Trial Outcomes & Findings for Check It! 2.0: Positive Psychology Intervention for Adolescents With Type 1 Diabetes (NCT NCT02984709)
NCT ID: NCT02984709
Last Updated: 2019-04-24
Results Overview
A1C is the percentage of glycosylated hemoglobin and represents an average of glycemic control over the previous 2-3 months.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
48 participants
Primary outcome timeframe
3 months
Results posted on
2019-04-24
Participant Flow
Participant milestones
| Measure |
Experimental: Positive Psychology Intervention
Adolescents randomized to the positive psychology group will receive the intervention components via text message. They will be instructed to think about things that make them feel good when they are struggling with diabetes management (i.e. gratitude). Also they will be instructed to think about a positive value when they are in a situation that makes it hard to check their blood sugar (i.e. 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. All adolescents will be given developmentally-appropriate diabetes education material at the time of enrollment.
|
Active Comparator: Education Group
Adolescents randomized to the education group will be given developmentally appropriate diabetes education material at the time of enrollment.
|
|---|---|---|
|
Overall Study
STARTED
|
24
|
24
|
|
Overall Study
COMPLETED
|
24
|
24
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Check It! 2.0: Positive Psychology Intervention for Adolescents With Type 1 Diabetes
Baseline characteristics by cohort
| Measure |
Experimental: Positive Psychology Intervention
n=24 Participants
The text message group will receive the intervention components via text message. They will be instructed to think about things that make them feel good when they are struggling with diabetes management (i.e. gratitude). Also they will be instructed to think about a positive value when they are in a situation that makes it hard to check their blood sugar (i.e. SelfAffirmation). 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. All adolescents will be given developmentally-appropriate diabetes education material at the time of enrollment.
|
Active Comparator: Education Group
n=24 Participants
The education group will be given developmentally appropriate diabetes education material at the time of enrollment.
|
Total
n=48 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
24 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
15.0 years
STANDARD_DEVIATION 1.3 • n=5 Participants
|
14.4 years
STANDARD_DEVIATION 1.2 • n=7 Participants
|
14.7 years
STANDARD_DEVIATION 1.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
22 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
24 participants
n=5 Participants
|
24 participants
n=7 Participants
|
48 participants
n=5 Participants
|
|
Glycemic Control (A1C)
|
8.60 percentage of glycosylated hemoglobin
STANDARD_DEVIATION 0.86 • n=5 Participants
|
9.00 percentage of glycosylated hemoglobin
STANDARD_DEVIATION 1.07 • n=7 Participants
|
8.81 percentage of glycosylated hemoglobin
STANDARD_DEVIATION 0.99 • n=5 Participants
|
|
Positive Affect
|
40.3 score on a scale
STANDARD_DEVIATION 7.9 • n=5 Participants
|
41.2 score on a scale
STANDARD_DEVIATION 9.0 • n=7 Participants
|
40.8 score on a scale
STANDARD_DEVIATION 8.4 • n=5 Participants
|
|
Frequency of Blood Glucose Monitoring
|
3.5 number of blood glucose checks
STANDARD_DEVIATION 1.4 • n=5 Participants
|
3.2 number of blood glucose checks
STANDARD_DEVIATION 1.4 • n=7 Participants
|
3.2 number of blood glucose checks
STANDARD_DEVIATION 1.4 • n=5 Participants
|
|
Diabetes Family Conflict Scale
Parent
|
24.1 score on a scale
STANDARD_DEVIATION 4.3 • n=5 Participants
|
30 score on a scale
STANDARD_DEVIATION 9.1 • n=7 Participants
|
27.2 score on a scale
STANDARD_DEVIATION 7.8 • n=5 Participants
|
|
Diabetes Family Conflict Scale
Teen
|
30 score on a scale
STANDARD_DEVIATION 12 • n=5 Participants
|
33 score on a scale
STANDARD_DEVIATION 12 • n=7 Participants
|
32 score on a scale
STANDARD_DEVIATION 12 • n=5 Participants
|
|
Quality of Life
|
70 score on a scale
STANDARD_DEVIATION 13 • n=5 Participants
|
72 score on a scale
STANDARD_DEVIATION 11 • n=7 Participants
|
71 score on a scale
STANDARD_DEVIATION 12 • n=5 Participants
|
|
Primary Control Coping
|
.17 ratio score
STANDARD_DEVIATION .04 • n=5 Participants
|
.18 ratio score
STANDARD_DEVIATION .04 • n=7 Participants
|
.18 ratio score
STANDARD_DEVIATION .04 • n=5 Participants
|
|
Secondary Control Coping
|
.26 ratio score
STANDARD_DEVIATION .05 • n=5 Participants
|
.27 ratio score
STANDARD_DEVIATION .05 • n=7 Participants
|
.27 ratio score
STANDARD_DEVIATION .05 • n=5 Participants
|
|
Disengagement Coping
|
.15 ratio score
STANDARD_DEVIATION .03 • n=5 Participants
|
.15 ratio score
STANDARD_DEVIATION .03 • n=7 Participants
|
.15 ratio score
STANDARD_DEVIATION .03 • n=5 Participants
|
|
Self Care Inventory
Parent
|
24.8 score on a scale
STANDARD_DEVIATION 4.2 • n=5 Participants
|
24.5 score on a scale
STANDARD_DEVIATION 4.6 • n=7 Participants
|
24.7 score on a scale
STANDARD_DEVIATION 4.4 • n=5 Participants
|
|
Self Care Inventory
Teen
|
24.8 score on a scale
STANDARD_DEVIATION 5.2 • n=5 Participants
|
25.0 score on a scale
STANDARD_DEVIATION 5.1 • n=7 Participants
|
24.9 score on a scale
STANDARD_DEVIATION 5.1 • n=5 Participants
|
PRIMARY outcome
Timeframe: 3 monthsPopulation: One participant in the Active Comparator group did not return for a clinic visit and therefore did not have an A1C value at follow-up.
A1C is the percentage of glycosylated hemoglobin and represents an average of glycemic control over the previous 2-3 months.
Outcome measures
| Measure |
Experimental: Positive Psychology Intervention
n=24 Participants
The text message group will receive the intervention components via text message. They will be instructed to think about things that make them feel good when they are struggling with diabetes management (i.e. gratitude). Also they will be instructed to think about a positive value when they are in a situation that makes it hard to check their blood sugar (i.e. SelfAffirmation). 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. All adolescents will be given developmentally-appropriate diabetes education material at the time of enrollment.
|
Active Comparator: Education Group
n=23 Participants
The education group will be given developmentally appropriate diabetes education material at the time of enrollment.
|
|---|---|---|
|
Glycemic Control (A1C)
|
8.60 percentage of glycosylated hemoglobin
Standard Deviation 1.49
|
9.35 percentage of glycosylated hemoglobin
Standard Deviation 1.39
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: One teen participant in the Experimental group did not complete follow-up survey data.
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 |
Experimental: Positive Psychology Intervention
n=23 Participants
The text message group will receive the intervention components via text message. They will be instructed to think about things that make them feel good when they are struggling with diabetes management (i.e. gratitude). Also they will be instructed to think about a positive value when they are in a situation that makes it hard to check their blood sugar (i.e. SelfAffirmation). 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. All adolescents will be given developmentally-appropriate diabetes education material at the time of enrollment.
|
Active Comparator: Education Group
n=24 Participants
The education group will be given developmentally appropriate diabetes education material at the time of enrollment.
|
|---|---|---|
|
Positive Affect
|
40.6 score on a scale
Standard Deviation 7.1
|
42.8 score on a scale
Standard Deviation 9.2
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SECONDARY outcome
Timeframe: 3 monthsPopulation: Three participants in the Experimental group and five participants in the Active Comparator group did not bring their glucometers to clinic visits and therefore frequency of blood glucose monitoring could not be obtained.
Glucometer download to determine frequency of blood glucose checks per day. Higher numbers indicates more frequent blood glucose checks.
Outcome measures
| Measure |
Experimental: Positive Psychology Intervention
n=21 Participants
The text message group will receive the intervention components via text message. They will be instructed to think about things that make them feel good when they are struggling with diabetes management (i.e. gratitude). Also they will be instructed to think about a positive value when they are in a situation that makes it hard to check their blood sugar (i.e. SelfAffirmation). 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. All adolescents will be given developmentally-appropriate diabetes education material at the time of enrollment.
|
Active Comparator: Education Group
n=19 Participants
The education group will be given developmentally appropriate diabetes education material at the time of enrollment.
|
|---|---|---|
|
Frequency of Blood Glucose Monitoring
|
3.8 blood glucose checks per day
Standard Deviation 1.3
|
3.2 blood glucose checks per day
Standard Deviation 1.5
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: One teen participant in the Experimental group did not complete follow-up survey data. All parents completed the follow-up surveys.
Diabetes-specific family conflict was measured with the Revised Diabetes Family Conflict Scale (DRCS), which consists of 19 items regarding how much adolescents and parents argue about diabetes management tasks. Scores range from 19 to 57, and higher scores indicate greater family conflict.
Outcome measures
| Measure |
Experimental: Positive Psychology Intervention
n=24 Participants
The text message group will receive the intervention components via text message. They will be instructed to think about things that make them feel good when they are struggling with diabetes management (i.e. gratitude). Also they will be instructed to think about a positive value when they are in a situation that makes it hard to check their blood sugar (i.e. SelfAffirmation). 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. All adolescents will be given developmentally-appropriate diabetes education material at the time of enrollment.
|
Active Comparator: Education Group
n=24 Participants
The education group will be given developmentally appropriate diabetes education material at the time of enrollment.
|
|---|---|---|
|
Diabetes Family Conflict Scale
Diabetes Family Conflict - Teen
|
30 score on a scale
Standard Deviation 12
|
36 score on a scale
Standard Deviation 12
|
|
Diabetes Family Conflict Scale
Diabetes Family Conflict - Parent
|
23.8 score on a scale
Standard Deviation 5.7
|
30.4 score on a scale
Standard Deviation 9.6
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: One teen participant in the Experimental group did not complete follow-up survey data.
Pediatric Quality of Life Diabetes-Specific Module (PedsQL) measures quality of life. A mean scaled score is calculated, ranging from 0-100, with higher values indicating better quality of life.
Outcome measures
| Measure |
Experimental: Positive Psychology Intervention
n=23 Participants
The text message group will receive the intervention components via text message. They will be instructed to think about things that make them feel good when they are struggling with diabetes management (i.e. gratitude). Also they will be instructed to think about a positive value when they are in a situation that makes it hard to check their blood sugar (i.e. SelfAffirmation). 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. All adolescents will be given developmentally-appropriate diabetes education material at the time of enrollment.
|
Active Comparator: Education Group
n=24 Participants
The education group will be given developmentally appropriate diabetes education material at the time of enrollment.
|
|---|---|---|
|
Diabetes-Specific Quality of Life
|
71 score on a scale
Standard Deviation 14
|
71 score on a scale
Standard Deviation 11
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: One teen participant in the Experimental group did not complete follow-up survey data.
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 |
Experimental: Positive Psychology Intervention
n=23 Participants
The text message group will receive the intervention components via text message. They will be instructed to think about things that make them feel good when they are struggling with diabetes management (i.e. gratitude). Also they will be instructed to think about a positive value when they are in a situation that makes it hard to check their blood sugar (i.e. SelfAffirmation). 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. All adolescents will be given developmentally-appropriate diabetes education material at the time of enrollment.
|
Active Comparator: Education Group
n=24 Participants
The education group will be given developmentally appropriate diabetes education material at the time of enrollment.
|
|---|---|---|
|
Primary Control Coping
|
.18 ratio score
Standard Deviation .03
|
.20 ratio score
Standard Deviation .04
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: One teen participant in the Experimental group did not complete follow-up survey data.
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 |
Experimental: Positive Psychology Intervention
n=23 Participants
The text message group will receive the intervention components via text message. They will be instructed to think about things that make them feel good when they are struggling with diabetes management (i.e. gratitude). Also they will be instructed to think about a positive value when they are in a situation that makes it hard to check their blood sugar (i.e. SelfAffirmation). 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. All adolescents will be given developmentally-appropriate diabetes education material at the time of enrollment.
|
Active Comparator: Education Group
n=24 Participants
The education group will be given developmentally appropriate diabetes education material at the time of enrollment.
|
|---|---|---|
|
Secondary Control Coping
|
.27 ratio score
Standard Deviation .05
|
.28 ratio score
Standard Deviation .04
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: One teen participant in the Experimental group did not complete follow-up survey data.
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 control coping (e.g., avoidance, denial).
Outcome measures
| Measure |
Experimental: Positive Psychology Intervention
n=23 Participants
The text message group will receive the intervention components via text message. They will be instructed to think about things that make them feel good when they are struggling with diabetes management (i.e. gratitude). Also they will be instructed to think about a positive value when they are in a situation that makes it hard to check their blood sugar (i.e. SelfAffirmation). 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. All adolescents will be given developmentally-appropriate diabetes education material at the time of enrollment.
|
Active Comparator: Education Group
n=24 Participants
The education group will be given developmentally appropriate diabetes education material at the time of enrollment.
|
|---|---|---|
|
Disengagement Coping
|
.14 ratio score
Standard Deviation .03
|
.14 ratio score
Standard Deviation .03
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: One teen participant in the Experimental group did not complete follow-up survey data. All parents completed the follow-up surveys.
The Self Care Inventory measures adherence to the recommended diabetes treatment regimen. Adolescents and parents report on the adolescents' self-care behaviors. Items are summed for a total score, ranging from 7-35. Higher scores indicate higher levels of adherence.
Outcome measures
| Measure |
Experimental: Positive Psychology Intervention
n=23 Participants
The text message group will receive the intervention components via text message. They will be instructed to think about things that make them feel good when they are struggling with diabetes management (i.e. gratitude). Also they will be instructed to think about a positive value when they are in a situation that makes it hard to check their blood sugar (i.e. SelfAffirmation). 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. All adolescents will be given developmentally-appropriate diabetes education material at the time of enrollment.
|
Active Comparator: Education Group
n=24 Participants
The education group will be given developmentally appropriate diabetes education material at the time of enrollment.
|
|---|---|---|
|
Self Care Inventory
Self Care Inventory - Parent
|
26.6 score on a scale
Standard Deviation 3.9
|
25.9 score on a scale
Standard Deviation 5.2
|
|
Self Care Inventory
Self Care Inventory - Teen
|
25.2 score on a scale
Standard Deviation 5.1
|
26.0 score on a scale
Standard Deviation 5.3
|
Adverse Events
Experimental: Positive Psychology Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Active Comparator: Education Group
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