PETS-D (Parent Education Thru Simulation-Diabetes)

Phase 3

Completed

• Conditions: Type 1 Diabetes

• Registration Number: NCT01517269
• Lead Sponsor: University of Massachusetts, Worcester

Brief Summary

Hypothesis: Parents who receive Parent Education Thru Simulation-Diabetes (PETS-D) will have significantly higher diabetes knowledge (cognitive visual schemata), better technical and problem-solving competence and confidence, and lower fear and stress/anxiety levels; and provide better diabetes management at 14 weeks compared to those parents receiving standard diabetes education.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-04
• Study First Submitted: 2012-01-13
• Study First Submitted QC: 2012-01-24
• Study First Posted: 2012-01-25
• Status Verified: 2015-03
• Primary Completion: 2015-03
• Study Completion: 2015-03
• Last Update Submitted: 2015-03-06
• Last Update Posted: 2015-03-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 191

Inclusion Criteria

• parents 18 years and older who have a child newly diagnosed with type 1 diabetes mellitus (T1DM) from 5 years old to under 13 years of age

Exclusion Criteria

• exclude children with developmental delays (such as Down Syndrome, Autism) or steroid induced diabetes (cancer treatment related or cystic fibrosis)
• exclude parents who require insulin treatment -or- those that have another child with TIDM

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in baseline of Diabetes Knowledge	Baseline and 14 weeks	Diabetes Awareness and Reasoning Test-Parents (DART-P)is a 47-item multiple-choice questionnaire. The subscales include general, insulin, hyper-hypglycemia, and problem-solving. Parent education was a significant predictor of total scores.

Secondary Outcome Measures

Name	Time	Method
Change in Baseline of Diabetes management	Baseline and 14 weeks	Diabetes Management Outcomes is a 5 question likert scale based on ADA2 management recommendations.
Change in Baseline of Diabetes self efficacy	Baseline and 14 weeks	The Self-Efficacy Diabetes-Pediatrics (SED-P) will be used to measure parent confidence in specific task and skill associated diabetes care, i.e. how confident they feel to perform day-to-day diabetes management.
Change in Baseline of Fear of hypoglycemia	Baseline and 14 weeks	The Hypoglycemia Fear Survey-Parents (HFS-P) total score will be used to measure parental fears and avoidance behaviors associated with hypoglycemia in their children.There are 2 subscales that measure parental concerns of their child experiencing an episode of hypoglycemia and behaviors they use to prevent these episodes from occurring
Change in Baseline of Problem solving	Baseline and 14 weeks	Wysocki's Modified Problem-solving measure18 (PSM) is a 5 item questionnaire that focuses on how to proactively prevent and treat hypoglycemia. Dr. Wysocki sent us one of his vignettes developed from the structured interview measure. Based on the examples of probes that are part of the interview, we constructed a 5-question multiple choice instrument to measure parental problem-solving abilities and knowledge synthesis. We will report the reliability and validity of this measure with data from the proposed study.
Change in Baseline of Parent anxiety	Baseline and 14 weeks	State-Trait Anxiety (STAI) is a well established 40-item instrument (Likert scale, with 1 being not at all, to 4 being almost always) used to measure situational (state, how one feels at this moment) and stable (trait, how one feels in general) tendencies toward anxiety. Higher scores signify more anxiety

Trial Locations

Locations (1)

University of Massachusetts, Worcester; 🇺🇸 Worcester, Massachusetts, United States