sex analyzed separately from adolescent sex. 1 caregiver did not report sex.
|
|
Sex: Female, Male
Adolescent Sex · Male
|
42 Participants
n=99 Participants • Caregiver sex analyzed separately from adolescent sex. 1 caregiver did not report sex.
|
41 Participants
n=99 Participants • Caregiver sex analyzed separately from adolescent sex. 1 caregiver did not report sex.
|
83 Participants
n=198 Participants • Caregiver sex analyzed separately from adolescent sex. 1 caregiver did not report sex.
|
|
Sex: Female, Male
Caregiver Sex · Female
|
84 Participants
n=98 Participants • Caregiver sex analyzed separately from adolescent sex. 1 caregiver did not report sex.
|
85 Participants
n=99 Participants • Caregiver sex analyzed separately from adolescent sex. 1 caregiver did not report sex.
|
169 Participants
n=197 Participants • Caregiver sex analyzed separately from adolescent sex. 1 caregiver did not report sex.
|
|
Sex: Female, Male
Caregiver Sex · Male
|
14 Participants
n=98 Participants • Caregiver sex analyzed separately from adolescent sex. 1 caregiver did not report sex.
|
14 Participants
n=99 Participants • Caregiver sex analyzed separately from adolescent sex. 1 caregiver did not report sex.
|
28 Participants
n=197 Participants • Caregiver sex analyzed separately from adolescent sex. 1 caregiver did not report sex.
|
|
Ethnicity (NIH/OMB)
Adolescent Ethnicity · Hispanic or Latino
|
7 Participants
n=99 Participants • Caregiver ethnicity analyzed separately from adolescent ethnicity.
|
2 Participants
n=99 Participants • Caregiver ethnicity analyzed separately from adolescent ethnicity.
|
9 Participants
n=198 Participants • Caregiver ethnicity analyzed separately from adolescent ethnicity.
|
|
Ethnicity (NIH/OMB)
Adolescent Ethnicity · Not Hispanic or Latino
|
92 Participants
n=99 Participants • Caregiver ethnicity analyzed separately from adolescent ethnicity.
|
97 Participants
n=99 Participants • Caregiver ethnicity analyzed separately from adolescent ethnicity.
|
189 Participants
n=198 Participants • Caregiver ethnicity analyzed separately from adolescent ethnicity.
|
|
Ethnicity (NIH/OMB)
Adolescent Ethnicity · Unknown or Not Reported
|
0 Participants
n=99 Participants • Caregiver ethnicity analyzed separately from adolescent ethnicity.
|
0 Participants
n=99 Participants • Caregiver ethnicity analyzed separately from adolescent ethnicity.
|
0 Participants
n=198 Participants • Caregiver ethnicity analyzed separately from adolescent ethnicity.
|
|
Ethnicity (NIH/OMB)
Caregiver Ethnicity · Hispanic or Latino
|
5 Participants
n=99 Participants • Caregiver ethnicity analyzed separately from adolescent ethnicity.
|
2 Participants
n=99 Participants • Caregiver ethnicity analyzed separately from adolescent ethnicity.
|
7 Participants
n=198 Participants • Caregiver ethnicity analyzed separately from adolescent ethnicity.
|
|
Ethnicity (NIH/OMB)
Caregiver Ethnicity · Not Hispanic or Latino
|
93 Participants
n=99 Participants • Caregiver ethnicity analyzed separately from adolescent ethnicity.
|
95 Participants
n=99 Participants • Caregiver ethnicity analyzed separately from adolescent ethnicity.
|
188 Participants
n=198 Participants • Caregiver ethnicity analyzed separately from adolescent ethnicity.
|
|
Ethnicity (NIH/OMB)
Caregiver Ethnicity · Unknown or Not Reported
|
1 Participants
n=99 Participants • Caregiver ethnicity analyzed separately from adolescent ethnicity.
|
2 Participants
n=99 Participants • Caregiver ethnicity analyzed separately from adolescent ethnicity.
|
3 Participants
n=198 Participants • Caregiver ethnicity analyzed separately from adolescent ethnicity.
|
|
Race (NIH/OMB)
Adolescent Race · American Indian or Alaska Native
|
1 Participants
n=99 Participants • Caregiver race analyzed separately from adolescent race.
|
1 Participants
n=99 Participants • Caregiver race analyzed separately from adolescent race.
|
2 Participants
n=198 Participants • Caregiver race analyzed separately from adolescent race.
|
|
Race (NIH/OMB)
Adolescent Race · Asian
|
3 Participants
n=99 Participants • Caregiver race analyzed separately from adolescent race.
|
5 Participants
n=99 Participants • Caregiver race analyzed separately from adolescent race.
|
8 Participants
n=198 Participants • Caregiver race analyzed separately from adolescent race.
|
|
Race (NIH/OMB)
Adolescent Race · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants • Caregiver race analyzed separately from adolescent race.
|
0 Participants
n=99 Participants • Caregiver race analyzed separately from adolescent race.
|
0 Participants
n=198 Participants • Caregiver race analyzed separately from adolescent race.
|
|
Race (NIH/OMB)
Adolescent Race · Black or African American
|
23 Participants
n=99 Participants • Caregiver race analyzed separately from adolescent race.
|
24 Participants
n=99 Participants • Caregiver race analyzed separately from adolescent race.
|
47 Participants
n=198 Participants • Caregiver race analyzed separately from adolescent race.
|
|
Race (NIH/OMB)
Adolescent Race · White
|
63 Participants
n=99 Participants • Caregiver race analyzed separately from adolescent race.
|
60 Participants
n=99 Participants • Caregiver race analyzed separately from adolescent race.
|
123 Participants
n=198 Participants • Caregiver race analyzed separately from adolescent race.
|
|
Race (NIH/OMB)
Adolescent Race · More than one race
|
8 Participants
n=99 Participants • Caregiver race analyzed separately from adolescent race.
|
8 Participants
n=99 Participants • Caregiver race analyzed separately from adolescent race.
|
16 Participants
n=198 Participants • Caregiver race analyzed separately from adolescent race.
|
|
Race (NIH/OMB)
Adolescent Race · Unknown or Not Reported
|
1 Participants
n=99 Participants • Caregiver race analyzed separately from adolescent race.
|
1 Participants
n=99 Participants • Caregiver race analyzed separately from adolescent race.
|
2 Participants
n=198 Participants • Caregiver race analyzed separately from adolescent race.
|
|
Race (NIH/OMB)
Caregiver Race · American Indian or Alaska Native
|
1 Participants
n=99 Participants • Caregiver race analyzed separately from adolescent race.
|
1 Participants
n=99 Participants • Caregiver race analyzed separately from adolescent race.
|
2 Participants
n=198 Participants • Caregiver race analyzed separately from adolescent race.
|
|
Race (NIH/OMB)
Caregiver Race · Asian
|
3 Participants
n=99 Participants • Caregiver race analyzed separately from adolescent race.
|
6 Participants
n=99 Participants • Caregiver race analyzed separately from adolescent race.
|
9 Participants
n=198 Participants • Caregiver race analyzed separately from adolescent race.
|
|
Race (NIH/OMB)
Caregiver Race · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants • Caregiver race analyzed separately from adolescent race.
|
1 Participants
n=99 Participants • Caregiver race analyzed separately from adolescent race.
|
1 Participants
n=198 Participants • Caregiver race analyzed separately from adolescent race.
|
|
Race (NIH/OMB)
Caregiver Race · Black or African American
|
21 Participants
n=99 Participants • Caregiver race analyzed separately from adolescent race.
|
20 Participants
n=99 Participants • Caregiver race analyzed separately from adolescent race.
|
41 Participants
n=198 Participants • Caregiver race analyzed separately from adolescent race.
|
|
Race (NIH/OMB)
Caregiver Race · White
|
70 Participants
n=99 Participants • Caregiver race analyzed separately from adolescent race.
|
67 Participants
n=99 Participants • Caregiver race analyzed separately from adolescent race.
|
137 Participants
n=198 Participants • Caregiver race analyzed separately from adolescent race.
|
|
Race (NIH/OMB)
Caregiver Race · More than one race
|
2 Participants
n=99 Participants • Caregiver race analyzed separately from adolescent race.
|
3 Participants
n=99 Participants • Caregiver race analyzed separately from adolescent race.
|
5 Participants
n=198 Participants • Caregiver race analyzed separately from adolescent race.
|
|
Race (NIH/OMB)
Caregiver Race · Unknown or Not Reported
|
2 Participants
n=99 Participants • Caregiver race analyzed separately from adolescent race.
|
1 Participants
n=99 Participants • Caregiver race analyzed separately from adolescent race.
|
3 Participants
n=198 Participants • Caregiver race analyzed separately from adolescent race.
|
|
Region of Enrollment
United States
|
99 participants
n=99 Participants • Adolescent region of enrollment
|
99 participants
n=99 Participants • Adolescent region of enrollment
|
198 participants
n=198 Participants • Adolescent region of enrollment
|
|
Diabetes Distress (PAID-T)
|
48.4 score on a scale
STANDARD_DEVIATION 10.3 • n=99 Participants • Diabetes distress was collected from adolescent participants (not caregivers).
|
48.3 score on a scale
STANDARD_DEVIATION 10.7 • n=99 Participants • Diabetes distress was collected from adolescent participants (not caregivers).
|
48.4 score on a scale
STANDARD_DEVIATION 10.5 • n=198 Participants • Diabetes distress was collected from adolescent participants (not caregivers).
|
|
HbA1c
|
9.4 percentage of glycated hemoglobin
STANDARD_DEVIATION 2.0 • n=93 Participants • HbA1c values not available for all adolescent participants due to COVID-related disruptions to clinical care.
|
8.9 percentage of glycated hemoglobin
STANDARD_DEVIATION 2.3 • n=94 Participants • HbA1c values not available for all adolescent participants due to COVID-related disruptions to clinical care.
|
9.1 percentage of glycated hemoglobin
STANDARD_DEVIATION 2.1 • n=187 Participants • HbA1c values not available for all adolescent participants due to COVID-related disruptions to clinical care.
|
PRIMARY outcome
Timeframe: 3 monthsPopulation: 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.
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%.
Outcome measures
| Measure |
Education
n=85 Participants
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.
|
PA + Education
n=89 Participants
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.
|
|---|---|---|
|
Hemoglobin A1c
|
9.0 Percentage of glycated hemoglobin
Standard Deviation 2.0
|
9.0 Percentage of glycated hemoglobin
Standard Deviation 2.4
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: 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.
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.
Outcome measures
| Measure |
Education
n=91 Participants
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.
|
PA + Education
n=87 Participants
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.
|
|---|---|---|
|
Diabetes Distress
|
43 score on a scale
Standard Deviation 16
|
45 score on a scale
Standard Deviation 14
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: 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.
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).
Outcome measures
| Measure |
Education
n=91 Participants
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.
|
PA + Education
n=87 Participants
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.
|
|---|---|---|
|
Primary Control Coping
|
.16 ratio score
Interval 0.14 to 0.18
|
.16 ratio score
Interval 0.13 to 0.18
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: 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.
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).
Outcome measures
| Measure |
Education
n=91 Participants
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.
|
PA + Education
n=87 Participants
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 Control Coping
|
.24 ratio score
Interval 0.2 to 0.27
|
.23 ratio score
Interval 0.21 to 0.26
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: 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.
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).
Outcome measures
| Measure |
Education
n=91 Participants
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.
|
PA + Education
n=87 Participants
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.
|
|---|---|---|
|
Disengagement Coping
|
.16 ratio score
Interval 0.14 to 0.17
|
.16 ratio score
Interval 0.14 to 0.18
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: 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.
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.
Outcome measures
| Measure |
Education
n=91 Participants
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.
|
PA + Education
n=87 Participants
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.
|
|---|---|---|
|
Positive Affect
|
41 score on a scale
Standard Deviation 11
|
44 score on a scale
Standard Deviation 11
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: Data were not collected from all participants at the 3-month time point due to COVID-related disruptions to diabetes clinic.
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.
Outcome measures
| Measure |
Education
n=91 Participants
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.
|
PA + Education
n=87 Participants
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.
|
|---|---|---|
|
Diabetes Self-Care Behavior
|
3.74 score on a scale
Standard Deviation 0.65
|
3.72 score on a scale
Standard Deviation 0.68
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: 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.
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.
Outcome measures
| Measure |
Education
n=91 Participants
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.
|
PA + Education
n=87 Participants
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.
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|---|---|---|
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Diabetes-Related Quality of Life
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52 score on a scale
Standard Deviation 14
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52 score on a scale
Standard Deviation 14
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Adverse Events
Education
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
PA + Education
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place