Comparing Interventions To Improve The Well-Being Of Custodial Grandfamilies

Study Overview
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Brief Summary
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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
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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.

Official Title
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Comparing Interventions To Improve The Well-Being Of Custodial Grandfamilies

Conditions
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Custodial Grandparents

Intervention / Treatment
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* Behavioral: Behavioral Parent Training
* Behavioral: Cognitive Behavioral Therapy
* Behavioral: Psychosocial-Informational support


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Behavioral Parenting Training<br>Triple-P Parenting Training Program (group level) | Behavioral: Behavioral Parent Training<br>* Triple-P program involves 11 weeks of ongoing group support with contact one time per week with trained group leaders<br>* Other names: BPT;|
| Experimental: Cognitive Behavioral Therapy<br>CBT group-level intervention (Designed by Larry Thompson & Dolores Gallagher Thompson) | Behavioral: Cognitive Behavioral Therapy<br>* 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<br>* Other names: Dolores Gallagher-Thompson;|
| Active Comparator: Psychosocial-Informational Support<br>Standard of Care informational support group | Behavioral: Psychosocial-Informational support<br>* 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.<br>* Other names: Support group;|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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custodial grandparents, kinship caregivers, grandparents raising grandchildren, grandmothers, grandchildren, psychological well-being