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

Type 1 Diabetes Clinical Trial

— IITT  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04589689
• Other study ID #: 58372
• Secondary ID: 1K23DK121771-01A
• Status: Active, not recruiting
• Phase: N/A
• Start date: December 18, 2020
• Est. completion date: March 31, 2025

Study information

• Verified date: November 2023
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 314
• Est. completion date: March 31, 2025
• Est. primary completion date: October 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

Inclusion Criteria:

1. Teen subject has a type 1 diabetes (T1D) diagnosis according to ADA criteria for at least 6 months

2. Teen subject is age 12-19 years at time of screening (no age limit for parent participants)

3. Participation of at least one cohabitating parent/caregiver.

Exclusion Criteria:

1. Subject lacks access to a smartphone or Wi-Fi via computer

2. Subject has restricted or no English proficiency

3. Subject has a pervasive developmental, cognitive, or psychiatric limitations that compromise participation in study

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes

Intervention

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

Locations

Country	Name	City	State
United States	Stanford University	Stanford	California

Sponsors (3)

Lead Sponsor	Collaborator
Stanford University	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
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.	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 score range is 0-20 with higher scores indicated more severe depressive symptoms.	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. The possible score range is 0-24 and higher scores indicate more depressive symptoms.	6-month follow-up
Secondary	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
Secondary	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
Secondary	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
Secondary	Hemoglobin A1c (HbA1c)	Medical record data on glycated hemoglobin in blood	6-month follow-up