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COMPLETED
NCT03914547
NA

Home Video-based Telemedicine to Reduce Hypoglycemia Fear in Parents of Young Children

Sponsor: Nemours Children's Clinic

View on ClinicalTrials.gov

Summary

Investigators developed REDCHiP (Reducing Emotional Distress for Childhood Hypoglycemia in Parents), an innovative video-based telemedicine intervention. In the pilot work, investigators found preliminary efficacy for REDCHiP in reducing parental FH, parenting stress, and children's HbA1c. The objective of this clinical trial is to conduct a randomized clinical trial (RCT) comparing REDCHiP to a relevant attention control intervention (ATTN) in families of young children, thereby continuing to establish its efficacy. The proposed R01 aims are: 1) To evaluate whether parents who receive REDCHiP report reductions in FH and parenting stress at post-treatment compared to parents who receive the ATTN; 2) To evaluate whether children of parents who receive REDCHiP have a lower HbA1c and less glycemic variability at post-treatment compared to children of parents who receive ATTN; 3) To examine whether families who receive REDCHiP maintain reductions in FH, parenting stress, and child HbA1c at a 3-month followup compared to families who receive ATTN.

Key Details

Gender

All

Age Range

2 Years - 6 Years

Study Type

INTERVENTIONAL

Enrollment

394

Start Date

2019-10-15

Completion Date

2026-03-31

Last Updated

2026-09-15

Healthy Volunteers

No

Interventions

BEHAVIORAL

REDCHiP

REDCHiP includes 10 telehealth sessions. REDCHiP uses a three-pronged approach to reduce parents' FH. It uses T1D education and problem-solving to enhance parents' knowledge and skills. It uses child age-appropriate behavioral parent training to promote parents' skills and confidence in managing disruptive child behaviors and reducing their reliance on hypoglycemia avoidance behaviors. It uses cognitive-behavioral therapy strategies to help parents reduce maladaptive thinking/coping related to hypoglycemia fear.

BEHAVIORAL

ATTN

Provides a similar attention control. ATTN includes 10 telehealth sessions.

Locations (2)

University of Florida

Gainesville, Florida, United States

The Children's Mercy Hospital

Kansas City, Missouri, United States