An interventional study of Insul-In This Together in Type 1 Diabetes, sponsored by Stanford University. Completed at 1 site in United States. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2025-05-15.
Sponsored by Stanford University · Not applicable, Interventional, and Prevention
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.
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.
10,923 studies on the registry are indexed under Diabetes Mellitus; 1,318 are open to participants now.
This study's enrollment of 366 is above the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →Stanford University is the lead sponsor of 2,117 studies on the registry; 425 are open to participants now.
Of its 259 completed or terminated interventional studies of FDA-regulated products, 197 (76%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
The intervention group will participated in the The Insul-In This Together intervention, which consists of 6 weekly 30-minute online family sessions to discuss topics related to diabetes distress and parent-teen communication. Sessions include structured education, discussions, and skill-building activities related to parental involvement, parental monitoring, and parent-adolescent conflict. The intervention will be conducted by the PI or clinically trained research staff via Zoom. Online surveys, and glucose monitoring data will be captured at baseline and 3,6 and 12-month follow-ups. Brief surveys will also be conducted at 2-, 4-, and 6-week follow-ups (after every 2 sessions for the intervention group and later the control group). Participants will be asked to provide A1C test results that will be collected via chart review or from participants sharing their test results at baseline, 6-month, and 12-month follow-up.
Behavioral: Insul-In This Together
The waitlisted control group will receive the same intervention as the intervention group, but at the 6-month follow-up mark. The intervention will be conducted by the PI or clinically trained research staff via Zoom. Online surveys, and glucose monitoring data will be captured at baseline and 3,6 and 12-month follow-ups. Brief surveys will also be conducted at 2-, 4-, and 6-week from baseline. Participants will be asked to provide A1C test results that will be collected via chart review or from participants sharing their test results at baseline, 6-month, and 12-month follow-up.
Behavioral: Insul-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
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)
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.
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.
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.
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
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.
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
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
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.
| Milestone | Intervention Group - Adolescents | Intervention Group - Parents | Waitlisted Control Group - Adolescents | Waitlisted Control Group - Parents |
|---|---|---|---|---|
| Started | 79 | 79 | 78 | 78 |
| Completed | 68 | 68 | 61 | 61 |
| Not completed | 11 | 11 | 17 | 17 |
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.
| percentage of time-in-range | Intervention Group | Waitlisted Control Group |
|---|---|---|
| Baseline | 61.185 ± 18.42 | 64.542 ± 17.74 |
| 3 months | 62.223 ± 18.57 | 64.571 ± 18.21 |
| 6 months | 61.680 ± 18.91 | 65.908 ± 17.82 |
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).
| score on a scale | Intervention Group | Waitlisted Control Group |
|---|---|---|
| Baseline | 67.902 ± 13.92 | 64.633 ± 15.38 |
| 3-month | 67.965 ± 14.47 | 63.675 ± 16.39 |
| 6-month | 69.523 ± 14.63 | 65.511 ± 16.16 |
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.
| score on a scale | Intervention Group | Waitlisted Control Group |
|---|---|---|
| Baseline | 2.278 ± 3.56 | 2.718 ± 3.63 |
| 3-month follow-up | 2.411 ± 4.27 | 3.130 ± 3.91 |
| 6-month follow-up | 2.419 ± 4.01 | 2.963 ± 3.96 |
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.
| score on a scale | Intervention Group | Waitlisted Control Group |
|---|---|---|
| Baseline | 4.772 ± 4.82 | 5.167 ± 5.25 |
| 3-month follow-up | 4.099 ± 4.02 | 4.346 ± 4.81 |
| 6-month follow-up | 4.088 ± 4.56 | 4.409 ± 4.43 |
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.
| score on a scale | Intervention Group | Waitlisted Control Group |
|---|---|---|
| Baseline | 28.608 ± 12.68 | 32.064 ± 14.98 |
| 3-month follow-up | 27.847 ± 13.07 | 32.219 ± 16.39 |
| 6-month follow-up | 27.883 ± 11.97 | 30.265 ± 16.16 |
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).
| score on a scale | Intervention Group | Waitlisted Control Group |
|---|---|---|
| Baseline | 43.177 ± 17.32 | 44.859 ± 17.81 |
| 3-month follow-up | 36.405 ± 14.27 | 38.817 ± 16.22 |
| 6-month follow-up | 36.393 ± 14.39 | 40.542 ± 18.09 |
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.
| score on a scale | Intervention Group | Waitlisted Control Group |
|---|---|---|
| Baseline | 73.633 ± 9.73 | 71.256 ± 10.88 |
| 3-month follow-up | 74.706 ± 9.16 | 71.777 ± 12.25 |
| 6-month follow-up | 74.376 ± 9.73 | 71.865 ± 10.93 |
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%.
| percentage of glycated hemoglobin | Intervention Group | Waitlisted Control Group |
|---|---|---|
| Baseline | 7.166 ± 1.20 | 7.19 ± 1.42 |
| 6-month follow-up | 7.260 ± 1.38 | 7.069 ± 1.29 |
Collected over Up to 12 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Intervention Group - Adolescents | 0/79 (0%) | 0/79 (0%) | 0/79 (0%) |
| Intervention Group - Parents | 0/79 (0%) | 0/79 (0%) | 0/79 (0%) |
| Waitlisted Control Group: Control - Adolescents | 0/78 (0%) | 0/78 (0%) | 0/78 (0%) |
| Waitlisted Control Group: Control - Parents | 0/78 (0%) | 0/78 (0%) | 0/78 (0%) |
| Waitlisted Control Group: Intervention - Adolescents | 0/78 (0%) | 0/78 (0%) | 0/78 (0%) |
| Waitlisted Control Group: Intervention - Parents | 0/78 (0%) | 0/78 (0%) | 0/78 (0%) |
| Age, Categorical(Participants) | Intervention Group - Adolescents | Intervention Group - Parents | Waitlisted Control Group - Adolescents | Waitlisted Control Group - Parents | Total |
|---|---|---|---|---|---|
| <=18 years | 73 | 0 | 72 | 0 | 145 |
| Between 18 and 65 years | 6 | 79 | 6 | 78 | 169 |
| >=65 years | 0 | 0 | 0 | 0 | 0 |
| Sex/Gender, Customized(Participants) | Intervention Group - Adolescents | Intervention Group - Parents | Waitlisted Control Group - Adolescents | Waitlisted Control Group - Parents | Total |
|---|---|---|---|---|---|
| Male | 45 | 7 | 34 | 9 | 95 |
| Female | 32 | 72 | 40 | 68 | 212 |
| Non-binary | 1 | 0 | 1 | 1 | 3 |
| Undisclosed | 1 | 0 | 3 | 0 | 4 |
| Race/Ethnicity, Customized(Participants) | Intervention Group - Adolescents | Intervention Group - Parents | Waitlisted Control Group - Adolescents | Waitlisted Control Group - Parents | Total |
|---|---|---|---|---|---|
| Non-Hispanic white | 61 | 66 | 61 | 65 | 253 |
| Hispanic white | 5 | 3 | 1 | 3 | 12 |
| Black | 2 | 1 | 3 | 2 | 8 |
| Asian/Pacific Islander | 2 | 4 | 2 | 7 | 15 |
| Native American | 0 | 1 | 0 | 0 | 1 |
| More than once race | 7 | 1 | 7 | 0 | 15 |
| Undisclosed | 2 | 3 | 4 | 1 | 10 |
| Region of Enrollment(Participants) | Intervention Group - Adolescents | Intervention Group - Parents | Waitlisted Control Group - Adolescents | Waitlisted Control Group - Parents | Total |
|---|---|---|---|---|---|
| United States | 79 | 79 | 78 | 78 | 314 |
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