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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2011 by Kent State University.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
Information provided by:
Kent State University
ClinicalTrials.gov Identifier:
NCT01389726
First received: July 5, 2011
Last updated: July 6, 2011
Last verified: July 2011
  Purpose

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.


Condition Intervention Phase
Custodial Grandparents
Behavioral: Behavioral Parent Training
Behavioral: Cognitive Behavioral Therapy
Behavioral: Psychosocial-Informational support
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Comparing Interventions To Improve The Well-Being Of Custodial Grandfamilies

Resource links provided by NLM:


Further study details as provided by Kent State University:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    Measured through grandmother report, grandchild report, and observer ratings

  • 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 ] [ Designated as safety issue: No ]
    Grandmother's psychological distressed as defined by anxiety and depression levels (measured both through self report and clinical ratings)

  • Intervention efficacy [ Time Frame: 2 to 6 weeks following intervention ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 504
Study Start Date: January 2012
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Support group

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01389726

Contacts
Contact: Karie E Feldman, Ph.D. 330-672-3029 kfeldma3@kent.edu
Contact: Greg Smith, Ed.D. 330-672-9993 gsmith2@kent.edu

Locations
United States, California
University of California, San Bernardino Not yet recruiting
San Bernardino, California, United States, 92407
Contact: Julian Montoro-Rodriguez, Ph.D.    909-537-5580    jmontoro@csusb.edu   
Sub-Investigator: Julian Montoro-Rodriquez, Ph.D.         
United States, Maryland
University of Maryland Baltimore County Not yet recruiting
Baltimore, Maryland, United States, 21201
Contact: Frederick Strieder, Ph.D.    410-706-5479    fstriede@ssw.umaryland.edu   
Contact: Patty Greenberg, MA    410-706-1460    pgreenberg@ssw.umaryland.edu   
Sub-Investigator: Frederick Strieder, Ph.D.         
United States, Ohio
Kent State University Not yet recruiting
Kent, Ohio, United States, 44242
Contact: Karie Feldman, Ph.D.    330-672-3029      
Principal Investigator: Greg Smith, Ed.D.         
United States, Texas
University of North Texas Not yet recruiting
Denton, Texas, United States, 76203
Contact: Bert Hayslip, Ph.D.    940-565-2675    hayslipb@unt.edu   
Principal Investigator: Bert Hayslip, Ph.D.         
Sponsors and Collaborators
Kent State University
Investigators
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
  More Information

No publications provided

Responsible Party: Gregory Smith, Ed.D.; Professor, Kent State University
ClinicalTrials.gov Identifier: NCT01389726     History of Changes
Other Study ID Numbers: R01NR012256, R01NR012256
Study First Received: July 5, 2011
Last Updated: July 6, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Kent State University:
custodial grandparents
kinship caregivers
grandparents raising grandchildren
grandmothers
grandchildren
psychological well-being

ClinicalTrials.gov processed this record on October 20, 2014