NCT03222180

Brief Summary

The first 2 years of this project consisted of user-centered design and development of an online resource designed by and for parents of very young children with type 1 diabetes (under 6 years old). That phase of the work has been completed and recruitment has begun for the second phase, which is a randomized controlled trial to evaluate the effects of use of this resource on a variety of pertinent child and parent outcomes. INTERESTED, ELIGIBLE PARENTS OR GUARDIANS CAN LEARN MORE BY NAVIGATING TO: www.bit.ly/youngT1D

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
174

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 17, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 19, 2017

Completed
7 months until next milestone

Study Start

First participant enrolled

February 15, 2018

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2020

Completed
Last Updated

July 9, 2020

Status Verified

July 1, 2020

Enrollment Period

2.1 years

First QC Date

July 17, 2017

Last Update Submit

July 7, 2020

Conditions

Type 1 Diabetes Mellitus

Outcome Measures

Primary Outcomes (3)

  • Parental adjustment

    Questionnaire scores

    12 months

  • Child adjustment

    Questionnaire scores

    12 months

  • Glycated hemoglobin (Hemoglobin A1c)

    Change in child's glycated hemoglobin level during the trial

    12 months

Secondary Outcomes (3)

  • Severe hypoglycemia

    12 months

  • Health care utilization

    12 months

  • Website utilization

    12 months

Study Arms (2)

Website

EXPERIMENTAL

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.

Behavioral: Website

Usual Care

NO INTERVENTION

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.

Interventions

WebsiteBEHAVIORAL

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.

Website

Eligibility Criteria

Age1 Day - 6 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nemours Children's Clinic

Jacksonville, Florida, 32207, United States

Location

Related Publications (4)

  • 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.

    PMID: 26712357BACKGROUND

  • 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.

    PMID: 28369409BACKGROUND

  • 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.

    PMID: 31006941BACKGROUND

  • 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. 2023 Mar;30(1):216-226. doi: 10.1007/s10880-022-09888-3. Epub 2022 Jun 18.

    PMID: 35716238DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Persons administering and scoring study questionnaires will be blinded to the participants' group assignments,
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
FACTORIAL
Model Details: The study design consists of randomization of parents of 150 children with T1D to either Website (n=100) or Usual Care (n=50) for 6 months followed by all participants reverting to the Website condition for the subsequent 6 months.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Scientist

Study Record Dates

First Submitted

July 17, 2017

First Posted

July 19, 2017

Study Start

February 15, 2018

Primary Completion

March 31, 2020

Study Completion

March 31, 2020

Last Updated

July 9, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will share

After the results pertinent to the specific aims have been accepted for publication, a de-identified data set will be placed in a publicly accessible secure location along with an accompanying data dictionary. Access to the data set will be limited to those persons who sing and submit a data use agreement that ensures protection of the confidentiality of the study participants.

Shared Documents
STUDY PROTOCOL, ICF, CSR, ANALYTIC CODE
Time Frame
Once the results pertinent to each of the specific aims have been accepted for publication.
Access Criteria
Access to the data set will be limited to those persons who sign and submit a data use agreement that ensures protection of the confidentiality of the study participants.

Locations

US(1)