Insul-In This Together Program for Adolescents With Type 1 Diabetes and Their Parents

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Insul-In This Together Program: Optimizing Family-based Interventions for Adolescents With Type 1 Diabetes and Their Parents

Conditions
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Type 1 Diabetes

Intervention / Treatment
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* Behavioral: Insul-In This Together


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Teen subject has a type 1 diabetes (T1D) diagnosis according to ADA criteria for at least 6 months Teen subject is age 12-19 years at time of screening (no age limit for parent participants) Participation of at least one cohabitating parent/caregiver. Exclusion Criteria: Subject lacks access to a smartphone or Wi-Fi via computer Subject has restricted or no English proficiency Subject has a pervasive developmental, cognitive, or psychiatric limitations that compromise participation in study

Ages Eligible for Study
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Minimum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Sequential Assignment
Interventional Model Description: Randomization to either the intervention group (receives program immediately) or a waitlisted control condition (receives the intervention 6 months later).
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention Group<br>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<br>* 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<br>|
| Experimental: Waitlisted Control Group<br>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<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glucose levels percent time in target range based on glucose monitoring | Glucose levels percent time in target range based on glucose monitoring to measure glycemic control | Average percent time in range based on two weeks of glucose monitoring data at 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. | 6-month follow-up | 

Secondary Outcome Measures

| Outcome Measure | 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 score range is 0-20 with higher scores indicated more severe depressive symptoms. | 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. The possible score range is 0-24 and higher scores indicate more depressive symptoms. | 6-month follow-up | 
| Adolescent distress | Measured by the Problem Areas In Diabetes (PAID) survey of diabetes distress, which includes 14 items and has a possible score range of 14-84. Higher scores indicate more diabetes distress. | 6-month follow-up | 
| Parent diabetes distress | Measured by the Problem Areas In Diabetes (PAID) survey of diabetes distress, which includes 15 items and has a possible score range of 15-90. Higher scores indicate more diabetes distress. | 6-month follow-up | 
| Parenting stress | Surveys of self-report on parenting stress via The Parenting Stress Scale. Includes 18 items with a possible score range from 18-90. Higher scores indicate more parenting stress. | 6-month follow-up | 
| Hemoglobin A1c (HbA1c) | Medical record data on glycated hemoglobin in blood | 6-month follow-up |