The Grandmother Study: Grandmother Initiatives in Family Transformation

NCT03263923 | Completed Results DMC

• 1 other identifier: R01NR015999
• Study Type: interventional
• Target: 346
• Locations: 1 country
• Sites: 1

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.

Conditions

Women; Grandmother

Keywords

grandmother caregivers; grandfamily; grandfamilies; custodial grandparent; custodial grandmother; multigenerational family; Grandmothers raising or living with grandchildren

Outcome Measures

Primary Outcomes (5)

• 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

Study Arms (2)

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.

Behavioral: Cognitive behavioral intervention and journaling

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.

Behavioral: Reflective journaling

Interventions

Cognitive behavioral intervention and journaling BEHAVIORAL

Cognitive behavioral skills training and 4 weeks of online journaling

Arm 1: Cognitive behavioral skills training & 4 wks online journaling

Reflective journaling BEHAVIORAL

Reflective journaling training and 4 weeks of online journaling Training in reflective journaling and 4 weeks of online journaling

Arm 2: Reflective journaling training & 4 wks online journaling

Eligibility Criteria

• Gender Eligibility Details: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Grandmother to one or more grandchildren (age 18 or younger) living in the same home (with or without parents)

You may not qualify if:

• Grandmothers to grandchildren who do not share their home
• Not a grandmother
• Not living in the United States.

Sponsors & Collaborators

• Case Western Reserve University: lead

Study Sites (1)

CWRU

Cleveland, Ohio, 44140-1140, United States

Location

Related Publications (5)

• 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.

  PMID: 33593072 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.

  PMID: 34265228 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.

  PMID: 32880239 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.

  PMID: 32513473 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.

  PMID: 35572175 RESULT

Limitations and Caveats

Does not include grandfathers.

Results Point of Contact

• Title: Dr. Carol M. Musil
• Organization: Case Western Reserve University

cmm4@case.edu

216-368-2545

Study Officials

• Carol M Musil, PhD

  Case Western Reserve University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants randomly assigned to groups
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Randomized controlled clinical trial

Study Record Dates

• First Submitted: August 21, 2017
• First Posted: August 28, 2017
• Study Start: August 1, 2017
• Primary Completion: June 15, 2021
• Study Completion: December 1, 2021
• Last Updated: November 8, 2022
• Results First Posted: October 12, 2022

Record last verified: 2022-10

Locations

US (1)