Ignite Creation Date:
2024-05-05 @ 11:39 PM
Last Modification Date:
2024-10-26 @ 10:37 AM
Study NCT ID:
NCT01389726
Status:
COMPLETED
Last Update Posted:
2020-10-19
First Post:
2011-07-05
Brief Title:
Comparing Interventions To Improve The Well-Being Of Custodial Grandfamilies
Sponsor:
Kent State University
Organization:
Kent State University
Study Overview
Official Title:
Comparing Interventions To Improve The Well-Being Of Custodial Grandfamilies
Status:
COMPLETED
Status Verified Date:
2020-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
COPE
Brief Summary:
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 grandchilds 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
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 CGMs psychological distress in the caregiver role and CGCs 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 raceethnicity 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 raceethnicity 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 eg raceethnicity initial risk and by unraveling the specific antecedent-consequent relations among CGM distress dysfunctional parenting and CGC adjustment
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01NR012256 | NIH | None | httpsreporternihgovquickSearchR01NR012256 |