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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stepped Care TF-CBT | Behavioral | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 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. | 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. | 6-month follow up |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Post treatment |
| Child Behavior Checklist Internalizing Symptoms |
| Measure | Description | Time Frame |
|---|---|---|
| Parenting Stress Scale (PSS) | The PSS scores will be used to measure change in parenting stress. Scores range from 18 to 90 with higher scores indicating higher parenting stress. | Post treatment |
| Parenting Stress Scale (PSS) |
Parent/Guardian-child dyads enrolled.
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alison A Salloum, PhD | University of South Florida | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Home Society | Jacksonville | Florida | 32207 | United States | ||
| Directions for Living |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25411544 | Background | 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. | |
| 25663796 | Background | Salloum 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. |
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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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Parent/guardian-child dyads participated. 212 dyads enrolled. 183 dyads met inclusion and were randomized to treatment. Exclusion before assignment included: Less than 5 trauma symptoms, perpetrator in home, not wanting to participate, no trauma after age 3, cognitive impairment, did not attended assessment, substance abuse within past 3 months, unsupervised visits with perpetrator, medication not stable, no traumatic symptoms, parent suicidal, autism spectrum, parent unable/unwilling.
Participants were recruited from six community clinics between October 2015 and April 2019 from five community behavioral health nonprofit organizations and one university community-based clinic. The first participant was enrolled 10/6/2015 and the last participant was enrolled 4/19/2019.
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| ID | Title | Description |
|---|---|---|
| FG000 | Stepped Care TF-CBT | Participants (parent-child dyads) received Step One which is a parent-led therapist assisted treatment: 3 therapist-led sessions along with 11 parent-child meetings using a parent-child workbook. Children who do not meet responder status will receive Step Two: 9 therapist-directed sessions of TF-CBT. Two as needed sessions could be provided |
| FG001 | Standard TF-CBT | Participants (parent-child dyads) received therapist led trauma-focused cognitive behavioral therapy (TF-CBT). Two as needed sessions could be provided. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline to Post-treatment |
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| Post-treatment to 6 Month Assessment |
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| 6 Month to 12 Month Assessment |
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The Overall Number of Baseline Participants represent the parent/guardian-child dyads in each arm. There were a total of 91 children and 91 parent/gaurdians analyzed in Stepped Care Trauma-Focused-CBT (TF-CBT). There were a total of 92 children and 92 parent/garudians analyzed in Standard Care Trauma-Focused-CBT (TF-CBT). Thus, the total analyzed was 366.
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| ID | Title | Description |
|---|---|---|
| BG000 | Stepped Care Trauma Focused-CBT (TF-CBT) | Stepped Care TF-CBT consist of two steps. Step One is a parent-led therapist-assisted treatment and Step Two is standard TF-CBT. Parent/Guardian-child dyads participated. Stepped Care TF-CBT: 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), 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Child's age: The evaluator conducting the assessment asked the parent/guardian for the child's age in years and asked for the child's date of birth. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Intent to treat population (ITT; all participants assigned to stepped care TF-CBT and standard TF-CBT). Multiple imputation was applied for ITT analysis, with ten imputations generated at item level and individual level. | Posted | Mean | Standard Deviation | score on a scale | Post treatment |
|
From enrollment to the end of the the 12 month post treatment follow-up assessment (approximately 1 year, 4 months). Assessed every visit from enrollment to the end of the 12 month post treatment follow up assessment.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Stepped Care TF-CBT | Participants (parents/guardian and children) received Step One which is a parent-led therapist-assisted treatment: 3 therapist-led sessions along with 11 parent-child meetings using a parent-child workbook. Children who do not meet responder status will receive Step Two: 9 therapist-directed sessions of TF-CBT. Two as needed sessions could be provided. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Child abuse report (children) | Social circumstances | Systematic Assessment | A child abuse report was made to authorities if there was reasonable cause to suspect child abuse, and it had not already been reported. Query was made to assess if abuse was reported. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Worsening of posttraumatic stress symptoms (children) | Psychiatric disorders | Systematic Assessment | For Children: Parents, children ages 7-12, therapists, evaluators rated change in child's posttraumatic stress symptoms since the first assessment. Three minimally worse ratings, or much worse, or very much worse were considered as worsening. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Alison Salloum | University of South Florida | 8139741535 | asalloum@usf.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 11, 2022 | Mar 2, 2022 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form: Informed Consent Form Parent | Dec 7, 2019 | Mar 2, 2022 | ICF_001.pdf |
| ICF | No | No | Yes | Informed Consent Form: Informed Assent Forms for Children | Dec 7, 2019 | Mar 2, 2022 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D013313 | Stress Disorders, Post-Traumatic |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
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| Standard TF-CBT | Behavioral | 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.). |
|
| 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. | 12-month follow up |
Changes in T scores in internalizing symptoms. T scores may range from 33 to 100 with higher T scores indicating greater internalizing symptoms. |
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 12-month follow up |
The PSS scores will be used to measure change in parenting stress. Scores range from 18 to 90 with higher scores indicating higher parenting stress.
| 6-month follow up |
| Parenting Stress Scale (PSS) | The PSS scores will be used to measure change in parenting stress. Scores range from 18 to 90 with higher scores indicating higher parenting stress. | 12-month follow up |
| Depression, Anxiety and Stress Scale (Short Form)- Depression Subscale | The depression subscale self-report will be used to measure change in parent depression, Scores range from 0 to 42 with higher scores indicating higher depressive symptoms. | Post treatment |
| Depression, Anxiety and Stress Scale (Short Form)- Depression Subscale | The depression subscale self-report will be used to measure change in parent depression, Scores range from 0 to 42 with higher scores indicating higher depressive symptoms. | 6-month follow up |
| Depression, Anxiety and Stress Scale (Short Form)- Depression Subscale | The depression subscale self-report will be used to measure change in parent depression, Scores range from 0 to 42 with higher scores indicating higher depressive symptoms. | 12-month follow up |
| The PTSD Checklist-Civilian (PCL-C) | The PCL-C will be used to measure change in parent self-report of PTSD symptom severity. Scores range from 0 to 80 with higher scores indicating greater posttraumatic stress symptoms. | Post treatment |
| The PTSD Checklist-Civilian (PCL-C) | The PCL-C will be used to measure change in parent self-report of PTSD symptom severity. Scores range from 0 to 80 with higher scores indicating greater posttraumatic stress symptoms. | 6-month follow up |
| The PTSD Checklist-Civilian (PCL-C) | The PCL-C will be used to measure change in parent self-report of PTSD symptom severity. Scores range from 0 to 80 with higher scores indicating greater posttraumatic stress symptoms. | 12-month follow up |
| Largo |
| Florida |
| 33773 |
| United States |
| Pasco Kids First | New Port Richey | Florida | 34654 | United States |
| USF St. Petersburg Family Study Center | St. Petersburg | Florida | 33701 | United States |
| Suncoast Center, Inc | St. Petersburg | Florida | 33733 | United States |
| Crisis Center of Tampa Bay | Tampa | Florida | 33613 | United States |
| 23584728 | Result | Salloum 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. |
| 35032578 | Result | Salloum 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. |
| 39325087 | Derived | Salloum 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. |
| Parent/Guardian-child dyads: Unknown |
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| Parent/Guardian-child: Dislike therapy |
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| Parent/Guardian barriers: work, moved, homeless, illness, transportation, perpetrator in home |
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| NOT COMPLETED |
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| BG001 | Standard Trauma Focused-CBT (TF-CBT) | Standard TF-CBT consist of therapist-directly weekly in-office therapy based on the trauma-focused components of TF-CBT. Parent/Guardian-child dyads participated. Standard TF-CBT: 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.). |
| BG002 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
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| Sex: Female, Male | Child's sex: The evaluator conducting the assessment asked the parent/guardian if their child was male or female. | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Child's ethnicity: The evaluator conducting the assessment asked the parent/guardian if they considered their child to be Hispanic or Latino or not Hispanic or Latino. | Count of Participants | Participants |
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| Race (NIH/OMB) | Child's race: The evaluator conducting the assessment asked the parent/guardian for child's race using the following categories: American Indian or Alaskan Native; Asian; Black or African American; Native Hawaiian or other Pacific Islander; White or more than one race. | Count of Participants | Participants |
|
| Parent/Guardian Relationship to the child | Parent/Guardian relationship: The evaluator conducting the assessment asked the parent/guardian for their relationship to the child such as mother, father, grandmother, grandfather or other. The researchers then categorized the reported relationships into 'parent' or 'relative'. | Count of Participants | Participants |
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| Parent /Guardian ethnicity | Parent/Guardian ethnicity: The evaluator conducting the assessment asked the parent/guardian if they are Hispanic or Latino or not Hispanic or Latino | Count of Participants | Participants |
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| Parent/Guardian race | Parent/Guardian race: The evaluator conducting the assessment asked the parent/guardian for their race by reading out the following categories: American Indian or Alaskan Native; Asian; Black or African American; Native Hawaiian or other Pacific Islander; White. | Count of Participants | Participants |
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| Household income | Parent/Guardian: The evaluator conducting the assessment asked the parent/guardian for their yearly income giving ranges of 0 to 9,999, 10,000 to 24,999, 25,000 to 34,999, 35,000 to 49,999 or 50,000 and above. | Count of Participants | Participants |
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| Education levels | Parent/Guardian education: The evaluator conducting the assessment asked the parent/guardian for their highest level of schooling. The researchers then matched the ranges to estimate education categories. The categories were: 9 to 11 years indicated no high school diploma, 12 years indicated high school graduate, 13 to 15 years indicated some college, and 16 or more years indicated college graduate and above. | Count of Participants | Participants |
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| Parent/Guardian employed | Parent/Guardian employment status: The evaluator conducting the assessment asked the parent/guardian if they were currently employed with the response option of yes or no. | Count of Participants | Participants |
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| Parent/Guardian with posttraumatic stress disorder | Parent/Guardian: The Structured Clinical Interview for Diagnostic and Statistical Manual-5 research version (First et al., 2015) PTSD module was administered by the evaluator conducting the assessment with the parent/guardian to assess for posttraumatic stress disorder. | Count of Participants | Participants |
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| Parent/Guardian age | Parent/Guardian age: The evaluator conducting the assessment asked the parent/guardian for their date of birth. The evaluator then used a statistical program to calculate the parent/guardians age by using the date of the assessment and their date of birth. | Mean | Standard Deviation | years |
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| Parent/Guardian relationship status | Parent/Guardian relationship status: The evaluator conducting the assessment asked the parent/guardian if their current relationship status was single, married, divorced, separated, widowed or other. | Count of Participants | Participants |
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| Trauma Symptom Checklist for Young Children Posttraumatic Stress Symptoms | Child posttraumatic stress: The Trauma Symptom Checklist for Young Children (TSCYC; Briere, 2005) is a caregiver report measure of trauma symptom severity in children ages 3-12 years that includes a 27-item posttraumatic stress symptom total subscale (TSCYC-PTS). The parent/guardian completed this measure using an online program. The range of the TSCYC-PTS is 27 to 108 with higher scores indicating more severe posttraumatic stress symptoms.The change in the TSCYC-PTS will be used to measure change in child's posttraumatic stress symptoms. | Mean | Standard Deviation | units on a scale |
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| Child Sheehan Disability Scale Parent Version | Child impairment: The Child Sheehan Disability Scale (Sheehan , 2008) is an adapted caregiver version (Whiteside, 2009) with 5-items to measure childhood impairment. The change in impairment scale will be used to measure change in impairment. Scores range from 0 to 50 with higher scores indicating greater impairment. | Mean | Standard Deviation | units on a scale |
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| OG001 | Standard TF-CBT | Participants received therapist led trauma-focused cognitive behavioral therapy (TF-CBT). Two as needed sessions could be provided. |
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| Primary | 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. | Intent to treat population (ITT; all participants assigned to stepped care TF-CBT and standard TF-CBT). Multiple imputation was applied for ITT analysis, with ten imputations generated at item level and individual level. | Posted | Mean | Standard Deviation | score on a scale | 6-month Follow up |
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| Primary | 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. | Intent to treat population (ITT; all participants assigned to stepped care TF-CBT and standard TF-CBT). Multiple imputation was applied for ITT analysis, with ten imputations generated at item level and individual level. | Posted | Mean | Standard Deviation | score on a scale | 12-month follow up |
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| Primary | 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. | Intent to treat population (ITT; all participants assigned to stepped care TF-CBT and standard TF-CBT). Multiple imputation was applied for ITT analysis, with ten imputations generated at item level and individual level. | Posted | Mean | Standard Deviation | score on a scale | Post treatment |
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| Primary | 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. | Intent to treat population (ITT; all participants assigned to stepped care TF-CBT and standard TF-CBT). Multiple imputation was applied for ITT analysis, with ten imputations generated at item level and individual level. | Posted | Mean | Standard Deviation | score on a scale | 6-month follow up |
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| Primary | 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. | Intent to treat population (ITT; all participants assigned to stepped care TF-CBT and standard TF-CBT). Multiple imputation was applied for ITT analysis, with ten imputations generated at item level and individual level. | Posted | Mean | Standard Deviation | score on a scale | 12-month follow up |
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| Secondary | 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. | Intent to treat population (ITT; all participants assigned to stepped care TF-CBT and standard TF-CBT). Multiple imputation was applied for ITT analysis, with ten imputations generated at item level and individual level. | Posted | Mean | Standard Deviation | score on a scale | Post treatment |
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| Secondary | 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. | Intent to treat population (ITT; all participants assigned to stepped care TF-CBT and standard TF-CBT). Multiple imputation was applied for ITT analysis, with ten imputations generated at item level and individual level. | Posted | Mean | Standard Deviation | score on a scale | 6-month follow up |
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| Secondary | 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. | Intent to treat population (ITT; all participants assigned to stepped care TF-CBT and standard TF-CBT). Multiple imputation was applied for ITT analysis, with ten imputations generated at item level and individual level. | Posted | Mean | Standard Deviation | score on a scale | 12-month follow up |
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| Secondary | 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. | Intent to treat population (ITT: all participants assigned to stepped care TF-CBT and standard TF-CBT). Multiple imputation was applied for ITT analysis, with ten imputations generated at item level and individual level. | Posted | Mean | Standard Deviation | score on a scale | Post treatment |
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| Secondary | 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. | Intent to treat population (ITT: all participants assigned to stepped care TF-CBT and standard TF-CBT). Multiple imputation was applied for ITT analysis, with ten imputations generated at item level and individual level. | Posted | Mean | Standard Deviation | score on a scale | 6-month follow up |
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| Secondary | 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. | Intent to treat population (ITT: all participants assigned to stepped care TF-CBT and standard TF-CBT). Multiple imputation was applied for ITT analysis, with ten imputations generated at item level and individual level. | Posted | Mean | Standard Deviation | score on a scale | 12-month follow up |
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| Secondary | 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. | Intent to treat population (ITT; all participants assigned to stepped care TF-CBT and standard TF-CBT). Multiple imputation was applied for ITT analysis, with ten imputations generated at item level and individual level. | Posted | Mean | Standard Deviation | score on a scale | Post treatment |
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| Secondary | 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. | Intent to treat population (ITT; all participants assigned to stepped care TF-CBT and standard TF-CBT). Multiple imputation was applied for ITT analysis, with ten imputations generated at item level and individual level. | Posted | Mean | Standard Deviation | score on a scale | 6-month assessment |
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| Secondary | 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. | Intent to treat population (ITT; all participants assigned to stepped care TF-CBT and standard TF-CBT). Multiple imputation was applied for ITT analysis, with ten imputations generated at item level and individual level. | Posted | Mean | Standard Deviation | score on a scale | 12-month follow up |
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| Secondary | 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. | Intent to treat population (ITT: all participants assigned to stepped care TF-CBT and standard TF-CBT). Multiple imputation was applied for ITT analysis, with ten imputations generated at item level and individual level. | Posted | Mean | Standard Deviation | score on a scale | Post treatment |
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| Secondary | 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. | Intent to treat population (ITT: all participants assigned to stepped care TF-CBT and standard TF-CBT). Multiple imputation was applied for ITT analysis, with ten imputations generated at item level and individual level. | Posted | Mean | Standard Deviation | score on a scale | 6-month treatment |
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| Secondary | 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. | Intent to treat population (ITT: all participants assigned to stepped care TF-CBT and standard TF-CBT). Multiple imputation was applied for ITT analysis, with ten imputations generated at item level and individual level. | Posted | Mean | Standard Deviation | score on a scale | 12-month follow up |
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| Other Pre-specified | Parenting Stress Scale (PSS) | The PSS scores will be used to measure change in parenting stress. Scores range from 18 to 90 with higher scores indicating higher parenting stress. | Intent to treat population (ITT; all participants assigned to stepped care TF-CBT and standard TF-CBT). Multiple imputation was applied for ITT analysis, with ten imputations generated at item level and individual level. | Posted | Mean | Standard Deviation | score on a scale | Post treatment |
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| Other Pre-specified | Parenting Stress Scale (PSS) | The PSS scores will be used to measure change in parenting stress. Scores range from 18 to 90 with higher scores indicating higher parenting stress. | Intent to treat population (ITT; all participants assigned to stepped care TF-CBT and standard TF-CBT). Multiple imputation was applied for ITT analysis, with ten imputations generated at item level and individual level. | Posted | Mean | Standard Deviation | score on a scale | 6-month follow up |
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| Other Pre-specified | Parenting Stress Scale (PSS) | The PSS scores will be used to measure change in parenting stress. Scores range from 18 to 90 with higher scores indicating higher parenting stress. | Intent to treat population (ITT; all participants assigned to stepped care TF-CBT and standard TF-CBT). Multiple imputation was applied for ITT analysis, with ten imputations generated at item level and individual level. | Posted | Mean | Standard Deviation | score on a scale | 12-month follow up |
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| Other Pre-specified | Depression, Anxiety and Stress Scale (Short Form)- Depression Subscale | The depression subscale self-report will be used to measure change in parent depression, Scores range from 0 to 42 with higher scores indicating higher depressive symptoms. | Intent to treat population (ITT; all participants assigned to stepped care TF-CBT and standard TF-CBT). Multiple imputation was applied for ITT analysis, with ten imputations generated at item level and individual level. | Posted | Mean | Standard Deviation | score on a scale | Post treatment |
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| Other Pre-specified | Depression, Anxiety and Stress Scale (Short Form)- Depression Subscale | The depression subscale self-report will be used to measure change in parent depression, Scores range from 0 to 42 with higher scores indicating higher depressive symptoms. | Intent to treat population (ITT; all participants assigned to stepped care TF-CBT and standard TF-CBT). Multiple imputation was applied for ITT analysis, with ten imputations generated at item level and individual level. | Posted | Mean | Standard Deviation | score on a scale | 6-month follow up |
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| Other Pre-specified | Depression, Anxiety and Stress Scale (Short Form)- Depression Subscale | The depression subscale self-report will be used to measure change in parent depression, Scores range from 0 to 42 with higher scores indicating higher depressive symptoms. | Intent to treat population (ITT; all participants assigned to stepped care TF-CBT and standard TF-CBT). Multiple imputation was applied for ITT analysis, with ten imputations generated at item level and individual level. | Posted | Mean | Standard Deviation | score on a scale | 12-month follow up |
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| Other Pre-specified | The PTSD Checklist-Civilian (PCL-C) | The PCL-C will be used to measure change in parent self-report of PTSD symptom severity. Scores range from 0 to 80 with higher scores indicating greater posttraumatic stress symptoms. | Intent to treat population (ITT: all participants assigned to stepped care TF-CBT and standard TF-CBT). Multiple imputation was applied for ITT analysis, with ten imputations generated at item level and individual level. | Posted | Mean | Standard Deviation | score on a scale | Post treatment |
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| Other Pre-specified | The PTSD Checklist-Civilian (PCL-C) | The PCL-C will be used to measure change in parent self-report of PTSD symptom severity. Scores range from 0 to 80 with higher scores indicating greater posttraumatic stress symptoms. | Intent to treat population (ITT: all participants assigned to stepped care TF-CBT and standard TF-CBT). Multiple imputation was applied for ITT analysis, with ten imputations generated at item level and individual level. | Posted | Mean | Standard Deviation | score on a scale | 6-month follow up |
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| Other Pre-specified | The PTSD Checklist-Civilian (PCL-C) | The PCL-C will be used to measure change in parent self-report of PTSD symptom severity. Scores range from 0 to 80 with higher scores indicating greater posttraumatic stress symptoms. | Intent to treat population (ITT: all participants assigned to stepped care TF-CBT and standard TF-CBT). Multiple imputation was applied for ITT analysis, with ten imputations generated at item level and individual level. | Posted | Mean | Standard Deviation | score on a scale | 12-month follow up |
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| 0 |
| 182 |
| 19 |
| 182 |
| 9 |
| 182 |
| EG001 | Standard TF-CBT | Participants (parents/guardians and children) received therapist-led trauma-focused cognitive behavioral therapy (TF-CBT). Two as needed sessions could be provided. | 0 | 184 | 29 | 184 | 16 | 184 |
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| Hospitalized due to psychiatric crisis and for evaluation (children) | Psychiatric disorders | Systematic Assessment | For children: Hospitalized for mental health. All child hospitalizations occured after treatment and before the last 12 month assessment. Interview was used to asses for hospitalizations. |
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| Heart surgery due to chronic condition (children) | Cardiac disorders | Non-systematic Assessment | For children: Heart surgery. Surgery was planned and child was able to complete study treatment. |
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| Hospitalized due to gastrointestinal issues (children) | Gastrointestinal disorders | Non-systematic Assessment | For children: Hospitalized due to gastrointestinal issues. Child had pending diagnosis of Crohn's disease. Occured between post-treatment and 12 month follow-up assessment. |
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| Hospitalized due to virus (children) | Infections and infestations | Non-systematic Assessment | For children: Admitted to the emergency room due to a virus |
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| Suicidal ideation (children) | Psychiatric disorders | Systematic Assessment | For children: Suicidal ideation. A structured assessment was used to assess for suicidal ideation. |
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| Hospitalized due to prior condition (parents/guardians) | General disorders | Non-systematic Assessment | For parents/guardians: Hospitalized for prior condition. |
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| Hospitalized due to meningitis (parents/guardians) | Infections and infestations | Non-systematic Assessment | For parents/guardians: Hospitalized due to meningitis |
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Not provided
Not provided
Treatment difference = standard Trauma Focused -CBT - stepped care Trauma Focused-CBT |
Treatment difference = standard TF-CBT - stepped care TF-CBT |
Treatment difference = standard TF-CBT - stepped care TF-CBT |
Treatment difference = standard TF-CBT - stepped care TF-CBT |
Treatment difference = standard TF-CBT - stepped care TF-CBT |
Treatment difference = standard TF-CBT - stepped care TF-CBT |