The Grandmother Study: Grandmother Initiatives in Family Transformation

Study Overview
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Brief Summary
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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.

Detailed Description
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This is a randomized clinical trial that will compare two methods of dealing with stress of grandparent caregiving to grandchildren.

Official Title
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GIFT Web Based Resourcefulness Training for Grandmother Caregivers

Conditions
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Women, Grandmother

Intervention / Treatment
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* Behavioral: Cognitive behavioral intervention and journaling
* Behavioral: Reflective journaling


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Grandmother to one or more grandchildren (age 18 or younger) living in the same home (with or without parents) Exclusion Criteria: Grandmothers to grandchildren who do not share their home Not a grandmother Not living in the United States.
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized controlled clinical trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1: Cognitive behavioral skills training & 4 wks online journaling<br>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. | Behavioral: Cognitive behavioral intervention and journaling<br>* Cognitive behavioral skills training and 4 weeks of online journaling<br>|
| Active Comparator: Arm 2: Reflective journaling training & 4 wks online journaling<br>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. | Behavioral: Reflective journaling<br>* Reflective journaling training and 4 weeks of online journaling Training in reflective journaling and 4 weeks of online journaling<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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grandmother caregivers, grandfamily, grandfamilies, custodial grandparent, custodial grandmother, multigenerational family, Grandmothers raising or living with grandchildren