Strengthening Family Coping Resources Open Trials

NCT01754610 | Completed DMC

• 1 other identifier: HP-00040466
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

Intervention Effectiveness; Practice-based Evidence; Posttraumatic Stress Disorder

Keywords

family trauma; multi-family therapy; Posttraumatic Stress Disorder; poverty

Outcome Measures

Primary Outcomes (7)

• Pre-post Treatment Effects

  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.

  Change from baseline to end of 10 or 15 week group and 3 month follow up

• McMaster Family Assessment Device (FAD) or General Functioning Scale (FAD 12)

  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.

  Change from baseline to end of 10 or 15 week group and 3 month follow up

• Child Behavior Checklist (CBCL)

  Providers of SFCR can choose to administer 1 of 3 measures of behavior problems in children. 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.

  Change from baseline to end of 10 or 15 week group and 3 month follow up

• UCLA PTSD Reaction Index

  This instrument measures exposure to and symptoms of trauma in school-age children and adolescents. Symptoms assessed are tied to Diagnostic and Statistical Manual criteria for Posttraumatic Stress Disorder (PTSD). 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.

  Change from baseline to end of 10 or 15 week group and 3 month follow up

• Pediatric Symptom Checklist (PSC 17)

  Providers of SFCR can choose to administer 1 of 3 measures of behavior problems in children. The PSC is a short 17-item measure of internalizing and externalizing behaviors.

  Change from baseline to end of 10 or 15 week group and 3 month follow up

• Strengths and Difficulties Questionnaire (SDQ)

  Providers of SFCR can choose to administer 1 of 3 measures of behavior problems in children. The SDQ is a short measure of child strengths and difficulties and includes indices of internalizing and externalizing problems.

  Change from baseline to end of 10 or 15 week group and 3 month follow up

• Family Crisis Oriented Personal Evaluation Scales (F-Copes)

  Inventory that measures family coping.

  Change from baseline to end of 10 or 15 week group and 3 month follow up

Secondary Outcomes (2)

• Parent Symptoms of PTSD

  Change from baseline to end of 10 or 15 week group

• Parent General Symptoms

  Change from baseline to end of 10 or 15 week group

Other Outcomes (2)

• SFCR Facilitator Competence and Fidelity

  Completed after each session

• Family Feedback and Satisfaction Forms

  Completed after each session and at the beginning and ending of SFCR

Study Arms (1)

Families participating in SFCR

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

Behavioral: Strengthening Family Coping Resources (SFCR)

Interventions

Strengthening Family Coping Resources (SFCR) 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.

Families participating in SFCR

Eligibility Criteria

• Age: 1 Year - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

community sample

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Maryland, Baltimore: lead

Study Sites (1)

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

Baltimore, Maryland, 21201, United States

Location

Related Publications (4)

• 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.

  PMID: 21105068 BACKGROUND

• 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.

  PMID: 21197420 BACKGROUND

• 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

  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

  BACKGROUND

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Officials

• Laurel J Kiser, Ph.D.

  University of Maryland, Baltimore

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prinicipal Investigator; Associate Professor

Study Record Dates

• First Submitted: December 14, 2012
• First Posted: December 21, 2012
• Study Start: February 1, 2006
• Primary Completion: March 31, 2025
• Study Completion: March 31, 2025
• Last Updated: June 5, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)