Trial Outcomes & Findings for Communication and Coping for Mothers of Adolescents With Type 1 Diabetes (NCT NCT03818711)
NCT ID: NCT03818711
Last Updated: 2025-02-07
Results Overview
Hemoglobin A1c measured as part of clinic visit indicates the amount of glucose attached to hemoglobin.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
302 participants
Primary outcome timeframe
12 months
Results posted on
2025-02-07
Participant Flow
Recruited from the Children's Diabetes Program at Vanderbilt, as well as the Vanderbilt Research Notifications Distribution List.
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.
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Baseline Through Intervention
STARTED
|
150
|
152
|
|
Baseline Through Intervention
Caregivers
|
75
|
76
|
|
Baseline Through Intervention
Adolescents
|
75
|
76
|
|
Baseline Through Intervention
COMPLETED
|
148
|
150
|
|
Baseline Through Intervention
NOT COMPLETED
|
2
|
2
|
|
3-month Data Collection
STARTED
|
148
|
150
|
|
3-month Data Collection
Caregiver
|
74
|
75
|
|
3-month Data Collection
Adolescent
|
74
|
75
|
|
3-month Data Collection
COMPLETED
|
144
|
148
|
|
3-month Data Collection
NOT COMPLETED
|
4
|
2
|
|
6-month Data Collection
STARTED
|
144
|
148
|
|
6-month Data Collection
Caregiver
|
72
|
74
|
|
6-month Data Collection
Adolescent
|
72
|
74
|
|
6-month Data Collection
COMPLETED
|
144
|
142
|
|
6-month Data Collection
NOT COMPLETED
|
0
|
6
|
|
12-month Data Collection
STARTED
|
144
|
142
|
|
12-month Data Collection
Caregiver
|
62
|
64
|
|
12-month Data Collection
Adolescent
|
59
|
62
|
|
12-month Data Collection
COMPLETED
|
121
|
126
|
|
12-month Data Collection
NOT COMPLETED
|
23
|
16
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Caregiver age analyzed separately from adolescent age.
Baseline characteristics by cohort
| Measure |
Communication & Coping Intervention
n=150 Participants
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.
|
Education & Check Ins
n=152 Participants
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.
|
Total
n=302 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
Caregiver Age
|
42 years
n=75 Participants • Caregiver age analyzed separately from adolescent age.
|
41 years
n=76 Participants • Caregiver age analyzed separately from adolescent age.
|
42 years
n=151 Participants • Caregiver age analyzed separately from adolescent age.
|
|
Age, Continuous
Adolescent Age
|
14 years
n=75 Participants • Caregiver age analyzed separately from adolescent age.
|
14 years
n=76 Participants • Caregiver age analyzed separately from adolescent age.
|
14 years
n=151 Participants • Caregiver age analyzed separately from adolescent age.
|
|
Sex: Female, Male
Caregiver Sex · Female
|
75 Participants
n=75 Participants • Participants were caregiver-adolescent dyads.
|
76 Participants
n=76 Participants • Participants were caregiver-adolescent dyads.
|
151 Participants
n=151 Participants • Participants were caregiver-adolescent dyads.
|
|
Sex: Female, Male
Caregiver Sex · Male
|
0 Participants
n=75 Participants • Participants were caregiver-adolescent dyads.
|
0 Participants
n=76 Participants • Participants were caregiver-adolescent dyads.
|
0 Participants
n=151 Participants • Participants were caregiver-adolescent dyads.
|
|
Sex: Female, Male
Adolescent Sex · Female
|
45 Participants
n=75 Participants • Participants were caregiver-adolescent dyads.
|
39 Participants
n=76 Participants • Participants were caregiver-adolescent dyads.
|
84 Participants
n=151 Participants • Participants were caregiver-adolescent dyads.
|
|
Sex: Female, Male
Adolescent Sex · Male
|
30 Participants
n=75 Participants • Participants were caregiver-adolescent dyads.
|
37 Participants
n=76 Participants • Participants were caregiver-adolescent dyads.
|
67 Participants
n=151 Participants • Participants were caregiver-adolescent dyads.
|
|
Ethnicity (NIH/OMB)
Maternal Caregiver Ethnicity · Hispanic or Latino
|
2 Participants
n=75 Participants • Ethnicity of caregivers and adolescents were analyzed separately.
|
2 Participants
n=76 Participants • Ethnicity of caregivers and adolescents were analyzed separately.
|
4 Participants
n=151 Participants • Ethnicity of caregivers and adolescents were analyzed separately.
|
|
Ethnicity (NIH/OMB)
Maternal Caregiver Ethnicity · Not Hispanic or Latino
|
73 Participants
n=75 Participants • Ethnicity of caregivers and adolescents were analyzed separately.
|
74 Participants
n=76 Participants • Ethnicity of caregivers and adolescents were analyzed separately.
|
147 Participants
n=151 Participants • Ethnicity of caregivers and adolescents were analyzed separately.
|
|
Ethnicity (NIH/OMB)
Maternal Caregiver Ethnicity · Unknown or Not Reported
|
0 Participants
n=75 Participants • Ethnicity of caregivers and adolescents were analyzed separately.
|
0 Participants
n=76 Participants • Ethnicity of caregivers and adolescents were analyzed separately.
|
0 Participants
n=151 Participants • Ethnicity of caregivers and adolescents were analyzed separately.
|
|
Ethnicity (NIH/OMB)
Adolescent Ethnicity · Hispanic or Latino
|
3 Participants
n=75 Participants • Ethnicity of caregivers and adolescents were analyzed separately.
|
2 Participants
n=76 Participants • Ethnicity of caregivers and adolescents were analyzed separately.
|
5 Participants
n=151 Participants • Ethnicity of caregivers and adolescents were analyzed separately.
|
|
Ethnicity (NIH/OMB)
Adolescent Ethnicity · Not Hispanic or Latino
|
72 Participants
n=75 Participants • Ethnicity of caregivers and adolescents were analyzed separately.
|
74 Participants
n=76 Participants • Ethnicity of caregivers and adolescents were analyzed separately.
|
146 Participants
n=151 Participants • Ethnicity of caregivers and adolescents were analyzed separately.
|
|
Ethnicity (NIH/OMB)
Adolescent Ethnicity · Unknown or Not Reported
|
0 Participants
n=75 Participants • Ethnicity of caregivers and adolescents were analyzed separately.
|
0 Participants
n=76 Participants • Ethnicity of caregivers and adolescents were analyzed separately.
|
0 Participants
n=151 Participants • Ethnicity of caregivers and adolescents were analyzed separately.
|
|
Race (NIH/OMB)
Maternal Caregiver Race · American Indian or Alaska Native
|
0 Participants
n=75 Participants • Race of caregivers and adolescents analyzed separately.
|
0 Participants
n=76 Participants • Race of caregivers and adolescents analyzed separately.
|
0 Participants
n=151 Participants • Race of caregivers and adolescents analyzed separately.
|
|
Race (NIH/OMB)
Maternal Caregiver Race · Asian
|
0 Participants
n=75 Participants • Race of caregivers and adolescents analyzed separately.
|
0 Participants
n=76 Participants • Race of caregivers and adolescents analyzed separately.
|
0 Participants
n=151 Participants • Race of caregivers and adolescents analyzed separately.
|
|
Race (NIH/OMB)
Maternal Caregiver Race · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=75 Participants • Race of caregivers and adolescents analyzed separately.
|
0 Participants
n=76 Participants • Race of caregivers and adolescents analyzed separately.
|
0 Participants
n=151 Participants • Race of caregivers and adolescents analyzed separately.
|
|
Race (NIH/OMB)
Maternal Caregiver Race · Black or African American
|
5 Participants
n=75 Participants • Race of caregivers and adolescents analyzed separately.
|
7 Participants
n=76 Participants • Race of caregivers and adolescents analyzed separately.
|
12 Participants
n=151 Participants • Race of caregivers and adolescents analyzed separately.
|
|
Race (NIH/OMB)
Maternal Caregiver Race · White
|
68 Participants
n=75 Participants • Race of caregivers and adolescents analyzed separately.
|
69 Participants
n=76 Participants • Race of caregivers and adolescents analyzed separately.
|
137 Participants
n=151 Participants • Race of caregivers and adolescents analyzed separately.
|
|
Race (NIH/OMB)
Maternal Caregiver Race · More than one race
|
2 Participants
n=75 Participants • Race of caregivers and adolescents analyzed separately.
|
0 Participants
n=76 Participants • Race of caregivers and adolescents analyzed separately.
|
2 Participants
n=151 Participants • Race of caregivers and adolescents analyzed separately.
|
|
Race (NIH/OMB)
Maternal Caregiver Race · Unknown or Not Reported
|
0 Participants
n=75 Participants • Race of caregivers and adolescents analyzed separately.
|
0 Participants
n=76 Participants • Race of caregivers and adolescents analyzed separately.
|
0 Participants
n=151 Participants • Race of caregivers and adolescents analyzed separately.
|
|
Race (NIH/OMB)
Adolescent Race · American Indian or Alaska Native
|
0 Participants
n=75 Participants • Race of caregivers and adolescents analyzed separately.
|
0 Participants
n=76 Participants • Race of caregivers and adolescents analyzed separately.
|
0 Participants
n=151 Participants • Race of caregivers and adolescents analyzed separately.
|
|
Race (NIH/OMB)
Adolescent Race · Asian
|
0 Participants
n=75 Participants • Race of caregivers and adolescents analyzed separately.
|
0 Participants
n=76 Participants • Race of caregivers and adolescents analyzed separately.
|
0 Participants
n=151 Participants • Race of caregivers and adolescents analyzed separately.
|
|
Race (NIH/OMB)
Adolescent Race · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=75 Participants • Race of caregivers and adolescents analyzed separately.
|
0 Participants
n=76 Participants • Race of caregivers and adolescents analyzed separately.
|
0 Participants
n=151 Participants • Race of caregivers and adolescents analyzed separately.
|
|
Race (NIH/OMB)
Adolescent Race · Black or African American
|
5 Participants
n=75 Participants • Race of caregivers and adolescents analyzed separately.
|
9 Participants
n=76 Participants • Race of caregivers and adolescents analyzed separately.
|
14 Participants
n=151 Participants • Race of caregivers and adolescents analyzed separately.
|
|
Race (NIH/OMB)
Adolescent Race · White
|
63 Participants
n=75 Participants • Race of caregivers and adolescents analyzed separately.
|
65 Participants
n=76 Participants • Race of caregivers and adolescents analyzed separately.
|
128 Participants
n=151 Participants • Race of caregivers and adolescents analyzed separately.
|
|
Race (NIH/OMB)
Adolescent Race · More than one race
|
6 Participants
n=75 Participants • Race of caregivers and adolescents analyzed separately.
|
2 Participants
n=76 Participants • Race of caregivers and adolescents analyzed separately.
|
8 Participants
n=151 Participants • Race of caregivers and adolescents analyzed separately.
|
|
Race (NIH/OMB)
Adolescent Race · Unknown or Not Reported
|
1 Participants
n=75 Participants • Race of caregivers and adolescents analyzed separately.
|
0 Participants
n=76 Participants • Race of caregivers and adolescents analyzed separately.
|
1 Participants
n=151 Participants • Race of caregivers and adolescents analyzed separately.
|
|
Region of Enrollment
United States
|
75 participants
n=150 Participants
|
76 participants
n=152 Participants
|
151 participants
n=302 Participants
|
|
Marital Status
Married/Partnered
|
60 Participants
n=75 Participants • Marital status only analyzed for caregiver participants (not adolescents).
|
62 Participants
n=76 Participants • Marital status only analyzed for caregiver participants (not adolescents).
|
122 Participants
n=151 Participants • Marital status only analyzed for caregiver participants (not adolescents).
|
|
Marital Status
Single/Divorced/Widowed
|
15 Participants
n=75 Participants • Marital status only analyzed for caregiver participants (not adolescents).
|
14 Participants
n=76 Participants • Marital status only analyzed for caregiver participants (not adolescents).
|
29 Participants
n=151 Participants • Marital status only analyzed for caregiver participants (not adolescents).
|
|
Household Income
<$19,999
|
4 Participants
n=75 Participants • Two caregivers did not provide information on income.
|
4 Participants
n=76 Participants • Two caregivers did not provide information on income.
|
8 Participants
n=151 Participants • Two caregivers did not provide information on income.
|
|
Household Income
$20-$39,999
|
5 Participants
n=75 Participants • Two caregivers did not provide information on income.
|
8 Participants
n=76 Participants • Two caregivers did not provide information on income.
|
13 Participants
n=151 Participants • Two caregivers did not provide information on income.
|
|
Household Income
$40-$59,999
|
13 Participants
n=75 Participants • Two caregivers did not provide information on income.
|
11 Participants
n=76 Participants • Two caregivers did not provide information on income.
|
24 Participants
n=151 Participants • Two caregivers did not provide information on income.
|
|
Household Income
$60-$79,999
|
14 Participants
n=75 Participants • Two caregivers did not provide information on income.
|
13 Participants
n=76 Participants • Two caregivers did not provide information on income.
|
27 Participants
n=151 Participants • Two caregivers did not provide information on income.
|
|
Household Income
$80-$99,999
|
11 Participants
n=75 Participants • Two caregivers did not provide information on income.
|
12 Participants
n=76 Participants • Two caregivers did not provide information on income.
|
23 Participants
n=151 Participants • Two caregivers did not provide information on income.
|
|
Household Income
$100,000 or more
|
27 Participants
n=75 Participants • Two caregivers did not provide information on income.
|
27 Participants
n=76 Participants • Two caregivers did not provide information on income.
|
54 Participants
n=151 Participants • Two caregivers did not provide information on income.
|
|
Household Income
Missing
|
1 Participants
n=75 Participants • Two caregivers did not provide information on income.
|
1 Participants
n=76 Participants • Two caregivers did not provide information on income.
|
2 Participants
n=151 Participants • Two caregivers did not provide information on income.
|
|
Hemoglobin A1c
|
8.2 percentage of glycated hemoglobin
n=75 Participants • A1c only collected from adolescents participants (not caregivers), since adolescents had type 1 diabetes.
|
8.7 percentage of glycated hemoglobin
n=76 Participants • A1c only collected from adolescents participants (not caregivers), since adolescents had type 1 diabetes.
|
8.5 percentage of glycated hemoglobin
n=151 Participants • A1c only collected from adolescents participants (not caregivers), since adolescents had type 1 diabetes.
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: Only adolescents participants have the A1C value.
Hemoglobin A1c measured as part of clinic visit indicates the amount of glucose attached to hemoglobin.
Outcome measures
| Measure |
Communication & Coping Intervention
n=70 Participants
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.
|
Education & Check Ins
n=71 Participants
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.
|
|---|---|---|
|
Glycemic Control (A1C)
|
8.4 Percentage of glycated hemoglobin
Interval 7.3 to 10.2
|
8.5 Percentage of glycated hemoglobin
Interval 7.4 to 9.8
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: Only maternal caregiver participants completed this measure.
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.
Outcome measures
| Measure |
Communication & Coping Intervention
n=60 Participants
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.
|
Education & Check Ins
n=69 Participants
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.
|
|---|---|---|
|
Maternal Depressive Symptoms
|
6.4 score on a scale
Standard Deviation 4.6
|
5.1 score on a scale
Standard Deviation 4.6
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: Only maternal caregiver participants completed this measure.
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.
Outcome measures
| Measure |
Communication & Coping Intervention
n=60 Participants
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.
|
Education & Check Ins
n=69 Participants
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.
|
|---|---|---|
|
Mothers' Diabetes Distress
|
1.58 score on a scale
Standard Deviation .80
|
1.72 score on a scale
Standard Deviation .84
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: Only maternal caregiver participants completed this measure.
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.
Outcome measures
| Measure |
Communication & Coping Intervention
n=47 Participants
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.
|
Education & Check Ins
n=49 Participants
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.
|
|---|---|---|
|
Adolescent Psychosocial Functioning - Parent Report
Internalizing Problems
|
55.4 T-Score
Standard Deviation 8.7
|
57.3 T-Score
Standard Deviation 12.6
|
|
Adolescent Psychosocial Functioning - Parent Report
Externalizing Problems
|
51.2 T-Score
Standard Deviation 9.9
|
52.4 T-Score
Standard Deviation 10.2
|
|
Adolescent Psychosocial Functioning - Parent Report
Depressive Problems
|
58.5 T-Score
Standard Deviation 7.9
|
60.8 T-Score
Standard Deviation 10.1
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: Only adolescent participants completed this measure.
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.
Outcome measures
| Measure |
Communication & Coping Intervention
n=43 Participants
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.
|
Education & Check Ins
n=45 Participants
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.
|
|---|---|---|
|
Adolescent Psychosocial Functioning - Self Report
Internalizing Problems
|
53.6 T-Score
Standard Deviation 12.3
|
54.4 T-Score
Standard Deviation 12.5
|
|
Adolescent Psychosocial Functioning - Self Report
Externalizing Problems
|
48.9 T-Score
Standard Deviation 10.9
|
48.6 T-Score
Standard Deviation 10.2
|
|
Adolescent Psychosocial Functioning - Self Report
Depressive Problems
|
58.5 T-Score
Standard Deviation 9.0
|
58.4 T-Score
Standard Deviation 8.3
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: Only adolescent participants completed this measure.
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.
Outcome measures
| Measure |
Communication & Coping Intervention
n=60 Participants
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.
|
Education & Check Ins
n=65 Participants
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.
|
|---|---|---|
|
Adolescent Quality of Life
|
67 score on a scale
Standard Deviation 15
|
69 score on a scale
Standard Deviation 14
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: Only maternal caregiver participants completed this measure.
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.
Outcome measures
| Measure |
Communication & Coping Intervention
n=60 Participants
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.
|
Education & Check Ins
n=69 Participants
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.
|
|---|---|---|
|
Diabetes-related Family Conflict - Parent Report
|
28.2 score on a scale
Standard Deviation 4.9
|
28.8 score on a scale
Standard Deviation 6.8
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: Only adolescent participants completed this measure.
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.
Outcome measures
| Measure |
Communication & Coping Intervention
n=60 Participants
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.
|
Education & Check Ins
n=65 Participants
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.
|
|---|---|---|
|
Diabetes-related Family Conflict - Adolescent Report
|
30.1 score on a scale
Standard Deviation 9.8
|
30.2 score on a scale
Standard Deviation 10.7
|
SECONDARY outcome
Timeframe: 3 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.
Outcome measures
| Measure |
Communication & Coping Intervention
n=60 Participants
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.
|
Education & Check Ins
n=65 Participants
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.
|
|---|---|---|
|
Adolescent Diabetes Distress
|
74 score on a scale
Standard Deviation 30
|
64 score on a scale
Standard Deviation 27
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: Only maternal caregiver participants completed this measure.
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.
Outcome measures
| Measure |
Communication & Coping Intervention
n=60 Participants
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.
|
Education & Check Ins
n=69 Participants
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.
|
|---|---|---|
|
Diabetes Knowledge
|
69 percentage of items correct
Standard Deviation 37
|
82 percentage of items correct
Standard Deviation 27
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: Only adolescent participants completed this measure.
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.
Outcome measures
| Measure |
Communication & Coping Intervention
n=60 Participants
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.
|
Education & Check Ins
n=65 Participants
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.
|
|---|---|---|
|
Parental Involvement
|
4.1 score on a scale
Standard Deviation 0.8
|
4.0 score on a scale
Standard Deviation 0.9
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: Only adolescent participants completed this measure.
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.
Outcome measures
| Measure |
Communication & Coping Intervention
n=60 Participants
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.
|
Education & Check Ins
n=65 Participants
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.
|
|---|---|---|
|
Adolescent Adherence
|
3.6 score on a scale
Interval 2.9 to 4.0
|
3.7 score on a scale
Interval 3.3 to 4.1
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Analysis conducted if participants had baseline and 6 month videos.
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.
Outcome measures
| Measure |
Communication & Coping Intervention
n=27 Participants
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.
|
Education & Check Ins
n=27 Participants
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.
|
|---|---|---|
|
Quality of Parental Involvement
Collaborative Parent Behaviors
|
14.8 score on a scale
Standard Deviation 3.6
|
13.1 score on a scale
Standard Deviation 3.6
|
|
Quality of Parental Involvement
Intrusive Parent Behaviors
|
9.6 score on a scale
Standard Deviation 4.2
|
9.9 score on a scale
Standard Deviation 4.0
|
Adverse Events
Communication & Coping Intervention
Serious events: 2 serious events
Other events: 7 other events
Deaths: 0 deaths
Education & Check Ins
Serious events: 3 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Communication & Coping Intervention
n=75 participants at risk
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.
|
Education & Check Ins
n=76 participants at risk
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.
|
|---|---|---|
|
Endocrine disorders
DKA
|
2.7%
2/75 • Number of events 3 • 1 year (study period)
Only adolescent participants were assessed for adverse events. Participants' medical records were reviewed for any emergency department visits during the study project period (12 months). These were reviewed by the study endocrinologist to determine if they met the criteria for Diabetic Ketoacidosis (DKA). None of the adverse events were related to participation in the trial.
|
3.9%
3/76 • Number of events 8 • 1 year (study period)
Only adolescent participants were assessed for adverse events. Participants' medical records were reviewed for any emergency department visits during the study project period (12 months). These were reviewed by the study endocrinologist to determine if they met the criteria for Diabetic Ketoacidosis (DKA). None of the adverse events were related to participation in the trial.
|
Other adverse events
| Measure |
Communication & Coping Intervention
n=75 participants at risk
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.
|
Education & Check Ins
n=76 participants at risk
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.
|
|---|---|---|
|
Psychiatric disorders
Indicated Self-Harm or Suicidality
|
9.3%
7/75 • Number of events 9 • 1 year (study period)
Only adolescent participants were assessed for adverse events. Participants' medical records were reviewed for any emergency department visits during the study project period (12 months). These were reviewed by the study endocrinologist to determine if they met the criteria for Diabetic Ketoacidosis (DKA). None of the adverse events were related to participation in the trial.
|
6.6%
5/76 • Number of events 9 • 1 year (study period)
Only adolescent participants were assessed for adverse events. Participants' medical records were reviewed for any emergency department visits during the study project period (12 months). These were reviewed by the study endocrinologist to determine if they met the criteria for Diabetic Ketoacidosis (DKA). None of the adverse events were related to participation in the trial.
|
Additional Information
Senior ClinicalTrials.gov Administrator
Vanderbilt University Medical Center
Phone: 615-322-3581
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place