Iterative Beta Testing of Videos for the DIPPer Academy

Not Applicable

Completed

• Conditions: Type1diabetes
• Interventions: Behavioral: DIPPer Academy; Other: Standard of Care

• Registration Number: NCT03385265
• Lead Sponsor: University of Kansas Medical Center

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.

Study Timeline

• Study First Submitted: 2017-12-20
• Study First Submitted QC: 2017-12-20
• Study First Posted: 2017-12-28
• Study Start: 2018-01-01
• Primary Completion: 2021-07-29
• Study Completion: 2021-09-01
• Results First Submitted: 2022-01-03
• Status Verified: 2022-03
• Results First Submitted QC: 2022-03-10
• Last Update Submitted: 2022-03-10
• Results First Posted: 2022-03-11
• Last Update Posted: 2022-03-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 62

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DIPPer Academy	DIPPer Academy	Parents randomized to this group will participate in the DIPPer Academy curriculum.
Standard of Care Control	Standard of Care	Parents randomized to this group will receive care as usual from their child's diabetes provider

Primary Outcome Measures

Name	Time	Method
Child Glycemic Control	absolute value Post-treatment (Week 33)	Measure of hemoglobin A1c (HbA1c).
Parent Depressive Symptoms	absolute value Post-treatment (Week 33)	Center for Epidemiological Studies-Depression Scale Revised (CES-D); higher scores suggest worse outcome. Range 0-60.
Parent Diabetes Distress	Absolute value at Post-treatment (Week 33)	Problem Areas in Diabetes Distress- Parent Report Questionnaire. Higher scores reflect worse outcome. Range 0-72

Secondary Outcome Measures

Name	Time	Method
Family Mealtime behaviors_Frequency	absolute value at Post-treatment (Week 33)	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	absolute value at Post-treatment (Week 33)	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	Absolute value at Post-treatment (Week 33)	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	Absolute value at Post-treatment (Week 33)	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	Absolute value at Post-treatment (Week 33)	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	Absolute value at Post-treatment (Week 33)	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.

Trial Locations

Locations (2)

The Children's Mercy Hospital; 🇺🇸 Kansas City, Missouri, United States

University of Kansas Medical Center; 🇺🇸 Kansas City, Kansas, United States