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| ID | Type | Description | Link |
|---|---|---|---|
| 1K23DK121771-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Group | Experimental | 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. |
|
| Waitlisted Control Group | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Insul-In This Together | Behavioral | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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). | Baseline, 3-month follow-up, and 6-month follow-up. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, 3-month follow-up, and 6-month follow-up. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Korey K Hood, PhD | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University | Stanford | California | 94305 | United States |
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366 participants signed informed consent (representing 183 parent-adolescent dyads); 314 participants were randomized to a study arm (representing 157 adolescent-parent dyads).
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| FG002 | 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. |
| FG003 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Enrolled adolescents; data for this outcome were not collected from parents | Posted | Mean | Standard Deviation | percentage of time-in-range | 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) |
|
Up to 12 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intervention Group - Adolescents | Data for adolescents in the dyads of the intervention group during their intervention period. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jessie Wong, PhD | Stanford University | 6507361517 | wongjj@stanford.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 11, 2021 | Feb 6, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 11, 2021 | Feb 7, 2025 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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Randomization to either the intervention group (receives program immediately) or a waitlisted control condition (receives the intervention 6 months later).
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|
| 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. | 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. | 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). | 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. | 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%. | Baseline and 6-month follow-up |
| BG001 | 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. |
| BG002 | 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. |
| BG003 | 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. |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Sex/Gender, Customized | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Based on parent report and representing parent-adolescent dyads | Count of Participants | Participants |
|
| OG001 | Waitlisted Control Group | 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. |
|
|
|
| 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). | Enrolled adolescents; data for this outcome were not collected from parents | Posted | Mean | Standard Deviation | score on a scale | Baseline, 3-month follow-up, and 6-month follow-up. |
|
|
|
|
| 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. | Enrolled adolescents; data for this outcome were not collected from parents | Posted | Mean | Standard Deviation | score on a scale | Baseline, 3-month follow-up, and 6-month follow-up. |
|
|
|
|
| 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. | Enrolled parents; data for this outcome were not collected from adolescents | Posted | Mean | Standard Deviation | score on a scale | Baseline, 3-month follow-up, and 6-month follow-up. |
|
|
|
|
| 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. | Enrolled adolescents; data for this outcome were not collected from parents | Posted | Mean | Standard Deviation | score on a scale | Baseline, 3-month follow-up, and 6-month follow-up |
|
|
|
|
| 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). | Enrolled parents; data for this outcome were not collected from adolescents | Posted | Mean | Standard Deviation | score on a scale | Baseline, 3-month follow-up, and 6-month follow-up. |
|
|
|
|
| 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. | Enrolled parents; data for this outcome were not collected from adolescents | Posted | Mean | Standard Deviation | score on a scale | Baseline, 3-month follow-up, and 6-month follow-up |
|
|
|
|
| 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%. | Enrolled adolescents with available data; data for this outcome were not collected from parents | Posted | Mean | Standard Deviation | percentage of glycated hemoglobin | Baseline and 6-month follow-up |
|
|
|
|
| 0 |
| 79 |
| 0 |
| 79 |
| 0 |
| 79 |
| EG001 | Intervention Group - Parents | Data for parents in the dyads of the intervention group during their intervention period. | 0 | 79 | 0 | 79 | 0 | 79 |
| EG002 | Waitlisted Control Group: Control - Adolescents | Data for adolescents in the dyads of the waitlisted group during their waiting (control) period. | 0 | 78 | 0 | 78 | 0 | 78 |
| EG003 | Waitlisted Control Group: Control - Parents | Data for parents in the dyads of the waitlisted group during their waiting (control) period. | 0 | 78 | 0 | 78 | 0 | 78 |
| EG004 | Waitlisted Control Group: Intervention - Adolescents | Data for adolescents in the dyads of the waitlisted group during their intervention period. | 0 | 78 | 0 | 78 | 0 | 78 |
| EG005 | Waitlisted Control Group: Intervention - Parents | Data for parents in the dyads of the waitlisted group during their intervention period. | 0 | 78 | 0 | 78 | 0 | 78 |
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| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| 6-month |
|
| t-test, 2 sided |
| 0.275 |
The a priori threshold for statistical significance is <.05. |
| Other |
| 6-month follow-up |
|
| t-test, 2 sided |
| 0.610 |
The a priori threshold for statistical significance is <.05. |
| Other |
| 6-month follow-up |
|
| t-test, 2 sided |
| 0.826 |
The a priori threshold for statistical significance is <.05. |
| Other |
| 6-month follow-up |
|
| t-test, 2 sided |
| 0.747 |
The a priori threshold for statistical significance is <.05. |
| Other |
| 6-month follow-up |
|
| t-test, 2 sided |
| 0.107 |
The a priori threshold for statistical significance is <.05. |
| Other |
| 6-month follow-up |
|
| t-test, 2 sided |
| 0.543 |
The a priori threshold for statistical significance is <.05. |
| Other |