What is the purpose of this trial?
The study will take place at The Yale School of Nursing and New England Research Institutes (NERI). Focus groups and in-person interviews will take place at the Yale Pediatric Endocrinology clinic or other convenient locations that assure privacy of participants. To address the overall goal of this grant, we will complete three major tasks during Phase I to establish feasibility, as follows:
Specific Aim 1: To finalize the overarching concept and technology components of the Parents.Cope program. We will conduct focus groups/interviews with parents of adolescents with T1DM and diabetes clinicians (MDs, NPs, diabetes educators, and psychologists) to:
1) Review program goals, components, and the content outline for relevance and completeness.
2) Explore ideas for content presentation, self-evaluations, and scenarios illustrating content.
3) Explore ideas for website functionality, components, design features, and interactivity.
Specific Aim 2: Develop a prototype of the Parents.Cope program to demonstrate the goals of the complete program. The prototype will include content on one psychosocial issue unique to parents of adolescents with T1DM (i.e., stress management), an interactive self-evaluation algorithm (i.e., to assess symptoms of stress, anxiety, depression and personalize advice/activities), a detailed outline of all content, and possible social media avenues for parents to communicate with one another, health professionals, and their adolescent.
Specific Aim 3: Independently evaluate the feasibility and acceptability of the Parents.Cope prototype using focus groups and interviews. Parents of adolescents with T1DM and clinicians will provide an assessment of the prototype interface, content, interactivity, technology platforms preferred and other features of the program. Participants from the content development focus groups will be included to ensure we addressed their suggestions. Pre-post evaluation of parent perceived stress will also be done. The product at the conclusion of Phase I will be an interactive web based program that includes design of the product menu (home page), self-evaluation, program content on stress, and placeholders for other components of the program (i.e., social media forum). During Phase ll we propose to complete the development of the web program, including all content and all interactive elements, social media, and linkages to the adolescent program. During Phase II we will also conduct a randomized clinical trial to evaluate the effectiveness of the program on parent psychosocial outcomes and adolescent metabolic control. Results will be presented at diabetes meetings, and published in top tier journals (to provide clinical and scientific evidence of the newly developed program). NOTE: Phase II is not included in this current grant, and the activities outlined for Phase II are not included in this protocol.
Ages: 11 - 16 years
National Institutes of Health
Dates: 02/23/2015 - 03/30/2018
Last Updated: 02/22/2018
Study HIC#: 1412015084