Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT03914547 |
| Other study ID # |
STUDY00000545 |
| Secondary ID |
1R01DK118514-01A |
| Status |
Active, not recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
October 15, 2019 |
| Est. completion date |
March 31, 2025 |
Study information
| Verified date |
January 2024 |
| Source |
Nemours Children's Clinic |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
Description:
The purpose of this trial is to examine the efficacy of a real-time video-based telemedicine
intervention addressing parental fear of hypoglycemia (FH) in families of young children with
type 1 diabetes (T1D). Hypoglycemia is a common negative event associated with intensive
insulin therapy in children with T1D. Young children with T1D are particularly vulnerable to
episodes of hypoglycemia because they tend to be more insulin sensitive, may engage in
unpredictable eating and physical activity patterns, and may be less able to recognize and
report symptoms. Parents and young children living with T1D quickly learn to fear
hypoglycemia because it is uncomfortable, embarrassing, seemingly unpredictable, and
potentially dangerous. Indeed, research shows that parents of young children report high
rates of moderate to severe FH. Unfortunately, FH leads to two problems: impaired quality of
life and compensatory behaviors that raise children's blood glucose levels leading to
on-going poor metabolic control (HbA1c) and an increased risk for long-term vascular
complications. Responding to a critical need for interventions to treat parental FH in
families of young children, investigators developed an innovative video-based telemedicine
intervention, called REDCHiP (Reducing Emotional Distress for Childhood Hypoglycemia in
Parents). REDCHiP uses cognitive behavioral therapy, T1D education, and behavioral parent
training in a 10-session individual and group-based telemedicine program, to reduce parental
FH and to teach parents how to change hypoglycemia avoidance behaviors. In the pilot work,
investigators found preliminary efficacy for REDCHiP in reducing parental FH, parenting
stress, and children's HbA1c. The objective of the proposed R01 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. Investigators will recruit
180 families with the goal of retaining at least 144 through the 3-month followup. After
informed consent, investigators will randomize parents to either REDCHiP or ATTN and have
them complete baseline measures (e.g., parent surveys, child glucose sensing, child/parent
accelerometry, and child HbA1c). Then, parents in both groups will participate in 10
video-based telemedicine sessions matched for time and format (group v individual). At
post-treatment, parents and children will repeat the baseline assessment; at the 3-month
followup, parents will complete surveys and children will undergo glucose sensing and an
HbA1c. Primary outcomes of the revised trial are: parents' FH, parenting stress, children's
HbA1c levels and children's glycemic variability (measured by percent time above, below and
within-range). Secondary measures include child physical activity and sleep, parent sleep,
parent depressive symptoms and anxiety, and parent psychopathology.
