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Type 1 Teamwork: A Tool for Parents of Adolescents With Type 1 Diabetes (Type1)

Primary Purpose

Type1diabetes, Type1 Diabetes Mellitus

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Type 1 Teamwork Program
Sponsored by
Carelon Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Type1diabetes focused on measuring Diabetes, Adolescence, Parents

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Parent of an adolescent with T1D aged 11-16;
  • Able to comply with the terms of the trial (available time commitment);
  • Able to speak, read, and write in English

Exclusion Criteria:

• Not meeting inclusion criteria

Sites / Locations

  • Yale University
  • New England Research Institutes

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Intervention

Control

Arm Description

Type 1 Teamwork program

Standard of care

Outcomes

Primary Outcome Measures

Change in Parent Stress using the Perceived Stress Scale (PSS)
Participants of the Type1Teamwork program will have a significant decrease in parent stress compared to the control arm participants at 3 and 6 month follow-up. The researchers are using the PSS, a 14-item scale that measures a person's perceived stress by considering the degree to which situations in one's life are appraised as stressful. Items evaluate how unpredictable, uncontrollable, and overloaded respondents find their lives. Higher scores indicate greater perceived stress. Chronbach's alpha was 0.89 in our sample. REF: Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. Journal of health and social behavior. Dec 1983;24(4):385-396.

Secondary Outcome Measures

Full Information

First Posted
March 11, 2019
Last Updated
August 28, 2019
Sponsor
Carelon Research
Collaborators
Yale University
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1. Study Identification

Unique Protocol Identification Number
NCT04073914
Brief Title
Type 1 Teamwork: A Tool for Parents of Adolescents With Type 1 Diabetes
Acronym
Type1
Official Title
Type 1 Teamwork: A Tool for Parents of Adolescents With Type 1 Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
June 29, 2017 (Actual)
Primary Completion Date
March 26, 2018 (Actual)
Study Completion Date
March 26, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Carelon Research
Collaborators
Yale University

4. Oversight

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

5. Study Description

Brief Summary
Type 1 Diabetes (T1DM) is a common chronic illness in children which presents difficult and often stressful management concerns for parents. As children approach adolescence, this burden increases with the desire for independence and self-management. No tool exists that addresses in a user friendly, easy to access and socio-culturally appropriate way, the psychosocial needs of parents as they move through this transition. This program targets the parents to help them at the very point where this transition is occurring.
Detailed Description
Type 1 diabetes (T1D) is one of the most common chronic illnesses in children, affecting 1 in 400,1 with evidence that its prevalence is increasing worldwide.2 The prevalence of T1D in adolescents is approximately 70% White, 22% Hispanic, and 8% Black.3-5 Parents of children with T1D are responsible for a labor-intensive and complicated daily regimen that has been described as an overwhelming experience, requiring constant vigilance.6 Intensive management of T1D requires frequent blood glucose monitoring, multiple insulin injections or use of an insulin pump, frequent alterations in insulin dose to match changing diet and activity patterns, and regular visits to health care providers. This 24/7 attention to their child's health manifests in elevated rates of parental perception of stress and increased risk for depression and anxiety. The prevalence of anxiety symptoms for parents of children with T1D range from 21-59%; depressive symptoms from 10-74%; psychological distress from 29-33%; and posttraumatic stress symptoms from 19-24%.7-9 Parental psychological distress has negative health implications for the parent, the overall functioning of the family, the psychological adjustment of their child with T1D, diabetes management, and child metabolic control.10-14 The goal of this application is to complete the psycho-educational web-based program for parents of adolescents with T1D (Type1Teamwork) which will help to: 1) decrease parental perceived stress and distress; 2) promote parental adjustment to the developmental transitions in adolescence; 3) support adolescent autonomy and transfer of diabetes responsibility from parent to adolescent; 4) decrease family conflict; and 5) maintain metabolic control during adolescence. The investigators propose to complete two major Aims in Phase II: Specific Aim 1: Develop the Type1Teamwork program (for use on computer, tablet, or smart phone) based on the activities completed in Phase I. Six content themes have been identified as important to parents and providers. Feasibility assessment has provided support of these content themes as well as substantive recommendations to ensure content and interactivity is engaging and meets the needs of parents of children with T1D as well as health care providers. The investigators will use an iterative process of development and evaluation, collaborating with our technology team, parent advisors, and clinical consultants to ensure development of a quality product and to submit a peer reviewed manuscript for publication of the results. Specific Aim 2: Evaluate the Type1Teamwork program through a modest randomized clinical trial. The investigators will determine the effect of the program on parent psychosocial outcomes (stress, depression, and anxiety), adolescent autonomy, parent-adolescent responsibility for T1D management, family conflict, and adolescent metabolic control. Results will be presented at diabetes meetings, published in top tier journals (to provide clinical and scientific evidence of the newly developed program), and widely disseminated per the commercialization and marketing plan.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type1diabetes, Type1 Diabetes Mellitus
Keywords
Diabetes, Adolescence, Parents

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
To evaluate the complete program the investigators conducted a modest randomized clinical trial, randomizing parents to the Type1Teamwork program or a wait-list control group. Results were analyzed using general linear repeated measures models with training group, and time as fixed effects. The primary hypotheses comparing changes in domain totals over time will be tested by the interaction effect of time by treatment group.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
158 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Active Comparator
Arm Description
Type 1 Teamwork program
Arm Title
Control
Arm Type
No Intervention
Arm Description
Standard of care
Intervention Type
Behavioral
Intervention Name(s)
Type 1 Teamwork Program
Intervention Description
Psychoeducational web program
Primary Outcome Measure Information:
Title
Change in Parent Stress using the Perceived Stress Scale (PSS)
Description
Participants of the Type1Teamwork program will have a significant decrease in parent stress compared to the control arm participants at 3 and 6 month follow-up. The researchers are using the PSS, a 14-item scale that measures a person's perceived stress by considering the degree to which situations in one's life are appraised as stressful. Items evaluate how unpredictable, uncontrollable, and overloaded respondents find their lives. Higher scores indicate greater perceived stress. Chronbach's alpha was 0.89 in our sample. REF: Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. Journal of health and social behavior. Dec 1983;24(4):385-396.
Time Frame
Baseline, 3 months, and 6 months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Parent of an adolescent with T1D aged 11-16; Able to comply with the terms of the trial (available time commitment); Able to speak, read, and write in English Exclusion Criteria: • Not meeting inclusion criteria
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lisa Marceau, MPH
Organizational Affiliation
Carelon Research
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yale University
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
Facility Name
New England Research Institutes
City
Watertown
State/Province
Massachusetts
ZIP/Postal Code
02472
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Type 1 Teamwork: A Tool for Parents of Adolescents With Type 1 Diabetes

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