Posttraumatic Stress Disorder
Conditions
Brief 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. 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.
Interventions
BEHAVIORALStepped 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),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
BEHAVIORALStandard 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.).
Sponsors
University of South Florida
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
4 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
Parent/Guardian-child dyads enrolled. Inclusion Criteria: 1. Child experienced at least one traumatic event after the age of 36 months 2. 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 3. At enrollment, the child must be between 4-12 years of age 4. The parent/guardian must be willing and able to participate in the treatment and complete informed consent
Exclusion criteria
1. 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 2. Parent has had substance use disorder (SUD) within the past 3 months. 3. Child or parent is suicidal 4. Child or parent is not fluent in English 5. 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. 6. Child is receiving trauma-focused psychotherapy during study treatment. 7. Parent/caregiver who would be treatment participant was the perpetrator, or the child was perpetrated by a person who still lives in the home 8. Child is having unsupervised face-to-face contact with the identified perpetrator 9. Siblings
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Trauma Symptom Checklist for Young Children Posttraumatic Stress Symptoms | 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. |
| Child Sheehan Disability Scale Parent Version | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Child Behavior Checklist Externalizing Symptoms | Post treatment | Changes in T scores in externalizing symptoms. T scores range from 33 to 100 with higher T scores indicating greater externalizing problems. |
| Child Behavior Checklist Internalizing Symptoms | Post treatment | Changes in T scores in internalizing symptoms. T scores may range from 33 to 100 with higher T scores indicating greater internalizing symptoms. |
| Clinical Global Impression-Severity (CGI-S) | Post treatment | 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. |
| Clinical Global Impression-Improvement (CGI-I) | Post treatment | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Depression, Anxiety and Stress Scale (Short Form)- Depression Subscale | Post treatment | 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. |
| Parenting Stress Scale (PSS) | Post treatment | 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. |
| The PTSD Checklist-Civilian (PCL-C) | Post treatment | 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. |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
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 by arm
| Arm | Count |
|---|---|
| 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 | 91 |
| 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.). | 92 |
| Total | 183 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| 6 Month to 12 Month Assessment | Lost to Follow-up | 0 | 1 |
| Baseline to Post-treatment | Parent/Guardian barriers: work, moved, homeless, illness, transportation, perpetrator in home | 14 | 6 |
| Baseline to Post-treatment | Parent/Guardian-child: Dislike therapy | 2 | 3 |
| Baseline to Post-treatment | Parent/Guardian- child dyads: Never started | 4 | 3 |
| Baseline to Post-treatment | Parent/Guardian-child dyads: Unknown | 6 | 5 |
| Baseline to Post-treatment | Parent/Guardian-child dyads: Withdrew | 4 | 4 |
| Post-treatment to 6 Month Assessment | Lost to Follow-up | 8 | 7 |
Baseline characteristics
| Characteristic | Stepped Care Trauma Focused-CBT (TF-CBT) | Standard Trauma Focused-CBT (TF-CBT) | Total |
|---|---|---|---|
| Age, Continuous | 8.32 years STANDARD_DEVIATION 2.39 | 7.46 years STANDARD_DEVIATION 2.45 | 7.89 years STANDARD_DEVIATION 2.46 |
| Child Sheehan Disability Scale Parent Version | 20.99 units on a scale STANDARD_DEVIATION 10.8 | 21.29 units on a scale STANDARD_DEVIATION 12.86 | 21.14 units on a scale STANDARD_DEVIATION 11.85 |
| Education levels College graduate and above (16+ years) | 23 Participants | 25 Participants | 48 Participants |
| Education levels High school graduate (12 years) | 20 Participants | 16 Participants | 36 Participants |
| Education levels No high school diploma (9-11yrs) | 7 Participants | 7 Participants | 14 Participants |
| Education levels Some college (13-15 years) | 41 Participants | 44 Participants | 85 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 26 Participants | 23 Participants | 49 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 65 Participants | 69 Participants | 134 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Household income $0 -9,999 | 15 Participants | 17 Participants | 32 Participants |
| Household income $10,000-24,999 | 13 Participants | 22 Participants | 35 Participants |
| Household income $25,000-34,999 | 13 Participants | 12 Participants | 25 Participants |
| Household income $35,000-49,999 | 21 Participants | 16 Participants | 37 Participants |
| Household income $50,000+ | 29 Participants | 25 Participants | 54 Participants |
| Parent/Guardian age | 38.23 years STANDARD_DEVIATION 10.11 | 36.52 years STANDARD_DEVIATION 9.97 | 37.37 years STANDARD_DEVIATION 10.05 |
| Parent/Guardian employed Employed | 63 Participants | 59 Participants | 122 Participants |
| Parent/Guardian employed Not employed | 28 Participants | 33 Participants | 61 Participants |
| Parent /Guardian ethnicity Hispanic or Latino | 28 Participants | 14 Participants | 42 Participants |
| Parent /Guardian ethnicity Not Hispanic of Latino | 63 Participants | 78 Participants | 141 Participants |
| Parent/Guardian race American Indian/Alaskan Native | 1 Participants | 1 Participants | 2 Participants |
| Parent/Guardian race Black or African American | 36 Participants | 30 Participants | 66 Participants |
| Parent/Guardian race Unknown | 0 Participants | 2 Participants | 2 Participants |
| Parent/Guardian race White | 54 Participants | 59 Participants | 113 Participants |
| Parent/Guardian relationship status Divorced | 12 Participants | 14 Participants | 26 Participants |
| Parent/Guardian relationship status Married | 25 Participants | 26 Participants | 51 Participants |
| Parent/Guardian relationship status Other | 5 Participants | 6 Participants | 11 Participants |
| Parent/Guardian relationship status Separated | 12 Participants | 13 Participants | 25 Participants |
| Parent/Guardian relationship status Single | 34 Participants | 29 Participants | 63 Participants |
| Parent/Guardian relationship status Widowed | 3 Participants | 4 Participants | 7 Participants |
| Parent/Guardian Relationship to the child Parent | 80 Participants | 88 Participants | 168 Participants |
| Parent/Guardian Relationship to the child Relative | 11 Participants | 4 Participants | 15 Participants |
| Parent/Guardian with posttraumatic stress disorder Parent/guardian did not meet criteria for PTSD | 46 Participants | 65 Participants | 111 Participants |
| Parent/Guardian with posttraumatic stress disorder Parent/guardian met criteria for PTSD | 45 Participants | 27 Participants | 72 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 30 Participants | 27 Participants | 57 Participants |
| Race (NIH/OMB) More than one race | 15 Participants | 16 Participants | 31 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 46 Participants | 48 Participants | 94 Participants |
| Sex: Female, Male Female | 48 Participants | 53 Participants | 101 Participants |
| Sex: Female, Male Male | 43 Participants | 39 Participants | 82 Participants |
| Trauma Symptom Checklist for Young Children Posttraumatic Stress Symptoms | 50.53 units on a scale STANDARD_DEVIATION 12.15 | 51.34 units on a scale STANDARD_DEVIATION 13.5 | 50.93 units on a scale STANDARD_DEVIATION 12.81 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 182 | 0 / 184 |
| other Total, other adverse events | 9 / 182 | 16 / 184 |
| serious Total, serious adverse events | 19 / 182 | 29 / 184 |
Outcome results
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.
Time frame: Post treatment
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Stepped Care TF-CBT | Child Sheehan Disability Scale Parent Version | 12.03 score on a scale | Standard Deviation 16.36 |
| Standard TF-CBT | Child Sheehan Disability Scale Parent Version | 12.82 score on a scale | Standard Deviation 13.28 |
Comparison: Based on the actual randomization of 183 participants (SC-TF-CBT=91; standard TF-CBT=92), we had more than 80% power to show that SC-TF-CBT is at least as effective as standard TF-CBT with alpha of .05 and a non-inferior margin of 0.41 standard deviation units.p-value: <0.001t-test, 1 sided
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.
Time frame: 12-month follow up
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Stepped Care TF-CBT | Child Sheehan Disability Scale Parent Version | 7.88 score on a scale | Standard Deviation 12.07 |
| Standard TF-CBT | Child Sheehan Disability Scale Parent Version | 8.25 score on a scale | Standard Deviation 11.38 |
Comparison: Based on the actual randomization of 183 participants (SC-TF-CBT=91; standard TF-CBT=92), we had more than 80% power to show that SC-TF-CBT is at least as effective as standard TF-CBT with alpha of .05 and a non-inferior margin of 0.41 standard deviation units.p-value: 0.002t-test, 1 sided
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.
Time frame: 6-month follow up
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Stepped Care TF-CBT | Child Sheehan Disability Scale Parent Version | 13.23 score on a scale | Standard Deviation 16.23 |
| Standard TF-CBT | Child Sheehan Disability Scale Parent Version | 11.33 score on a scale | Standard Deviation 12.93 |
Comparison: Based on the actual randomization of 183 participants (SC-TF-CBT=91; standard TF-CBT=92), we had more than 80% power to show that SC-TF-CBT is at least as effective as standard TF-CBT with alpha of .05 and a non-inferior margin of 0.41 standard deviation units.p-value: 0.044t-test, 1 sided
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.
Time frame: Post treatment
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Stepped Care TF-CBT | Trauma Symptom Checklist for Young Children Posttraumatic Stress Symptoms | 36.00 score on a scale | Standard Deviation 10.52 |
| Standard TF-CBT | Trauma Symptom Checklist for Young Children Posttraumatic Stress Symptoms | 35.57 score on a scale | Standard Deviation 9.17 |
Comparison: Based on the actual randomization of 183 participants (SC-TF-CBT=91; standard TF-CBT=92), we had more than 80% power to show that SC-TF-CBT is at least as effective as standard TF-CBT with alpha of .05 and a non-inferior margin of 0.41 SD units.p-value: 0.006t-test, 1 sided
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.
Time frame: 12-month follow up
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Stepped Care TF-CBT | Trauma Symptom Checklist for Young Children Posttraumatic Stress Symptoms | 35.05 score on a scale | Standard Deviation 8.26 |
| Standard TF-CBT | Trauma Symptom Checklist for Young Children Posttraumatic Stress Symptoms | 34.92 score on a scale | Standard Deviation 9.14 |
Comparison: Based on the actual randomization of 183 participants (SC-TF-CBT=91; standard TF-CBT=92), we had more than 80% power to show that SC-TF-CBT is at least as effective as standard TF-CBT with alpha of .05 and a non-inferior margin of 0.41 standard deviation units.p-value: 0.001t-test, 1 sided
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.
Time frame: 6-month Follow up
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Stepped Care TF-CBT | Trauma Symptom Checklist for Young Children Posttraumatic Stress Symptoms | 36.84 score on a scale | Standard Deviation 11.56 |
| Standard TF-CBT | Trauma Symptom Checklist for Young Children Posttraumatic Stress Symptoms | 36.31 score on a scale | Standard Deviation 9.68 |
Comparison: Based on the actual randomization of 183 participants (SC-TF-CBT=91; standard TF-CBT=92), we had more than 80% power to show that SC-TF-CBT is at least as effective as standard TF-CBT with alpha of .05 and a non-inferior margin of 0.41 SD units.p-value: 0.004t-test, 1 sided
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.
Time frame: Post treatment
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Stepped Care TF-CBT | Child Behavior Checklist Externalizing Symptoms | 47.41 score on a scale | Standard Deviation 12 |
| Standard TF-CBT | Child Behavior Checklist Externalizing Symptoms | 46.40 score on a scale | Standard Deviation 11.3 |
p-value: 0.008t-test, 1 sided
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.
Time frame: 12-month follow up
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Stepped Care TF-CBT | Child Behavior Checklist Externalizing Symptoms | 46.92 score on a scale | Standard Deviation 14.82 |
| Standard TF-CBT | Child Behavior Checklist Externalizing Symptoms | 45.17 score on a scale | Standard Deviation 12.63 |
p-value: 0.024t-test, 1 sided
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.
Time frame: 6-month follow up
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Stepped Care TF-CBT | Child Behavior Checklist Externalizing Symptoms | 49.76 score on a scale | Standard Deviation 12.52 |
| Standard TF-CBT | Child Behavior Checklist Externalizing Symptoms | 48.40 score on a scale | Standard Deviation 12.47 |
p-value: 0.015t-test, 1 sided
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.
Time frame: 6-month follow up
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Stepped Care TF-CBT | Child Behavior Checklist Internalizing Symptoms | 47.17 score on a scale | Standard Deviation 12.33 |
| Standard TF-CBT | Child Behavior Checklist Internalizing Symptoms | 46.93 score on a scale | Standard Deviation 12.52 |
Comparison: Based on the actual randomization of 183 participants (SC-TF-CBT=91; standard TF-CBT=92), we had more than 80% power to show that SC-TF-CBT is at least as effective as standard TF-CBT with alpha of .05 and a non-inferior margin of 0.41 standard deviation units.p-value: 0.003t-test, 1 sided
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.
Time frame: Post treatment
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Stepped Care TF-CBT | Child Behavior Checklist Internalizing Symptoms | 45.68 score on a scale | Standard Deviation 10.42 |
| Standard TF-CBT | Child Behavior Checklist Internalizing Symptoms | 44.62 score on a scale | Standard Deviation 10.53 |
p-value: 0.016t-test, 1 sided
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.
Time frame: 12-month follow up
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Stepped Care TF-CBT | Child Behavior Checklist Internalizing Symptoms | 45.71 score on a scale | Standard Deviation 12.46 |
| Standard TF-CBT | Child Behavior Checklist Internalizing Symptoms | 45.56 score on a scale | Standard Deviation 12.39 |
p-value: 0.007t-test, 1 sided
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.
Time frame: Post treatment
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Stepped Care TF-CBT | Clinical Global Impression-Improvement (CGI-I) | 2.17 score on a scale | Standard Deviation 1.08 |
| Standard TF-CBT | Clinical Global Impression-Improvement (CGI-I) | 2.15 score on a scale | Standard Deviation 0.98 |
p-value: 0.001t-test, 1 sided
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.
Time frame: 12-month follow up
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Stepped Care TF-CBT | Clinical Global Impression-Improvement (CGI-I) | 1.74 score on a scale | Standard Deviation 0.83 |
| Standard TF-CBT | Clinical Global Impression-Improvement (CGI-I) | 1.78 score on a scale | Standard Deviation 0.84 |
p-value: <0.001t-test, 1 sided
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.
Time frame: 6-month treatment
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Stepped Care TF-CBT | Clinical Global Impression-Improvement (CGI-I) | 2.16 score on a scale | Standard Deviation 1.09 |
| Standard TF-CBT | Clinical Global Impression-Improvement (CGI-I) | 2.09 score on a scale | Standard Deviation 1.21 |
p-value: 0.004t-test, 1 sided
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.
Time frame: 6-month assessment
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Stepped Care TF-CBT | Clinical Global Impression-Severity (CGI-S) | 1.45 score on a scale | Standard Deviation 1.47 |
| Standard TF-CBT | Clinical Global Impression-Severity (CGI-S) | 1.41 score on a scale | Standard Deviation 1.57 |
p-value: 0.003t-test, 1 sided
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.
Time frame: Post treatment
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Stepped Care TF-CBT | Clinical Global Impression-Severity (CGI-S) | 1.66 score on a scale | Standard Deviation 1.46 |
| Standard TF-CBT | Clinical Global Impression-Severity (CGI-S) | 1.66 score on a scale | Standard Deviation 1.52 |
p-value: 0.001t-test, 1 sided
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.
Time frame: 12-month follow up
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Stepped Care TF-CBT | Clinical Global Impression-Severity (CGI-S) | 1.09 score on a scale | Standard Deviation 1.31 |
| Standard TF-CBT | Clinical Global Impression-Severity (CGI-S) | 1.13 score on a scale | Standard Deviation 1.25 |
p-value: <0.001t-test, 1 sided
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.
Time frame: Post treatment
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Stepped Care TF-CBT | Depression, Anxiety and Stress Scale (Short Form)- Depression Subscale | 5.06 score on a scale | Standard Deviation 6.97 |
| Standard TF-CBT | Depression, Anxiety and Stress Scale (Short Form)- Depression Subscale | 4.00 score on a scale | Standard Deviation 5.4 |
p-value: 0.006t-test, 1 sided
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.
Time frame: 6-month follow up
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Stepped Care TF-CBT | Depression, Anxiety and Stress Scale (Short Form)- Depression Subscale | 4.64 score on a scale | Standard Deviation 6.69 |
| Standard TF-CBT | Depression, Anxiety and Stress Scale (Short Form)- Depression Subscale | 4.07 score on a scale | Standard Deviation 6 |
p-value: 0.001t-test, 1 sided
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.
Time frame: 12-month follow up
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Stepped Care TF-CBT | Depression, Anxiety and Stress Scale (Short Form)- Depression Subscale | 4.18 score on a scale | Standard Deviation 5.66 |
| Standard TF-CBT | Depression, Anxiety and Stress Scale (Short Form)- Depression Subscale | 4.39 score on a scale | Standard Deviation 5.62 |
p-value: <0.001t-test, 1 sided
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.
Time frame: Post treatment
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Stepped Care TF-CBT | Parenting Stress Scale (PSS) | 32.46 score on a scale | Standard Deviation 10.67 |
| Standard TF-CBT | Parenting Stress Scale (PSS) | 32.03 score on a scale | Standard Deviation 9.7 |
p-value: 0.005t-test, 1 sided
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.
Time frame: 6-month follow up
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Stepped Care TF-CBT | Parenting Stress Scale (PSS) | 33.77 score on a scale | Standard Deviation 13.42 |
| Standard TF-CBT | Parenting Stress Scale (PSS) | 32.30 score on a scale | Standard Deviation 10.51 |
p-value: 0.028t-test, 1 sided
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.
Time frame: 12-month follow up
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Stepped Care TF-CBT | Parenting Stress Scale (PSS) | 32.26 score on a scale | Standard Deviation 11.2 |
| Standard TF-CBT | Parenting Stress Scale (PSS) | 31.82 score on a scale | Standard Deviation 10.43 |
p-value: 0.009t-test, 1 sided
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.
Time frame: Post treatment
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Stepped Care TF-CBT | The PTSD Checklist-Civilian (PCL-C) | 13.40 score on a scale | Standard Deviation 15.82 |
| Standard TF-CBT | The PTSD Checklist-Civilian (PCL-C) | 12.63 score on a scale | Standard Deviation 15.87 |
p-value: <0.001t-test, 1 sided
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.
Time frame: 6-month follow up
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Stepped Care TF-CBT | The PTSD Checklist-Civilian (PCL-C) | 14.67 score on a scale | Standard Deviation 17.78 |
| Standard TF-CBT | The PTSD Checklist-Civilian (PCL-C) | 12.27 score on a scale | Standard Deviation 14.35 |
p-value: 0.003t-test, 1 sided
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.
Time frame: 12-month follow up
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Stepped Care TF-CBT | The PTSD Checklist-Civilian (PCL-C) | 13.51 score on a scale | Standard Deviation 15.25 |
| Standard TF-CBT | The PTSD Checklist-Civilian (PCL-C) | 11.78 score on a scale | Standard Deviation 13.77 |
p-value: <0.001t-test, 1 sided