A Crowdsourced Social Media Portal for Parents of Very Young Children With Type 1 Diabetes
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Detailed Description
In response to PA-DK-14-022, the researchers propose to design and test an intervention to improve management of type 1 diabetes (T1D) in very young children (<6 years). Parents of very young children with T1D (YC-T1D) often experience distress and anxiety that can impede T1D care, threatening the child's current and future adaptation to T1D.Typical health care often does not equip parents to contend with these issues, but YC-T1D parents can offer support/guidance to each other to promote parental coping and thus child outcomes. The many obstacles to direct interaction among parents suggest that social media may be an efficacious way to facilitate timely, meaningful and needed social support such as parenting guidance, affective support, provision of information, and sharing of creative solutions to common T1D management problems in YC-T1D. Many good social media resources exist, but there is not a focused portal that facilitates parents' access to these resources, nor have potential benefits been validated empirically. The researchers applied crowdsourcing methods to achieve the iterative development and initial evaluation of an online resource designed by and for YC-T1D parents with continuous input from health professionals and technical expertise in crowdsourcing and application development provided by our web development agency partners (e-city interactive, Philadelphia) and Nemours web development team.
Crowdsourcing is a flexible online activity that has been applied to diverse problems in many fields, including public health, with four elements: 1.) An organization that has a task it needs to be performed, (development of an online resource that meets the needs of parents of YC-T1D); 2.) A community, "the crowd", that agrees to perform the necessary tasks voluntarily (here parents of YC-T1D, T1D clinicians, and professional application developers); 3.) An online environment that allows the work to take place by enabling collaboration between the crowd and the organization, (the infrastructure proposed in this grant); and 4.) Mutual benefit for the organization and members of the crowd (better glycemic control, improved quality of life and decreased burden of care for YC-T1D and their families).
To the researchers' knowledge, crowdsourcing has not been applied to the design and development of online health behavior resources such as that proposed in this application. They will design the portal with stakeholders based on principles of User-Centered Design and then collect preliminary data needed to justify and then conduct a rigorous controlled trial of the effectiveness of an online resource that will provide parents of YC-T1D (<6 years old) with timely, responsible, safe and effective support and guidance regarding parental management of common behavioral, affective and cognitive barriers to effective T1D care in this age group. The proposed work will address these specific aims:
Aim 1 (Completed): The team used crowdsourcing methods to 1.) Identify the most important concerns about management of YC-T1D from key stakeholders (parents, pediatric endocrinologists, diabetes nurses, dietitians, psychologists and social workers) to specify content areas that the online resource should address; 2.) Collaborate with parents (with available input from T1D professionals) to design the optimal content, structure, functions and governance of a social media resource for parents of YC-T1D to improve daily T1D care and problem solving, to enhance parental coping with sources of distress and care burden that uniquely affect this clinical population and to facilitate parents' access to and use of other beneficial resources of the diabetes online community.
Aim 2 (Completed): The researchers iteratively incorporated the knowledge, experience and perspectives gained in Aim 1 to systematically build and refine an online resource enabling parents of very young children with T1D to obtain real-time emotional support, information and parenting guidance, enabling them to cope more effectively with the daily demands of diabetes management in this population. The team relied on the web development agency partners, Nemours web development team, and ongoing stakeholder input.
Aim 3 (Completed): The researchers will conduct a randomized controlled trial of a final version of the online resource with parents of at least 150 children <6 years old who receive T1D care at any Nemours operating entity in the Delaware Valley and Florida or who enroll in response to online announcements. The team will explore treatment effects on metabolic, behavioral and affective outcomes of T1D care, patterns of portal utilization by parents and users' feedback on website use during and after the trial.
Having designed, built, tested, validated and refined the proposed online resource, the team will be well-positioned to plan and complete a rigorous randomized controlled trial to evaluate effects of portal use/access on metabolic, behavioral, affective and social outcomes of T1D care for YC-T1D. While completing Aim 3, the researchers will solidify partnerships with several key organizations (PEDSnet, T1D Exchange, JDRF, American Diabetes Association) to enable economical completion of a major multisite trial. The design of the proposed preliminary RCT will position the team to propose a completely electronic multisite RCT that does not require face to face contact between parents and the research team and can be completed totally in cyberspace.
Study Type
Study Type
Enrollment (Actual)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Florida
-
Jacksonville, Florida, United States, 32207
- Nemours Children's Clinic
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-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Parent or legal guardian of a child with T1D < 6 years old at enrollment
- Child and parent/guardian live in the United States
- Parent is able to read and comprehend written English
- Access to the internet
Exclusion Criteria:
- Inability to read or comprehend study questionnaires or website content
INTERESTED, ELIGIBLE PARENTS OR GUARDIANS CAN LEARN MORE BY NAVIGATING TO: www.bit.ly/youngT1D
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Single
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Experimental: Website
Participants will be provided with password-protected access to use of the online resource created during the first phase of the project during the one year randomized controlled trial.
Participants' children with T1D will receive Usual Care for T1D as described below.
|
Participants in the Website condition will be provided with password-protected access to the online resource created for this trial that provides a variety of information, support and guidance that could permit them to adapt more effectively to the demands of parenting a very young child with type 1 diabetes.
|
|
No Intervention: Usual Care
Participants' children with T1D will receive care for T1D at their respective institutions equivalent to that received by comparable patients who do not enroll in the trial.
At all sites, Usual Care is designed to be consistent with the current American Diabetes Association Standards of Care for T1D in this clinical population.
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Parental adjustment
Time Frame: 12 months
|
Questionnaire scores
|
12 months
|
|
Child adjustment
Time Frame: 12 months
|
Questionnaire scores
|
12 months
|
|
Glycated hemoglobin (Hemoglobin A1c)
Time Frame: 12 months
|
Change in child's glycated hemoglobin level during the trial
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12 months
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Severe hypoglycemia
Time Frame: 12 months
|
Frequency of severe hypoglycemic events
|
12 months
|
|
Health care utilization
Time Frame: 12 months
|
Hospitalizations or ED visits associated with T1D
|
12 months
|
|
Website utilization
Time Frame: 12 months
|
Automated collection of website logins, navigation, duration of use, etc.
|
12 months
|
Collaborators and Investigators
Sponsor
Sponsor
Publications and helpful links
General Publications
- Pierce JS, Kozikowski C, Lee JM, Wysocki T. Type 1 diabetes in very young children: a model of parent and child influences on management and outcomes. Pediatr Diabetes. 2017 Feb;18(1):17-25. doi: 10.1111/pedi.12351. Epub 2015 Dec 29.
- Pierce JS, Aroian K, Caldwell C, Ross JL, Lee JM, Schifano E, Novotny R, Tamayo A, Wysocki T. The Ups and Downs of Parenting Young Children With Type 1 Diabetes: A Crowdsourcing Study. J Pediatr Psychol. 2017 Sep 1;42(8):846-860. doi: 10.1093/jpepsy/jsx056.
- Pierce JS, Wasserman R, Enlow P, Aroian K, Lee J, Wysocki T. Benefit finding among parents of young children with type 1 diabetes. Pediatr Diabetes. 2019 Aug;20(5):652-660. doi: 10.1111/pedi.12860. Epub 2019 May 20.
- Wilcocks CP, Enlow P, Wasserman R, Wysocki T, Lee J, Aroian K, Pierce JS. Development and Evaluation of the Pediatric Diabetes Routine Questionnaire for Parents of Young Children with Type 1 Diabetes. J Clin Psychol Med Settings. 2022 Jun 18. doi: 10.1007/s10880-022-09888-3. Online ahead of print.
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Actual)
Primary Completion
Study Completion (Actual)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- 1DP3DK108198 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- ICF
- ANALYTIC_CODE
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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