Trial Outcomes & Findings for A School Program for Children Exposed to Violence (NCT NCT00260195)
NCT ID: NCT00260195
Last Updated: 2014-05-22
Results Overview
We used the Child PTSD Symptom Scale (CPSS; Foa,Treadwell, Johnson, \& Feeny, 2001), to assess PTSD symptoms for both screening into the program and for use in examining child outcomes over time. This scale has been used in school aged children as young as 8 and has shown good convergent and discriminant validity and high reliability (Foa et al., 2001). In our earlier work, scale internal consistency was high (Cronbach's alpha = 0.89; Jaycox et al., 2002). In this study, we use it as a continuous scale as designed, and also use cut-points to determine eligibility for the study as in prior work (Kataoka et al., 2003; Stein et al., 2003), requiring a total score of 11 or greater, indicating moderate levels of current PTSD symptoms. A high score indicates more symptoms, and total scores can range from 0 to 51.
COMPLETED
PHASE2
78 participants
Symptoms over the past two weeks were assessed at baseline, after intervention for the SSET group (10 weeks), and after all receive intervention (20 weeks).
2014-05-22
Participant Flow
We recruited and screened 6th and 7th grade students in two schools over two school years (2005-2006 and 2006-2007) in Los Angeles Unified School District.
There are 3 steps in enrollment: consent for screening, screening, consent for participation for those who screened positive. 383 students were screened, 193 screened positive, 78 consented for the project (active parental consent and child assent). 2 students withdrew from the school prior groups and thus did not participate further.
Participant milestones
| Measure |
School-based Cognitive Behavioral Support Group
Ten group lessons facilitated by a teacher or school counselor that focuses on psycho-education, development of a trauma narrative, approaching trauma-related situations, social problem solving, and cognitive skills.
|
Wait-list Control Group
Students assigned to this group waited while the experimental arm received SSET, and then completed the first follow-up assessment. They then received SSET between the first and second follow-up assessment.
|
|---|---|---|
|
Overall Study
STARTED
|
39
|
37
|
|
Overall Study
COMPLETED
|
39
|
37
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A School Program for Children Exposed to Violence
Baseline characteristics by cohort
| Measure |
School-based Cognitive Behavioral Support Group
n=39 Participants
Ten group lessons facilitated by a teacher or school counselor that focuses on psycho-education, development of a trauma narrative, approaching trauma-related situations, social problem solving, and cognitive skills.
|
Wait-list Control Group
n=37 Participants
Students assigned to this group waited while the experimental arm received SSET, and then completed the first follow-up assessment. They then received SSET between the first and second follow-up assessment.
|
Total
n=76 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
39 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
76 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
11.4 years
STANDARD_DEVIATION 0.6 • n=5 Participants
|
11.5 years
STANDARD_DEVIATION 0.7 • n=7 Participants
|
11.5 years
STANDARD_DEVIATION 0.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
39 participants
n=5 Participants
|
37 participants
n=7 Participants
|
76 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Symptoms over the past two weeks were assessed at baseline, after intervention for the SSET group (10 weeks), and after all receive intervention (20 weeks).We used the Child PTSD Symptom Scale (CPSS; Foa,Treadwell, Johnson, \& Feeny, 2001), to assess PTSD symptoms for both screening into the program and for use in examining child outcomes over time. This scale has been used in school aged children as young as 8 and has shown good convergent and discriminant validity and high reliability (Foa et al., 2001). In our earlier work, scale internal consistency was high (Cronbach's alpha = 0.89; Jaycox et al., 2002). In this study, we use it as a continuous scale as designed, and also use cut-points to determine eligibility for the study as in prior work (Kataoka et al., 2003; Stein et al., 2003), requiring a total score of 11 or greater, indicating moderate levels of current PTSD symptoms. A high score indicates more symptoms, and total scores can range from 0 to 51.
Outcome measures
| Measure |
School-based Cognitive Behavioral Support Group
n=39 Participants
Ten group lessons facilitated by a teacher or school counselor that focuses on psycho-education, development of a trauma narrative, approaching trauma-related situations, social problem solving, and cognitive skills.
|
Wait-list Control Group
n=37 Participants
Students assigned to this group waited while the experimental arm received SSET, and then completed the first follow-up assessment. They then received SSET between the first and second follow-up assessment.
|
|---|---|---|
|
Post-traumatic Stress Disorder Symptoms
Baseline
|
17.46 units on a scale
Standard Deviation 10.37
|
19.41 units on a scale
Standard Deviation 10.00
|
|
Post-traumatic Stress Disorder Symptoms
After Intervention for SSET Group
|
13.72 units on a scale
Standard Deviation 8.43
|
18.32 units on a scale
Standard Deviation 11.31
|
|
Post-traumatic Stress Disorder Symptoms
After all receive intervention
|
11.97 units on a scale
Standard Deviation 9.07
|
15.59 units on a scale
Standard Deviation 9.42
|
PRIMARY outcome
Timeframe: Symptoms over the past two weeks were assessed at baseline, after intervention for the SSET group (10 weeks), and after all receive intervention (20 weeks).Children's Depression Inventory (CDI; Kovacs, 1981) This 27-item measure assesses children's cognitive, affective, and behavioral depressive symptoms. The scale has high internal consistency, moderate test-retest reliability, and correlates in the expected direction with measures of related constructs (e.g., self-esteem, negative attributions, and hopelessness; Kendall, Cantwell, \& Kazdin, 1989). Normative data are available (Finch, Saylor, \& Edwards, 1985). We used a 26-item version of the scale that omits an item about suicidal ideation. Higher scores indicate more symptoms, and total scores can range from 0 to 52.
Outcome measures
| Measure |
School-based Cognitive Behavioral Support Group
n=39 Participants
Ten group lessons facilitated by a teacher or school counselor that focuses on psycho-education, development of a trauma narrative, approaching trauma-related situations, social problem solving, and cognitive skills.
|
Wait-list Control Group
n=37 Participants
Students assigned to this group waited while the experimental arm received SSET, and then completed the first follow-up assessment. They then received SSET between the first and second follow-up assessment.
|
|---|---|---|
|
Depressive Symptoms
Baseline
|
13.87 units on a scale
Standard Deviation 8.52
|
14.32 units on a scale
Standard Deviation 9.20
|
|
Depressive Symptoms
After Intervention for SSET Group
|
11.77 units on a scale
Standard Deviation 7.90
|
14.92 units on a scale
Standard Deviation 9.02
|
|
Depressive Symptoms
After all receive intervention
|
12.21 units on a scale
Standard Deviation 9.79
|
12.91 units on a scale
Standard Deviation 8.55
|
PRIMARY outcome
Timeframe: Problems over the prior month were assessed at baseline, after intervention for the SSET group (10 weeks), and after all receive intervention (20 weeks).Strengths and Difficulties Questionnaire-Parent Report, and Teacher Report (SDQ, Goodman, 1997; Goodman, Meltzer, \& Bailey, 1998) This questionnaire contains 25 items, 20 assessing problem areas (emotional symptoms, conduct problems, hyperactivity/inattention, and peer relationship problems), 5 assessing prosocial behavior, and items that tap functional impairment related to these problems (Goodman, 1999). Higher scores indicate more problems, with total scores for problem areas ranging from 0 to 40.
Outcome measures
| Measure |
School-based Cognitive Behavioral Support Group
n=39 Participants
Ten group lessons facilitated by a teacher or school counselor that focuses on psycho-education, development of a trauma narrative, approaching trauma-related situations, social problem solving, and cognitive skills.
|
Wait-list Control Group
n=37 Participants
Students assigned to this group waited while the experimental arm received SSET, and then completed the first follow-up assessment. They then received SSET between the first and second follow-up assessment.
|
|---|---|---|
|
Parent Report of Behavioral Problems
Baseline
|
11.64 units on a scale
Standard Deviation 5.80
|
12.46 units on a scale
Standard Deviation 5.90
|
|
Parent Report of Behavioral Problems
After Intervention for SSET Group
|
9.72 units on a scale
Standard Deviation 4.94
|
11.30 units on a scale
Standard Deviation 5.84
|
|
Parent Report of Behavioral Problems
After all receive intervention
|
8.41 units on a scale
Standard Deviation 4.91
|
8.91 units on a scale
Standard Deviation 6.08
|
PRIMARY outcome
Timeframe: Problems over the month were assessed at baseline, after intervention for the SSET group (10 weeks), and after all receive intervention (20 weeks).Strengths and Difficulties Questionnaire-Parent Report, and Teacher Report (SDQ, Goodman, 1997; Goodman, Meltzer, \& Bailey, 1998) This questionnaire contains 25 items, 20 assessing problem areas (emotional symptoms, conduct problems, hyperactivity/inattention, and peer relationship problems), 5 assessing prosocial behavior, and items that tap functional impairment related to these problems (Goodman, 1999). Higher scores indicates more problems, with total problem area scores ranging from 0 to 40.
Outcome measures
| Measure |
School-based Cognitive Behavioral Support Group
n=39 Participants
Ten group lessons facilitated by a teacher or school counselor that focuses on psycho-education, development of a trauma narrative, approaching trauma-related situations, social problem solving, and cognitive skills.
|
Wait-list Control Group
n=37 Participants
Students assigned to this group waited while the experimental arm received SSET, and then completed the first follow-up assessment. They then received SSET between the first and second follow-up assessment.
|
|---|---|---|
|
Teacher Report of Behavior Problems
Baseline
|
11.33 units on a scale
Standard Deviation 7.87
|
8.59 units on a scale
Standard Deviation 7.37
|
|
Teacher Report of Behavior Problems
After Intervention for SSET Group
|
10.28 units on a scale
Standard Deviation 6.95
|
9.30 units on a scale
Standard Deviation 7.98
|
|
Teacher Report of Behavior Problems
After all receive intervention
|
10.47 units on a scale
Standard Deviation 5.75
|
9.19 units on a scale
Standard Deviation 6.86
|
Adverse Events
School-based Cognitive Behavioral Support Group
Wait-list Control Group
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place