Clinical trial NCT04589689: Insul-In This Together Program for Adolescents With Type 1 Diabetes and Their Parents
Official title: Insul-In This Together Program: Optimizing Family-based Interventions for Adolescents With Type 1 Diabetes and Their Parents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 1 Diabetes
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2020-10-19
Enrollment: 366
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomization to either the intervention group (receives program immediately) or a waitlisted control condition (receives the intervention 6 months later).
Primary purpose: PREVENTION

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.

Eligibility 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. 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

Primary outcomes:
measure: Glucose Levels Percent Time in Target Range Based on Glucose Monitoring
timeFrame: 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)
measure: Adolescent Quality of Life
timeFrame: Baseline, 3-month follow-up, and 6-month follow-up.
Secondary outcomes:
measure: Adolescent Depression
timeFrame: Baseline, 3-month follow-up, and 6-month follow-up.
measure: Parent Depression
timeFrame: Baseline, 3-month follow-up, and 6-month follow-up.
measure: Adolescent Diabetes Distress
timeFrame: Baseline, 3-month follow-up, and 6-month follow-up
measure: Parent Diabetes Distress
timeFrame: Baseline, 3-month follow-up, and 6-month follow-up.
measure: Parenting Stress
timeFrame: Baseline, 3-month follow-up, and 6-month follow-up
measure: Hemoglobin A1c (HbA1c)
timeFrame: Baseline and 6-month follow-up
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University
state: California
Study officials:
affiliation: Stanford University
name: Korey K Hood, PhD
role: PRINCIPAL_INVESTIGATOR
References: