Strengthening Family Coping Resources Open Trials

NCT ID: NCT01754610

Last Updated: 2025-06-05

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 500 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2006-02-28
• Study Completion Date: 2025-03-31

Brief Summary

Strengthening Families Coping Resources (SFCR) Open Trials completes the second stage of the National Institute on Drug Abuse's 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.

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 family's 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 s/he 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.

Conditions

Intervention Effectiveness; Practice-based Evidence; Posttraumatic Stress Disorder

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Families participating in SFCR

Families who have experienced multiple traumas and high stress related to poverty

Strengthening Family Coping Resources (SFCR)

Intervention Type: BEHAVIORAL

Trauma Version (15 weeks) and High Risk Version (10 weeks) are 2 hour sessions. Dinner will be provided at the start of group for all participants.

Activities will be conducted at each group to encourage family involvement. The treatment modules focus on family rituals and routine, strengthening families' collaborative coping, and resolution of the trauma(s) bringing the families to treatment. Activities will be both family-based and age-based.

Interventions

Strengthening Family Coping Resources (SFCR)

Trauma Version (15 weeks) and High Risk Version (10 weeks) are 2 hour sessions. Dinner will be provided at the start of group for all participants.

Activities will be conducted at each group to encourage family involvement. The treatment modules focus on family rituals and routine, strengthening families' collaborative coping, and resolution of the trauma(s) bringing the families to treatment. Activities will be both family-based and age-based.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Children aged 1 through 17 years old at the time of recruitment
• Child and family exposed to multiple traumas
• a partial diagnosis of PTSD (15-week treatment version)
• currently in the custody of a caregiver who agrees to participate in the study.
• a stable caregiving system as defined by a recent history of stability and unlikely to change in the next 6 months.

Exclusion Criteria

• Children will be excluded only if they have active suicide ideation, an imminent risk for re-exposure due to their living environment, active psychosis, severe mental retardation or brain injury
• Parent/caregiver has active psychosis or is a danger to self/others.

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Maryland, Baltimore

OTHER

Sponsor Role: lead

Responsible Party

Laurel J Kiser

Prinicipal Investigator; Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Laurel J Kiser, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Maryland, Baltimore

Locations

University of Maryland, School of Medicine, Department of Psychiatry, Divsion of Services Research

Baltimore, Maryland, United States

Countries

United States

References

Kiser LJ, Donohue A, Hodgkinson S, Medoff D, Black MM. Strengthening family coping resources: the feasibility of a multifamily group intervention for families exposed to trauma. J Trauma Stress. 2010 Dec;23(6):802-6. doi: 10.1002/jts.20587.

Reference Type: BACKGROUND

PMID: 21105068 (View on PubMed)

Kiser LJ, Baumgardner B, Dorado J. Who Are We, But for the Stories We Tell: Family Stories and Healing. Psychol Trauma. 2010 Sep 1;2(3):243-249. doi: 10.1037/a0019893.

Reference Type: BACKGROUND

PMID: 21197420 (View on PubMed)

Kiser, LJ., Backer, PM., Winkles, JK., Medoff, D. Strengthening Family Coping Resources (SFCR): Practice-Based Evidence for a Promising Trauma Intervention. Couple and Family Psychology: Research and Practice 4:49-59, 2015. Doi:10/1037/cfp0000034

Reference Type: BACKGROUND

Kiser, LJ, Miller, AB, Mooney, MA, Vivrette, R, Davis, S. Integrating parents into child trauma treatment: Reviewing evidence and establishing core components. Practice Innovations. 2020; 5:65-80. doi: http://dx.doi.org/10.1037/pri0000109

Reference Type: BACKGROUND

Other Identifiers

HP-00040466

Identifier Type: -

Identifier Source: org_study_id