Clinical trial NCT04073914: Type 1 Teamwork: A Tool for Parents of Adolescents With Type 1 Diabetes
Official title: Type 1 Teamwork: A Tool for Parents of Adolescents With Type 1 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type1diabetes
Type1 Diabetes Mellitus
Keywords: Diabetes
Adolescence
Parents
Lead sponsor: Carelon Research
Sponsor class: OTHER
Collaborators: name: Yale University
First posted: 2019-08-29
Enrollment: 158
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Change in Parent Stress using the Perceived Stress Scale (PSS)
timeFrame: Baseline, 3 months, and 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale University
state: Connecticut
city: Watertown
country: United States
facility: New England Research Institutes
state: Massachusetts
Study officials:
affiliation: Carelon Research
name: Lisa Marceau, MPH
role: PRINCIPAL_INVESTIGATOR
References: