Trial Outcomes & Findings for Stepped Care for Children After Trauma: Optimizing Treatment (NCT NCT02537678)
NCT ID: NCT02537678
Last Updated: 2022-05-06
Results Overview
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.
COMPLETED
NA
183 participants
12-month follow up
2022-05-06
Participant Flow
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.
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.
Participant milestones
| Measure |
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
|
Standard TF-CBT
Participants (parent-child dyads) received therapist led trauma-focused cognitive behavioral therapy (TF-CBT). Two as needed sessions could be provided.
|
|---|---|---|
|
Baseline to Post-treatment
STARTED
|
91
|
92
|
|
Baseline to Post-treatment
Completed Post-treatment
|
61
|
71
|
|
Baseline to Post-treatment
COMPLETED
|
61
|
71
|
|
Baseline to Post-treatment
NOT COMPLETED
|
30
|
21
|
|
Post-treatment to 6 Month Assessment
STARTED
|
61
|
71
|
|
Post-treatment to 6 Month Assessment
COMPLETED
|
53
|
64
|
|
Post-treatment to 6 Month Assessment
NOT COMPLETED
|
8
|
7
|
|
6 Month to 12 Month Assessment
STARTED
|
53
|
64
|
|
6 Month to 12 Month Assessment
COMPLETED
|
53
|
63
|
|
6 Month to 12 Month Assessment
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
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
|
Standard TF-CBT
Participants (parent-child dyads) received therapist led trauma-focused cognitive behavioral therapy (TF-CBT). Two as needed sessions could be provided.
|
|---|---|---|
|
Baseline to Post-treatment
Parent/Guardian- child dyads: Never started
|
4
|
3
|
|
Baseline to Post-treatment
Parent/Guardian-child dyads: Withdrew
|
4
|
4
|
|
Baseline to Post-treatment
Parent/Guardian-child dyads: Unknown
|
6
|
5
|
|
Baseline to Post-treatment
Parent/Guardian-child: Dislike therapy
|
2
|
3
|
|
Baseline to Post-treatment
Parent/Guardian barriers: work, moved, homeless, illness, transportation, perpetrator in home
|
14
|
6
|
|
Post-treatment to 6 Month Assessment
Lost to Follow-up
|
8
|
7
|
|
6 Month to 12 Month Assessment
Lost to Follow-up
|
0
|
1
|
Baseline Characteristics
Stepped Care for Children After Trauma: Optimizing Treatment
Baseline characteristics by cohort
| Measure |
Stepped Care Trauma Focused-CBT (TF-CBT)
n=91 Participants
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
|
Standard Trauma Focused-CBT (TF-CBT)
n=92 Participants
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.).
|
Total
n=183 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
8.32 years
STANDARD_DEVIATION 2.39 • n=99 Participants
|
7.46 years
STANDARD_DEVIATION 2.45 • n=107 Participants
|
7.89 years
STANDARD_DEVIATION 2.46 • n=206 Participants
|
|
Sex: Female, Male
Female
|
48 Participants
n=99 Participants
|
53 Participants
n=107 Participants
|
101 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
43 Participants
n=99 Participants
|
39 Participants
n=107 Participants
|
82 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
26 Participants
n=99 Participants
|
23 Participants
n=107 Participants
|
49 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
65 Participants
n=99 Participants
|
69 Participants
n=107 Participants
|
134 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
30 Participants
n=99 Participants
|
27 Participants
n=107 Participants
|
57 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
46 Participants
n=99 Participants
|
48 Participants
n=107 Participants
|
94 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
15 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
31 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Parent/Guardian Relationship to the child
Parent
|
80 Participants
n=99 Participants
|
88 Participants
n=107 Participants
|
168 Participants
n=206 Participants
|
|
Parent/Guardian Relationship to the child
Relative
|
11 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
|
Parent /Guardian ethnicity
Hispanic or Latino
|
28 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
42 Participants
n=206 Participants
|
|
Parent /Guardian ethnicity
Not Hispanic of Latino
|
63 Participants
n=99 Participants
|
78 Participants
n=107 Participants
|
141 Participants
n=206 Participants
|
|
Parent/Guardian race
White
|
54 Participants
n=99 Participants
|
59 Participants
n=107 Participants
|
113 Participants
n=206 Participants
|
|
Parent/Guardian race
Black or African American
|
36 Participants
n=99 Participants
|
30 Participants
n=107 Participants
|
66 Participants
n=206 Participants
|
|
Parent/Guardian race
American Indian/Alaskan Native
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Parent/Guardian race
Unknown
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Household income
$0 -9,999
|
15 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
32 Participants
n=206 Participants
|
|
Household income
$10,000-24,999
|
13 Participants
n=99 Participants
|
22 Participants
n=107 Participants
|
35 Participants
n=206 Participants
|
|
Household income
$25,000-34,999
|
13 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
25 Participants
n=206 Participants
|
|
Household income
$35,000-49,999
|
21 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
37 Participants
n=206 Participants
|
|
Household income
$50,000+
|
29 Participants
n=99 Participants
|
25 Participants
n=107 Participants
|
54 Participants
n=206 Participants
|
|
Education levels
No high school diploma (9-11yrs)
|
7 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
|
Education levels
High school graduate (12 years)
|
20 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
36 Participants
n=206 Participants
|
|
Education levels
Some college (13-15 years)
|
41 Participants
n=99 Participants
|
44 Participants
n=107 Participants
|
85 Participants
n=206 Participants
|
|
Education levels
College graduate and above (16+ years)
|
23 Participants
n=99 Participants
|
25 Participants
n=107 Participants
|
48 Participants
n=206 Participants
|
|
Parent/Guardian employed
Employed
|
63 Participants
n=99 Participants
|
59 Participants
n=107 Participants
|
122 Participants
n=206 Participants
|
|
Parent/Guardian employed
Not employed
|
28 Participants
n=99 Participants
|
33 Participants
n=107 Participants
|
61 Participants
n=206 Participants
|
|
Parent/Guardian with posttraumatic stress disorder
Parent/guardian met criteria for PTSD
|
45 Participants
n=99 Participants
|
27 Participants
n=107 Participants
|
72 Participants
n=206 Participants
|
|
Parent/Guardian with posttraumatic stress disorder
Parent/guardian did not meet criteria for PTSD
|
46 Participants
n=99 Participants
|
65 Participants
n=107 Participants
|
111 Participants
n=206 Participants
|
|
Parent/Guardian age
|
38.23 years
STANDARD_DEVIATION 10.11 • n=99 Participants
|
36.52 years
STANDARD_DEVIATION 9.97 • n=107 Participants
|
37.37 years
STANDARD_DEVIATION 10.05 • n=206 Participants
|
|
Parent/Guardian relationship status
Single
|
34 Participants
n=99 Participants
|
29 Participants
n=107 Participants
|
63 Participants
n=206 Participants
|
|
Parent/Guardian relationship status
Married
|
25 Participants
n=99 Participants
|
26 Participants
n=107 Participants
|
51 Participants
n=206 Participants
|
|
Parent/Guardian relationship status
Divorced
|
12 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
26 Participants
n=206 Participants
|
|
Parent/Guardian relationship status
Separated
|
12 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
25 Participants
n=206 Participants
|
|
Parent/Guardian relationship status
Widowed
|
3 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Parent/Guardian relationship status
Other
|
5 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
|
Trauma Symptom Checklist for Young Children Posttraumatic Stress Symptoms
|
50.53 units on a scale
STANDARD_DEVIATION 12.15 • n=99 Participants
|
51.34 units on a scale
STANDARD_DEVIATION 13.50 • n=107 Participants
|
50.93 units on a scale
STANDARD_DEVIATION 12.81 • n=206 Participants
|
|
Child Sheehan Disability Scale Parent Version
|
20.99 units on a scale
STANDARD_DEVIATION 10.80 • n=99 Participants
|
21.29 units on a scale
STANDARD_DEVIATION 12.86 • n=107 Participants
|
21.14 units on a scale
STANDARD_DEVIATION 11.85 • n=206 Participants
|
PRIMARY outcome
Timeframe: Post treatmentPopulation: 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.
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.
Outcome measures
| Measure |
Stepped Care TF-CBT
n=91 Participants
Participants 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
|
Standard TF-CBT
n=92 Participants
Participants received therapist led trauma-focused cognitive behavioral therapy (TF-CBT). Two as needed sessions could be provided.
|
|---|---|---|
|
Trauma Symptom Checklist for Young Children Posttraumatic Stress Symptoms
|
36.00 score on a scale
Standard Deviation 10.52
|
35.57 score on a scale
Standard Deviation 9.17
|
PRIMARY outcome
Timeframe: 6-month Follow upPopulation: 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.
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.
Outcome measures
| Measure |
Stepped Care TF-CBT
n=91 Participants
Participants 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
|
Standard TF-CBT
n=92 Participants
Participants received therapist led trauma-focused cognitive behavioral therapy (TF-CBT). Two as needed sessions could be provided.
|
|---|---|---|
|
Trauma Symptom Checklist for Young Children Posttraumatic Stress Symptoms
|
36.84 score on a scale
Standard Deviation 11.56
|
36.31 score on a scale
Standard Deviation 9.68
|
PRIMARY outcome
Timeframe: 12-month follow upPopulation: 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.
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.
Outcome measures
| Measure |
Stepped Care TF-CBT
n=91 Participants
Participants 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
|
Standard TF-CBT
n=92 Participants
Participants received therapist led trauma-focused cognitive behavioral therapy (TF-CBT). Two as needed sessions could be provided.
|
|---|---|---|
|
Trauma Symptom Checklist for Young Children Posttraumatic Stress Symptoms
|
35.05 score on a scale
Standard Deviation 8.26
|
34.92 score on a scale
Standard Deviation 9.14
|
PRIMARY outcome
Timeframe: Post treatmentPopulation: 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.
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.
Outcome measures
| Measure |
Stepped Care TF-CBT
n=91 Participants
Participants 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
|
Standard TF-CBT
n=92 Participants
Participants received therapist led trauma-focused cognitive behavioral therapy (TF-CBT). Two as needed sessions could be provided.
|
|---|---|---|
|
Child Sheehan Disability Scale Parent Version
|
12.03 score on a scale
Standard Deviation 16.36
|
12.82 score on a scale
Standard Deviation 13.28
|
PRIMARY outcome
Timeframe: 6-month follow upPopulation: 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.
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.
Outcome measures
| Measure |
Stepped Care TF-CBT
n=91 Participants
Participants 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
|
Standard TF-CBT
n=92 Participants
Participants received therapist led trauma-focused cognitive behavioral therapy (TF-CBT). Two as needed sessions could be provided.
|
|---|---|---|
|
Child Sheehan Disability Scale Parent Version
|
13.23 score on a scale
Standard Deviation 16.23
|
11.33 score on a scale
Standard Deviation 12.93
|
PRIMARY outcome
Timeframe: 12-month follow upPopulation: 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.
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.
Outcome measures
| Measure |
Stepped Care TF-CBT
n=91 Participants
Participants 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
|
Standard TF-CBT
n=92 Participants
Participants received therapist led trauma-focused cognitive behavioral therapy (TF-CBT). Two as needed sessions could be provided.
|
|---|---|---|
|
Child Sheehan Disability Scale Parent Version
|
7.88 score on a scale
Standard Deviation 12.07
|
8.25 score on a scale
Standard Deviation 11.38
|
SECONDARY outcome
Timeframe: Post treatmentPopulation: 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.
Changes in T scores in internalizing symptoms. T scores may range from 33 to 100 with higher T scores indicating greater internalizing symptoms.
Outcome measures
| Measure |
Stepped Care TF-CBT
n=91 Participants
Participants 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
|
Standard TF-CBT
n=92 Participants
Participants received therapist led trauma-focused cognitive behavioral therapy (TF-CBT). Two as needed sessions could be provided.
|
|---|---|---|
|
Child Behavior Checklist Internalizing Symptoms
|
45.68 score on a scale
Standard Deviation 10.42
|
44.62 score on a scale
Standard Deviation 10.53
|
SECONDARY outcome
Timeframe: 6-month follow upPopulation: 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.
Changes in T scores in internalizing symptoms. T scores may range from 33 to 100 with higher T scores indicating greater internalizing symptoms.
Outcome measures
| Measure |
Stepped Care TF-CBT
n=91 Participants
Participants 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
|
Standard TF-CBT
n=92 Participants
Participants received therapist led trauma-focused cognitive behavioral therapy (TF-CBT). Two as needed sessions could be provided.
|
|---|---|---|
|
Child Behavior Checklist Internalizing Symptoms
|
47.17 score on a scale
Standard Deviation 12.33
|
46.93 score on a scale
Standard Deviation 12.52
|
SECONDARY outcome
Timeframe: 12-month follow upPopulation: 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.
Changes in T scores in internalizing symptoms. T scores may range from 33 to 100 with higher T scores indicating greater internalizing symptoms.
Outcome measures
| Measure |
Stepped Care TF-CBT
n=91 Participants
Participants 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
|
Standard TF-CBT
n=92 Participants
Participants received therapist led trauma-focused cognitive behavioral therapy (TF-CBT). Two as needed sessions could be provided.
|
|---|---|---|
|
Child Behavior Checklist Internalizing Symptoms
|
45.71 score on a scale
Standard Deviation 12.46
|
45.56 score on a scale
Standard Deviation 12.39
|
SECONDARY outcome
Timeframe: Post treatmentPopulation: 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.
Changes in T scores in externalizing symptoms. T scores range from 33 to 100 with higher T scores indicating greater externalizing problems.
Outcome measures
| Measure |
Stepped Care TF-CBT
n=91 Participants
Participants 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
|
Standard TF-CBT
n=92 Participants
Participants received therapist led trauma-focused cognitive behavioral therapy (TF-CBT). Two as needed sessions could be provided.
|
|---|---|---|
|
Child Behavior Checklist Externalizing Symptoms
|
47.41 score on a scale
Standard Deviation 12.00
|
46.40 score on a scale
Standard Deviation 11.30
|
SECONDARY outcome
Timeframe: 6-month follow upPopulation: 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.
Changes in T scores in externalizing symptoms. T scores range from 33 to 100 with higher T scores indicating greater externalizing problems.
Outcome measures
| Measure |
Stepped Care TF-CBT
n=91 Participants
Participants 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
|
Standard TF-CBT
n=92 Participants
Participants received therapist led trauma-focused cognitive behavioral therapy (TF-CBT). Two as needed sessions could be provided.
|
|---|---|---|
|
Child Behavior Checklist Externalizing Symptoms
|
49.76 score on a scale
Standard Deviation 12.52
|
48.40 score on a scale
Standard Deviation 12.47
|
SECONDARY outcome
Timeframe: 12-month follow upPopulation: 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.
Changes in T scores in externalizing symptoms. T scores range from 33 to 100 with higher T scores indicating greater externalizing problems.
Outcome measures
| Measure |
Stepped Care TF-CBT
n=91 Participants
Participants 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
|
Standard TF-CBT
n=92 Participants
Participants received therapist led trauma-focused cognitive behavioral therapy (TF-CBT). Two as needed sessions could be provided.
|
|---|---|---|
|
Child Behavior Checklist Externalizing Symptoms
|
46.92 score on a scale
Standard Deviation 14.82
|
45.17 score on a scale
Standard Deviation 12.63
|
SECONDARY outcome
Timeframe: Post treatmentPopulation: 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.
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.
Outcome measures
| Measure |
Stepped Care TF-CBT
n=91 Participants
Participants 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
|
Standard TF-CBT
n=92 Participants
Participants received therapist led trauma-focused cognitive behavioral therapy (TF-CBT). Two as needed sessions could be provided.
|
|---|---|---|
|
Clinical Global Impression-Severity (CGI-S)
|
1.66 score on a scale
Standard Deviation 1.46
|
1.66 score on a scale
Standard Deviation 1.52
|
SECONDARY outcome
Timeframe: 6-month assessmentPopulation: 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.
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.
Outcome measures
| Measure |
Stepped Care TF-CBT
n=91 Participants
Participants 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
|
Standard TF-CBT
n=92 Participants
Participants received therapist led trauma-focused cognitive behavioral therapy (TF-CBT). Two as needed sessions could be provided.
|
|---|---|---|
|
Clinical Global Impression-Severity (CGI-S)
|
1.45 score on a scale
Standard Deviation 1.47
|
1.41 score on a scale
Standard Deviation 1.57
|
SECONDARY outcome
Timeframe: 12-month follow upPopulation: 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.
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.
Outcome measures
| Measure |
Stepped Care TF-CBT
n=91 Participants
Participants 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
|
Standard TF-CBT
n=92 Participants
Participants received therapist led trauma-focused cognitive behavioral therapy (TF-CBT). Two as needed sessions could be provided.
|
|---|---|---|
|
Clinical Global Impression-Severity (CGI-S)
|
1.09 score on a scale
Standard Deviation 1.31
|
1.13 score on a scale
Standard Deviation 1.25
|
SECONDARY outcome
Timeframe: Post treatmentPopulation: 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.
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.
Outcome measures
| Measure |
Stepped Care TF-CBT
n=91 Participants
Participants 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
|
Standard TF-CBT
n=92 Participants
Participants received therapist led trauma-focused cognitive behavioral therapy (TF-CBT). Two as needed sessions could be provided.
|
|---|---|---|
|
Clinical Global Impression-Improvement (CGI-I)
|
2.17 score on a scale
Standard Deviation 1.08
|
2.15 score on a scale
Standard Deviation 0.98
|
SECONDARY outcome
Timeframe: 6-month treatmentPopulation: 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.
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.
Outcome measures
| Measure |
Stepped Care TF-CBT
n=91 Participants
Participants 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
|
Standard TF-CBT
n=92 Participants
Participants received therapist led trauma-focused cognitive behavioral therapy (TF-CBT). Two as needed sessions could be provided.
|
|---|---|---|
|
Clinical Global Impression-Improvement (CGI-I)
|
2.16 score on a scale
Standard Deviation 1.09
|
2.09 score on a scale
Standard Deviation 1.21
|
SECONDARY outcome
Timeframe: 12-month follow upPopulation: 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.
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.
Outcome measures
| Measure |
Stepped Care TF-CBT
n=91 Participants
Participants 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
|
Standard TF-CBT
n=92 Participants
Participants received therapist led trauma-focused cognitive behavioral therapy (TF-CBT). Two as needed sessions could be provided.
|
|---|---|---|
|
Clinical Global Impression-Improvement (CGI-I)
|
1.74 score on a scale
Standard Deviation 0.83
|
1.78 score on a scale
Standard Deviation 0.84
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Post treatmentPopulation: 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.
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.
Outcome measures
| Measure |
Stepped Care TF-CBT
n=91 Participants
Participants 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
|
Standard TF-CBT
n=92 Participants
Participants received therapist led trauma-focused cognitive behavioral therapy (TF-CBT). Two as needed sessions could be provided.
|
|---|---|---|
|
Parenting Stress Scale (PSS)
|
32.46 score on a scale
Standard Deviation 10.67
|
32.03 score on a scale
Standard Deviation 9.70
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 6-month follow upPopulation: 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.
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.
Outcome measures
| Measure |
Stepped Care TF-CBT
n=91 Participants
Participants 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
|
Standard TF-CBT
n=92 Participants
Participants received therapist led trauma-focused cognitive behavioral therapy (TF-CBT). Two as needed sessions could be provided.
|
|---|---|---|
|
Parenting Stress Scale (PSS)
|
33.77 score on a scale
Standard Deviation 13.42
|
32.30 score on a scale
Standard Deviation 10.51
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 12-month follow upPopulation: 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.
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.
Outcome measures
| Measure |
Stepped Care TF-CBT
n=91 Participants
Participants 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
|
Standard TF-CBT
n=92 Participants
Participants received therapist led trauma-focused cognitive behavioral therapy (TF-CBT). Two as needed sessions could be provided.
|
|---|---|---|
|
Parenting Stress Scale (PSS)
|
32.26 score on a scale
Standard Deviation 11.20
|
31.82 score on a scale
Standard Deviation 10.43
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Post treatmentPopulation: 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.
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.
Outcome measures
| Measure |
Stepped Care TF-CBT
n=91 Participants
Participants 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
|
Standard TF-CBT
n=92 Participants
Participants received therapist led trauma-focused cognitive behavioral therapy (TF-CBT). Two as needed sessions could be provided.
|
|---|---|---|
|
Depression, Anxiety and Stress Scale (Short Form)- Depression Subscale
|
5.06 score on a scale
Standard Deviation 6.97
|
4.00 score on a scale
Standard Deviation 5.40
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 6-month follow upPopulation: 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.
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.
Outcome measures
| Measure |
Stepped Care TF-CBT
n=91 Participants
Participants 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
|
Standard TF-CBT
n=92 Participants
Participants received therapist led trauma-focused cognitive behavioral therapy (TF-CBT). Two as needed sessions could be provided.
|
|---|---|---|
|
Depression, Anxiety and Stress Scale (Short Form)- Depression Subscale
|
4.64 score on a scale
Standard Deviation 6.69
|
4.07 score on a scale
Standard Deviation 6.00
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 12-month follow upPopulation: 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.
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.
Outcome measures
| Measure |
Stepped Care TF-CBT
n=91 Participants
Participants 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
|
Standard TF-CBT
n=92 Participants
Participants received therapist led trauma-focused cognitive behavioral therapy (TF-CBT). Two as needed sessions could be provided.
|
|---|---|---|
|
Depression, Anxiety and Stress Scale (Short Form)- Depression Subscale
|
4.18 score on a scale
Standard Deviation 5.66
|
4.39 score on a scale
Standard Deviation 5.62
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Post treatmentPopulation: 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.
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.
Outcome measures
| Measure |
Stepped Care TF-CBT
n=91 Participants
Participants 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
|
Standard TF-CBT
n=92 Participants
Participants received therapist led trauma-focused cognitive behavioral therapy (TF-CBT). Two as needed sessions could be provided.
|
|---|---|---|
|
The PTSD Checklist-Civilian (PCL-C)
|
13.40 score on a scale
Standard Deviation 15.82
|
12.63 score on a scale
Standard Deviation 15.87
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 6-month follow upPopulation: 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.
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.
Outcome measures
| Measure |
Stepped Care TF-CBT
n=91 Participants
Participants 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
|
Standard TF-CBT
n=92 Participants
Participants received therapist led trauma-focused cognitive behavioral therapy (TF-CBT). Two as needed sessions could be provided.
|
|---|---|---|
|
The PTSD Checklist-Civilian (PCL-C)
|
14.67 score on a scale
Standard Deviation 17.78
|
12.27 score on a scale
Standard Deviation 14.35
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 12-month follow upPopulation: 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.
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.
Outcome measures
| Measure |
Stepped Care TF-CBT
n=91 Participants
Participants 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
|
Standard TF-CBT
n=92 Participants
Participants received therapist led trauma-focused cognitive behavioral therapy (TF-CBT). Two as needed sessions could be provided.
|
|---|---|---|
|
The PTSD Checklist-Civilian (PCL-C)
|
13.51 score on a scale
Standard Deviation 15.25
|
11.78 score on a scale
Standard Deviation 13.77
|
Adverse Events
Stepped Care TF-CBT
Standard TF-CBT
Serious adverse events
| Measure |
Stepped Care TF-CBT
n=182 participants at risk
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.
|
Standard TF-CBT
n=184 participants at risk
Participants (parents/guardians and children) received therapist-led trauma-focused cognitive behavioral therapy (TF-CBT). Two as needed sessions could be provided.
|
|---|---|---|
|
Social circumstances
Child abuse report (children)
|
6.6%
12/182 • Number of events 16 • 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.
|
8.2%
15/184 • Number of events 19 • 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.
|
|
Psychiatric disorders
Hospitalized due to psychiatric crisis and for evaluation (children)
|
1.1%
2/182 • Number of events 2 • 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.
|
1.1%
2/184 • Number of events 7 • 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.
|
|
Cardiac disorders
Heart surgery due to chronic condition (children)
|
0.00%
0/182 • 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.
|
0.54%
1/184 • Number of events 1 • 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.
|
|
Gastrointestinal disorders
Hospitalized due to gastrointestinal issues (children)
|
0.55%
1/182 • Number of events 1 • 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.
|
0.00%
0/184 • 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.
|
|
Infections and infestations
Hospitalized due to virus (children)
|
0.55%
1/182 • Number of events 1 • 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.
|
0.00%
0/184 • 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.
|
|
Psychiatric disorders
Suicidal ideation (children)
|
1.6%
3/182 • Number of events 3 • 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.
|
3.3%
6/184 • Number of events 7 • 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.
|
|
General disorders
Hospitalized due to prior condition (parents/guardians)
|
0.00%
0/182 • 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.
|
2.2%
4/184 • Number of events 4 • 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.
|
|
Infections and infestations
Hospitalized due to meningitis (parents/guardians)
|
0.00%
0/182 • 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.
|
0.54%
1/184 • Number of events 1 • 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.
|
Other adverse events
| Measure |
Stepped Care TF-CBT
n=182 participants at risk
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.
|
Standard TF-CBT
n=184 participants at risk
Participants (parents/guardians and children) received therapist-led trauma-focused cognitive behavioral therapy (TF-CBT). Two as needed sessions could be provided.
|
|---|---|---|
|
Psychiatric disorders
Worsening of posttraumatic stress symptoms (children)
|
4.9%
9/182 • Number of events 10 • 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.
|
8.7%
16/184 • Number of events 26 • 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.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place