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Communication and Coping for Mothers of Adolescents With Type 1 Diabetes

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03818711
Acronym
T1D
Enrollment
302
Registered
2019-01-28
Start date
2019-04-01
Completion date
2023-09-02
Last updated
2025-02-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 1 Diabetes Mellitus

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.

Detailed description

Mothers of adolescents with type 1 diabetes experience high levels of depressive symptoms, which impair their ability to monitor and manage diabetes treatment effectively. The regimen recommended for type 1 diabetes is complex and demanding, and caregivers - especially mothers - experience stress related to the burden of treatment management. This stress is associated with increased risk for psychosocial problems in caregivers, with rates of clinically significant depressive symptoms evident in up to 61% of parents. 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. Responding to the American Diabetes Association's call to address the psychosocial needs of people with diabetes and their family members, the proposed project has the potential to improve outcomes in both adolescents with type 1 diabetes and their mothers. 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. We hypothesize that the adolescents of mothers who receive the intervention will demonstrate improvements in diabetes outcomes (i.e., glycemic control, adherence), as well as psychosocial outcomes (i.e., improved quality of life, fewer depressive symptoms) compared to those in the attention control condition. This approach is innovative by targeting maternal depressive symptoms and the quality of parental involvement in mothers of adolescents with type 1 diabetes.

Interventions

BEHAVIORALCommunication & Coping Intervention

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.

BEHAVIORALEducation & Check Ins

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

Sponsors

University of Connecticut
CollaboratorOTHER
Vanderbilt University Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Glycemic Control (A1C)12 monthsHemoglobin A1c measured as part of clinic visit indicates the amount of glucose attached to hemoglobin.

Secondary

MeasureTime frameDescription
Mothers' Diabetes Distress3 monthsParent 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.
Adolescent Psychosocial Functioning - Parent Report3 monthsChild 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.
Adolescent Psychosocial Functioning - Self Report3 monthsYouth 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.
Adolescent Quality of Life3 monthsPediatric 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.
Diabetes-related Family Conflict - Parent Report3 monthsDiabetes-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.
Maternal Depressive Symptoms3 monthsDepressive 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.
Adolescent Diabetes Distress3 monthsProblem 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.
Diabetes Knowledge3 monthsRevised 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.
Parental Involvement3 monthsCollaborative 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.
Adolescent Adherence3 monthsSelf 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.
Quality of Parental Involvement6 monthsMothers and adolescents will participate in a videotaped conversation, which will be scored by objective raters using the Iowa Family Interaction Rating Scales (IFIRS). The collaborative parenting composite includes the following codes: Communication; Positive Reinforcement; and Child Centered. Scores on the collaborative parenting composite range from 3-27, with higher scores indicating higher levels of collaborative parenting. The overinvolved/intrusive parenting composite includes: Parental Influence; Intrusiveness; and Lecture/Moralize. Scores on the overinvolved scale range from 3-27, with higher scores indicating higher levels of observed behavior.
Diabetes-related Family Conflict - Adolescent Report3 monthsDiabetes-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.

Countries

United States

Participant flow

Recruitment details

Recruited from the Children's Diabetes Program at Vanderbilt, as well as the Vanderbilt Research Notifications Distribution List.

Pre-assignment details

Caregiver-adolescent dyads were enrolled and randomized. After enrollment, maternal caregiver participants were required to connect to the study Facebook account prior to randomization. Protocol Enrollment, Number Started, and Completed reflect participants. 3 dyads were enrolled but not randomized: Two caregivers completed baseline data but did not connect to the study Facebook account. One dyad consented and started baseline surveys but decided not to continue.

Participants by arm

ArmCount
Communication & Coping Intervention
A cognitive behavioral intervention for mothers of adolescents with type 1 diabetes to improve coping and the quality of parental involvement. Communication & Coping Intervention: 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.
150
Education & Check Ins
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. Education & Check Ins: Mothers receive educational materials and participate in individual phone calls related to these materials. A concurrent secret Facebook group will have daily educational posts.
152
Total302

Baseline characteristics

CharacteristicCommunication & Coping InterventionEducation & Check InsTotal
Age, Continuous
Adolescent Age
14 years14 years14 years
Age, Continuous
Caregiver Age
42 years41 years42 years
Ethnicity (NIH/OMB)
Adolescent Ethnicity
Hispanic or Latino
3 Participants2 Participants5 Participants
Ethnicity (NIH/OMB)
Adolescent Ethnicity
Not Hispanic or Latino
72 Participants74 Participants146 Participants
Ethnicity (NIH/OMB)
Adolescent Ethnicity
Unknown or Not Reported
0 Participants0 Participants0 Participants
Ethnicity (NIH/OMB)
Maternal Caregiver Ethnicity
Hispanic or Latino
2 Participants2 Participants4 Participants
Ethnicity (NIH/OMB)
Maternal Caregiver Ethnicity
Not Hispanic or Latino
73 Participants74 Participants147 Participants
Ethnicity (NIH/OMB)
Maternal Caregiver Ethnicity
Unknown or Not Reported
0 Participants0 Participants0 Participants
Hemoglobin A1c8.2 percentage of glycated hemoglobin8.7 percentage of glycated hemoglobin8.5 percentage of glycated hemoglobin
Household Income
$100,000 or more
27 Participants27 Participants54 Participants
Household Income
<$19,999
4 Participants4 Participants8 Participants
Household Income
$20-$39,999
5 Participants8 Participants13 Participants
Household Income
$40-$59,999
13 Participants11 Participants24 Participants
Household Income
$60-$79,999
14 Participants13 Participants27 Participants
Household Income
$80-$99,999
11 Participants12 Participants23 Participants
Household Income
Missing
1 Participants1 Participants2 Participants
Marital Status
Married/Partnered
60 Participants62 Participants122 Participants
Marital Status
Single/Divorced/Widowed
15 Participants14 Participants29 Participants
Race (NIH/OMB)
Adolescent Race
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Adolescent Race
Asian
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Adolescent Race
Black or African American
5 Participants9 Participants14 Participants
Race (NIH/OMB)
Adolescent Race
More than one race
6 Participants2 Participants8 Participants
Race (NIH/OMB)
Adolescent Race
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Adolescent Race
Unknown or Not Reported
1 Participants0 Participants1 Participants
Race (NIH/OMB)
Adolescent Race
White
63 Participants65 Participants128 Participants
Race (NIH/OMB)
Maternal Caregiver Race
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Maternal Caregiver Race
Asian
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Maternal Caregiver Race
Black or African American
5 Participants7 Participants12 Participants
Race (NIH/OMB)
Maternal Caregiver Race
More than one race
2 Participants0 Participants2 Participants
Race (NIH/OMB)
Maternal Caregiver Race
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Maternal Caregiver Race
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Maternal Caregiver Race
White
68 Participants69 Participants137 Participants
Region of Enrollment
United States
75 participants76 participants151 participants
Sex: Female, Male
Adolescent Sex
Female
45 Participants39 Participants84 Participants
Sex: Female, Male
Adolescent Sex
Male
30 Participants37 Participants67 Participants
Sex: Female, Male
Caregiver Sex
Female
75 Participants76 Participants151 Participants
Sex: Female, Male
Caregiver Sex
Male
0 Participants0 Participants0 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 750 / 76
other
Total, other adverse events
7 / 755 / 76
serious
Total, serious adverse events
2 / 753 / 76

Outcome results

Primary

Glycemic Control (A1C)

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

Time frame: 12 months

Population: Only adolescents participants have the A1C value.

ArmMeasureValue (MEDIAN)
Communication & Coping InterventionGlycemic Control (A1C)8.4 Percentage of glycated hemoglobin
Education & Check InsGlycemic Control (A1C)8.5 Percentage of glycated hemoglobin
Secondary

Adolescent Adherence

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.

Time frame: 3 months

Population: Only adolescent participants completed this measure.

ArmMeasureValue (MEDIAN)
Communication & Coping InterventionAdolescent Adherence3.6 score on a scale
Education & Check InsAdolescent Adherence3.7 score on a scale
Secondary

Adolescent Diabetes Distress

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.

Time frame: 3 months

ArmMeasureValue (MEAN)Dispersion
Communication & Coping InterventionAdolescent Diabetes Distress74 score on a scaleStandard Deviation 30
Education & Check InsAdolescent Diabetes Distress64 score on a scaleStandard Deviation 27
Secondary

Adolescent Psychosocial Functioning - Parent Report

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.

Time frame: 3 months

Population: Only maternal caregiver participants completed this measure.

ArmMeasureGroupValue (MEAN)Dispersion
Communication & Coping InterventionAdolescent Psychosocial Functioning - Parent ReportInternalizing Problems55.4 T-ScoreStandard Deviation 8.7
Communication & Coping InterventionAdolescent Psychosocial Functioning - Parent ReportExternalizing Problems51.2 T-ScoreStandard Deviation 9.9
Communication & Coping InterventionAdolescent Psychosocial Functioning - Parent ReportDepressive Problems58.5 T-ScoreStandard Deviation 7.9
Education & Check InsAdolescent Psychosocial Functioning - Parent ReportInternalizing Problems57.3 T-ScoreStandard Deviation 12.6
Education & Check InsAdolescent Psychosocial Functioning - Parent ReportExternalizing Problems52.4 T-ScoreStandard Deviation 10.2
Education & Check InsAdolescent Psychosocial Functioning - Parent ReportDepressive Problems60.8 T-ScoreStandard Deviation 10.1
Secondary

Adolescent Psychosocial Functioning - Self Report

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.

Time frame: 3 months

Population: Only adolescent participants completed this measure.

ArmMeasureGroupValue (MEAN)Dispersion
Communication & Coping InterventionAdolescent Psychosocial Functioning - Self ReportInternalizing Problems53.6 T-ScoreStandard Deviation 12.3
Communication & Coping InterventionAdolescent Psychosocial Functioning - Self ReportExternalizing Problems48.9 T-ScoreStandard Deviation 10.9
Communication & Coping InterventionAdolescent Psychosocial Functioning - Self ReportDepressive Problems58.5 T-ScoreStandard Deviation 9
Education & Check InsAdolescent Psychosocial Functioning - Self ReportInternalizing Problems54.4 T-ScoreStandard Deviation 12.5
Education & Check InsAdolescent Psychosocial Functioning - Self ReportExternalizing Problems48.6 T-ScoreStandard Deviation 10.2
Education & Check InsAdolescent Psychosocial Functioning - Self ReportDepressive Problems58.4 T-ScoreStandard Deviation 8.3
Secondary

Adolescent Quality of Life

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.

Time frame: 3 months

Population: Only adolescent participants completed this measure.

ArmMeasureValue (MEAN)Dispersion
Communication & Coping InterventionAdolescent Quality of Life67 score on a scaleStandard Deviation 15
Education & Check InsAdolescent Quality of Life69 score on a scaleStandard Deviation 14
Secondary

Diabetes Knowledge

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.

Time frame: 3 months

Population: Only maternal caregiver participants completed this measure.

ArmMeasureValue (MEAN)Dispersion
Communication & Coping InterventionDiabetes Knowledge69 percentage of items correctStandard Deviation 37
Education & Check InsDiabetes Knowledge82 percentage of items correctStandard Deviation 27
Secondary

Diabetes-related Family Conflict - Adolescent Report

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.

Time frame: 3 months

Population: Only adolescent participants completed this measure.

ArmMeasureValue (MEAN)Dispersion
Communication & Coping InterventionDiabetes-related Family Conflict - Adolescent Report30.1 score on a scaleStandard Deviation 9.8
Education & Check InsDiabetes-related Family Conflict - Adolescent Report30.2 score on a scaleStandard Deviation 10.7
Secondary

Diabetes-related Family Conflict - Parent Report

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.

Time frame: 3 months

Population: Only maternal caregiver participants completed this measure.

ArmMeasureValue (MEAN)Dispersion
Communication & Coping InterventionDiabetes-related Family Conflict - Parent Report28.2 score on a scaleStandard Deviation 4.9
Education & Check InsDiabetes-related Family Conflict - Parent Report28.8 score on a scaleStandard Deviation 6.8
Secondary

Maternal Depressive Symptoms

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.

Time frame: 3 months

Population: Only maternal caregiver participants completed this measure.

ArmMeasureValue (MEAN)Dispersion
Communication & Coping InterventionMaternal Depressive Symptoms6.4 score on a scaleStandard Deviation 4.6
Education & Check InsMaternal Depressive Symptoms5.1 score on a scaleStandard Deviation 4.6
Secondary

Mothers' Diabetes Distress

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.

Time frame: 3 months

Population: Only maternal caregiver participants completed this measure.

ArmMeasureValue (MEAN)Dispersion
Communication & Coping InterventionMothers' Diabetes Distress1.58 score on a scaleStandard Deviation 0.8
Education & Check InsMothers' Diabetes Distress1.72 score on a scaleStandard Deviation 0.84
Secondary

Parental Involvement

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.

Time frame: 3 months

Population: Only adolescent participants completed this measure.

ArmMeasureValue (MEAN)Dispersion
Communication & Coping InterventionParental Involvement4.1 score on a scaleStandard Deviation 0.8
Education & Check InsParental Involvement4.0 score on a scaleStandard Deviation 0.9
Secondary

Quality of Parental Involvement

Mothers and adolescents will participate in a videotaped conversation, which will be scored by objective raters using the Iowa Family Interaction Rating Scales (IFIRS). The collaborative parenting composite includes the following codes: Communication; Positive Reinforcement; and Child Centered. Scores on the collaborative parenting composite range from 3-27, with higher scores indicating higher levels of collaborative parenting. The overinvolved/intrusive parenting composite includes: Parental Influence; Intrusiveness; and Lecture/Moralize. Scores on the overinvolved scale range from 3-27, with higher scores indicating higher levels of observed behavior.

Time frame: 6 months

Population: Analysis conducted if participants had baseline and 6 month videos.

ArmMeasureGroupValue (MEAN)Dispersion
Communication & Coping InterventionQuality of Parental InvolvementCollaborative Parent Behaviors14.8 score on a scaleStandard Deviation 3.6
Communication & Coping InterventionQuality of Parental InvolvementIntrusive Parent Behaviors9.6 score on a scaleStandard Deviation 4.2
Education & Check InsQuality of Parental InvolvementCollaborative Parent Behaviors13.1 score on a scaleStandard Deviation 3.6
Education & Check InsQuality of Parental InvolvementIntrusive Parent Behaviors9.9 score on a scaleStandard Deviation 4

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026