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

NCT04589689 | Completed Results DMC

• 2 other identifiers: 583721K23DK121771-01A1
• Study Type: interventional
• Target: 366
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 1 Diabetes

Outcome Measures

Primary Outcomes (2)

• 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.

Secondary Outcomes (6)

• Adolescent Depression

  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.

• Parenting Stress

  Baseline, 3-month follow-up, and 6-month follow-up

Study Arms (2)

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.

Behavioral: Insul-In This Together

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.

Behavioral: Insul-In This Together

Interventions

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

Intervention Group; Waitlisted Control Group

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Stanford University: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Stanford University

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Results Point of Contact

• Title: Jessie Wong, PhD
• Organization: Stanford University

wongjj@stanford.edu

6507361517

Study Officials

• Korey K Hood, PhD

  Stanford University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Medicine

Model Details: Randomization to either the intervention group (receives program immediately) or a waitlisted control condition (receives the intervention 6 months later).

Study Record Dates

• First Submitted: October 1, 2020
• First Posted: October 19, 2020
• Study Start: December 18, 2020
• Primary Completion: May 6, 2024
• Study Completion: May 6, 2024
• Last Updated: May 15, 2025
• Results First Posted: May 15, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)