Custodial GrandparentsPhase 1/2COPENCT01389726
Comparing Interventions To Improve The Well-Being Of Custodial Grandfamilies
A Phase 1/2 study testing Behavioral Parent Training, Cognitive Behavioral Therapy and Psychosocial-Informational support in people with Custodial Grandparents, run by Kent State University at 4 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Custodial Grandparents
- What is being tested?
- Behavioral Parent Training, Cognitive Behavioral Therapy and Psychosocial-Informational support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 343 participants
- Where
- 4 sitesUnited States
- Study dates
- Jan 2012to Oct 2014
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country.
United States4 sites
University of Maryland Baltimore County
Baltimore, Maryland, 21201
University of North Texas
Denton, Texas, 76203
Kent State University
Kent, Ohio, 44242
University of California, San Bernardino
San Bernardino, California, 92407
About this study
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.
Read the 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.
- Conditions
- Custodial Grandparents
- Being tested
- Behavioral Parent Training, Cognitive Behavioral Therapy, Psychosocial-Informational support
- Keywords
- custodial grandparents, kinship caregivers, grandparents raising grandchildren, grandmothers, grandchildren, psychological well-being
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral Parent TrainingBehavioural
Also called Triple-P, BPT
Triple-P program involves 11 weeks of ongoing group support with contact one time per week with trained group leaders
Cognitive Behavioral TherapyBehavioural
Also called CBT, Cognitive therapy, Larry Thompson, Dolores Gallagher-Thompson
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
Psychosocial-Informational supportBehavioural
Also called Support group
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.
| Study group | Role | What they receive |
|---|---|---|
| Behavioral Parenting Training | Experimental | Triple-P Parenting Training Program (group level) Receives: Behavioral: Behavioral Parent Training |
| Cognitive Behavioral Therapy | Experimental | CBT group-level intervention (Designed by Larry Thompson \& Dolores Gallagher Thompson) Receives: Behavioral: Cognitive Behavioral Therapy |
| Psychosocial-Informational Support | Active comparator | Standard of Care informational support group Receives: Behavioral: Psychosocial-Informational support |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured through grandmother report, grandchild report, and observer ratings
Measured: 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)
Measured: 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.
Measured: 2 to 6 weeks following intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2011 (estimated)
- Study startJan 2012
- Primary completionOct 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Custodial GrandparentsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 343 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kent State University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Investigators
- Gregory Smith, Ed.D., Principal investigator, Kent State UniversityBert Hayslip, Ph.D., Principal investigator, University of North Texas Health Science CenterKarie Feldman, Ph.D., Study director, Kent State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01389726
- Sponsor's protocol ID
- R01NR012256
- Other IDs
- R01NR012256
- Acronym
- COPE
- Status last verified
- Aug 2020
- First submitted
- 5 Jul 2011
- Last updated
- 19 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33393377Smith 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.
PubMed 30188171
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Interventions To Improve The Well-Being Of Custodial Grandfamilies
- ClinicalTrials.gov ID
- NCT01389726
- Acronym / sponsor ID
- COPE / R01NR012256
- Conditions
- Custodial Grandparents
- Keywords
- custodial grandparents, kinship caregivers, grandparents raising grandchildren, grandmothers, grandchildren, psychological well-being
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 343 participants (actual)
- Lead sponsor
- Kent State UniversityUniversity, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Study start
- Jan 2012 (actual)
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 8 Jul 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Behavioral Parenting Training | Experimental | Behavioral: Behavioral Parent TrainingTriple-P Parenting Training Program (group level) |
| Cognitive Behavioral Therapy | Experimental | Behavioral: Cognitive Behavioral TherapyCBT group-level intervention (Designed by Larry Thompson \& Dolores Gallagher Thompson) |
| Psychosocial-Informational Support | Active comparator | Behavioral: Psychosocial-Informational supportStandard of Care informational support group |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Behavioral Parent TrainingAlso: Triple-P, BPTTriple-P program involves 11 weeks of ongoing group support with contact one time per week with trained group leaders | Behavioural | Behavioral Parenting Training |
| Cognitive Behavioral TherapyAlso: CBT, Cognitive therapy, Larry Thompson, Dolores Gallagher-ThompsonSupport 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 | Behavioural | Cognitive Behavioral Therapy |
| Psychosocial-Informational supportAlso: Support groupStandard 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. | Behavioural | Psychosocial-Informational Support |
Primary outcome
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
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.
3 secondary outcomes
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
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
Intervention efficacy
Time frame: 2 to 6 weeks following intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2020.
- Derived from this study: PubMed 33393377Smith 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.
- Derived from this study: PubMed 30188171Smith 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.
- Individual participant dataSharing planned: No
Related trials for Custodial Grandparents
Not yet recruiting
Empowering Cardiovascular Health in Custodial Grandparents
Cardiovascular Disease (CVD) Risk Factors
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gregory Smith, Ed.D. principal investigator
Kent State University
Bert Hayslip, Ph.D. principal investigator
University of North Texas Health Science Center
Karie Feldman, Ph.D. study director
Kent State University
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Behavioral Parent Training, Cognitive Behavioral Therapy and Psychosocial-Informational support in people with Custodial Grandparents, run by Kent State University at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01389726, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2020.