Comparing Interventions To Improve The Well-Being Of Custodial Grandfamilies (COPE)

October 13, 2020 updated by: Kent State University
This study is a multi-site, four-year long clinical trial study in which several mental health interventions will be delivered to custodial grandmothers and then compared. The study will examine effects on the mental health of these grandmothers and the grandchildren they provide full-time care to in complete absence of the grandchild's birth parents. Grandparents from diverse racial, ethnic, and socio-economic backgrounds will be recruited to test for cultural differences in response to these interventions. This study is important because there is growing evidence that custodial grandchildren are at-risk for psychological difficulties due to neglect and abuse by birth parents, challenges to parenting faced by custodial grandparents, and limited access to needed services. This study is funded by the National Institute of Nursing Research, a division of the National Institutes of Health, and it is anticipated that more than 500 custodial grandfamilies in four sites across the United States will partake.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Although prior studies reveal that custodial grandmothers (CGM) and grandchildren (CGC) face high risk for psychological difficulties, virtually no rigorous studies of psychosocial interventions based on solid conceptual frameworks have been conducted with these vulnerable families. In view of preliminary findings that disrupted parenting mediates the relationship between CGM's psychological distress in the caregiver role and CGC's emotional and behavioral problems, this project involves a randomized clinical trial (RCT) of the comparative feasibility and efficacy of two evidenced-based psychoeducational interventions widely used with other caregiver populations. Grandmothers (N = 504) of CGC (age 5 - 12) will be randomly assigned to one of three conditions: Behavioral Parent Training (BPT; derived from Project KEEP for foster parents; Cognitive Behavioral Therapy (CBT; derived from Coping with Caregiving for caregivers of frail elders); Minimal Support Condition (to control for non-specific treatment factors). The proposed universal interventions include prevention and remediation objectives and involve a group format approach with mental health professionals and grandparent peers serving as co-leaders. The RCT will occur in multiple locations across the US to ensure that findings generalize beyond a single area and that equal numbers of Black (n = 168), Hispanic (n = 168), and White (n = 168) families participate. Prior to the RCT, focus groups will be held separately with CGMs of each race (n = 10 apiece) and experienced practitioners (n = 10) with the aim of assessing the perceived importance and acceptability of recruitment methods, treatment goals, and procedures, including possible differences by race/ethnicity. Multiple-informant and multiple-method assessments during the RCT at pretest, posttest and 6, 12, 18, and 24 month follow-ups will include indicators of CGM psychological distress (anxiety, depression); CGC adjustment (internalizing and externalizing problems); and disrupted parenting (use of ineffective discipline and low nurturance). Based on the conceptual framework of the prominent Family Stress Model, multi-group structural equation modeling analyses will be used to achieve four aims: (a) To compare the short and long-term effectiveness of CBT and BPT; (b) to examine longitudinally the dynamic linkages between CGM parenting practices, CGM' psychological distress, and CGC adjustment as modified by BPT and CBT; (c) to determine if key moderating variables (race/ethnicity, CGC, initial psychological difficulties in CGC and CGM influence RCT outcomes; and (d) to examine key factors related to acceptability and adherence to the proposed interventions. The findings will inform future clinical practice with custodial grandfamilies by identifying which of the proposed interventions are most effective and most acceptable among specific sub-groups (e.g., race/ethnicity; initial risk) and by unraveling the specific antecedent-consequent relations among CGM distress, dysfunctional parenting, and CGC adjustment.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
343

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Bernardino, California, United States, 92407
        • University of California, San Bernardino
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • University of Maryland Baltimore County
    • Ohio
      • Kent, Ohio, United States, 44242
        • Kent State University
    • Texas
      • Denton, Texas, United States, 76203
        • University of North Texas

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Grandmother raising grandchildren
  • No biological resides in grandmother's home
  • At least one grandchild between ages 4 and 12
  • Grandchild has lived with grandmother for minimum of 3 months
  • Grandchild is expected to stay with grandmother

Exclusion Criteria:

  • Biological parent is directly involved in raising child
  • Grandmother is unable to leave the home to attend weekly meetings
  • Grandmother is unable to speak English
  • Grandmother is unable to answer simple questions

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Behavioral Parenting Training
Triple-P Parenting Training Program (group level)
Behavioral: Behavioral Parent Training
Triple-P program involves 11 weeks of ongoing group support with contact one time per week with trained group leaders
Other Names:
  • Triple-P
  • BPT
Experimental: Cognitive Behavioral Therapy
CBT group-level intervention (Designed by Larry Thompson & Dolores Gallagher Thompson)
Behavioral: Cognitive Behavioral Therapy
Support group based intervention involving sessions one time per week for 11 weeks with 9-12 grandmothers, 1 trained professional group leader, and 1 trained peer leader
Other Names:
  • CBT
  • Cognitive therapy
  • Larry Thompson
  • Dolores Gallagher-Thompson
Active Comparator: Psychosocial-Informational Support
Standard of Care informational support group
Behavioral: Psychosocial-Informational support
Standard of care normally provided to custodial grandparents. Involves providing information and support in the context of a weekly group meeting with 9-12 grandparents, 1 professional group leader & 1 peer leader over the course of 11 weeks.
Other Names:
  • Support group

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Parenting Quality after intervention up to two years
Time Frame: post-test (2 to 6 weeks following intervention), 6 mos, 12 mos, 18 mos, 2 years
Parenting quality will be measured in terms of the degree to which grandparents employ positive discipline strategies and engage in warm or nurturing parenting styles. Measured both using self-report and observer ratings.
post-test (2 to 6 weeks following intervention), 6 mos, 12 mos, 18 mos, 2 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Grandchild Internalizing and Externalizing Symptoms after intervention up to two years
Time Frame: post-test (2 to 6 weeks following intervention), 6 mos, 12 mos, 18 mos, 24 mos
Measured through grandmother report, grandchild report, and observer ratings
post-test (2 to 6 weeks following intervention), 6 mos, 12 mos, 18 mos, 24 mos
Change in GM Psychological Distress after intervention up to two years
Time Frame: post-test (2 to 6 weeks following intervention), 6mos, 12 mos, 18 mos, 24 mos
Grandmother's psychological distressed as defined by anxiety and depression levels (measured both through self report and clinical ratings)
post-test (2 to 6 weeks following intervention), 6mos, 12 mos, 18 mos, 24 mos
Intervention efficacy
Time Frame: 2 to 6 weeks following intervention
GM satisfaction with intervention, and comparative impact of interventions vs. control. These variables will be measured at the post-test which will take place between two and 6 weeks following the completion of the intervention.
2 to 6 weeks following intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Kent State University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute of Nursing Research (NINR)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Gregory Smith, Ed.D., Kent State University
  • Principal Investigator: Bert Hayslip, Ph.D., University of North Texas Health Science Center
  • Study Director: Karie Feldman, Ph.D., Kent State University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 5, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 6, 2011

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 8, 2011

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 19, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 13, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • R01NR012256 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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