Intervention EffectivenessSFCRNCT01754610
Strengthening Family Coping Resources Open Trials
An observational study of Intervention Effectiveness and Practice-based Evidence, run by University of Maryland, Baltimore at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 year to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Intervention Effectiveness, Practice-based Evidence, Posttraumatic Stress Disorder
- What is being tested?
- Strengthening Family Coping Resources (SFCR)
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2006to 31 Mar 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: community sample
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Maryland, School of Medicine, Department of Psychiatry, Divsion of Services Research
Baltimore, Maryland, 21201
About this study
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.
Read the 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.
- Being tested
- Strengthening Family Coping Resources (SFCR)
- Keywords
- family trauma, multi-family therapy, Posttraumatic Stress Disorder, poverty
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Strengthening Family Coping Resources (SFCR)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Families participating in SFCR | Families who have experienced multiple traumas and high stress related to poverty Receives: Behavioral: Strengthening Family Coping Resources (SFCR) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Change from baseline to end of 10 or 15 week group and 3 month follow up
Secondary outcomes (2)
Parent Symptoms of PTSD
Measured using the PTSD Checklist for DSM-5, a 20-item self-report measure that assesses the 20 DSM-5 symptoms of PTSD (Blevins, Weathers, Davis, Witte, \& Domino, 2015). The PCL-5 was developed to assess symptom change during and after treatment, to screen for clinically significant PTSD symptoms, and to make provisional PTSD diagnoses.
Measured: Change from baseline to end of 10 or 15 week group
Parent General Symptoms
Brief Symptom Inventory-18 item (BSI) (Derogatis, 2000) is an 18-item self-report inventory of adult (18 years and older) psychological symptoms.
Measured: Change from baseline to end of 10 or 15 week group
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2012 (estimated)
- Study startFeb 2006
- Primary completion31 Mar 2025
- Study completion31 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Intervention EffectivenessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Laurel J Kiser, University of Maryland, Baltimore
- Investigators
- Laurel J Kiser, Ph.D., Principal investigator, University of Maryland, Baltimore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01754610
- Sponsor's protocol ID
- HP-00040466
- Acronym
- SFCR
- Status last verified
- Apr 2025
- First submitted
- 14 Dec 2012
- Last updated
- 5 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 21105068Kiser 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.
PubMed 21197420Kiser, 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
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
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Strengthening Family Coping Resources Open Trials
- ClinicalTrials.gov ID
- NCT01754610
- Acronym / sponsor ID
- SFCR / HP-00040466
- Keywords
- family trauma, multi-family therapy, Posttraumatic Stress Disorder, poverty
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Study start
- Feb 2006
- Primary completion
- 31 Mar 2025 (actual)
- Study completion
- 31 Mar 2025 (actual)
- First posted
- 21 Dec 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Families participating in SFCR | – | Behavioral: Strengthening Family Coping Resources (SFCR)Families who have experienced multiple traumas and high stress related to poverty |
Who may qualify
- Ages
- 1 year to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- community sample
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Families participating in SFCR |
Primary outcome
Pre-post Treatment Effects
Time frame: Change from baseline to end of 10 or 15 week group and 3 month follow up
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) or General Functioning Scale (FAD 12)
Time frame: Change from baseline to end of 10 or 15 week group and 3 month follow up
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 and 3 month follow up
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.
UCLA PTSD Reaction Index
Time frame: Change from baseline to end of 10 or 15 week group and 3 month follow up
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.
Pediatric Symptom Checklist (PSC 17)
Time frame: Change from baseline to end of 10 or 15 week group and 3 month follow up
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.
Strengths and Difficulties Questionnaire (SDQ)
Time frame: Change from baseline to end of 10 or 15 week group and 3 month follow up
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.
Family Crisis Oriented Personal Evaluation Scales (F-Copes)
Time frame: Change from baseline to end of 10 or 15 week group and 3 month follow up
Inventory that measures family coping.
2 secondary outcomes
Parent Symptoms of PTSD
Time frame: Change from baseline to end of 10 or 15 week group
Parent General Symptoms
Time frame: Change from baseline to end of 10 or 15 week group
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2025.
- Background: PubMed 21105068Kiser 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.
- Background: PubMed 21197420Kiser 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.
- BackgroundKiser, 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
- Results publicationKiser, 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laurel J Kiser, Ph.D. principal investigator
University of Maryland, Baltimore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intervention Effectiveness and Practice-based Evidence, run by University of Maryland, Baltimore at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pre-post Treatment Effects (time frame: Change from baseline to end of 10 or 15 week group and 3 month follow up). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01754610, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2025.