Trial Outcomes & Findings for The Grandmother Study: Grandmother Initiatives in Family Transformation (NCT NCT03263923)
NCT ID: NCT03263923
Last Updated: 2022-11-08
Results Overview
Center for Epidemiologic Disease - Depression Scale (CES-D) Radloff, 1977. Composite item derived from 20 item scale. Individual items are scored on a 4 point likert scale (0-3). Individual items are summed and possible scale scores range from 0-60. Higher scores represent greater depressive symptoms. Scores of 16 or greater are interpreted as indicating an increased risk of diagnosis of clinical depression.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
346 participants
Primary outcome timeframe
comparison of baseline with 24 weeks post journaling completion
Results posted on
2022-11-08
Participant Flow
Participant milestones
| Measure |
Arm 1: Cognitive Behavioral Skills Training & 4 Wks Online Journaling
Cognitive behavioral skills' training and 4 weeks of online journaling.
Participants receive cognitive behavioral skills training by online video, then participants must complete a 28 day online journal reflecting on the cognitive skills they used to handle various situations.
|
Arm 2: Reflective Journaling Training & 4 Wks Online Journaling
Reflective journaling training and 4 weeks of online journaling.
Participants watch a reflective journaling video and complete a 28 day journal using a different set of prompts to reflect on their days and describe how they handled various situations.
|
|---|---|---|
|
Overall Study
STARTED
|
174
|
172
|
|
Overall Study
Completed Enrolled Participants Who Completed the Baseline Questionnaire
|
173
|
169
|
|
Overall Study
Completed Intervention and T2 Questionnaire
|
149
|
151
|
|
Overall Study
COMPLETED
|
149
|
151
|
|
Overall Study
NOT COMPLETED
|
25
|
21
|
Reasons for withdrawal
| Measure |
Arm 1: Cognitive Behavioral Skills Training & 4 Wks Online Journaling
Cognitive behavioral skills' training and 4 weeks of online journaling.
Participants receive cognitive behavioral skills training by online video, then participants must complete a 28 day online journal reflecting on the cognitive skills they used to handle various situations.
|
Arm 2: Reflective Journaling Training & 4 Wks Online Journaling
Reflective journaling training and 4 weeks of online journaling.
Participants watch a reflective journaling video and complete a 28 day journal using a different set of prompts to reflect on their days and describe how they handled various situations.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
10
|
8
|
|
Overall Study
Lost to Follow-up
|
15
|
13
|
Baseline Characteristics
The Grandmother Study: Grandmother Initiatives in Family Transformation
Baseline characteristics by cohort
| Measure |
Arm 1: Cognitive Behavioral Skills Training & 4 Wks Online Journaling
n=173 Participants
Cognitive behavioral skills' training and 4 weeks of online journaling.
Participants receive cognitive behavioral skills training by online video, then participants must complete a 28 day online journal reflecting on the cognitive skills they used to handle various situations.
|
Arm 2: Reflective Journaling Training & 4 Wks Online Journaling
n=169 Participants
Reflective journaling training and 4 weeks of online journaling.
Participants watch a reflective journaling video and complete a 28 day journal using a different set of prompts to reflect on their days and describe how they handled various situations.
|
Total
n=342 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
55.792 years
STANDARD_DEVIATION 7.080 • n=99 Participants
|
56.584 years
STANDARD_DEVIATION 8.052 • n=107 Participants
|
56.194 years
STANDARD_DEVIATION 7.588 • n=206 Participants
|
|
Sex: Female, Male
Female
|
173 Participants
n=99 Participants
|
169 Participants
n=107 Participants
|
342 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
12 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
29 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
161 Participants
n=99 Participants
|
152 Participants
n=107 Participants
|
313 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Self-identified racial identity · American Indian or Alaska Native
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Self-identified racial identity · Asian
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Self-identified racial identity · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Self-identified racial identity · Black or African American
|
30 Participants
n=99 Participants
|
34 Participants
n=107 Participants
|
64 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Self-identified racial identity · White
|
124 Participants
n=99 Participants
|
122 Participants
n=107 Participants
|
246 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Self-identified racial identity · More than one race
|
8 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Self-identified racial identity · Unknown or Not Reported
|
9 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
173 participants
n=99 Participants
|
169 participants
n=107 Participants
|
342 participants
n=206 Participants
|
|
Marital Status
Married or living with a partner
|
86 Participants
n=99 Participants
|
84 Participants
n=107 Participants
|
170 Participants
n=206 Participants
|
|
Marital Status
Not married or living with a partner
|
87 Participants
n=99 Participants
|
85 Participants
n=107 Participants
|
172 Participants
n=206 Participants
|
|
Job Status
Working full-time
|
63 Participants
n=99 Participants
|
54 Participants
n=107 Participants
|
117 Participants
n=206 Participants
|
|
Job Status
Working part-time
|
20 Participants
n=99 Participants
|
30 Participants
n=107 Participants
|
50 Participants
n=206 Participants
|
|
Job Status
Not working
|
90 Participants
n=99 Participants
|
85 Participants
n=107 Participants
|
175 Participants
n=206 Participants
|
|
Educational Attainment
8 years or less
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Educational Attainment
Some high school
|
2 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Educational Attainment
High school complete/GED
|
26 Participants
n=99 Participants
|
31 Participants
n=107 Participants
|
57 Participants
n=206 Participants
|
|
Educational Attainment
Post high school, business or trade school
|
19 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
32 Participants
n=206 Participants
|
|
Educational Attainment
1-3 years of college, no degree completed
|
45 Participants
n=99 Participants
|
47 Participants
n=107 Participants
|
92 Participants
n=206 Participants
|
|
Educational Attainment
Completed Associate's or other 2 year degree
|
31 Participants
n=99 Participants
|
28 Participants
n=107 Participants
|
59 Participants
n=206 Participants
|
|
Educational Attainment
4 years college (completed degree)
|
30 Participants
n=99 Participants
|
24 Participants
n=107 Participants
|
54 Participants
n=206 Participants
|
|
Educational Attainment
Graduate school
|
19 Participants
n=99 Participants
|
19 Participants
n=107 Participants
|
38 Participants
n=206 Participants
|
|
Number of co-residential grandchildren
One (1) in-home grandchild
|
93 Participants
n=99 Participants
|
75 Participants
n=107 Participants
|
168 Participants
n=206 Participants
|
|
Number of co-residential grandchildren
Two (2) in-home grandchildren
|
45 Participants
n=99 Participants
|
57 Participants
n=107 Participants
|
102 Participants
n=206 Participants
|
|
Number of co-residential grandchildren
Three (3) in-home grandchildren
|
21 Participants
n=99 Participants
|
26 Participants
n=107 Participants
|
47 Participants
n=206 Participants
|
|
Number of co-residential grandchildren
Four (4) in-home grandchildren
|
11 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
17 Participants
n=206 Participants
|
|
Number of co-residential grandchildren
Five (5) in-home grandchildren
|
3 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Number of co-residential grandchildren
Six (6) in-home grandchildren
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Number of co-residential grandchildren
Seven (7) in-home grandchildren
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Self-appraised caregiving stress
|
7.847 score on scale
STANDARD_DEVIATION 2.394 • n=99 Participants
|
7.131 score on scale
STANDARD_DEVIATION 2.575 • n=107 Participants
|
7.419 score on scale
STANDARD_DEVIATION 2.410 • n=206 Participants
|
|
Self-appraised caregiving reward
|
7.865 score on scale
STANDARD_DEVIATION 2.43 • n=99 Participants
|
7.847 score on scale
STANDARD_DEVIATION 2.394 • n=107 Participants
|
7.856 score on scale
STANDARD_DEVIATION 2.410 • n=206 Participants
|
|
Duke Subjective Social Support
|
8.775 score on scale
STANDARD_DEVIATION 3.236 • n=99 Participants
|
8.773 score on scale
STANDARD_DEVIATION 3.443 • n=107 Participants
|
8.774 score on scale
STANDARD_DEVIATION 3.338 • n=206 Participants
|
|
Duke Instrumental Social Support
|
5.965 score on scale
STANDARD_DEVIATION 3.443 • n=99 Participants
|
5.799 score on scale
STANDARD_DEVIATION 3.236 • n=107 Participants
|
5.883 score on scale
STANDARD_DEVIATION 3.338 • n=206 Participants
|
|
Resourcefulness
|
81.208 score on scale
STANDARD_DEVIATION 19.237 • n=99 Participants
|
81.630 score on scale
STANDARD_DEVIATION 18.079 • n=107 Participants
|
81.422 score on scale
STANDARD_DEVIATION 18.631 • n=206 Participants
|
|
Depressive Cognitions
|
7.799 score on scale
STANDARD_DEVIATION 5.592 • n=99 Participants
|
7.76 score on scale
STANDARD_DEVIATION 6.09 • n=107 Participants
|
7.781 score on scale
STANDARD_DEVIATION 5.841 • n=206 Participants
|
|
Caregiving status
Primary caregivers (grandchild(ren), no parents live with grandmother)
|
143 Participants
n=99 Participants
|
140 Participants
n=107 Participants
|
283 Participants
n=206 Participants
|
|
Caregiving status
Multigenerational caregivers (grandchild(ren) and at least 1 parent live with grandmother)
|
30 Participants
n=99 Participants
|
29 Participants
n=107 Participants
|
59 Participants
n=206 Participants
|
|
Intra-family strain
|
5.256 score on scale
STANDARD_DEVIATION 2.460 • n=99 Participants
|
5.107 score on scale
STANDARD_DEVIATION 2.570 • n=107 Participants
|
5.182 score on scale
STANDARD_DEVIATION 2.513 • n=206 Participants
|
|
Family income
Under $999/month
|
16 Participants
n=99 Participants
|
20 Participants
n=107 Participants
|
36 Participants
n=206 Participants
|
|
Family income
$1,000-2,000/month
|
32 Participants
n=99 Participants
|
41 Participants
n=107 Participants
|
73 Participants
n=206 Participants
|
|
Family income
$2,001-3,000/month
|
32 Participants
n=99 Participants
|
27 Participants
n=107 Participants
|
59 Participants
n=206 Participants
|
|
Family income
$3,001-4,000/month
|
18 Participants
n=99 Participants
|
26 Participants
n=107 Participants
|
44 Participants
n=206 Participants
|
|
Family income
$4,001-5,000/month
|
22 Participants
n=99 Participants
|
24 Participants
n=107 Participants
|
46 Participants
n=206 Participants
|
|
Family income
Over $5,000/month
|
37 Participants
n=99 Participants
|
23 Participants
n=107 Participants
|
60 Participants
n=206 Participants
|
|
Family income
Prefer not to answer
|
16 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
24 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: comparison of baseline with 24 weeks post journaling completionCenter for Epidemiologic Disease - Depression Scale (CES-D) Radloff, 1977. Composite item derived from 20 item scale. Individual items are scored on a 4 point likert scale (0-3). Individual items are summed and possible scale scores range from 0-60. Higher scores represent greater depressive symptoms. Scores of 16 or greater are interpreted as indicating an increased risk of diagnosis of clinical depression.
Outcome measures
| Measure |
Arm 1: Cognitive Behavioral Skills Training & 4 Wks Online Journaling (N=149)
n=149 Participants
Cognitive behavioral skills' training and 4 weeks of online journaling.
Participants receive cognitive behavioral skills training by online video, then participants must complete a 28 day online journal reflecting on the cognitive skills they used to handle various situations.
|
Arm 2: Reflective Journaling Training & 4 Wks Online Journaling (N = 151)
n=151 Participants
Reflective journaling training and 4 weeks of online journaling.
Participants watch a reflective journaling video and complete a 28 day journal using a different set of prompts to reflect on their days and describe how they handled various situations.
|
|---|---|---|
|
Depressive Symptoms
Time 1 (baseline)
|
18.116 score on a scale
Standard Deviation 11.650
|
18.231 score on a scale
Standard Deviation 11.51
|
|
Depressive Symptoms
Time 4 (24 wks post-journaling)
|
15.135 score on a scale
Standard Deviation 11.650
|
15.873 score on a scale
Standard Deviation 10.425
|
PRIMARY outcome
Timeframe: comparison of baseline with 24 weeks post journalingSF 12 individual item: overall self-appraised health. This is a single response item "In general, would you say your health is..." Participants respond on 5 point scale with response options ranging from Poor (1) to Excellent (5). Higher scores indicate better self-appraised health.
Outcome measures
| Measure |
Arm 1: Cognitive Behavioral Skills Training & 4 Wks Online Journaling (N=149)
n=149 Participants
Cognitive behavioral skills' training and 4 weeks of online journaling.
Participants receive cognitive behavioral skills training by online video, then participants must complete a 28 day online journal reflecting on the cognitive skills they used to handle various situations.
|
Arm 2: Reflective Journaling Training & 4 Wks Online Journaling (N = 151)
n=151 Participants
Reflective journaling training and 4 weeks of online journaling.
Participants watch a reflective journaling video and complete a 28 day journal using a different set of prompts to reflect on their days and describe how they handled various situations.
|
|---|---|---|
|
Well Being
Time 1 (baseline)
|
2.97 score on a scale
Standard Deviation .974
|
3.00 score on a scale
Standard Deviation .982
|
|
Well Being
Time 4 (24 wks post-journaling)
|
2.92 score on a scale
Standard Deviation .929
|
2.95 score on a scale
Standard Deviation .909
|
PRIMARY outcome
Timeframe: comparison of baseline with 24 weeks post journalingGeneral Family Functioning 12 item subscale of the McMaster Family Assessment Device (FAD). Participants respond on a 5 point likert scale. The subscale is the mean of the participant's responses to the 12 items with possible composite scores of 0-5. Higher scores indicate worse family well being.
Outcome measures
| Measure |
Arm 1: Cognitive Behavioral Skills Training & 4 Wks Online Journaling (N=149)
n=149 Participants
Cognitive behavioral skills' training and 4 weeks of online journaling.
Participants receive cognitive behavioral skills training by online video, then participants must complete a 28 day online journal reflecting on the cognitive skills they used to handle various situations.
|
Arm 2: Reflective Journaling Training & 4 Wks Online Journaling (N = 151)
n=151 Participants
Reflective journaling training and 4 weeks of online journaling.
Participants watch a reflective journaling video and complete a 28 day journal using a different set of prompts to reflect on their days and describe how they handled various situations.
|
|---|---|---|
|
Family Well Being - Composite Score Derived From 12 Items.
Time 1 (baseline)
|
2.300 score on a scale
Standard Deviation .532
|
2.300 score on a scale
Standard Deviation .503
|
|
Family Well Being - Composite Score Derived From 12 Items.
Time 4 (24 wks post-journaling)
|
2.172 score on a scale
Standard Deviation .600
|
2.172 score on a scale
Standard Deviation .564
|
PRIMARY outcome
Timeframe: Baseline vs 24 week followupNormed score generated by vendor-provided software using all 12 items of the SF-12v2 Health Survey. Scores range from 0-100, with higher scores indicating better mental health. Note: the SF-12 measures 8 health domains (Physical Function, Bodily Pain, Vitality, Role-Emotional, Role-Physical, General Health, Social Function, Mental Health) across 12 individual response questions. All 12 responses are normed for gender, and country of origin and differentially weighted to calculate scores for both physical and mental health.
Outcome measures
| Measure |
Arm 1: Cognitive Behavioral Skills Training & 4 Wks Online Journaling (N=149)
n=149 Participants
Cognitive behavioral skills' training and 4 weeks of online journaling.
Participants receive cognitive behavioral skills training by online video, then participants must complete a 28 day online journal reflecting on the cognitive skills they used to handle various situations.
|
Arm 2: Reflective Journaling Training & 4 Wks Online Journaling (N = 151)
n=151 Participants
Reflective journaling training and 4 weeks of online journaling.
Participants watch a reflective journaling video and complete a 28 day journal using a different set of prompts to reflect on their days and describe how they handled various situations.
|
|---|---|---|
|
SF-12 Mental Health Composite Score
T1 (baseline)
|
43.452 score on a scale
Standard Deviation 11.298
|
41.613 score on a scale
Standard Deviation 12.003
|
|
SF-12 Mental Health Composite Score
T4 (24 week followup post journal)
|
45.611 score on a scale
Standard Deviation 11.001
|
45.230 score on a scale
Standard Deviation 10.357
|
PRIMARY outcome
Timeframe: Baseline vs 24 week followupNormed score generated by vendor-provided software using all 12 items of the SF-12v2 Health Survey. Scores range from 0-100, with higher scores indicating better physical health. Note: the SF-12 measures 8 health domains (Physical Function, Bodily Pain, Vitality, Role-Emotional, Role-Physical, General Health, Social Function, Mental Health) across 12 individual response questions. All 12 responses are normed for gender, and country of origin and differentially weighted to calculate scores for both physical and mental health.
Outcome measures
| Measure |
Arm 1: Cognitive Behavioral Skills Training & 4 Wks Online Journaling (N=149)
n=149 Participants
Cognitive behavioral skills' training and 4 weeks of online journaling.
Participants receive cognitive behavioral skills training by online video, then participants must complete a 28 day online journal reflecting on the cognitive skills they used to handle various situations.
|
Arm 2: Reflective Journaling Training & 4 Wks Online Journaling (N = 151)
n=151 Participants
Reflective journaling training and 4 weeks of online journaling.
Participants watch a reflective journaling video and complete a 28 day journal using a different set of prompts to reflect on their days and describe how they handled various situations.
|
|---|---|---|
|
SF-12 Physical Health Composite Score
T1 (Baseline)
|
44.344 score on a scale
Standard Deviation 11.907
|
45.125 score on a scale
Standard Deviation 11.700
|
|
SF-12 Physical Health Composite Score
T4 (24 week followup post journal)
|
44.654 score on a scale
Standard Deviation 11.303
|
44.506 score on a scale
Standard Deviation 11.531
|
Adverse Events
Arm 1: Cognitive Behavioral Skills Training & 4 Wks Online Journaling
Serious events: 0 serious events
Other events: 52 other events
Deaths: 0 deaths
Arm 2: Reflective Journaling Training & 4 Wks Online Journaling
Serious events: 0 serious events
Other events: 45 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Arm 1: Cognitive Behavioral Skills Training & 4 Wks Online Journaling
n=173 participants at risk
Cognitive behavioral skills' training and 4 weeks of online journaling.
Participants receive cognitive behavioral skills training by online video, then participants must complete a 28 day online journal reflecting on the cognitive skills they used to handle various situations.
|
Arm 2: Reflective Journaling Training & 4 Wks Online Journaling
n=169 participants at risk
Reflective journaling training and 4 weeks of online journaling.
Participants watch a reflective journaling video and complete a 28 day journal using a different set of prompts to reflect on their days and describe how they handled various situations.
|
|---|---|---|
|
Psychiatric disorders
Elevated depressive symptoms at T1: Baseline
|
17.9%
31/173 • Number of events 31 • Participants were screened for depressive symptoms (using the CES-D 20 item scale) at baseline (T1) and 2 weeks (T2), 12 weeks (T3), and 24 weeks post-intervention (T4).
|
18.3%
31/169 • Number of events 31 • Participants were screened for depressive symptoms (using the CES-D 20 item scale) at baseline (T1) and 2 weeks (T2), 12 weeks (T3), and 24 weeks post-intervention (T4).
|
|
Psychiatric disorders
Elevated depressive symptoms at T2: 2 weeks post-intervention
|
5.2%
9/173 • Number of events 9 • Participants were screened for depressive symptoms (using the CES-D 20 item scale) at baseline (T1) and 2 weeks (T2), 12 weeks (T3), and 24 weeks post-intervention (T4).
|
5.3%
9/169 • Number of events 9 • Participants were screened for depressive symptoms (using the CES-D 20 item scale) at baseline (T1) and 2 weeks (T2), 12 weeks (T3), and 24 weeks post-intervention (T4).
|
|
Psychiatric disorders
Elevated depressive symptoms at T3: 12 weeks post-intervention
|
7.5%
13/173 • Number of events 13 • Participants were screened for depressive symptoms (using the CES-D 20 item scale) at baseline (T1) and 2 weeks (T2), 12 weeks (T3), and 24 weeks post-intervention (T4).
|
10.1%
17/169 • Number of events 17 • Participants were screened for depressive symptoms (using the CES-D 20 item scale) at baseline (T1) and 2 weeks (T2), 12 weeks (T3), and 24 weeks post-intervention (T4).
|
|
Psychiatric disorders
Elevated depressive symptoms at T4: 24 weeks post-intervention
|
4.6%
8/173 • Number of events 8 • Participants were screened for depressive symptoms (using the CES-D 20 item scale) at baseline (T1) and 2 weeks (T2), 12 weeks (T3), and 24 weeks post-intervention (T4).
|
7.7%
13/169 • Number of events 13 • Participants were screened for depressive symptoms (using the CES-D 20 item scale) at baseline (T1) and 2 weeks (T2), 12 weeks (T3), and 24 weeks post-intervention (T4).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place