Iterative Beta Testing of Videos for the DIPPer Academy

Study Overview
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Brief Summary
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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
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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.

Official Title
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An Interactive mHealth App for Better Glycemic Control in Parents of Young Kids With T1D

Conditions
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Type1diabetes

Intervention / Treatment
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* Behavioral: DIPPer Academy
* Other: Standard of Care


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DIPPer Academy<br>Parents randomized to this group will participate in the DIPPer Academy curriculum. | Behavioral: DIPPer Academy<br>* 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.<br>|
| Active Comparator: Standard of Care Control<br>Parents randomized to this group will receive care as usual from their child's diabetes provider | Other: Standard of Care<br>* Parents in the standard of care control group will be instructed to manage their child's T1D as recommended by the diabetes team.<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | absolute value at Post-treatment (Week 33) | 
| 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. | absolute value at Post-treatment (Week 33) | 
| 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 | Absolute value at Post-treatment (Week 33) | 
| 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. | Absolute value at Post-treatment (Week 33) | 
| 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. | Absolute value at Post-treatment (Week 33) | 
| 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. | Absolute value at Post-treatment (Week 33) |