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

Not Applicable

Completed

Conditions: Type 1 Diabetes

Registration Number: NCT04589689

Lead Sponsor: Stanford University

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 366

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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.
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).
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%.