Comparing Interventions To Improve The Well-Being Of Custodial Grandfamilies

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

343 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2014-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

The Grandmother Study: Grandmother Initiatives in Family Transformation

NCT03263923

Women Grandmother

COMPLETED NA

Telephone-Based Support for Caregivers of Patients With Dementia

NCT00052104

Dementia

COMPLETED PHASE2/PHASE3

Telephone Intervention for Caregivers of Persons With Traumatic Brain Injury

NCT00692575

Brain Injuries

COMPLETED PHASE2

Effect of Improving Caregiving on Early Mental Health

NCT00057291

Child Development Disorders

COMPLETED NA

Caring for the Carer

NCT07167641

Care Burden Care Giving Burden Caregiver Burnout +1 more

RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Custodial Grandparents

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Behavioral Parenting Training

Triple-P Parenting Training Program (group level)

Group Type EXPERIMENTAL

Behavioral Parent Training

Intervention Type BEHAVIORAL

Triple-P program involves 11 weeks of ongoing group support with contact one time per week with trained group leaders

Cognitive Behavioral Therapy

CBT group-level intervention (Designed by Larry Thompson \& Dolores Gallagher Thompson)

Group Type EXPERIMENTAL

Cognitive Behavioral Therapy

Intervention Type BEHAVIORAL

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 Support

Standard of Care informational support group

Group Type ACTIVE_COMPARATOR

Psychosocial-Informational support

Intervention Type BEHAVIORAL

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Behavioral Parent Training

Triple-P program involves 11 weeks of ongoing group support with contact one time per week with trained group leaders

Intervention Type BEHAVIORAL

Cognitive Behavioral Therapy

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

Intervention Type BEHAVIORAL

Psychosocial-Informational support

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.

Intervention Type BEHAVIORAL

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Triple-P BPT CBT Cognitive therapy Larry Thompson Dolores Gallagher-Thompson Support group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes