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Communication and Coping for Mothers of Adolescents With Type 1 Diabetes
NA trial testing Communication & Coping Intervention in Type 1 Diabetes Mellitus in 302 participants. Completed in 2 September 2023.
| Lead sponsor | Vanderbilt University Medical Center |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 302 |
| Start date | 1 April 2019 |
| Primary completion | 7 August 2023 |
| Estimated completion | 2 September 2023 |
| Sites | 1 location across United States |
Vanderbilt University Medical Center
Eligibility, any sex, with Type 1 Diabetes Mellitus. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Hemoglobin A1c measured as part of clinic visit indicates the amount of glucose attached to hemoglobin.
| Group | Value | 95% CI |
|---|---|---|
| Communication & Coping Intervention | 8.4 | 7.3 – 10.2 |
| Education & Check Ins | 8.5 | 7.4 – 9.8 |
Depressive symptoms measured using the Patient Health Questionnaire (PHQ-9), a 9-item measure. Scores range from 0-27; scores 0-4 indicate minimal depression, scores 5-9 indicate mild depression, scores 10-14 indicate moderate depression, scores 15-19 indicate moderately severe depression, and scores 20-27 indicate severe depression.
| Group | Value | 95% CI |
|---|---|---|
| Communication & Coping Intervention | 6.4 | ± 4.6 |
| Education & Check Ins | 5.1 | ± 4.6 |
Parent Diabetes Distress Scale (PDDS) is a measure consisting of 20 items to rate diabetes-related stress for parents of children with type 1 diabetes. A mean total score will be calculated, ranging from 0-5, with higher scores indicating greater distress.
| Group | Value | 95% CI |
|---|---|---|
| Communication & Coping Intervention | 1.58 | ± .80 |
| Education & Check Ins | 1.72 | ± .84 |
Child Behavior Checklist (CBCL) is a parent-reported measure of behavior problems in children ages 6-18. Raw scores are converted to age- and sex-normed T-Scores (mean = 50, SD = 10). Higher scores indicate greater problem behaviors.
| Group | Value | 95% CI |
|---|---|---|
| Communication & Coping Intervention | 55.4 | ± 8.7 |
| Education & Check Ins | 57.3 | ± 12.6 |
| Group | Value | 95% CI |
|---|---|---|
| Communication & Coping Intervention | 51.2 | ± 9.9 |
| Education & Check Ins | 52.4 | ± 10.2 |
| Group | Value | 95% CI |
|---|---|---|
| Communication & Coping Intervention | 58.5 | ± 7.9 |
| Education & Check Ins | 60.8 | ± 10.1 |
Youth Self Report (YSR) is a measure of self-reported behavior problems in youth ages 11-18. The Child Behavior Checklist was completed by caregivers as a proxy report of adolescent's behaviors. Raw scores are converted to age- and sex-normed T-Scores (mean = 50, SD = 10). Higher scores indicate greater problem behaviors.
| Group | Value | 95% CI |
|---|---|---|
| Communication & Coping Intervention | 53.6 | ± 12.3 |
| Education & Check Ins | 54.4 | ± 12.5 |
| Group | Value | 95% CI |
|---|---|---|
| Communication & Coping Intervention | 48.9 | ± 10.9 |
| Education & Check Ins | 48.6 | ± 10.2 |
| Group | Value | 95% CI |
|---|---|---|
| Communication & Coping Intervention | 58.5 | ± 9.0 |
| Education & Check Ins | 58.4 | ± 8.3 |
Pediatric Quality of Life (PedsQL) is a self-reported measure of diabetes-related quality of life in youth. Scaled scores range from 0-100, with higher scores indicating better quality of life.
| Group | Value | 95% CI |
|---|---|---|
| Communication & Coping Intervention | 67 | ± 15 |
| Education & Check Ins | 69 | ± 14 |
Diabetes-specific family conflict was measured with the Revised Diabetes Family Conflict Scale (DFCS), which consists of 19 items regarding how much adolescents and parents argue about diabetes management. Scores range from 19-57, with higher scores indicating higher levels of conflict.
| Group | Value | 95% CI |
|---|---|---|
| Communication & Coping Intervention | 28.2 | ± 4.9 |
| Education & Check Ins | 28.8 | ± 6.8 |
Diabetes-specific family conflict will be measured with the Revised Diabetes Family Conflict Scale (DFCS), which consists of 19 items regarding how much adolescents and parents argue about diabetes management. Scores range from 19-57, with higher scores indicating higher levels of conflict.
| Group | Value | 95% CI |
|---|---|---|
| Communication & Coping Intervention | 30.1 | ± 9.8 |
| Education & Check Ins | 30.2 | ± 10.7 |
Problem Area in Diabetes - Teen (PAID-T) consists of 14 items measuring adolescents' diabetes distress. Scores range from 14-84, and scores of 44 or higher are considered clinically meaningful.
| Group | Value | 95% CI |
|---|---|---|
| Communication & Coping Intervention | 74 | ± 30 |
| Education & Check Ins | 64 | ± 27 |
Revised Brief Diabetes Knowledge Test is a measure of parents' diabetes knowledge. It consists of 23 items that ask about diabetes-related information. Scores range from 0-23, with higher scores indicating greater diabetes knowledge.
| Group | Value | 95% CI |
|---|---|---|
| Communication & Coping Intervention | 69 | ± 37 |
| Education & Check Ins | 82 | ± 27 |
Collaborative Parent Involvement (CPI) is a 12-item scale completed by adolescents to assess parental involvement in diabetes care. Mean scores range from 1-5, with higher scores indicating more collaborative parental involvement.
| Group | Value | 95% CI |
|---|---|---|
| Communication & Coping Intervention | 4.1 | ± 0.8 |
| Education & Check Ins | 4.0 | ± 0.9 |
Self Care Inventory (SCI) is a 14-item measure completed by adolescents to assess their diabetes self-management behaviors. Mean scores range from 1-5, and higher scores indicate better adherence to the diabetes regimen.
| Group | Value | 95% CI |
|---|---|---|
| Communication & Coping Intervention | 3.6 | 2.9 – 4.0 |
| Education & Check Ins | 3.7 | 3.3 – 4.1 |
Time frame: 1 year (study period). Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Communication & Coping Int… | Education & Check Ins |
|---|---|---|---|
| DKA | Endocrine disorders | — | — |
| Reaction | System | Communication & Coping Int… | Education & Check Ins |
|---|---|---|---|
| Indicated Self-Harm or Suicidality | Psychiatric disorders | — | — |
Most-reported serious reactions: DKA.
Data from ClinicalTrials.gov NCT03818711 adverse events section.
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.
2 peer-reviewed publications reference this trial (live from Europe PMC):
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