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

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ClinicalTrials.gov Identifier: NCT04589689
Recruitment Status : Recruiting
First Posted : October 19, 2020
Last Update Posted : February 2, 2021
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Korey Hood, Stanford University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Type 1 Diabetes Behavioral: Insul-In This Together Not Applicable

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 330 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Intervention 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)
Primary Purpose: Prevention
Official Title: Insul-In This Together Program: Optimizing Family-based Interventions for Adolescents With Type 1 Diabetes and Their Parents
Actual Study Start Date : December 18, 2020
Estimated Primary Completion Date : October 1, 2024
Estimated Study Completion Date : January 31, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Arms and Interventions
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Arm Intervention/treatment
Experimental: Intervention Group
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
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
Experimental: Waitlisted Control Group
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
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


Outcome Measures
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Primary Outcome Measures :
  1. 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 6-month follow-up (plus or minus 2 weeks around target data collection date) ]
    Glucose levels percent time in target range based on glucose monitoring to measure glycemic control

  2. Adolescent quality of life [ Time Frame: 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.


Secondary Outcome Measures :
  1. Adolescent depression [ Time Frame: 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 score range is 0-20 with higher scores indicated more severe depressive symptoms.

  2. Parent depression [ Time Frame: 6-month follow-up ]
    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.

  3. Adolescent distress [ Time Frame: 6-month follow-up ]
    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.

  4. Parent diabetes distress [ Time Frame: 6-month follow-up ]
    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.

  5. Parenting stress [ Time Frame: 6-month follow-up ]
    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. Hemoglobin A1c (HbA1c) [ Time Frame: 6-month follow-up ]
    Medical record data on glycated hemoglobin in blood


Eligibility Criteria
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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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. A1c results within the past month at time of screening and results above 7.5%,
  4. 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 English proficiency
  3. Subject has a pervasive developmental, cognitive, or psychiatric limitations that compromise participation in study
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04589689


Contacts
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Contact: Jessie J Wong, PhD (650) 736-1517 wongjj@stanford.edu
Contact: Jessica Ngo, BS (650) 723-3659 jessngo@stanford.edu

Locations
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United States, California
Stanford University Recruiting
Stanford, California, United States, 94305
Contact: Jessie Wong, PhD    650-736-1517    wongjj@stanford.edu   
Contact: Jessica Ngo    (650) 723-3659    jessngo@stanford.edu   
Principal Investigator: Korey Hood, PhD         
Sponsors and Collaborators
Stanford University
National Institutes of Health (NIH)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
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Principal Investigator: Korey K Hood, PhD Stanford University
More Information
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Responsible Party: Korey Hood, Professor, Medicine, Stanford University
ClinicalTrials.gov Identifier: NCT04589689    
Other Study ID Numbers: 58372
1K23DK121771-01A1 ( U.S. NIH Grant/Contract )
First Posted: October 19, 2020    Key Record Dates
Last Update Posted: February 2, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
 Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases