Clinical trial NCT01389726: Comparing Interventions To Improve The Well-Being Of Custodial Grandfamilies
Official title: Comparing Interventions To Improve The Well-Being Of Custodial Grandfamilies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Custodial Grandparents
Keywords: custodial grandparents
kinship caregivers
grandparents raising grandchildren
grandmothers
grandchildren
psychological well-being
Lead sponsor: Kent State University
Sponsor class: OTHER
Collaborators: name: National Institute of Nursing Research (NINR)
First posted: 2011-07-08
Enrollment: 343
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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 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.

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 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

Primary outcomes:
measure: Change in Parenting Quality after intervention up to two years
timeFrame: post-test (2 to 6 weeks following intervention), 6 mos, 12 mos, 18 mos, 2 years
Secondary outcomes:
measure: Change in Grandchild Internalizing and Externalizing Symptoms after intervention up to two years
timeFrame: post-test (2 to 6 weeks following intervention), 6 mos, 12 mos, 18 mos, 24 mos
measure: Change in GM Psychological Distress after intervention up to two years
timeFrame: post-test (2 to 6 weeks following intervention), 6mos, 12 mos, 18 mos, 24 mos
measure: Intervention efficacy
timeFrame: 2 to 6 weeks following intervention
Other outcomes:
Locations:
city: San Bernardino
country: United States
facility: University of California, San Bernardino
state: California
city: Baltimore
country: United States
facility: University of Maryland Baltimore County
state: Maryland
city: Kent
country: United States
facility: Kent State University
state: Ohio
city: Denton
country: United States
facility: University of North Texas
state: Texas
Study officials:
affiliation: Kent State University
name: Gregory Smith, Ed.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of North Texas Health Science Center
name: Bert Hayslip, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Kent State University
name: Karie Feldman, Ph.D.
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.