Iterative Beta Testing of Videos for the DIPPer Academy (DIPPer Academy)
Primary Purpose
Type1diabetes
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
DIPPer Academy
Standard of Care
Sponsored by
About this trial
This is an interventional prevention trial for Type1diabetes
Eligibility Criteria
Inclusion Criteria:
- Parents of a young child who is between 3-5.99 years old and at least 6 months post T1D diagnosis
- Parents who are English-speaking.
Exclusion Criteria:
- Parents of young children with evidence of type 2 diabetes or monogenic diabetes.
- Parents with evidence of severe psychiatric disorder.
- Parents of young children with a comorbid chronic illness (e.g., renal disease) that requires ongoing care beyond T1D.
- Parents of young children with a history of anemia or medication use that may interact with glycemic control (e.g., systemic steroids).
Sites / Locations
- University of Kansas Medical Center
- The Children's Mercy Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
DIPPer Academy
Standard of Care Control
Arm Description
Parents randomized to this group will participate in the DIPPer Academy curriculum.
Parents randomized to this group will receive care as usual from their child's diabetes provider
Outcomes
Primary Outcome Measures
Child Glycemic Control
Measure of hemoglobin A1c (HbA1c).
Parent Depressive Symptoms
Center for Epidemiological Studies-Depression Scale Revised (CES-D); higher scores suggest worse outcome. Range 0-60.
Parent Diabetes Distress
Problem Areas in Diabetes Distress- Parent Report Questionnaire. Higher scores reflect worse outcome. Range 0-72
Secondary Outcome Measures
Family Mealtime behaviors_Frequency
Behavioral Pediatrics Feeding Assessment Scale. This is a 35 item scale. This subscale reflects the frequency of perceived mealtime behavior problems (possible range: 35-175). Higher scores represent a worse outcome.
Parents' Hypoglycemia Fear
Measured using the Hypoglycemia Fear Survey (HFS-PYC). This is a 26 item measure and higher values represent a worse outcome. Range: 26-130.
Parenting Stress- Frequency
Measured using the Pediatric Inventory for Parents. This is a 42 item measure. Measure is scored so that higher values represent a worse outcome. Range: 42-210
Parents' T1D Self-efficacy
Measured using the Parental Self-Efficacy Scale for Diabetes Management. This is an 8 item measure of self-efficacy. It has only a total score (items are summed for the total). Range 8-40. Higher scores represent a better outcome.
Parent Knowledge of T1D
Test of Diabetes Knowledge-5. This is a 41 item measure. There is general knowledge (0-29) and Problem solving (0-11). This is scored based on percent of items correct, so higher scores represent a better outcome.
Behavioral Pediatric Feeding Assessment Scale_Problem
Measured using the Behavioral Pediatrics Feeding Assessment Scale. This is a 35 item scale. This subscale reflects the number of mealtime behaviors that parents identify as problematic (possible range: 0-35). Higher scores represent a worse outcome.
Full Information
NCT ID
NCT03385265
First Posted
December 20, 2017
Last Updated
March 10, 2022
Sponsor
University of Kansas Medical Center
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
1. Study Identification
Unique Protocol Identification Number
NCT03385265
Brief Title
Iterative Beta Testing of Videos for the DIPPer Academy
Acronym
DIPPer Academy
Official Title
An Interactive mHealth App for Better Glycemic Control in Parents of Young Kids With T1D
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
January 1, 2018 (Actual)
Primary Completion Date
July 29, 2021 (Actual)
Study Completion Date
September 1, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Kansas Medical Center
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this research is to develop DIPPer Academy, a parent-focused, mobile health (mHealth) behavioral intervention to promote glycemic control in young children.
Detailed Description
Because many young children with T1D have glucose levels that exceed targets, investigators need to develop efficacious, accessible, and readily disseminable interventions to help them to improve their glycemic control. To do this, the investigators need efficacious interventions that specifically address the challenges that parents of young children face in daily T1D management. Providers need mHealth interventions that minimize barriers that parents experience when trying to access face-to-face or in clinic interventions. Finally, interventions are needed that are packaged to be easily deployable by other diabetes centers. The investigator's proposed intervention, DIPPer Academy, will include all of these recommended advancements.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type1diabetes
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
62 (Actual)
8. Arms, Groups, and Interventions
Arm Title
DIPPer Academy
Arm Type
Experimental
Arm Description
Parents randomized to this group will participate in the DIPPer Academy curriculum.
Arm Title
Standard of Care Control
Arm Type
Active Comparator
Arm Description
Parents randomized to this group will receive care as usual from their child's diabetes provider
Intervention Type
Behavioral
Intervention Name(s)
DIPPer Academy
Intervention Description
The DIPPer Academy curricula will build on treatment models guided by the Health Beliefs Model (HBM) and Social Cognitive Theory (SCT). The curricula includes video microlectures, personalize progress reports, and other features delivered via the internet.
Intervention Type
Other
Intervention Name(s)
Standard of Care
Intervention Description
Parents in the standard of care control group will be instructed to manage their child's T1D as recommended by the diabetes team.
Primary Outcome Measure Information:
Title
Child Glycemic Control
Description
Measure of hemoglobin A1c (HbA1c).
Time Frame
absolute value Post-treatment (Week 33)
Title
Parent Depressive Symptoms
Description
Center for Epidemiological Studies-Depression Scale Revised (CES-D); higher scores suggest worse outcome. Range 0-60.
Time Frame
absolute value Post-treatment (Week 33)
Title
Parent Diabetes Distress
Description
Problem Areas in Diabetes Distress- Parent Report Questionnaire. Higher scores reflect worse outcome. Range 0-72
Time Frame
Absolute value at Post-treatment (Week 33)
Secondary Outcome Measure Information:
Title
Family Mealtime behaviors_Frequency
Description
Behavioral Pediatrics Feeding Assessment Scale. This is a 35 item scale. This subscale reflects the frequency of perceived mealtime behavior problems (possible range: 35-175). Higher scores represent a worse outcome.
Time Frame
absolute value at Post-treatment (Week 33)
Title
Parents' Hypoglycemia Fear
Description
Measured using the Hypoglycemia Fear Survey (HFS-PYC). This is a 26 item measure and higher values represent a worse outcome. Range: 26-130.
Time Frame
absolute value at Post-treatment (Week 33)
Title
Parenting Stress- Frequency
Description
Measured using the Pediatric Inventory for Parents. This is a 42 item measure. Measure is scored so that higher values represent a worse outcome. Range: 42-210
Time Frame
Absolute value at Post-treatment (Week 33)
Title
Parents' T1D Self-efficacy
Description
Measured using the Parental Self-Efficacy Scale for Diabetes Management. This is an 8 item measure of self-efficacy. It has only a total score (items are summed for the total). Range 8-40. Higher scores represent a better outcome.
Time Frame
Absolute value at Post-treatment (Week 33)
Title
Parent Knowledge of T1D
Description
Test of Diabetes Knowledge-5. This is a 41 item measure. There is general knowledge (0-29) and Problem solving (0-11). This is scored based on percent of items correct, so higher scores represent a better outcome.
Time Frame
Absolute value at Post-treatment (Week 33)
Title
Behavioral Pediatric Feeding Assessment Scale_Problem
Description
Measured using the Behavioral Pediatrics Feeding Assessment Scale. This is a 35 item scale. This subscale reflects the number of mealtime behaviors that parents identify as problematic (possible range: 0-35). Higher scores represent a worse outcome.
Time Frame
Absolute value at Post-treatment (Week 33)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Parents of a young child who is between 3-5.99 years old and at least 6 months post T1D diagnosis
Parents who are English-speaking.
Exclusion Criteria:
Parents of young children with evidence of type 2 diabetes or monogenic diabetes.
Parents with evidence of severe psychiatric disorder.
Parents of young children with a comorbid chronic illness (e.g., renal disease) that requires ongoing care beyond T1D.
Parents of young children with a history of anemia or medication use that may interact with glycemic control (e.g., systemic steroids).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eve-Lynn Nelson, PhD
Organizational Affiliation
University of Kansas Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
The Children's Mercy Hospital
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64108
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Iterative Beta Testing of Videos for the DIPPer Academy
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