SBIR-STTR Award

Type 1 Teamwork: a Tool for Parents of Adolescents with Type 1 Diabetes
Award last edited on: 11/6/17

Sponsored Program
SBIR
Awarding Agency
NIH : NIDDK
Total Award Amount
$1,140,949
Award Phase
2
Solicitation Topic Code
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Principal Investigator
Lisa D Marceau

Company Information

New England Research Institute Inc (AKA: NERI)

480 Pleasant Street
Watertown, MA 02472
   (617) 923-7747
   media@neriscience.com
   www.neriscience.com
Location: Single
Congr. District: 05
County: Middlesex

Phase I

Contract Number: 1R43DK098857-01A1
Start Date: 9/23/14    Completed: 8/31/15
Phase I year
2014
Phase I Amount
$150,000
Type 1 diabetes (T1DM) is the most common chronic illness in children, affecting 1 in 400 with evidence that its prevalence is increasing worldwide. Parents of children with T1DM are responsible for a labor-intensive and complicated daily regimen that has been described as an overwhelming experience, requiring constant vigilance. The prevalence of anxiety symptoms for parents of children with T1DM range from 21-59%; depressive symptoms from 10-74%; psychological distress from 29-33%; and symptoms of Post Traumatic Stress Disorder (PTSD) from 19-24%. Parental psychological distress has negative health implications for the parent, the overall functioning of the family, the psychological adjustment of their child with T1DM, and diabetes management. Combined with parental stress, children (as they reach adolescence) have an increasing need for autonomy in T1DM management, creating additional concerns about good metabolic control. Most health care visits are thus focused on the adolescent with diabetes, but overlook the equally important health of the parent: their overburdened caretakers. There is currently no program readily available for parents of youth with T1DM in a user-friendly, socioculturally appropriate format, which addresses psychosocial burden. Therefore, the goal of this application is to develop an internet program for parents of early adolescents with T1DM (Parents.Cope) ¿ to promote parental adjustment to this developmental transition, ¿ to decrease parental stress and distress, and ¿ to support appropriate parental transfer of diabetes responsibility from parent to adolescent. We propose to complete three major Aims during Phase I to establish feasibility: Aim 1: Develop the content outline and foundational technology components of the Parents.Cope program. Aim 2: Develop a prototype of Parents.Connect to demonstrate the goals of the complete program. Aim 3: Independently evaluate the feasibility and acceptability of the Parents.Cope prototype using focus groups and interviews involving think aloud procedures.

Public Health Relevance Statement:


Public Health Relevance:
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 i occurring.

Project Terms:
Address; Adherence (attribute); Adolescence; Adolescent; Affect; Algorithms; Anxiety; Attention; Awareness; base; Camping; Child; Child health care; Chronic; Chronic Disease; Clinic Visits; Clinical; Complement; coping; Coupled; depressive symptoms; design; Development; diabetes educator; diabetes management; Diabetes Mellitus; Distress; Elements; Ensure; Evaluation; experience; Family; Focus Groups; Friends; Goals; Grant; Group Interviews; Health; Health Care Visit; Health Professional; Hispanics; Home Page; Hormonal Change; Independent Living; Insulin-Dependent Diabetes Mellitus; Internet; Journals; Lead; Learning; meetings; Mental Depression; Metabolic; Metabolic Control; Online Systems; Outcome; Parents; Participant; Perception; Phase; post-traumatic stress; Post-Traumatic Stress Disorders; Prevalence; Procedures; Program Effectiveness; Program Reviews; programs; prototype; Psychological adjustment; psychological distress; Psychologist; psychosocial; Psychosocial Influences; Puberty; public health relevance; Publishing; Randomized Clinical Trials; Regimen; Research; Risk; Schools; Self Management; Self-Evaluation Programs; social; Stress; stress management; Suggestion; Symptoms; Tablets; Technology; Time; tool; Treatment Protocols; user-friendly; vigilance; web site; You

Phase II

Contract Number: 2R44DK098857-02
Start Date: 9/23/14    Completed: 3/31/18
Phase II year
2016
(last award dollars: 2017)
Phase II Amount
$990,949

Type 1 diabetes (T1D) is one of the most common chronic illnesses in children, affecting 1 in 400, with evidence that its prevalence is increasing worldwide. The prevalence of T1D in adolescents is approximately 70 percent White, 22 percent Hispanic, and 8 percent Black. 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 percent; depressive symptoms from 10-74 percent; psychological distress from 29-33 percent; and posttraumatic stress symptoms from 19-24 percent. 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. 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. We propose to complete two major Aims in Phase II: Specific Aim 1: Develop the Type1Teamwork program (for use on computer, tablet, or smartphone) 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. We 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. We 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.

Public Health Relevance Statement:


Public Health Relevance:
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.

NIH Spending Category:
Autoimmune Disease; Basic Behavioral and Social Science; Behavioral and Social Science; Brain Disorders; Clinical Research; Depression; Diabetes; Mental Health; Pediatric

Project Terms:
Address; Adherence; Adolescence; Adolescent; adolescent health outcomes; Affect; Anxiety; anxiety symptoms; Attention; Awareness; base; Blood Glucose; Camping; Cellular Phone; Child; Child health care; Chronic; Chronic Disease; Clinic Visits; Clinical; commercialization; Complement; Conflict (Psychology); Control Groups; Coupled; depressive symptoms; Development; diabetes management; Diabetes Mellitus; Diet; Distress; Dose; Ensure; Evaluation; experience; Family; Friends; glucose monitor; Goals; Grant; Health; Health Personnel; Hispanics; Hormonal Change; improved; Independent Living; Injection of therapeutic agent; Insulin; Insulin Infusion Systems; Insulin-Dependent Diabetes Mellitus; Internet; Journals; Lead; Learning; Manuscripts; Marketing; meetings; Mental Depression; Metabolic Control; Online Systems; Outcome; Parents; Participant; Patients; Pattern; Peer Review; Perception; Phase; post-traumatic stress; Prevalence; Process; programs; prototype; Provider; Psychological adjustment; psychological distress; psychosocial; Puberty; Publications; Publishing; Randomized Clinical Trials; Recommendation; Regimen; Research; Risk; Schools; Self Management; Stress; stress symptom; Tablet Computer; Tablets; Technology; Thinking; Time; tool; Treatment Protocols; user-friendly; Visit; Waiting Lists; Youth