Comparing Interventions To Improve The Well-Being Of Custodial Grandfamilies
COPE
1 other identifier
interventional
343
1 country
4
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Jan 2012
Typical duration for phase_1
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 5, 2011
CompletedFirst Posted
Study publicly available on registry
July 8, 2011
CompletedStudy Start
First participant enrolled
January 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2014
CompletedOctober 19, 2020
August 1, 2020
2.8 years
July 5, 2011
October 13, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
Change in Grandchild Internalizing and Externalizing Symptoms after intervention up to two years
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
post-test (2 to 6 weeks following intervention), 6mos, 12 mos, 18 mos, 24 mos
Intervention efficacy
2 to 6 weeks following intervention
Study Arms (3)
Behavioral Parenting Training
EXPERIMENTALTriple-P Parenting Training Program (group level)
Cognitive Behavioral Therapy
EXPERIMENTALCBT group-level intervention (Designed by Larry Thompson \& Dolores Gallagher Thompson)
Psychosocial-Informational Support
ACTIVE COMPARATORStandard of Care informational support group
Interventions
Triple-P program involves 11 weeks of ongoing group support with contact one time per week with trained group leaders
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
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
University of California, San Bernardino
San Bernardino, California, 92407, United States
University of Maryland Baltimore County
Baltimore, Maryland, 21201, United States
Kent State University
Kent, Ohio, 44242, United States
University of North Texas
Denton, Texas, 76203, United States
Related Publications (2)
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.
PMID: 33393377DERIVEDSmith 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.
PMID: 30188171DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- 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
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
July 5, 2011
First Posted
July 8, 2011
Study Start
January 1, 2012
Primary Completion
October 1, 2014
Study Completion
October 1, 2014
Last Updated
October 19, 2020
Record last verified: 2020-08
Data Sharing
- IPD Sharing
- Will not share