The Grandmother Study: Grandmother Initiatives in Family Transformation

Women Clinical Trial

— GIFT  

Official title:

GIFT Web Based Resourcefulness Training for Grandmother Caregivers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03263923
• Other study ID #: R01NR015999
• Status: Completed
• Phase: N/A
• Start date: August 1, 2017
• Est. completion date: December 1, 2021

Study information

• Verified date: October 2022
• Source: Case Western Reserve University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 346
• Est. completion date: December 1, 2021
• Est. primary completion date: June 15, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Grandmother
• Women

Intervention

Behavioral:
• Cognitive behavioral intervention and journaling
Cognitive behavioral skills training and 4 weeks of online journaling
• Reflective journaling
Reflective journaling training and 4 weeks of online journaling Training in reflective journaling and 4 weeks of online journaling

Locations

Country	Name	City	State
United States	CWRU	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Case Western Reserve University

Country where clinical trial is conducted

United States, 

References & Publications (5)

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. doi: 10.1002/pits.22714. [Epub ahead of print] — View Citation

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. — View Citation

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 2 — View Citation

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. — View Citation

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/ — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	comparison of baseline with 24 weeks post journaling completion
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.	comparison of baseline with 24 weeks post journaling
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.	comparison of baseline with 24 weeks post journaling
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.	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.	Baseline vs 24 week followup