Grandmother, Women
Conditions
Keywords
grandmother caregivers, grandfamily, grandfamilies, custodial grandparent, custodial grandmother, multigenerational family, Grandmothers raising or living with grandchildren
Brief summary
CWRU Research Study: Looking for grandmothers living with grandchildren, 18 years of age or younger, to take part in a study to compare methods of dealing with the stress of caregiving to grandchildren. Participants need to have daily access to a computer, complete four surveys online, and be willing to write in a journal every day for a month. Participants will be compensated for their time.
Detailed description
This is a randomized clinical trial that will compare two methods of dealing with stress of grandparent caregiving to grandchildren.
Interventions
BEHAVIORALCognitive behavioral intervention and journaling
Cognitive behavioral skills training and 4 weeks of online journaling
BEHAVIORALReflective journaling
Reflective journaling training and 4 weeks of online journaling Training in reflective journaling and 4 weeks of online journaling
Sponsors
Case Western Reserve University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
Participants randomly assigned to groups
Intervention model description
Randomized controlled clinical trial
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
Yes
Inclusion criteria
* Grandmother to one or more grandchildren (age 18 or younger) living in the same home (with or without parents)
Exclusion criteria
1. Grandmothers to grandchildren who do not share their home 2. Not a grandmother 3. Not living in the United States.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Depressive Symptoms | comparison of baseline with 24 weeks post journaling completion | 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. |
| Well Being | comparison of baseline with 24 weeks post journaling | SF 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. |
| Family Well Being - Composite Score Derived From 12 Items. | comparison of baseline with 24 weeks post journaling | General 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. |
| SF-12 Mental Health Composite Score | Baseline vs 24 week followup | Normed 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. |
| SF-12 Physical Health Composite Score | Baseline vs 24 week followup | Normed 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 173 |
| 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. | 169 |
| Total | 342 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 15 | 13 |
| Overall Study | Withdrawal by Subject | 10 | 8 |
Baseline characteristics
| Characteristic | Arm 1: Cognitive Behavioral Skills Training & 4 Wks Online Journaling | Arm 2: Reflective Journaling Training & 4 Wks Online Journaling | Total |
|---|---|---|---|
| Age, Continuous | 55.792 years STANDARD_DEVIATION 7.08 | 56.584 years STANDARD_DEVIATION 8.052 | 56.194 years STANDARD_DEVIATION 7.588 |
| Caregiving status Multigenerational caregivers (grandchild(ren) and at least 1 parent live with grandmother) | 30 Participants | 29 Participants | 59 Participants |
| Caregiving status Primary caregivers (grandchild(ren), no parents live with grandmother) | 143 Participants | 140 Participants | 283 Participants |
| Depressive Cognitions | 7.799 score on scale STANDARD_DEVIATION 5.592 | 7.76 score on scale STANDARD_DEVIATION 6.09 | 7.781 score on scale STANDARD_DEVIATION 5.841 |
| Duke Instrumental Social Support | 5.965 score on scale STANDARD_DEVIATION 3.443 | 5.799 score on scale STANDARD_DEVIATION 3.236 | 5.883 score on scale STANDARD_DEVIATION 3.338 |
| Duke Subjective Social Support | 8.775 score on scale STANDARD_DEVIATION 3.236 | 8.773 score on scale STANDARD_DEVIATION 3.443 | 8.774 score on scale STANDARD_DEVIATION 3.338 |
| Educational Attainment 1-3 years of college, no degree completed | 45 Participants | 47 Participants | 92 Participants |
| Educational Attainment 4 years college (completed degree) | 30 Participants | 24 Participants | 54 Participants |
| Educational Attainment 8 years or less | 1 Participants | 1 Participants | 2 Participants |
| Educational Attainment Completed Associate's or other 2 year degree | 31 Participants | 28 Participants | 59 Participants |
| Educational Attainment Graduate school | 19 Participants | 19 Participants | 38 Participants |
| Educational Attainment High school complete/GED | 26 Participants | 31 Participants | 57 Participants |
| Educational Attainment Post high school, business or trade school | 19 Participants | 13 Participants | 32 Participants |
| Educational Attainment Some high school | 2 Participants | 6 Participants | 8 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 12 Participants | 17 Participants | 29 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 161 Participants | 152 Participants | 313 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Family income $1,000-2,000/month | 32 Participants | 41 Participants | 73 Participants |
| Family income $2,001-3,000/month | 32 Participants | 27 Participants | 59 Participants |
| Family income $3,001-4,000/month | 18 Participants | 26 Participants | 44 Participants |
| Family income $4,001-5,000/month | 22 Participants | 24 Participants | 46 Participants |
| Family income Over $5,000/month | 37 Participants | 23 Participants | 60 Participants |
| Family income Prefer not to answer | 16 Participants | 8 Participants | 24 Participants |
| Family income Under $999/month | 16 Participants | 20 Participants | 36 Participants |
| Intra-family strain | 5.256 score on scale STANDARD_DEVIATION 2.46 | 5.107 score on scale STANDARD_DEVIATION 2.57 | 5.182 score on scale STANDARD_DEVIATION 2.513 |
| Job Status Not working | 90 Participants | 85 Participants | 175 Participants |
| Job Status Working full-time | 63 Participants | 54 Participants | 117 Participants |
| Job Status Working part-time | 20 Participants | 30 Participants | 50 Participants |
| Marital Status Married or living with a partner | 86 Participants | 84 Participants | 170 Participants |
| Marital Status Not married or living with a partner | 87 Participants | 85 Participants | 172 Participants |
| Number of co-residential grandchildren Five (5) in-home grandchildren | 3 Participants | 3 Participants | 6 Participants |
| Number of co-residential grandchildren Four (4) in-home grandchildren | 11 Participants | 6 Participants | 17 Participants |
| Number of co-residential grandchildren One (1) in-home grandchild | 93 Participants | 75 Participants | 168 Participants |
| Number of co-residential grandchildren Seven (7) in-home grandchildren | 0 Participants | 1 Participants | 1 Participants |
| Number of co-residential grandchildren Six (6) in-home grandchildren | 0 Participants | 1 Participants | 1 Participants |
| Number of co-residential grandchildren Three (3) in-home grandchildren | 21 Participants | 26 Participants | 47 Participants |
| Number of co-residential grandchildren Two (2) in-home grandchildren | 45 Participants | 57 Participants | 102 Participants |
| Race (NIH/OMB) Self-identified racial identity American Indian or Alaska Native | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Self-identified racial identity Asian | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Self-identified racial identity Black or African American | 30 Participants | 34 Participants | 64 Participants |
| Race (NIH/OMB) Self-identified racial identity More than one race | 8 Participants | 5 Participants | 13 Participants |
| Race (NIH/OMB) Self-identified racial identity Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Self-identified racial identity Unknown or Not Reported | 9 Participants | 7 Participants | 16 Participants |
| Race (NIH/OMB) Self-identified racial identity White | 124 Participants | 122 Participants | 246 Participants |
| Region of Enrollment United States | 173 participants | 169 participants | 342 participants |
| Resourcefulness | 81.208 score on scale STANDARD_DEVIATION 19.237 | 81.630 score on scale STANDARD_DEVIATION 18.079 | 81.422 score on scale STANDARD_DEVIATION 18.631 |
| Self-appraised caregiving reward | 7.865 score on scale STANDARD_DEVIATION 2.43 | 7.847 score on scale STANDARD_DEVIATION 2.394 | 7.856 score on scale STANDARD_DEVIATION 2.41 |
| Self-appraised caregiving stress | 7.847 score on scale STANDARD_DEVIATION 2.394 | 7.131 score on scale STANDARD_DEVIATION 2.575 | 7.419 score on scale STANDARD_DEVIATION 2.41 |
| Sex: Female, Male Female | 173 Participants | 169 Participants | 342 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 173 | 0 / 169 |
| other Total, other adverse events | 52 / 173 | 45 / 169 |
| serious Total, serious adverse events | 0 / 173 | 0 / 169 |
Outcome results
Primary
Depressive Symptoms
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.
Time frame: comparison of baseline with 24 weeks post journaling completion
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm 1: Cognitive Behavioral Skills Training & 4 Wks Online Journaling (N=149) | Depressive Symptoms | Time 1 (baseline) | 18.116 score on a scale | Standard Deviation 11.65 |
| Arm 1: Cognitive Behavioral Skills Training & 4 Wks Online Journaling (N=149) | Depressive Symptoms | Time 4 (24 wks post-journaling) | 15.135 score on a scale | Standard Deviation 11.65 |
| Arm 2: Reflective Journaling Training & 4 Wks Online Journaling (N = 151) | Depressive Symptoms | Time 1 (baseline) | 18.231 score on a scale | Standard Deviation 11.51 |
| Arm 2: Reflective Journaling Training & 4 Wks Online Journaling (N = 151) | Depressive Symptoms | Time 4 (24 wks post-journaling) | 15.873 score on a scale | Standard Deviation 10.425 |
Primary
Family Well Being - Composite Score Derived From 12 Items.
General 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.
Time frame: comparison of baseline with 24 weeks post journaling
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm 1: Cognitive Behavioral Skills Training & 4 Wks Online Journaling (N=149) | Family Well Being - Composite Score Derived From 12 Items. | Time 1 (baseline) | 2.300 score on a scale | Standard Deviation 0.532 |
| Arm 1: Cognitive Behavioral Skills Training & 4 Wks Online Journaling (N=149) | Family Well Being - Composite Score Derived From 12 Items. | Time 4 (24 wks post-journaling) | 2.172 score on a scale | Standard Deviation 0.6 |
| Arm 2: Reflective Journaling Training & 4 Wks Online Journaling (N = 151) | Family Well Being - Composite Score Derived From 12 Items. | Time 1 (baseline) | 2.300 score on a scale | Standard Deviation 0.503 |
| Arm 2: Reflective Journaling Training & 4 Wks Online Journaling (N = 151) | Family Well Being - Composite Score Derived From 12 Items. | Time 4 (24 wks post-journaling) | 2.172 score on a scale | Standard Deviation 0.564 |
Primary
SF-12 Mental Health Composite Score
Normed 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.
Time frame: Baseline vs 24 week followup
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm 1: Cognitive Behavioral Skills Training & 4 Wks Online Journaling (N=149) | SF-12 Mental Health Composite Score | T1 (baseline) | 43.452 score on a scale | Standard Deviation 11.298 |
| Arm 1: Cognitive Behavioral Skills Training & 4 Wks Online Journaling (N=149) | SF-12 Mental Health Composite Score | T4 (24 week followup post journal) | 45.611 score on a scale | Standard Deviation 11.001 |
| Arm 2: Reflective Journaling Training & 4 Wks Online Journaling (N = 151) | SF-12 Mental Health Composite Score | T1 (baseline) | 41.613 score on a scale | Standard Deviation 12.003 |
| Arm 2: Reflective Journaling Training & 4 Wks Online Journaling (N = 151) | SF-12 Mental Health Composite Score | T4 (24 week followup post journal) | 45.230 score on a scale | Standard Deviation 10.357 |
Primary
SF-12 Physical Health Composite Score
Normed 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.
Time frame: Baseline vs 24 week followup
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm 1: Cognitive Behavioral Skills Training & 4 Wks Online Journaling (N=149) | SF-12 Physical Health Composite Score | T1 (Baseline) | 44.344 score on a scale | Standard Deviation 11.907 |
| Arm 1: Cognitive Behavioral Skills Training & 4 Wks Online Journaling (N=149) | SF-12 Physical Health Composite Score | T4 (24 week followup post journal) | 44.654 score on a scale | Standard Deviation 11.303 |
| Arm 2: Reflective Journaling Training & 4 Wks Online Journaling (N = 151) | SF-12 Physical Health Composite Score | T1 (Baseline) | 45.125 score on a scale | Standard Deviation 11.7 |
| Arm 2: Reflective Journaling Training & 4 Wks Online Journaling (N = 151) | SF-12 Physical Health Composite Score | T4 (24 week followup post journal) | 44.506 score on a scale | Standard Deviation 11.531 |
Primary
Well Being
SF 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.
Time frame: comparison of baseline with 24 weeks post journaling
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm 1: Cognitive Behavioral Skills Training & 4 Wks Online Journaling (N=149) | Well Being | Time 1 (baseline) | 2.97 score on a scale | Standard Deviation 0.974 |
| Arm 1: Cognitive Behavioral Skills Training & 4 Wks Online Journaling (N=149) | Well Being | Time 4 (24 wks post-journaling) | 2.92 score on a scale | Standard Deviation 0.929 |
| Arm 2: Reflective Journaling Training & 4 Wks Online Journaling (N = 151) | Well Being | Time 1 (baseline) | 3.00 score on a scale | Standard Deviation 0.982 |
| Arm 2: Reflective Journaling Training & 4 Wks Online Journaling (N = 151) | Well Being | Time 4 (24 wks post-journaling) | 2.95 score on a scale | Standard Deviation 0.909 |