WomenGIFTNCT03263923

The Grandmother Study: Grandmother Initiatives in Family Transformation

A study testing Cognitive behavioral intervention and journaling and Reflective journaling in people with Women and Grandmother, run by Case Western Reserve University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Any age, women onlyHealthy volunteers can take part
Conditions the study is for: Women, Grandmother
What is being tested?: Cognitive behavioral intervention and journaling and Reflective journaling
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 346 participants
Where: 1 siteUnited States
Study dates: 1 Aug 2017to 1 Dec 2021
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Any age
Women only
Healthy volunteers accepted
Child, Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

CWRU
Cleveland, Ohio, 44140-1140

Other trials in United States

About this study

Official title: GIFT Web Based Resourcefulness Training for Grandmother Caregivers

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.

Read the detailed description

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

Conditions: Women, Grandmother
Being tested: Cognitive behavioral intervention and journaling, Reflective journaling
Keywords: grandmother caregivers, grandfamily, grandfamilies, custodial grandparent, custodial grandmother, multigenerational family, Grandmothers raising or living with grandchildren

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Cognitive behavioral intervention and journalingBehavioural
Cognitive behavioral skills training and 4 weeks of online journaling
Reflective journalingBehavioural
Reflective journaling training and 4 weeks of online journaling
Training in reflective journaling and 4 weeks of online journaling

Study groups in NCT03263923
Study group	Role	What they receive
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. Receives: 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. Receives: Behavioral: Reflective journaling

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline vs 24 week followup

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Aug 20171 Dec 2021

First posted28 Aug 2017
Study start1 Aug 2017
Primary completion15 Jun 2021
Study completion1 Dec 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (5)Papers the sponsor has linked to this study.
Other trials for WomenStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: Randomized controlled clinical trial
Masking: Single blind
Who is masked: Participant
Enrolment: 346 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03263923
Sponsor's protocol ID: R01NR015999
Acronym: GIFT
Status last verified: Oct 2022
First submitted: 21 Aug 2017
Last updated: 8 Nov 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

Publications

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.
PubMed 33593072
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.
PubMed 34265228
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.
PubMed 32880239
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.
PubMed 32513473
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.
PubMed 35572175

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 8 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: GIFT Web Based Resourcefulness Training for Grandmother Caregivers
ClinicalTrials.gov ID: NCT03263923
Acronym / sponsor ID: GIFT / R01NR015999
Conditions: Women, Grandmother
Keywords: grandmother caregivers, grandfamily, grandfamilies, custodial grandparent, custodial grandmother, multigenerational family, Grandmothers raising or living with grandchildren
Study type: Interventional
Recruitment status: Completed
Enrolment: 346 participants (actual)
Lead sponsor: Case Western Reserve UniversityUniversity, hospital or other
Study start: 1 Aug 2017 (actual)
Primary completion: 15 Jun 2021 (actual)
Study completion: 1 Dec 2021 (actual)
First posted: 28 Aug 2017 (actual)
Results: Posted 12 Oct 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2
Model description: Randomized controlled clinical trial

Arm	Type	Receives
Arm 1: Cognitive behavioral skills training & 4 wks online journaling	Experimental	Behavioral: Cognitive behavioral intervention and journalingCognitive 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	Active comparator	Behavioral: Reflective journalingReflective 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.

Who may qualify

Sex: Female only
Healthy volunteers: Accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (1 listed)

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

Key exclusion criteria (3 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Cognitive behavioral intervention and journalingCognitive behavioral skills training and 4 weeks of online journaling	Behavioural	Arm 1: Cognitive behavioral skills training & 4 wks online journaling
Reflective journalingReflective journaling training and 4 weeks of online journaling Training in reflective journaling and 4 weeks of online journaling	Behavioural	Arm 2: Reflective journaling training & 4 wks online journaling

Primary outcome

Depressive Symptoms
Time frame: 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.
Well Being
Time frame: 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.
Family Well Being - Composite Score Derived From 12 Items.
Time frame: 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.
SF-12 Mental Health Composite Score
Time frame: 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.
SF-12 Physical Health Composite Score
Time frame: 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.

Results and safety

Results posted to the registry on 12 Oct 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Arm 1: Cognitive Behavioral Skills Training & 4 Wks Online Journaling	174	149
Arm 2: Reflective Journaling Training & 4 Wks Online Journaling	172	151

Primary outcome: Depressive Symptoms

Time frame: comparison of baseline with 24 weeks post journaling completion. Mean (Standard Deviation). Unit: score on a scale

Measure	Arm 1: Cognitive Behavioral Skills Training & 4 Wks Online Journaling (N=149) n = 149	Arm 2: Reflective Journaling Training & 4 Wks Online Journaling (N = 151) n = 151
Time 1 (baseline)	18.116 (11.650)	18.231 (11.51)
Time 4 (24 wks post-journaling)	15.135 (11.650)	15.873 (10.425)

Primary outcome: Well Being

Time frame: comparison of baseline with 24 weeks post journaling. Mean (Standard Deviation). Unit: score on a scale

Measure	Arm 1: Cognitive Behavioral Skills Training & 4 Wks Online Journaling (N=149) n = 149	Arm 2: Reflective Journaling Training & 4 Wks Online Journaling (N = 151) n = 151
Time 1 (baseline)	2.97 (.974)	3.00 (.982)
Time 4 (24 wks post-journaling)	2.92 (.929)	2.95 (.909)

Primary outcome: Family Well Being - Composite Score Derived From 12 Items.

Time frame: comparison of baseline with 24 weeks post journaling. Mean (Standard Deviation). Unit: score on a scale

Measure	Arm 1: Cognitive Behavioral Skills Training & 4 Wks Online Journaling (N=149) n = 149	Arm 2: Reflective Journaling Training & 4 Wks Online Journaling (N = 151) n = 151
Time 1 (baseline)	2.300 (.532)	2.300 (.503)
Time 4 (24 wks post-journaling)	2.172 (.600)	2.172 (.564)

Primary outcome: SF-12 Mental Health Composite Score

Time frame: Baseline vs 24 week followup. Mean (Standard Deviation). Unit: score on a scale

Measure	Arm 1: Cognitive Behavioral Skills Training & 4 Wks Online Journaling n = 149	Arm 2: Reflective Journaling Training & 4 Wks Online Journaling n = 151
T1 (baseline)	43.452 (11.298)	41.613 (12.003)
T4 (24 week followup post journal)	45.611 (11.001)	45.230 (10.357)

Adverse events

Time frame: 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).. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Arm 1: Cognitive Behavioral Skills Training & 4 Wks Online Journaling	0 of 173 (0%)	52 of 173 (30.1%)	0 of 173
Arm 2: Reflective Journaling Training & 4 Wks Online Journaling	0 of 169 (0%)	45 of 169 (26.6%)	0 of 169

Limitations and caveats (from the sponsor): Does not include grandfathers.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 33593072Wallace 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.
Results publication: PubMed 34265228Tracy 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.
Results publication: PubMed 32880239Musil 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.
Results publication: PubMed 32513473Wallace 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.
Results publication: PubMed 35572175Dolbin-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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Carol M Musil, PhD principal investigator

Case Western Reserve University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Cognitive behavioral intervention and journaling and Reflective journaling in people with Women and Grandmother, run by Case Western Reserve University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 Oct 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Depressive Symptoms (time frame: comparison of baseline with 24 weeks post journaling completion). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03263923, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2022.