Strengthening Family Coping Resources Open Trials (SFCR)

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2012 by University of Maryland
Sponsor:
Collaborator:
Substance Abuse and Mental Health Services Administration (SAMHSA)
Information provided by (Responsible Party):
Laurel J Kiser, University of Maryland
ClinicalTrials.gov Identifier:
NCT01754610
First received: December 14, 2012
Last updated: December 21, 2012
Last verified: December 2012
  Purpose

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) Families will engage and participate in the treatment. 4) Providers will implement SFCR with fidelity.

Cortisol sub-study: Overall Objective: To pilot the feasibility of collecting salivary samples from families participating in SFCR and gather preliminary data on efficacy of SFCR in improving regulatory processes for families of young children who experience high levels of stress related to urban poverty.

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.


Condition Intervention
Intervention Effectiveness
Practice-based Evidence
Behavioral: Strengthening Family Coping Resources (SFCR)

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Strengthening Family Coping Resources Open Trials

Resource links provided by NLM:


Further study details as provided by University of Maryland:

Primary Outcome Measures:
  • Pre-post Treatment Effects [ Time Frame: Change from baseline to end of 10 or 15 week group ] [ Designated as safety issue: No ]

    This is a large open-ended sample involving collection of practice-based evidence of intervention effectiveness related to broad dissemination. The sample size is not being constrained by a specific research question.

    Data analysis: Indications of change were assessed using pre-post measures. Post-intervention change will be assessed with t-tests for dependent samples. Cohen's d will be used to calculate effect size. Comparison of pre-post scores for the target child will be assessed on PTSD symptoms (UCLA-PTSD Reaction Index Parent and Child Versions) and on behavior problems (CBCL). Comparison of pre-post scores on standardized measures of family functioning (Family Assessment Device), family coping (F-COPES), and parental stress (PSI_SF), and scores on the Family Mealtime Q-Sort will be made.


  • McMaster Family Assessment Device (FAD) [ Time Frame: Change from baseline to end of 10 or 15 week group ] [ Designated as safety issue: No ]
    The McMaster Family Assessment Device (FAD) (Epstein et al., 1983; Miller, Epstein, Bishop, & Keitner, 1985) is a 60-question, Likert scale instrument designed to measure family functioning based upon the McMaster Model. Items are scored on a 4-point scale from 1 "healthy" to 4 "unhealthy." The instrument provides scores for seven scales, including problem-solving, communication, roles, affective responsiveness, affective involvement, behavior control, and overall functioning.

  • Child Behavior Checklist (CBCL) [ Time Frame: Change from baseline to end of 10 or 15 week group ] [ Designated as safety issue: No ]
    The CBCL/1½-5 and 6-18 (Achenbach & Rescorla, 2001)requires a caregiver to rate, on a three-point scale from 0 (not true) to 2 (often true), each of 118 problems as they are perceived to reflect the child's behavior over the past six months. The instrument has 8-9 subscales that can be collapsed into broadband scales: Internalizing, Externalizing, and a Total Score.

  • UCLA PTSD Reaction Index [ Time Frame: Change from baseline to end of 10 or 15 week group ] [ Designated as safety issue: No ]
    This instrument measures exposure to and symptoms of trauma in school-age children and adolescents. Symptoms assessed are tied to Diagnostic and Statistical Manual IV (DSM-IV) criteria for Posttraumatic Stress Disorder (PTSD). Twenty of these items assess PTSD symptoms; two additional items assess associated features--fear of recurrence and trauma-related guilt. The UCLA PTSD-RI can be used as either a self-report or clinician-administered instrument. Reliability and validity are fairly robust (Steinberg et al., 2004). It has been used in many research designs and, importantly for the purposes of this study, among children exposed to community stress and violence.


Secondary Outcome Measures:
  • SFCR Facilitator Competence and Fidelity [ Time Frame: Completed after each session ] [ Designated as safety issue: No ]
    These are short self-report measures of each facilitators' impressions of their competence during the group and their adherence to the session guidelines.

  • Family Crisis Oriented Personal Evaluation Scales (F-COPES) [ Time Frame: Change from baseline to end of 10 or 15 week group ] [ Designated as safety issue: No ]
    Family Crisis Oriented Personal Evaluation Scales (F-COPES; 183) is a 30-item measure designed to assess family-level coping. Dimensions derive from the Family Resiliency model. They include acquiring social support, reframing, seeking spiritual support, mobilizing family to acquire/accept help, and passive appraisal. Items are scored on a 5-point Likert scale from always to never.

  • Parenting Stress Index-Short Form (PSI-SF) [ Time Frame: Change from baseline to end of 10 or 15 week group ] [ Designated as safety issue: No ]
    The Parenting Stress Index-Short Form (PSI-SF)194 is a 36-item scale measuring caregiver stress and inappropriate parenting. Each statement is rated using a 5-point Likert scale indicating how much that item disturbed the caregiver in the past week and yields scores for Parental Distress (contributing parental factors), Difficult Child (contributing child factors related to parenting stress and dysfunction), Parent-Child Dysfunction Interaction.


Other Outcome Measures:
  • Family Mealtime Q-Sort [ Time Frame: Change from baseline to end of 10 or 15 week group ] [ Designated as safety issue: No ]
    The Family Mealtime Q-Sort provides a methodology for examining mealtime practices. The results of formative research on the measure demonstrate that coders could rate family mealtimes with adequate inter-rater reliability, construct validity was satisfactory, and family mealtimes could be compared to an independently derived, culturally appropriate standard.


Estimated Enrollment: 500
Study Start Date: February 2006
Estimated Study Completion Date: October 2017
Estimated Primary Completion Date: October 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Families participating in SFCR
Families who have experienced multiple traumas and high stress related to poverty
Behavioral: 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.


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 accepted, empirically supported 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.

500 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).

At least one child in each family will be designated as the research subject. The target child(ren) 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.

Cortisol sub-study: Specific Aim 1: To determine whether the cortisol stress response is better regulated and synchronized following SFCR participation. Hypothesis 1: Intervention caregivers and children will increase pre-post morning cortisol levels over the course of the 10-week intervention. Hypothesis 1a: Intervention caregivers and children will develop more synchronous cortisol levels following the intervention. The sample for this substudy will consist of 20 families participating in SFCR groups at two participating centers. Saliva samples will be collected from one caregiver and one child in the family who is willing to participate.

  Eligibility

Ages Eligible for Study:   1 Year to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Primary care clinic and community sample

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01754610

Locations
United States, Maryland
University of Maryland, School of Medicine, Department of Psychiatry, Divsion of Services Research Recruiting
Baltimore, Maryland, United States, 21201
Contact: Laurel J Kiser, Ph.D.    410-706-2490    lkiser@gmail.com   
Principal Investigator: Laurel J. Kiser, Ph.D.         
Sponsors and Collaborators
University of Maryland
Substance Abuse and Mental Health Services Administration (SAMHSA)
Investigators
Principal Investigator: Laurel J Kiser, Ph.D. University of Maryland, Baltimore County
  More Information

Publications:
Responsible Party: Laurel J Kiser, Prinicipal Investigator; Associate Professor, University of Maryland
ClinicalTrials.gov Identifier: NCT01754610     History of Changes
Other Study ID Numbers: HP-00040466
Study First Received: December 14, 2012
Last Updated: December 21, 2012
Health Authority: United States: Federal Government

Keywords provided by University of Maryland:
family trauma
multi-family therapy
Posttraumatic Stress Disorder
poverty

ClinicalTrials.gov processed this record on August 27, 2014