Comparing Interventions To Improve The Well-Being Of Custodial Grandfamilies (COPE)
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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 |
- 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.
- 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:
|
|
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:
|
|
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 |
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| Contact: Karie E Feldman, Ph.D. | 330-672-3029 | kfeldma3@kent.edu |
| Contact: Greg Smith, Ed.D. | 330-672-9993 | gsmith2@kent.edu |
| 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. | |
| 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 June 18, 2013