Posttraumatic Stress DisorderNCT02537678
Stepped Care for Children After Trauma: Optimizing Treatment
A study testing Stepped Care TF-CBT and Standard TF-CBT in people with Posttraumatic Stress Disorder, run by University of South Florida at 6 sites in United States.
Trial summary
Children who are exposed to traumatic events are at risk for developing PTSD and other mental health problems. Although effective treatments for childhood PTSD exist, service delivery approaches that are more accessible, efficient, and cost-effective are needed to improve access to evidence-based treatment. Read more about this study
- Who is it for?
- Ages 4 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Posttraumatic Stress Disorder
- What is being tested?
- Stepped Care TF-CBT and Standard TF-CBT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 183 participants
- Where
- 6 sitesUnited States
- Study dates
- 1 Aug 2015to 23 Jul 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 4 to 70 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Child experienced at least one traumatic event after the age of 36 months
- Child age 4-6 must meet at least four PTSD symptoms and children age 7 to 12 must meet at least five PTSD symptoms with at least one symptom in re-experiencing or one symptom in avoidance
- At enrollment, the child must be between 4-12 years of age
- The parent/guardian must be willing and able to participate in the treatment and complete informed consent
Who cannot join
- Psychosis, mental retardation, autism spectrum disorder in the child or any condition that would limit the caregiver's ability to understand CBT and the child's ability to follow instructions
- Parent has had substance use disorder (SUD) within the past 3 months.
- Child or parent is suicidal
- Child or parent is not fluent in English
- Child is currently taking psychotropic medication and is not on a stable medication regimen for at least 4 weeks prior to admission to the study. For stimulants or benzodiazepines, the medication regimen must be stable for 2 weeks. If appropriate, a delayed entry will be allowed so that once a child is on a stable dosage the child may be enrolled in the study.
- Child is receiving trauma-focused psychotherapy during study treatment.
Show all 9Show fewer
- Parent/caregiver who would be treatment participant was the perpetrator, or the child was perpetrated by a person who still lives in the home
- Child is having unsupervised face-to-face contact with the identified perpetrator
- Siblings
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Children's Home Society
Jacksonville, Florida, 32207
Directions for Living
Largo, Florida, 33773
Pasco Kids First
New Port Richey, Florida, 34654
USF St. Petersburg Family Study Center
St. Petersburg, Florida, 33701
Suncoast Center, Inc
St. Petersburg, Florida, 33733
Crisis Center of Tampa Bay
Tampa, Florida, 33613
About this study
Children who are exposed to traumatic events are at risk for developing PTSD and other mental health problems. Although effective treatments for childhood PTSD exist, service delivery approaches that are more accessible, efficient, and cost-effective are needed to improve access to evidence-based treatment. The proposed study furthers our pilot work and evaluates an innovative Stepped Care Trauma-Focused Cognitive Behavioral Therapy designed to optimize treatment in community settings and improve the value and efficiency of trauma-focused treatment for children compared to existing approaches, thereby reducing childhood PTSD and related societal impacts and costs.
Read the detailed description
Approximately 68-80% of youth will experience at least one potentially traumatic event during their childhood with about one third experiencing more than one traumatic event. Exposure to traumatic events markedly elevates the risk of developing posttraumatic stress disorder (PTSD) and associated impairment. Despite advances in effective trauma-focused treatments for children, the lack of efficient, accessible, personalized, and cost-effective trauma treatment for children is a major public health concern. Thus, there is a critical need for interventions to improve efficiency, access, and cost-effectiveness and to offer tailored approaches that meet the unique needs of the child. The present study builds on the investigators NIH-funded pilot work (1R34MH092373-01A1) that developed an innovative Stepped Care Trauma-Focused Cognitive Behavioral Therapy (SC-TF-CBT). The purpose of the proposed study is to examine how to optimize the efficiency (e.g., via matching children to appropriate treatment dosage at baseline, utilizing second-stage tailoring variables, and identifying mechanisms of change) and cost-effectiveness of Stepped Care TF-CBT. The long-term goal is to develop an effective, efficient, accessible, and cost-effective adaptive Stepped Care TF-CBT intervention that can be available to more trauma-exposed children, and to advance knowledge about service delivery approaches that may be applicable to providing treatment for other childhood mental health disorders. The goal of the study is consistent with the strategic objective to "Develop New and Better Interventions that Incorporate the Diverse Needs and Circumstances of People with Mental Illness," and the research priorities that call for trials that foster prescriptive, personalized mental health care, incorporate tailoring variables to match patient interventions, improve access to services, decrease costs of services, and incorporate measures of putative mechanisms of action in trials in "real world" settings. In a randomized clinical trial with 216 children ages 4 to 12 years at community-based agencies, the following aims are proposed:
Aim 1: To examine Stepped Care TF-CBT (e.g., starting with Step One parent-led, therapist-assisted treatment and then either maintenance or Step Two TF-CBT) relative to standard TF-CBT (e.g., therapist-led treatment);
Aim 2: To examine tailoring variables that could be used to individualize (i.e., tailor) the decision of which children should be assigned at baseline to Stepped Care TF-CBT versus standard TF-CBT;
Aim 3: To examine if changes in the potential mechanisms of change variables (e.g., fear arousal, maladaptive cognitions, negative expectancy, and fear toleration) mediate treatment on child PTSD symptoms (PTSS) and impairment;
Aim 4: To examine the economic cost of delivering Stepped Care TF-CBT versus standard TF-CBT. Children with PTSD are at considerable risk for numerous biopsychosocial problems. Without accessible, effective treatment, these problems tend to persist into adulthood. This study will yield clinically important data which will improve the value and efficiency of treatment of children with PTSD, thereby reducing childhood PTSD and related societal impacts and costs.
- Conditions
- Posttraumatic Stress Disorder
- Being tested
- Stepped Care TF-CBT, Standard TF-CBT
- 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.
Stepped Care TF-CBTBehavioural
Stepped Care TF-CBT: Patients will receive Step One: 3 (1 hr.) in-office therapist-led sessions over 6 weeks, the parent-child workbook (Stepping Together),60, 61 scheduled weekly phone meetings (15 minutes), and information from the Stepping Together website and the National Center for Childhood Traumatic Stress website (via web or paper for those without access). Children who do not meet responder status will receive Step Two: 9 (1.5 hr.) in-office therapist-directed sessions of TF-CBT over 6 to 8 weeks
Standard TF-CBTBehavioural
Standard TF-CBT: Patients will receive 12 (1.5 hr.) standard weekly in-office therapist-directed sessions (2 additional weeks allow for scheduling difficulty). TF-CBT includes child, parent and conjoint parent-child sessions addressing the 10 core trauma treatment components of TF-CBT (e.g., parenting skills, affect modulation, cognitive coping, trauma narrative, etc.).
| Study group | Role | What they receive |
|---|---|---|
| Stepped Care TF-CBT | Experimental | Stepped Care TF-CBT consist of two steps. Step One is a parent-led therapist-assisted treatment and Step Two is standard TF-CBT. Receives: Behavioral: Stepped Care TF-CBT |
| Standard TF-CBT | Active comparator | Standard TF-CBT consist of therapist-directly weekly in-office therapy based on the trauma-focused components of TF-CBT. Receives: Behavioral: Standard TF-CBT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Trauma Symptom Checklist for Young Children Posttraumatic Stress Symptoms
Trauma Symptom Children for Young Children Posttraumatic Stress total score will measure changes in child posttraumatic stress symptoms for children ages 4-12. Score ranges from 27 to 108 with higher scores indicating greater posttraumatic stress symptoms.
Measured: Post treatment
Trauma Symptom Checklist for Young Children Posttraumatic Stress Symptoms
Trauma Symptom Children for Young Children Posttraumatic Stress total score will measure changes in child posttraumatic stress symptoms for children ages 4-12. Score ranges from 27 to 108 with higher scores indicating greater posttraumatic stress symptoms.
Measured: 6-month Follow up
Trauma Symptom Checklist for Young Children Posttraumatic Stress Symptoms
Trauma Symptom Children for Young Children Posttraumatic Stress total score will measure changes in child posttraumatic stress symptoms for children ages 4-12. Score ranges from 27 to 108 with higher scores indicating greater posttraumatic stress symptoms.
Measured: 12-month follow up
Child Sheehan Disability Scale Parent Version
The Child Sheehan Disability Scale is a caregiver report to measure childhood impairment. The change in the impairment scores will be used to measure change in impairment.Scores range from 0 to 50 with higher scores indicating greater impairment.
Measured: Post treatment
Child Sheehan Disability Scale Parent Version
The Child Sheehan Disability Scale is a caregiver report to measure childhood impairment. The change in the impairment scores will be used to measure change in impairment.Scores range from 0 to 50 with higher scores indicating greater impairment.
Measured: 6-month follow up
Child Sheehan Disability Scale Parent Version
The Child Sheehan Disability Scale is a caregiver report to measure childhood impairment. The change in the impairment scores will be used to measure change in impairment.Scores range from 0 to 50 with higher scores indicating greater impairment.
Measured: 12-month follow up
Secondary outcomes (12)
Child Behavior Checklist Internalizing Symptoms
Changes in T scores in internalizing symptoms. T scores may range from 33 to 100 with higher T scores indicating greater internalizing symptoms.
Measured: Post treatment
Child Behavior Checklist Internalizing Symptoms
Changes in T scores in internalizing symptoms. T scores may range from 33 to 100 with higher T scores indicating greater internalizing symptoms.
Measured: 6-month follow up
Child Behavior Checklist Internalizing Symptoms
Changes in T scores in internalizing symptoms. T scores may range from 33 to 100 with higher T scores indicating greater internalizing symptoms.
Measured: 12-month follow up
Child Behavior Checklist Externalizing Symptoms
Changes in T scores in externalizing symptoms. T scores range from 33 to 100 with higher T scores indicating greater externalizing problems.
Measured: Post treatment
Child Behavior Checklist Externalizing Symptoms
Changes in T scores in externalizing symptoms. T scores range from 33 to 100 with higher T scores indicating greater externalizing problems.
Measured: 6-month follow up
Child Behavior Checklist Externalizing Symptoms
Changes in T scores in externalizing symptoms. T scores range from 33 to 100 with higher T scores indicating greater externalizing problems.
Measured: 12-month follow up
Clinical Global Impression-Severity (CGI-S)
The CGI-S is a widely used 7-point rating of severity of psychopathology including. impairment (0=no illness, 6=extremely severe). Changes in ratings will be used to measure change in severity.
Measured: Post treatment
Clinical Global Impression-Severity (CGI-S)
The CGI-S is a widely used 7-point rating of severity of psychopathology including. impairment (0=no illness, 6=extremely severe). Changes in ratings will be used to measure change in severity.
Measured: 6-month assessment
Clinical Global Impression-Severity (CGI-S)
The CGI-S is a widely used 7-point rating of severity of psychopathology including. impairment (0=no illness, 6=extremely severe). Changes in ratings will be used to measure change in severity.
Measured: 12-month follow up
Clinical Global Impression-Improvement (CGI-I)
The CGI-I modified version, 8-point rating will be used for treatment response. A 1, 2 or 3 will be used to indicate treatment response.
Measured: Post treatment
Clinical Global Impression-Improvement (CGI-I)
The CGI-I modified version, 8-point rating will be used for treatment response. A 1, 2 or 3 will be used to indicate treatment response.
Measured: 6-month treatment
Clinical Global Impression-Improvement (CGI-I)
The CGI-I modified version, 8-point rating will be used for treatment response. A 1, 2 or 3 will be used to indicate treatment response.
Measured: 12-month follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2015 (estimated)
- Study start1 Aug 2015
- Primary completion23 Jul 2020
- Study completion23 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Posttraumatic Stress DisorderStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 183 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of South Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alison A Salloum, PhD, Principal investigator, University of South Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02537678
- Sponsor's protocol ID
- 1R01MH107522-01
- Status last verified
- Apr 2019
- First submitted
- 26 Aug 2015
- Last updated
- 6 May 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: The data dictionaries for the descriptive and analyzed data were uploaded for the National Institute of Mental Health (NIMH) Data Archive (Salloum C2318).
Publications
Salloum A, Scheeringa MS, Cohen JA, Storch EA. Development of Stepped Care Trauma-Focused Cognitive-Behavioral Therapy for Young Children. Cogn Behav Pract. 2014 Feb 1;21(1):97-108. doi: 10.1016/j.cbpra.2013.07.004.
PubMed 25411544Salloum A, Scheeringa MS, Cohen JA, Storch EA. Responder Status Criterion for Stepped Care Trauma-Focused Cognitive Behavioral Therapy for Young Children. Child Youth Care Forum. 2015 Feb;44(1):59-78. doi: 10.1007/s10566-014-9270-1.
PubMed 25663796Salloum A, Robst J, Scheeringa MS, Cohen JA, Wang W, Murphy TK, Tolin DF, Storch EA. Step one within stepped care trauma-focused cognitive behavioral therapy for young children: a pilot study. Child Psychiatry Hum Dev. 2014 Feb;45(1):65-77. doi: 10.1007/s10578-013-0378-6.
PubMed 23584728Salloum A, Lu Y, Chen H, Quast T, Cohen JA, Scheeringa MS, Salomon K, Storch EA. Stepped Care Versus Standard Care for Children After Trauma: A Randomized Non-Inferiority Clinical Trial. J Am Acad Child Adolesc Psychiatry. 2022 Aug;61(8):1010-1022.e4. doi: 10.1016/j.jaac.2021.12.013. Epub 2022 Jan 12.
PubMed 35032578Salloum A, Boedeker P, Morris C, Storch EA. Suicidal Ideation, Clinical Worsening and Outcomes among Child Participants in Trauma-Focused Treatment. Res Child Adolesc Psychopathol. 2025 May;53(5):687-700. doi: 10.1007/s10802-024-01242-5. Epub 2024 Sep 26.
PubMed 39325087
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stepped Care for Children After Trauma: Optimizing Treatment
- ClinicalTrials.gov ID
- NCT02537678
- Acronym / sponsor ID
- 1R01MH107522-01
- Conditions
- Posttraumatic Stress Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 183 participants (actual)
- Lead sponsor
- University of South FloridaUniversity, hospital or other
- Study start
- 1 Aug 2015 (actual)
- Primary completion
- 23 Jul 2020 (actual)
- Study completion
- 23 Jul 2020 (actual)
- First posted
- 2 Sep 2015 (estimated)
- Results
- Posted 6 May 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Children who are exposed to traumatic events are at risk for developing PTSD and other mental health problems. Although effective treatments for childhood PTSD exist, service delivery approaches that are more accessible, efficient, and cost-effective are needed to improve access to evidence-based treatment. The proposed study furthers our pilot work and evaluates an innovative Stepped Care Trauma-Focused Cognitive Behavioral Therapy designed to optimize treatment in community settings and improve the value and efficiency of trauma-focused treatment for children compared to existing approaches, thereby reducing childhood PTSD and related societal impacts and costs.
Detailed description
Approximately 68-80% of youth will experience at least one potentially traumatic event during their childhood with about one third experiencing more than one traumatic event. Exposure to traumatic events markedly elevates the risk of developing posttraumatic stress disorder (PTSD) and associated impairment. Despite advances in effective trauma-focused treatments for children, the lack of efficient, accessible, personalized, and cost-effective trauma treatment for children is a major public health concern. Thus, there is a critical need for interventions to improve efficiency, access, and cost-effectiveness and to offer tailored approaches that meet the unique needs of the child. The present study builds on the investigators NIH-funded pilot work (1R34MH092373-01A1) that developed an innovative Stepped Care Trauma-Focused Cognitive Behavioral Therapy (SC-TF-CBT). The purpose of the proposed study is to examine how to optimize the efficiency (e.g., via matching children to appropriate treatment dosage at baseline, utilizing second-stage tailoring variables, and identifying mechanisms of change) and cost-effectiveness of Stepped Care TF-CBT. The long-term goal is to develop an effective, efficient, accessible, and cost-effective adaptive Stepped Care TF-CBT intervention that can be available to more trauma-exposed children, and to advance knowledge about service delivery approaches that may be applicable to providing treatment for other childhood mental health disorders. The goal of the study is consistent with the strategic objective to "Develop New and Better Interventions that Incorporate the Diverse Needs and Circumstances of People with Mental Illness," and the research priorities that call for trials that foster prescriptive, personalized mental health care, incorporate tailoring variables to match patient interventions, improve access to services, decrease costs of services, and incorporate measures of putative mechanisms of action in trials in "real world" settings. In a randomized clinical trial with 216 children ages 4 to 12 years at community-based agencies, the following aims are proposed:
Aim 1: To examine Stepped Care TF-CBT (e.g., starting with Step One parent-led, therapist-assisted treatment and then either maintenance or Step Two TF-CBT) relative to standard TF-CBT (e.g., therapist-led treatment);
Aim 2: To examine tailoring variables that could be used to individualize (i.e., tailor) the decision of which children should be assigned at baseline to Stepped Care TF-CBT versus standard TF-CBT;
Aim 3: To examine if changes in the potential mechanisms of change variables (e.g., fear arousal, maladaptive cognitions, negative expectancy, and fear toleration) mediate treatment on child PTSD symptoms (PTSS) and impairment;
Aim 4: To examine the economic cost of delivering Stepped Care TF-CBT versus standard TF-CBT. Children with PTSD are at considerable risk for numerous biopsychosocial problems. Without accessible, effective treatment, these problems tend to persist into adulthood. This study will yield clinically important data which will improve the value and efficiency of treatment of children with PTSD, thereby reducing childhood PTSD and related societal impacts and costs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stepped Care TF-CBT | Experimental | Behavioral: Stepped Care TF-CBTStepped Care TF-CBT consist of two steps. Step One is a parent-led therapist-assisted treatment and Step Two is standard TF-CBT. |
| Standard TF-CBT | Active comparator | Behavioral: Standard TF-CBTStandard TF-CBT consist of therapist-directly weekly in-office therapy based on the trauma-focused components of TF-CBT. |
Who may qualify
- Ages
- 4 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Child experienced at least one traumatic event after the age of 36 months
- Child age 4-6 must meet at least four PTSD symptoms and children age 7 to 12 must meet at least five PTSD symptoms with at least one symptom in re-experiencing or one symptom in avoidance
- At enrollment, the child must be between 4-12 years of age
- The parent/guardian must be willing and able to participate in the treatment and complete informed consent
Key exclusion criteria (9 listed)
- Psychosis, mental retardation, autism spectrum disorder in the child or any condition that would limit the caregiver's ability to understand CBT and the child's ability to follow instructions
- Parent has had substance use disorder (SUD) within the past 3 months.
- Child or parent is suicidal
- Child or parent is not fluent in English
- Child is currently taking psychotropic medication and is not on a stable medication regimen for at least 4 weeks prior to admission to the study. For stimulants or benzodiazepines, the medication regimen must be stable for 2 weeks. If appropriate, a delayed entry will be allowed so that once a child is on a stable dosage the child may be enrolled in the study.
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 |
|---|---|---|
| Stepped Care TF-CBTStepped Care TF-CBT: Patients will receive Step One: 3 (1 hr.) in-office therapist-led sessions over 6 weeks, the parent-child workbook (Stepping Together),60, 61 scheduled weekly phone meetings (15 minutes), and information from the Stepping Together website and the National Center for Childhood Traumatic Stress website (via web or paper for those without access). Children who do not meet responder status will receive Step Two: 9 (1.5 hr.) in-office therapist-directed sessions of TF-CBT over 6 to 8 weeks | Behavioural | Stepped Care TF-CBT |
| Standard TF-CBTStandard TF-CBT: Patients will receive 12 (1.5 hr.) standard weekly in-office therapist-directed sessions (2 additional weeks allow for scheduling difficulty). TF-CBT includes child, parent and conjoint parent-child sessions addressing the 10 core trauma treatment components of TF-CBT (e.g., parenting skills, affect modulation, cognitive coping, trauma narrative, etc.). | Behavioural | Standard TF-CBT |
Primary outcome
Trauma Symptom Checklist for Young Children Posttraumatic Stress Symptoms
Time frame: Post treatment
Trauma Symptom Children for Young Children Posttraumatic Stress total score will measure changes in child posttraumatic stress symptoms for children ages 4-12. Score ranges from 27 to 108 with higher scores indicating greater posttraumatic stress symptoms.
Trauma Symptom Checklist for Young Children Posttraumatic Stress Symptoms
Time frame: 6-month Follow up
Trauma Symptom Children for Young Children Posttraumatic Stress total score will measure changes in child posttraumatic stress symptoms for children ages 4-12. Score ranges from 27 to 108 with higher scores indicating greater posttraumatic stress symptoms.
Trauma Symptom Checklist for Young Children Posttraumatic Stress Symptoms
Time frame: 12-month follow up
Trauma Symptom Children for Young Children Posttraumatic Stress total score will measure changes in child posttraumatic stress symptoms for children ages 4-12. Score ranges from 27 to 108 with higher scores indicating greater posttraumatic stress symptoms.
Child Sheehan Disability Scale Parent Version
Time frame: Post treatment
The Child Sheehan Disability Scale is a caregiver report to measure childhood impairment. The change in the impairment scores will be used to measure change in impairment.Scores range from 0 to 50 with higher scores indicating greater impairment.
Child Sheehan Disability Scale Parent Version
Time frame: 6-month follow up
The Child Sheehan Disability Scale is a caregiver report to measure childhood impairment. The change in the impairment scores will be used to measure change in impairment.Scores range from 0 to 50 with higher scores indicating greater impairment.
Child Sheehan Disability Scale Parent Version
Time frame: 12-month follow up
The Child Sheehan Disability Scale is a caregiver report to measure childhood impairment. The change in the impairment scores will be used to measure change in impairment.Scores range from 0 to 50 with higher scores indicating greater impairment.
12 secondary outcomes
Child Behavior Checklist Internalizing Symptoms
Time frame: Post treatment
Child Behavior Checklist Internalizing Symptoms
Time frame: 6-month follow up
Child Behavior Checklist Internalizing Symptoms
Time frame: 12-month follow up
Child Behavior Checklist Externalizing Symptoms
Time frame: Post treatment
Child Behavior Checklist Externalizing Symptoms
Time frame: 6-month follow up
Child Behavior Checklist Externalizing Symptoms
Time frame: 12-month follow up
Clinical Global Impression-Severity (CGI-S)
Time frame: Post treatment
Clinical Global Impression-Severity (CGI-S)
Time frame: 6-month assessment
Clinical Global Impression-Severity (CGI-S)
Time frame: 12-month follow up
Clinical Global Impression-Improvement (CGI-I)
Time frame: Post treatment
Clinical Global Impression-Improvement (CGI-I)
Time frame: 6-month treatment
Clinical Global Impression-Improvement (CGI-I)
Time frame: 12-month follow up
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 25411544Salloum A, Scheeringa MS, Cohen JA, Storch EA. Development of Stepped Care Trauma-Focused Cognitive-Behavioral Therapy for Young Children. Cogn Behav Pract. 2014 Feb 1;21(1):97-108. doi: 10.1016/j.cbpra.2013.07.004.
- Background: PubMed 25663796Salloum A, Scheeringa MS, Cohen JA, Storch EA. Responder Status Criterion for Stepped Care Trauma-Focused Cognitive Behavioral Therapy for Young Children. Child Youth Care Forum. 2015 Feb;44(1):59-78. doi: 10.1007/s10566-014-9270-1.
- Results publication: PubMed 23584728Salloum A, Robst J, Scheeringa MS, Cohen JA, Wang W, Murphy TK, Tolin DF, Storch EA. Step one within stepped care trauma-focused cognitive behavioral therapy for young children: a pilot study. Child Psychiatry Hum Dev. 2014 Feb;45(1):65-77. doi: 10.1007/s10578-013-0378-6.
- Results publication: PubMed 35032578Salloum A, Lu Y, Chen H, Quast T, Cohen JA, Scheeringa MS, Salomon K, Storch EA. Stepped Care Versus Standard Care for Children After Trauma: A Randomized Non-Inferiority Clinical Trial. J Am Acad Child Adolesc Psychiatry. 2022 Aug;61(8):1010-1022.e4. doi: 10.1016/j.jaac.2021.12.013. Epub 2022 Jan 12.
- Derived from this study: PubMed 39325087Salloum A, Boedeker P, Morris C, Storch EA. Suicidal Ideation, Clinical Worsening and Outcomes among Child Participants in Trauma-Focused Treatment. Res Child Adolesc Psychopathol. 2025 May;53(5):687-700. doi: 10.1007/s10802-024-01242-5. Epub 2024 Sep 26.
- Individual participant dataSharing planned: Yes. The data dictionaries for the descriptive and analyzed data were uploaded for the National Institute of Mental Health (NIMH) Data Archive (Salloum C2318).
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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.
Alison A Salloum, PhD principal investigator
University of South Florida
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stepped Care TF-CBT and Standard TF-CBT in people with Posttraumatic Stress Disorder, run by University of South Florida at 6 sites 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 4 inclusion and 9 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 6 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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?
Yes. Results are posted in the registry (first posted 6 May 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Trauma Symptom Checklist for Young Children Posttraumatic Stress Symptoms (time frame: Post treatment). The study lists 6 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 NCT02537678, which also lists 5 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 6 May 2022.