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

NCT03914547 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 396

Last updated 2026-04-06

No results posted yet for this study

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.

Conditions

  • Type 1 Diabetes Mellitus

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.

Sponsors & Collaborators

  • Children's Mercy Hospital Kansas City

    collaborator OTHER

  • University of Florida

    collaborator OTHER

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    collaborator NIH

  • Nemours Children's Clinic

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
6 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-10-15
Primary Completion
2025-06-01
Completion
2026-03-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03914547 on ClinicalTrials.gov