Type 1 Diabetes
Conditions
Brief summary
The Insul-In This Together intervention is designed for teens with Type 1 Diabetes and their parents. This study seeks to evaluate an evidence-based family intervention for teens with type 1 diabetes and their parents to offset the psychosocial and diabetes self-management risks. This information will provide a more in-depth understanding of family-based program efficacy for teens with adolescents and provide more judicious and streamlined intervention options to be offered in diabetes clinics in the future.
Detailed description
This study will collect survey and biomedical data to assess this program in a randomized controlled trial with 165 families (including an adolescent and parent/caregiver) will be enrolled, complete surveys, provide biomedical data via continuous glucose monitors and receive a 6-week psychosocial intervention. The results of this study will inform future intervention redesign to provide more judicious interventions to be disseminated across diabetes care.This study will evaluate the relative efficacy of each of the individual intervention components and also identify the mechanisms of actions (mediators) that are most impacted by these types of interventions as well as most linked to long-term outcomes for adolescents.
Interventions
BEHAVIORALInsul-In This Together
Session 1: Introduction to Parental Monitoring Session 2: Advanced Parental Monitoring Session 3: Introduction to Parental Involvement Session 4: Advanced Parental Involvement Session 5: Introduction to Parent-Teen Conflict Management Session 6: Advanced Parent-Teen Conflict Management
Sponsors
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Stanford University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
Randomization to either the intervention group (receives program immediately) or a waitlisted control condition (receives the intervention 6 months later).
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Teen subject has a type 1 diabetes (T1D) diagnosis according to ADA criteria for at least 6 months 2. Teen subject is age 12-19 years at time of screening (no age limit for parent participants) 3. Participation of at least one cohabitating parent/caregiver.
Exclusion criteria
1. Subject lacks access to a smartphone or Wi-Fi via computer 2. Subject has restricted or no English proficiency 3. Subject has a pervasive developmental, cognitive, or psychiatric limitations that compromise participation in study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Glucose Levels Percent Time in Target Range Based on Glucose Monitoring | Average percent time in range based on two weeks of glucose monitoring data at baseline, 3-month, and 6-month follow-up (plus or minus 2 weeks around target data collection date) | Adolescent glucose levels percent time in target range (70-180 mg/dL) based on glucose monitoring to measure glycemic control. The clinical recommendation is a percent time-in-range of 70% or more. |
| Adolescent Quality of Life | Baseline, 3-month follow-up, and 6-month follow-up. | Self-report via Type 1 Diabetes and Life (T1DAL) surveys for adolescents to measure the adolescent's quality of life. Possible score range is 0-100 and the higher scores indicated better quality of life. Adolescent quality of life was measured for adolescents only (not parents). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adolescent Diabetes Distress | Baseline, 3-month follow-up, and 6-month follow-up | Measured by the Problem Areas In Diabetes (PAID) survey of diabetes distress, which includes 14 items that were summed to create a total score with a possible total score range of 14-84. Item response options range from 1 (not a problem) to 6 (serious problem). Higher scores indicate more diabetes distress. |
| Parent Diabetes Distress | Baseline, 3-month follow-up, and 6-month follow-up. | Measured by the Problem Areas In Diabetes (PAID) survey of diabetes distress, which includes 15 items that were summed into a total score with a possible total score range of 15-90. Higher scores indicate more diabetes distress. Response options ranged from 1 (not a problem) to 6 (serious problem). |
| Adolescent Depression | Baseline, 3-month follow-up, and 6-month follow-up. | Surveys of self-report via Children's Depression Inventory - short version (CDI:S80), a 10 scale item, will be used to assess adolescent depression. Possible total score range is 0-20 with higher scores indicated more severe depressive symptoms. Item response options included 0 = Not at all, 1 = Somewhat, and 2 = A lot. Total score was the sum of all item scores. |
| Hemoglobin A1c (HbA1c) | Baseline and 6-month follow-up | Medical record data on glycated hemoglobin in blood reported as National Glycohemoglobin Standardization Program (NGSP) percentage. The clinical recommendation for pediatrics is below 7.5%. |
| Parenting Stress | Baseline, 3-month follow-up, and 6-month follow-up | Surveys of self-report on parenting stress via The Parenting Stress Scale. Includes 18 items that were summed into a total score with a possible total score range from 18-90. Higher scores indicate more parenting stress. Item responses included 1 = strongly agree, 2 = agree, 3 = not sure, 4 = disagree, and 5 = strongly disagree. |
| Parent Depression | Baseline, 3-month follow-up, and 6-month follow-up. | Surveys of self-report via the Patient Health Questionnaire (PHQ-8) - 8 item scale to assess depression among parents. Response options for each item included 0 = not at all, 1 = several days, 2 = more than half the days, and 3 = nearly every day. Items were summed into a total score. The possible total score range is 0-24 and higher scores indicate more depressive symptoms. |
Countries
United States
Participant flow
Recruitment details
Enrollment was of adolescent/parent dyads, both had to sign informed consent for either of them to enroll, and they received the study intervention together.
Pre-assignment details
366 participants signed informed consent (representing 183 parent-adolescent dyads); 314 participants were randomized to a study arm (representing 157 adolescent-parent dyads).
Participants by arm
| Arm | Count |
|---|---|
| Intervention Group - Adolescents Group assignment and intervention delivery was based on parent-adolescent dyads. The intervention group were offered the The Insul-In This Together intervention beginning immediately after baseline data collection. The intervention consists of 6 weekly 30-minute online family sessions to discuss topics related to diabetes distress and parent-teen communication, with follow-up visits through 12 months after randomization. | 79 |
| Intervention Group - Parents Group assignment and intervention delivery was based on parent-adolescent dyads. The intervention group were offered the The Insul-In This Together intervention beginning immediately after baseline data collection. The intervention consists of 6 weekly 30-minute online family sessions to discuss topics related to diabetes distress and parent-teen communication, with follow-up visits through 12 months after randomization. | 79 |
| Waitlisted Control Group - Adolescents Group assignment and intervention delivery was based on parent-adolescent dyads. The waitlisted control group were offered the same intervention as the intervention group, beginning after 6-month data collection completion. The intervention consists of 6 weekly 30-minute online family sessions to discuss topics related to diabetes distress and parent-teen communication, with follow-up visits through 12 months after randomization. | 78 |
| Waitlisted Control Group - Parents Group assignment and intervention delivery was based on parent-adolescent dyads. The waitlisted control group were offered the same intervention as the intervention group, beginning after 6-month data collection completion. The intervention consists of 6 weekly 30-minute online family sessions to discuss topics related to diabetes distress and parent-teen communication, with follow-up visits through 12 months after randomization. | 78 |
| Total | 314 |
Baseline characteristics
| Characteristic | Total | Waitlisted Control Group - Parents | Intervention Group - Adolescents | Waitlisted Control Group - Adolescents | Intervention Group - Parents |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 145 Participants | 0 Participants | 73 Participants | 72 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 169 Participants | 78 Participants | 6 Participants | 6 Participants | 79 Participants |
| Race/Ethnicity, Customized Asian/Pacific Islander | 15 Participants | 7 Participants | 2 Participants | 2 Participants | 4 Participants |
| Race/Ethnicity, Customized Black | 8 Participants | 2 Participants | 2 Participants | 3 Participants | 1 Participants |
| Race/Ethnicity, Customized Hispanic white | 12 Participants | 3 Participants | 5 Participants | 1 Participants | 3 Participants |
| Race/Ethnicity, Customized More than once race | 15 Participants | 0 Participants | 7 Participants | 7 Participants | 1 Participants |
| Race/Ethnicity, Customized Native American | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Non-Hispanic white | 253 Participants | 65 Participants | 61 Participants | 61 Participants | 66 Participants |
| Race/Ethnicity, Customized Undisclosed | 10 Participants | 1 Participants | 2 Participants | 4 Participants | 3 Participants |
| Region of Enrollment United States | 314 Participants | 78 Participants | 79 Participants | 78 Participants | 79 Participants |
| Sex/Gender, Customized Female | 212 Participants | 68 Participants | 32 Participants | 40 Participants | 72 Participants |
| Sex/Gender, Customized Male | 95 Participants | 9 Participants | 45 Participants | 34 Participants | 7 Participants |
| Sex/Gender, Customized Non-binary | 3 Participants | 1 Participants | 1 Participants | 1 Participants | 0 Participants |
| Sex/Gender, Customized Undisclosed | 4 Participants | 0 Participants | 1 Participants | 3 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 79 | 0 / 79 | 0 / 78 | 0 / 78 | 0 / 78 | 0 / 78 |
| other Total, other adverse events | 0 / 79 | 0 / 79 | 0 / 78 | 0 / 78 | 0 / 78 | 0 / 78 |
| serious Total, serious adverse events | 0 / 79 | 0 / 79 | 0 / 78 | 0 / 78 | 0 / 78 | 0 / 78 |
Outcome results
Primary
Adolescent Quality of Life
Self-report via Type 1 Diabetes and Life (T1DAL) surveys for adolescents to measure the adolescent's quality of life. Possible score range is 0-100 and the higher scores indicated better quality of life. Adolescent quality of life was measured for adolescents only (not parents).
Time frame: Baseline, 3-month follow-up, and 6-month follow-up.
Population: Enrolled adolescents; data for this outcome were not collected from parents
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention Group | Adolescent Quality of Life | Baseline | 67.902 score on a scale | Standard Deviation 13.92 |
| Intervention Group | Adolescent Quality of Life | 3-month | 67.965 score on a scale | Standard Deviation 14.47 |
| Intervention Group | Adolescent Quality of Life | 6-month | 69.523 score on a scale | Standard Deviation 14.63 |
| Waitlisted Control Group | Adolescent Quality of Life | Baseline | 64.633 score on a scale | Standard Deviation 15.38 |
| Waitlisted Control Group | Adolescent Quality of Life | 3-month | 63.675 score on a scale | Standard Deviation 16.39 |
| Waitlisted Control Group | Adolescent Quality of Life | 6-month | 65.511 score on a scale | Standard Deviation 16.16 |
Comparison: Analysis at 3-month follow-up.p-value: 0.16t-test, 2 sided
Comparison: Analysis at 6-month follow-up.p-value: 0.275t-test, 2 sided
Primary
Glucose Levels Percent Time in Target Range Based on Glucose Monitoring
Adolescent glucose levels percent time in target range (70-180 mg/dL) based on glucose monitoring to measure glycemic control. The clinical recommendation is a percent time-in-range of 70% or more.
Time frame: Average percent time in range based on two weeks of glucose monitoring data at baseline, 3-month, and 6-month follow-up (plus or minus 2 weeks around target data collection date)
Population: Enrolled adolescents; data for this outcome were not collected from parents
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention Group | Glucose Levels Percent Time in Target Range Based on Glucose Monitoring | Baseline | 61.185 percentage of time-in-range | Standard Deviation 18.42 |
| Intervention Group | Glucose Levels Percent Time in Target Range Based on Glucose Monitoring | 3 months | 62.223 percentage of time-in-range | Standard Deviation 18.57 |
| Intervention Group | Glucose Levels Percent Time in Target Range Based on Glucose Monitoring | 6 months | 61.680 percentage of time-in-range | Standard Deviation 18.91 |
| Waitlisted Control Group | Glucose Levels Percent Time in Target Range Based on Glucose Monitoring | Baseline | 64.542 percentage of time-in-range | Standard Deviation 17.74 |
| Waitlisted Control Group | Glucose Levels Percent Time in Target Range Based on Glucose Monitoring | 3 months | 64.571 percentage of time-in-range | Standard Deviation 18.21 |
| Waitlisted Control Group | Glucose Levels Percent Time in Target Range Based on Glucose Monitoring | 6 months | 65.908 percentage of time-in-range | Standard Deviation 17.82 |
Comparison: Analysis at 3 months.p-value: 0.777t-test, 2 sided
Comparison: Analysis at 6-month.p-value: 0.247t-test, 2 sided
Secondary
Adolescent Depression
Surveys of self-report via Children's Depression Inventory - short version (CDI:S80), a 10 scale item, will be used to assess adolescent depression. Possible total score range is 0-20 with higher scores indicated more severe depressive symptoms. Item response options included 0 = Not at all, 1 = Somewhat, and 2 = A lot. Total score was the sum of all item scores.
Time frame: Baseline, 3-month follow-up, and 6-month follow-up.
Population: Enrolled adolescents; data for this outcome were not collected from parents
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention Group | Adolescent Depression | Baseline | 2.278 score on a scale | Standard Deviation 3.56 |
| Intervention Group | Adolescent Depression | 3-month follow-up | 2.411 score on a scale | Standard Deviation 4.27 |
| Intervention Group | Adolescent Depression | 6-month follow-up | 2.419 score on a scale | Standard Deviation 4.01 |
| Waitlisted Control Group | Adolescent Depression | Baseline | 2.718 score on a scale | Standard Deviation 3.63 |
| Waitlisted Control Group | Adolescent Depression | 3-month follow-up | 3.130 score on a scale | Standard Deviation 3.91 |
| Waitlisted Control Group | Adolescent Depression | 6-month follow-up | 2.963 score on a scale | Standard Deviation 3.96 |
Comparison: Analysis at 3-month follow-up.p-value: 0.509t-test, 2 sided
Comparison: Analysis at 6-month follow-up.p-value: 0.61t-test, 2 sided
Secondary
Adolescent Diabetes Distress
Measured by the Problem Areas In Diabetes (PAID) survey of diabetes distress, which includes 14 items that were summed to create a total score with a possible total score range of 14-84. Item response options range from 1 (not a problem) to 6 (serious problem). Higher scores indicate more diabetes distress.
Time frame: Baseline, 3-month follow-up, and 6-month follow-up
Population: Enrolled adolescents; data for this outcome were not collected from parents
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention Group | Adolescent Diabetes Distress | Baseline | 28.608 score on a scale | Standard Deviation 12.68 |
| Intervention Group | Adolescent Diabetes Distress | 3-month follow-up | 27.847 score on a scale | Standard Deviation 13.07 |
| Intervention Group | Adolescent Diabetes Distress | 6-month follow-up | 27.883 score on a scale | Standard Deviation 11.97 |
| Waitlisted Control Group | Adolescent Diabetes Distress | Baseline | 32.064 score on a scale | Standard Deviation 14.98 |
| Waitlisted Control Group | Adolescent Diabetes Distress | 3-month follow-up | 32.219 score on a scale | Standard Deviation 16.39 |
| Waitlisted Control Group | Adolescent Diabetes Distress | 6-month follow-up | 30.265 score on a scale | Standard Deviation 16.16 |
Comparison: Analysis at 3-month follow-up.p-value: 0.076t-test, 2 sided
Comparison: Analysis at 6-month follow-up.p-value: 0.747t-test, 2 sided
Secondary
Hemoglobin A1c (HbA1c)
Medical record data on glycated hemoglobin in blood reported as National Glycohemoglobin Standardization Program (NGSP) percentage. The clinical recommendation for pediatrics is below 7.5%.
Time frame: Baseline and 6-month follow-up
Population: Enrolled adolescents with available data; data for this outcome were not collected from parents
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention Group | Hemoglobin A1c (HbA1c) | Baseline | 7.166 percentage of glycated hemoglobin | Standard Deviation 1.2 |
| Intervention Group | Hemoglobin A1c (HbA1c) | 6-month follow-up | 7.260 percentage of glycated hemoglobin | Standard Deviation 1.38 |
| Waitlisted Control Group | Hemoglobin A1c (HbA1c) | Baseline | 7.19 percentage of glycated hemoglobin | Standard Deviation 1.42 |
| Waitlisted Control Group | Hemoglobin A1c (HbA1c) | 6-month follow-up | 7.069 percentage of glycated hemoglobin | Standard Deviation 1.29 |
Comparison: Analysis at 6-month follow-up.p-value: 0.157t-test, 2 sided
Secondary
Parent Depression
Surveys of self-report via the Patient Health Questionnaire (PHQ-8) - 8 item scale to assess depression among parents. Response options for each item included 0 = not at all, 1 = several days, 2 = more than half the days, and 3 = nearly every day. Items were summed into a total score. The possible total score range is 0-24 and higher scores indicate more depressive symptoms.
Time frame: Baseline, 3-month follow-up, and 6-month follow-up.
Population: Enrolled parents; data for this outcome were not collected from adolescents
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention Group | Parent Depression | Baseline | 4.772 score on a scale | Standard Deviation 4.82 |
| Intervention Group | Parent Depression | 3-month follow-up | 4.099 score on a scale | Standard Deviation 4.02 |
| Intervention Group | Parent Depression | 6-month follow-up | 4.088 score on a scale | Standard Deviation 4.56 |
| Waitlisted Control Group | Parent Depression | Baseline | 5.167 score on a scale | Standard Deviation 5.25 |
| Waitlisted Control Group | Parent Depression | 3-month follow-up | 4.346 score on a scale | Standard Deviation 4.81 |
| Waitlisted Control Group | Parent Depression | 6-month follow-up | 4.409 score on a scale | Standard Deviation 4.43 |
Comparison: Analysis at 3-month follow-up.p-value: 0.807t-test, 2 sided
Comparison: Analysis at 6-month follow-up.p-value: 0.826t-test, 2 sided
Secondary
Parent Diabetes Distress
Measured by the Problem Areas In Diabetes (PAID) survey of diabetes distress, which includes 15 items that were summed into a total score with a possible total score range of 15-90. Higher scores indicate more diabetes distress. Response options ranged from 1 (not a problem) to 6 (serious problem).
Time frame: Baseline, 3-month follow-up, and 6-month follow-up.
Population: Enrolled parents; data for this outcome were not collected from adolescents
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention Group | Parent Diabetes Distress | Baseline | 43.177 score on a scale | Standard Deviation 17.32 |
| Intervention Group | Parent Diabetes Distress | 3-month follow-up | 36.405 score on a scale | Standard Deviation 14.27 |
| Intervention Group | Parent Diabetes Distress | 6-month follow-up | 36.393 score on a scale | Standard Deviation 14.39 |
| Waitlisted Control Group | Parent Diabetes Distress | Baseline | 44.859 score on a scale | Standard Deviation 17.81 |
| Waitlisted Control Group | Parent Diabetes Distress | 3-month follow-up | 38.817 score on a scale | Standard Deviation 16.22 |
| Waitlisted Control Group | Parent Diabetes Distress | 6-month follow-up | 40.542 score on a scale | Standard Deviation 18.09 |
Comparison: Analysis at 3-month follow-up.p-value: 0.154t-test, 2 sided
Comparison: Analysis at 6-month follow-up.p-value: 0.107t-test, 2 sided
Secondary
Parenting Stress
Surveys of self-report on parenting stress via The Parenting Stress Scale. Includes 18 items that were summed into a total score with a possible total score range from 18-90. Higher scores indicate more parenting stress. Item responses included 1 = strongly agree, 2 = agree, 3 = not sure, 4 = disagree, and 5 = strongly disagree.
Time frame: Baseline, 3-month follow-up, and 6-month follow-up
Population: Enrolled parents; data for this outcome were not collected from adolescents
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention Group | Parenting Stress | Baseline | 73.633 score on a scale | Standard Deviation 9.73 |
| Intervention Group | Parenting Stress | 3-month follow-up | 74.706 score on a scale | Standard Deviation 9.16 |
| Intervention Group | Parenting Stress | 6-month follow-up | 74.376 score on a scale | Standard Deviation 9.73 |
| Waitlisted Control Group | Parenting Stress | Baseline | 71.256 score on a scale | Standard Deviation 10.88 |
| Waitlisted Control Group | Parenting Stress | 3-month follow-up | 71.777 score on a scale | Standard Deviation 12.25 |
| Waitlisted Control Group | Parenting Stress | 6-month follow-up | 71.865 score on a scale | Standard Deviation 10.93 |
Comparison: Analysis at 3-month follow-up.p-value: 0.445t-test, 2 sided
Comparison: Analysis at 6-month follow-up.p-value: 0.543t-test, 2 sided