Type 1 Diabetes MellitusT1DNCT03818711
Communication and Coping for Mothers of Adolescents With Type 1 Diabetes
A study testing Communication & Coping Intervention and Education & Check Ins in people with Type 1 Diabetes Mellitus, run by Vanderbilt University Medical Center at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Type 1 Diabetes Mellitus
- What is being tested?
- Communication & Coping Intervention and Education & Check Ins
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 302 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2019to 2 Sep 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
About this study
Official title: Communication and Coping: Addressing Mothers' Needs to Improve Outcomes in Adolescents With T1D
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.
Read the 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.
- Conditions
- Type 1 Diabetes Mellitus
- Being tested
- Communication & Coping Intervention, Education & Check Ins
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Communication & Coping InterventionBehavioural
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 InsBehavioural
Mothers receive educational materials and participate in individual phone calls related to these materials. A concurrent secret Facebook group will have daily educational posts.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Education & Check Ins |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycemic Control (A1C)
Hemoglobin A1c measured as part of clinic visit indicates the amount of glucose attached to hemoglobin.
Measured: 12 months
Secondary outcomes (12)
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.
Measured: 3 months
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.
Measured: 3 months
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.
Measured: 3 months
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.
Measured: 3 months
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.
Measured: 3 months
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.
Measured: 3 months
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.
Measured: 3 months
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.
Measured: 3 months
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.
Measured: 3 months
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.
Measured: 3 months
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.
Measured: 3 months
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2019
- Study start1 Apr 2019
- Primary completion7 Aug 2023
- Study completion2 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Type 1 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 302 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- University of Connecticut
- Responsible party
- Principal investigator, Sarah Jaser, Vanderbilt University Medical Center
- Investigators
- Sarah Jaser, PhD, Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03818711
- Sponsor's protocol ID
- 171940
- Acronym
- T1D
- Status last verified
- Feb 2025
- First submitted
- 24 Jan 2019
- Last updated
- 7 Feb 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Communication and Coping: Addressing Mothers' Needs to Improve Outcomes in Adolescents With T1D
- ClinicalTrials.gov ID
- NCT03818711
- Acronym / sponsor ID
- T1D / 171940
- Conditions
- Type 1 Diabetes Mellitus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 302 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Collaborators
- University of Connecticut
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 7 Aug 2023 (actual)
- Study completion
- 2 Sep 2023 (actual)
- First posted
- 28 Jan 2019 (actual)
- Results
- Posted 7 Feb 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Communication & Coping Intervention | Experimental | Behavioral: Communication & Coping InterventionA cognitive behavioral intervention for mothers of adolescents with type 1 diabetes to improve coping and the quality of parental involvement. |
| Education & Check Ins | Active comparator | Behavioral: Education & Check InsThe 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Communication & Coping InterventionMothers 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. | Behavioural | Communication & Coping Intervention |
| Education & Check InsMothers receive educational materials and participate in individual phone calls related to these materials. A concurrent secret Facebook group will have daily educational posts. | Behavioural | Education & Check Ins |
Primary outcome
Glycemic Control (A1C)
Time frame: 12 months
Hemoglobin A1c measured as part of clinic visit indicates the amount of glucose attached to hemoglobin.
12 secondary outcomes
Maternal Depressive Symptoms
Time frame: 3 months
Mothers' Diabetes Distress
Time frame: 3 months
Adolescent Psychosocial Functioning - Parent Report
Time frame: 3 months
Adolescent Psychosocial Functioning - Self Report
Time frame: 3 months
Adolescent Quality of Life
Time frame: 3 months
Diabetes-related Family Conflict - Parent Report
Time frame: 3 months
Diabetes-related Family Conflict - Adolescent Report
Time frame: 3 months
Adolescent Diabetes Distress
Time frame: 3 months
Diabetes Knowledge
Time frame: 3 months
Parental Involvement
Time frame: 3 months
Adolescent Adherence
Time frame: 3 months
Quality of Parental Involvement
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sarah Jaser, PhD principal investigator
Vanderbilt University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Communication & Coping Intervention and Education & Check Ins in people with Type 1 Diabetes Mellitus, run by Vanderbilt University Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glycemic Control (A1C) (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2025.