N/A
N=302
Communication and Coping for Mothers of Adolescents With Type 1 Diabetes
Type 1 Diabetes Mellitus
Bottom Line
View on ClinicalTrials.gov: NCT03818711 ↗Enrolled (actual)
302
Serious AEs
3.3%
Results posted
Feb 2025
Primary outcome: Primary: Glycemic Control (A1C) — 8.4; 8.5 Percentage of glycated hemoglobin
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Communication & Coping Intervention (Behavioral); Education & Check Ins (Behavioral)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Vanderbilt University Medical Center
- Primary completion
- Aug 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Glycemic Control (A1C) |
8.4; 8.5 | — |
| SECONDARY Maternal Depressive Symptoms |
6.4; 5.1 | — |
| SECONDARY Mothers' Diabetes Distress |
1.58; 1.72 | — |
| SECONDARY Adolescent Psychosocial Functioning - Parent Report |
55.4; 57.3; 51.2; 52.4; 58.5; 60.8 | — |
| SECONDARY Adolescent Psychosocial Functioning - Self Report |
53.6; 54.4; 48.9; 48.6; 58.5; 58.4 | — |
| SECONDARY Adolescent Quality of Life |
67; 69 | — |
| SECONDARY Diabetes-related Family Conflict - Parent Report |
28.2; 28.8 | — |
| SECONDARY Diabetes-related Family Conflict - Adolescent Report |
30.1; 30.2 | — |
| SECONDARY Adolescent Diabetes Distress |
74; 64 | — |
| SECONDARY Diabetes Knowledge |
69; 82 | — |
| SECONDARY Parental Involvement |
4.1; 4.0 | — |
| SECONDARY Adolescent Adherence |
3.6; 3.7 | — |
| SECONDARY Quality of Parental Involvement |
14.8; 13.1; 9.6; 9.9 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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)
Data sourced from ClinicalTrials.gov (NCT03818711). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.