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

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: Completed
• Conditions: Custodial Grandparents
• Intervention / Treatment: Behavioral: Behavioral Parent Training; Behavioral: Cognitive Behavioral Therapy; Behavioral: Psychosocial-Informational support

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: Interventional
• Enrollment (Actual): 343
• Phase: Phase 2; Phase 1

Contacts and Locations

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

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Change in Parenting Quality after intervention up to two 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

Outcome Measure	Measure Description	Time Frame
Change in Grandchild Internalizing and Externalizing Symptoms after intervention up to two years	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	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	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

• Sponsor: Kent State University
• Collaborators: National Institute of Nursing Research (NINR)
• 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

Publications and helpful links

General Publications

• Smith GC, Hancock GR, Hayslip B. Predictors and moderators of treatment efficacy in reducing custodial grandmothers' psychological distress. Aging Ment Health. 2022 Feb;26(2):250-262. doi: 10.1080/13607863.2020.1857688. Epub 2021 Jan 4.
• Smith GC, Hayslip B, Hancock GR, Strieder FH, Montoro-Rodriguez J. A randomized clinical trial of interventions for improving well-being in custodial grandfamilies. J Fam Psychol. 2018 Sep;32(6):816-827. doi: 10.1037/fam0000457.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2012
• Primary Completion (Actual): October 1, 2014
• Study Completion (Actual): October 1, 2014

Study Registration Dates

• First Submitted: July 5, 2011
• First Submitted That Met QC Criteria: July 6, 2011
• First Posted (Estimate): July 8, 2011

Study Record Updates

• Last Update Posted (Actual): October 19, 2020
• Last Update Submitted That Met QC Criteria: October 13, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Keywords: psychological well-being; custodial grandparents; kinship caregivers; grandparents raising grandchildren; grandmothers; grandchildren
• Other Study ID 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