CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 302 enrolled
Drug / intervention
Communication & Coping Intervention +1 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03818711
NCT03818711N/ACompleted

Communication and Coping: Addressing Mothers' Needs to Improve Outcomes in Adolescents With T1D

Vanderbilt University Medical Center·interventional·Posted Jan 28, 2019·Updated Feb 7, 2025

In Brief

A clinical study evaluating Communication & Coping Intervention and Education & Check Ins for Type 1 Diabetes Mellitus. Completed, enrolled 302 participants across 1 site.

Detailed Summary

Mothers of adolescents with type 1 diabetes experience high levels of depressive symptoms, which impair their ability to monitor and manage diabetes treatment effectively. Further, maternal depressive symptoms are one of the strongest predictors of negative outcomes in adolescents, including deteriorating glycemic control, problems with adherence, poorer quality of life, and greater risk for depression. Given that adolescents are a high-risk population for suboptimal glycemic control - with only 17% meeting treatment goals - there is a critical need for novel interventions to improve outcomes in adolescents with T1D. Yet, previous behavioral interventions for youth with diabetes have had only modest effects on glycemic control, and none have directly targeted maternal depressive symptoms. Building on effective interventions to treat depression in adults, and our own pilot work in this population, the proposed study will use a rigorous approach to evaluate the efficacy of a cognitive-behavioral intervention for mothers of adolescents with type 1 diabetes to promote the use of adaptive coping strategies and positive parenting practices. The aims of this study are to: 1) evaluate the effects of the Communication \& Coping intervention on diabetes-related outcomes; 2) evaluate the effects of the Communication \& Coping intervention on psychosocial outcomes; and 3) explore the differential impact of the intervention across demographic factors. Mothers who are randomized to the Communication \& Coping Intervention will receive individual cognitive-behavioral therapy sessions by phone, as well as access to a Facebook group to augment the material covered in calls and provide social support. Mothers randomized to the Attention Control condition will receive educational materials and phone check-ins, as well as a Facebook group with educational posts. Adolescents and their mothers will be assessed at baseline and again post-intervention, at 3 months, 6 months, and 12 months.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedJan 28, 2019
Enrollment StartApr 1, 2019
Primary CompletionAug 7, 2023
Study CompletionSep 2, 2023
TodayJul 2, 2026
Enrollment to primary: 4.4 yearsPosted 7.4 years ago

Interventions

Communication & Coping Interventionbehavioral

Mothers receive a treatment manual and participate in individual phone calls aimed at reducing depressive symptoms and improving the quality of parental involvement. A concurrent secret Facebook group will have daily posts to reinforce concepts.

Education & Check Insbehavioral

Mothers receive educational materials and participate in individual phone calls related to these materials. A concurrent secret Facebook group will have daily educational posts.