The Grandmother Study: Grandmother Initiatives in Family Transformation

Not Applicable

Completed

• Conditions: Women; Grandmother
• Interventions: Behavioral: Cognitive behavioral intervention and journaling; Behavioral: Reflective journaling

• Registration Number: NCT03263923
• Lead Sponsor: Case Western Reserve University

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.

Study Timeline

• Study Start: 2017-08-01
• Study First Submitted: 2017-08-21
• Study First Submitted QC: 2017-08-24
• Study First Posted: 2017-08-28
• Primary Completion: 2021-06-15
• Study Completion: 2021-12-01
• Results First Submitted: 2022-05-31
• Results First Submitted QC: 2022-09-17
• Status Verified: 2022-10
• Results First Posted: 2022-10-12
• Last Update Submitted: 2022-10-12
• Last Update Posted: 2022-11-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 346

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 1: Cognitive behavioral skills training & 4 wks online journaling	Cognitive behavioral intervention and 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	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.

Primary Outcome Measures

Name	Time	Method
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.
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.
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.
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.
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.

Trial Locations

Locations (1)

CWRU; 🇺🇸 Cleveland, Ohio, United States