Ignite Creation Date:
2024-05-06 @ 1:13 AM
Last Modification Date:
2024-10-26 @ 11:00 AM
Study NCT ID:
NCT01754610
Status:
RECRUITING
Last Update Posted:
2024-03-22
First Post:
2012-12-14
Brief Title:
Strengthening Family Coping Resources Open Trials
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
Official Title:
Strengthening Family Coping Resources Open Trials
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SFCR
Brief Summary:
Strengthening Families Coping Resources SFCR Open Trials completes the second stage of the National Institute on Drug Abuses intervention development model by testing a new family skills-based intervention involving pre-post evaluation of families participating in multi-family groups The purpose of this study is to gather practice-based evidence on the effectiveness of the manualized treatment on the dynamics involved in the group format and on implementation fidelity and feasibility Analyses will involve initial exploration of the following hypotheses 1 Families will show a significant increase in the constructive use of family coping skills and in general family functioning 2 The target child will show a reduction in trauma-related symptoms and behavior problems 3 Parents will show significant reductions in traumatic stress and other symptoms of distress 4 Families will engage and participate in the treatment 5 Providers will implement SFCR with fidelity
Other outcomes of interest are the process measures that will be collected to monitor participation in the groups cultural sensitivity and acceptability clinician competence and intervention integrity
Other outcomes of interest are the process measures that will be collected to monitor participation in the groups cultural sensitivity and acceptability clinician competence and intervention integrity
Detailed Description:
Strengthening Family Coping Resources SFCR is a manualized trauma-focused skills-based intervention that uses a multi-family group format SFCR is designed for families living in traumatic contexts with the goal of reducing the symptoms of posttraumatic stress disorder PTSD and other trauma-related disorders in children and adult caregivers Since most families living in traumatic contexts contend with on-going stressors and threats SFCR is also designed to increase coping resources in children adult caregivers and in the family system to prevent relapse and re-exposure SFCR provides trauma treatment within a family format SFCR includes additional therapeutic strategies designed to improve the familys ability to cope with on-going stress and threats of re-exposure Specifically SFCR builds the coping resources necessary to help families boost their sense of safety function with stability regulate their emotions and behaviors and improve communication about and understanding of the traumas they have experienced The model includes family work on storytelling and narration which builds to a family trauma narrative SFCR is currently being implemented at University of Maryland Medical Center UMMC at sites that are part of the National Child Traumatic Stress Network NCTSN and at community agencies within the Baltimore Metro area and beyond
Families will participate in a multifamily version of the intervention Multiple groups of 5-6 families will be conducted with pre-post data collected in addition to information on the feasibility of the intervention Prior to beginning each group families will be assessed using a structured assessment This assessment will be repeated at the end of group all groups and approximately one year following the completion of the group for UMMC groups only
One child in each family will be designated as the research subject The target child will be chosen according to age aged 1 through 17 years old and referral for services If more than one child in the family meet these criteria the primary caregiver will be given the option of how many children she would like to be assessed for inclusion in the study Data on the parents will only be collected from mothers or female caregivers If no female caregiver is available the primary caregiver will complete the assessments
Families will participate in a multifamily version of the intervention Multiple groups of 5-6 families will be conducted with pre-post data collected in addition to information on the feasibility of the intervention Prior to beginning each group families will be assessed using a structured assessment This assessment will be repeated at the end of group all groups and approximately one year following the completion of the group for UMMC groups only
One child in each family will be designated as the research subject The target child will be chosen according to age aged 1 through 17 years old and referral for services If more than one child in the family meet these criteria the primary caregiver will be given the option of how many children she would like to be assessed for inclusion in the study Data on the parents will only be collected from mothers or female caregivers If no female caregiver is available the primary caregiver will complete the assessments
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None