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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.
This is a randomized clinical trial that will compare two methods of dealing with stress of grandparent caregiving to grandchildren.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1: Cognitive behavioral skills training & 4 wks online journaling | Experimental | 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. |
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| Arm 2: Reflective journaling training & 4 wks online journaling | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cognitive behavioral intervention and journaling | Behavioral | Cognitive behavioral skills training and 4 weeks of online journaling |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | comparison of baseline with 24 weeks post journaling completion |
| 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. | comparison of baseline with 24 weeks post journaling |
| 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. | comparison of baseline with 24 weeks post journaling |
| 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. | Baseline vs 24 week followup |
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Inclusion Criteria:
Exclusion Criteria:
female
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| Name | Affiliation | Role |
|---|---|---|
| Carol M Musil, PhD | Case Western Reserve University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CWRU | Cleveland | Ohio | 44140-1140 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33593072 | Result | Wallace MK, Still CH, Jeanblanc AB, Musil CM. Successful and Cost-Effective Facebook Recruitment: Is It Possible? Results From a Longitudinal Randomized Clinical Trial in Grandmother Caregivers. Int J Aging Hum Dev. 2021 Dec;93(4):1031-1050. doi: 10.1177/0091415020987667. Epub 2021 Feb 17. | |
| 34265228 | Result | Tracy EM, Braxton R, Henrich C, Jeanblanc A, Wallace M, Burant CJ, Musil C. Grandmothers raising grandchildren: managing, balancing and maintaining family relationships. J Women Aging. 2022 Nov-Dec;34(6):757-772. doi: 10.1080/08952841.2021.1951114. Epub 2021 Jul 15. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Age, reported in years, at baseline |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | score on a scale | comparison of baseline with 24 weeks post journaling completion |
|
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).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Elevated depressive symptoms at T1: Baseline | Psychiatric disorders | Systematic Assessment | CES-D scores over 30 |
Does not include grandfathers.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Carol M. Musil | Case Western Reserve University | 216-368-2545 | cmm4@case.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 21, 2022 | Sep 17, 2022 | Prot_SAP_000.pdf |
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Randomized controlled clinical trial
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Participants randomly assigned to groups
| Reflective journaling | Behavioral | Reflective journaling training and 4 weeks of online journaling Training in reflective journaling and 4 weeks of online journaling |
|
| 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. |
| Baseline vs 24 week followup |
| 32880239 | Result | Musil CM, Wallace MK, Jeanblanc AB, Toly VB, Zauszniewski JA, Burant CJ. Theoretical and Operational Consideration of Mindfulness, Resilience, and Resourcefulness. West J Nurs Res. 2021 Mar;43(3):210-218. doi: 10.1177/0193945920956684. Epub 2020 Sep 3. |
| 32513473 | Result | Wallace MK, Jeanblanc AB, Musil CM. Incidental findings: A practical protocol for reporting elevated depressive symptoms in behavioral health research. Arch Psychiatr Nurs. 2020 Jun;34(3):96-99. doi: 10.1016/j.apnu.2020.04.005. Epub 2020 Apr 13. |
| 35572175 | Result | Dolbin-MacNab ML, Jeanblanc AB, Musil CM, Infurna FJ, Smith GC. Supporting grandchildren's remote instruction during COVID-19: Experiences of custodial grandmothers. Psychol Sch. 2022 Apr 29:10.1002/pits.22714. doi: 10.1002/pits.22714. Online ahead of print. |
| BG001 |
| 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. |
| BG002 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | Gender was not directly measured. Participants were eligible for enrollment if they self-identified as a "grandmother" living with grandchildren. | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Participants were asked (yes/no) whether they identified as Hispanic or Latina. Asked separately from race. | Count of Participants | Participants |
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| Race (NIH/OMB) | Participants were asked to select their preferred racial identity from the list given here. Participants could select as many as applied and also had the option to select "other" or "prefer not to answer. | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
| Marital Status | Participants asked their current domestic arrangements. Responses collapsed into a dichotomous measure of Married/Living with a Partner or Single | Count of Participants | Participants |
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| Job Status | Participants asked whether they were employed in a paying job | Count of Participants | Participants |
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| Educational Attainment | Participants were asked "How far did you go in school?" | Count of Participants | Participants |
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| Number of co-residential grandchildren | Participants were asked how many of their grandchildren live with them on a daily basis. | Count of Participants | Participants |
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| Self-appraised caregiving stress | Participants were asked to rate their stress associated with living with and raising grandchildren on a continuous sliding scale from 0-10 (0=no stress). | Mean | Standard Deviation | score on scale |
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| Self-appraised caregiving reward | Participants were asked to rate the amount of reward they feel associated with living with and raising grandchildren on a continuous sliding scale from 0-10 (0=no reward). | Mean | Standard Deviation | score on scale |
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| Duke Subjective Social Support | Composite score representing the amount of subjective social support participants receive from family and friends. Derived from the Subjective Social Support subscale items of the Duke Social Support Index. Scores range from 0-14, higher scores indicate more support. | Mean | Standard Deviation | score on scale |
|
| Duke Instrumental Social Support | Composite score representing the amount of instrumental social support participants receive from family and friends. Derived from the Instrumental Social Support subscale items of the Duke Social Support Index. Scores range from 0-13, higher scores indicate more support. | Mean | Standard Deviation | score on scale |
|
| Resourcefulness | Composite measure of Resourcefulness, from the 28 items of Zausniewski et al's Resourcefulness scale. Possible scores range from 0-140, higher scores represent greater resourcefulness. | Mean | Standard Deviation | score on scale |
|
| Depressive Cognitions | Composite scale capturing negative thinking patterns that precede clinical depression. comprising of items from Zausniewski's Depressive Cognitions Scale. Possible scores range from 0-40, higher scores reflect more depressive cognitions | Mean | Standard Deviation | score on scale |
|
| Caregiving status | Count of Participants | Participants |
|
| Intra-family strain | Intra-family strain was assessed with a 10- item composite scale of the intra-family strain subscale of the Family Inventory of Life Events (FILE) (McCubbin, et al., 1996). Participants response to 10 yes/no questions about stressful events that may have happened in their family. Scores range from 0-10 and higher scores represent more strain. | Mean | Standard Deviation | score on scale |
|
| Family income | Participants were asked to select the category their monthly household income fit into. | Count of Participants | Participants |
|
| OG001 | Arm 2: Reflective Journaling Training & 4 Wks Online Journaling (N = 151) | 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. |
|
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| 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. | Posted | Mean | Standard Deviation | score on a scale | comparison of baseline with 24 weeks post journaling |
|
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|
| 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. | Posted | Mean | Standard Deviation | score on a scale | comparison of baseline with 24 weeks post journaling |
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| 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline vs 24 week followup |
|
|
|
| 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline vs 24 week followup |
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| 0 |
| 173 |
| 0 |
| 173 |
| 52 |
| 173 |
| EG001 | 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. | 0 | 169 | 0 | 169 | 45 | 169 |
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| Elevated depressive symptoms at T2: 2 weeks post-intervention | Psychiatric disorders | Systematic Assessment |
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| Elevated depressive symptoms at T3: 12 weeks post-intervention | Psychiatric disorders | Systematic Assessment |
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| Elevated depressive symptoms at T4: 24 weeks post-intervention | Psychiatric disorders | Systematic Assessment |
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