Trial Outcomes & Findings for Stepped Care for Children After Trauma: Optimizing Treatment (NCT 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.

Recruitment status

COMPLETED

Study phase

Target enrollment

183 participants

Primary outcome timeframe

Post treatment

Results posted on

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

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

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

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=93 Participants	7.46 years STANDARD_DEVIATION 2.45 • n=4 Participants	7.89 years STANDARD_DEVIATION 2.46 • n=27 Participants
Sex: Female, Male Female	48 Participants n=93 Participants	53 Participants n=4 Participants	101 Participants n=27 Participants
Sex: Female, Male Male	43 Participants n=93 Participants	39 Participants n=4 Participants	82 Participants n=27 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	26 Participants n=93 Participants	23 Participants n=4 Participants	49 Participants n=27 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	65 Participants n=93 Participants	69 Participants n=4 Participants	134 Participants n=27 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants	1 Participants n=4 Participants	1 Participants n=27 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Black or African American	30 Participants n=93 Participants	27 Participants n=4 Participants	57 Participants n=27 Participants
Race (NIH/OMB) White	46 Participants n=93 Participants	48 Participants n=4 Participants	94 Participants n=27 Participants
Race (NIH/OMB) More than one race	15 Participants n=93 Participants	16 Participants n=4 Participants	31 Participants n=27 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Parent/Guardian Relationship to the child Parent	80 Participants n=93 Participants	88 Participants n=4 Participants	168 Participants n=27 Participants
Parent/Guardian Relationship to the child Relative	11 Participants n=93 Participants	4 Participants n=4 Participants	15 Participants n=27 Participants
Parent /Guardian ethnicity Hispanic or Latino	28 Participants n=93 Participants	14 Participants n=4 Participants	42 Participants n=27 Participants
Parent /Guardian ethnicity Not Hispanic of Latino	63 Participants n=93 Participants	78 Participants n=4 Participants	141 Participants n=27 Participants
Parent/Guardian race White	54 Participants n=93 Participants	59 Participants n=4 Participants	113 Participants n=27 Participants
Parent/Guardian race Black or African American	36 Participants n=93 Participants	30 Participants n=4 Participants	66 Participants n=27 Participants
Parent/Guardian race American Indian/Alaskan Native	1 Participants n=93 Participants	1 Participants n=4 Participants	2 Participants n=27 Participants
Parent/Guardian race Unknown	0 Participants n=93 Participants	2 Participants n=4 Participants	2 Participants n=27 Participants
Household income $0 -9,999	15 Participants n=93 Participants	17 Participants n=4 Participants	32 Participants n=27 Participants
Household income $10,000-24,999	13 Participants n=93 Participants	22 Participants n=4 Participants	35 Participants n=27 Participants
Household income $25,000-34,999	13 Participants n=93 Participants	12 Participants n=4 Participants	25 Participants n=27 Participants
Household income $35,000-49,999	21 Participants n=93 Participants	16 Participants n=4 Participants	37 Participants n=27 Participants
Household income $50,000+	29 Participants n=93 Participants	25 Participants n=4 Participants	54 Participants n=27 Participants
Education levels No high school diploma (9-11yrs)	7 Participants n=93 Participants	7 Participants n=4 Participants	14 Participants n=27 Participants
Education levels High school graduate (12 years)	20 Participants n=93 Participants	16 Participants n=4 Participants	36 Participants n=27 Participants
Education levels Some college (13-15 years)	41 Participants n=93 Participants	44 Participants n=4 Participants	85 Participants n=27 Participants
Education levels College graduate and above (16+ years)	23 Participants n=93 Participants	25 Participants n=4 Participants	48 Participants n=27 Participants
Parent/Guardian employed Employed	63 Participants n=93 Participants	59 Participants n=4 Participants	122 Participants n=27 Participants
Parent/Guardian employed Not employed	28 Participants n=93 Participants	33 Participants n=4 Participants	61 Participants n=27 Participants
Parent/Guardian with posttraumatic stress disorder Parent/guardian met criteria for PTSD	45 Participants n=93 Participants	27 Participants n=4 Participants	72 Participants n=27 Participants
Parent/Guardian with posttraumatic stress disorder Parent/guardian did not meet criteria for PTSD	46 Participants n=93 Participants	65 Participants n=4 Participants	111 Participants n=27 Participants
Parent/Guardian age	38.23 years STANDARD_DEVIATION 10.11 • n=93 Participants	36.52 years STANDARD_DEVIATION 9.97 • n=4 Participants	37.37 years STANDARD_DEVIATION 10.05 • n=27 Participants
Parent/Guardian relationship status Single	34 Participants n=93 Participants	29 Participants n=4 Participants	63 Participants n=27 Participants
Parent/Guardian relationship status Married	25 Participants n=93 Participants	26 Participants n=4 Participants	51 Participants n=27 Participants
Parent/Guardian relationship status Divorced	12 Participants n=93 Participants	14 Participants n=4 Participants	26 Participants n=27 Participants
Parent/Guardian relationship status Separated	12 Participants n=93 Participants	13 Participants n=4 Participants	25 Participants n=27 Participants
Parent/Guardian relationship status Widowed	3 Participants n=93 Participants	4 Participants n=4 Participants	7 Participants n=27 Participants
Parent/Guardian relationship status Other	5 Participants n=93 Participants	6 Participants n=4 Participants	11 Participants n=27 Participants
Trauma Symptom Checklist for Young Children Posttraumatic Stress Symptoms	50.53 units on a scale STANDARD_DEVIATION 12.15 • n=93 Participants	51.34 units on a scale STANDARD_DEVIATION 13.50 • n=4 Participants	50.93 units on a scale STANDARD_DEVIATION 12.81 • n=27 Participants
Child Sheehan Disability Scale Parent Version	20.99 units on a scale STANDARD_DEVIATION 10.80 • n=93 Participants	21.29 units on a scale STANDARD_DEVIATION 12.86 • n=4 Participants	21.14 units on a scale STANDARD_DEVIATION 11.85 • n=27 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

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 up

Outcome measures

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 up

Outcome measures

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 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.

Outcome measures

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 up

Outcome measures

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 up

Outcome measures

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 treatment

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

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 up

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

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 up

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

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 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.

Changes in T scores in externalizing symptoms. T scores range from 33 to 100 with higher T scores indicating greater externalizing problems.

Outcome measures

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 up

Changes in T scores in externalizing symptoms. T scores range from 33 to 100 with higher T scores indicating greater externalizing problems.

Outcome measures

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 up

Changes in T scores in externalizing symptoms. T scores range from 33 to 100 with higher T scores indicating greater externalizing problems.

Outcome measures

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 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.

Outcome measures

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 assessment

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

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 up

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

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 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.

Outcome measures

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 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.

Outcome measures

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 up

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

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 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.

Outcome measures

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 up

The PSS scores will be used to measure change in parenting stress. Scores range from 18 to 90 with higher scores indicating higher parenting stress.

Outcome measures

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 up

The PSS scores will be used to measure change in parenting stress. Scores range from 18 to 90 with higher scores indicating higher parenting stress.

Outcome measures

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 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.

Outcome measures

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 up

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

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 up

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

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 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.

Outcome measures

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 up

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

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 up

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

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

Serious events: 19 serious events

Other events: 9 other events

Deaths: 0 deaths

Standard TF-CBT

Serious events: 29 serious events

Other events: 16 other events

Deaths: 0 deaths

Serious adverse events

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

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

Alison Salloum

University of South Florida

Phone: 8139741535

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place