Communication and Coping for Mothers of Adolescents With Type 1 Diabetes

NCT03818711 | Completed Results DMC

• 1 other identifier: 171940
• Study Type: interventional
• Target: 302
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Type 1 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• Glycemic Control (A1C)

  Hemoglobin A1c measured as part of clinic visit indicates the amount of glucose attached to hemoglobin.

  12 months

Secondary Outcomes (12)

• Maternal Depressive Symptoms

  3 months

• Mothers' Diabetes Distress

  3 months

• Adolescent Psychosocial Functioning - Parent Report

  3 months

• Adolescent Psychosocial Functioning - Self Report

  3 months

• Adolescent Quality of Life

  3 months

Study Arms (2)

Communication & Coping Intervention

EXPERIMENTAL

A cognitive behavioral intervention for mothers of adolescents with type 1 diabetes to improve coping and the quality of parental involvement.

Behavioral: Communication & Coping Intervention

Education & Check Ins

ACTIVE COMPARATOR

The comparison group receives educational materials on diabetes management and phone calls, as well as access to a secret Facebook group with daily posts on diabetes management.

Behavioral: Education & Check Ins

Interventions

Communication & Coping Intervention BEHAVIORAL

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.

Communication & Coping Intervention

Education & Check Ins BEHAVIORAL

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

Education & Check Ins

Eligibility Criteria

• Gender Eligibility Details: Female caregiver
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Female caregiver of an adolescent with type 1 diabetes
• Adolescent age 11-17
• Adolescent diagnosed with type 1 diabetes for at least 12 months
• Caregiver reports mild to moderate depressive symptoms (PHQ-9 score of 5-19) OR OR caregiver reports diabetes distress (Parent/Teen Relationship Distress Subscale score of 2 or higher)
• English speaking

You may not qualify if:

• Caregiver reports minimal depressive symptoms (PHQ-9 score less than 5)
• Caregiver reports severe depressive symptoms (PHQ-9 score 20 or higher)
• Caregiver reports history of severe psychopathology (bipolar disorder or schizophrenia)
• Caregiver reports that adolescent has history of severe psychopathology (bipolar disorder or schizophrenia)

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead
• University of Connecticut: collaborator

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics

Results Point of Contact

• Title: Senior ClinicalTrials.gov Administrator
• Organization: Vanderbilt University Medical Center

natalie.dilts@vumc.org

615-322-3581

Study Officials

• Sarah Jaser, PhD

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: January 24, 2019
• First Posted: January 28, 2019
• Study Start: April 1, 2019
• Primary Completion: August 7, 2023
• Study Completion: September 2, 2023
• Last Updated: February 7, 2025
• Results First Posted: February 7, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)