Insul-In This Together Program: Optimizing Family-based Interventions for Adolescents With Type 1 Diabetes and Their Parents
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Type 1 Diabetes
- Sponsor
- Stanford University
- Enrollment
- 366
- Locations
- 1
- Primary Endpoint
- Glucose Levels Percent Time in Target Range Based on Glucose Monitoring
- Status
- Completed
- Last Updated
- 11 months ago
Overview
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.
Investigators
Korey Hood
Professor, Medicine
Stanford University
Eligibility Criteria
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
Outcomes
Primary Outcomes
Glucose Levels Percent Time in Target Range Based on Glucose Monitoring
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 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
Time Frame: 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 Outcomes
- Adolescent Depression(Baseline, 3-month follow-up, and 6-month follow-up.)
- Parenting Stress(Baseline, 3-month follow-up, and 6-month follow-up)
- Parent Depression(Baseline, 3-month follow-up, and 6-month follow-up.)
- Adolescent Diabetes Distress(Baseline, 3-month follow-up, and 6-month follow-up)
- Parent Diabetes Distress(Baseline, 3-month follow-up, and 6-month follow-up.)
- Hemoglobin A1c (HbA1c)(Baseline and 6-month follow-up)