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

Primary Purpose

Type 1 Diabetes

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Insul-In This Together
Sponsored by
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Type 1 Diabetes

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Stanford UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Intervention Group

Waitlisted Control Group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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
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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
Hemoglobin A1c (HbA1c)
Medical record data on glycated hemoglobin in blood

Full Information

First Posted
October 1, 2020
Last Updated
December 9, 2022
Sponsor
Stanford University
Collaborators
National Institutes of Health (NIH), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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1. Study Identification

Unique Protocol Identification Number
NCT04589689
Brief Title
Insul-In This Together Program for Adolescents With Type 1 Diabetes and Their Parents
Acronym
IITT
Official Title
Insul-In This Together Program: Optimizing Family-based Interventions for Adolescents With Type 1 Diabetes and Their Parents
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 18, 2020 (Actual)
Primary Completion Date
October 1, 2024 (Anticipated)
Study Completion Date
March 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University
Collaborators
National Institutes of Health (NIH), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
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)
Allocation
Randomized
Enrollment
330 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Waitlisted Control Group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Insul-In This Together
Intervention Description
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
Primary Outcome Measure Information:
Title
Glucose levels percent time in target range based on glucose monitoring
Description
Glucose levels percent time in target range based on glucose monitoring to measure glycemic control
Time Frame
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)
Title
Adolescent quality of life
Description
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.
Time Frame
6-month follow-up
Secondary Outcome Measure Information:
Title
Adolescent depression
Description
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.
Time Frame
6-month follow-up
Title
Parent depression
Description
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.
Time Frame
6-month follow-up
Title
Adolescent distress
Description
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.
Time Frame
6-month follow-up
Title
Parent diabetes distress
Description
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.
Time Frame
6-month follow-up
Title
Parenting stress
Description
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.
Time Frame
6-month follow-up
Title
Hemoglobin A1c (HbA1c)
Description
Medical record data on glycated hemoglobin in blood
Time Frame
6-month follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jessie J Wong, PhD
Phone
(650) 736-1517
Email
wongjj@stanford.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Haley Linzmeyer, MA
Phone
650-721-6432
Email
hlinz@stanford.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Korey K Hood, PhD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jessie Wong, PhD
Phone
650-736-1517
Email
wongjj@stanford.edu
First Name & Middle Initial & Last Name & Degree
Haley Linzmeyer, MA
Phone
650-721-6432
Email
hlinz@stanford.edu
First Name & Middle Initial & Last Name & Degree
Korey Hood, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

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

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