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Completed

NCT Number: NCT03263923

The Grandmother Study: Grandmother Initiatives in Family Transformation

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.

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Key information

Conditions

Women Grandmother

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

CWRU

Cleveland, Ohio, 44140-1140, United States

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cognitive behavioral intervention and journaling

Behavioral

Cognitive behavioral skills training and 4 weeks of online journaling

Reflective Journaling

Behavioral

Reflective journaling training and 4 weeks of online journaling

Training in reflective journaling and 4 weeks of online journaling

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Sponsors and collaborators

Lead sponsor

Case Western Reserve University

Other

Registry information

Official study title

GIFT Web Based Resourcefulness Training for Grandmother Caregivers

Acronym: GIFT

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
Aug 28, 2017
Registry last updated
Nov 8, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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