Depression, Stress Disorders, Post-Traumatic
Conditions
Keywords
Trauma, Violence, Adolescent, Schools, Cognitive behavioral therapy
Brief summary
This study will develop a program to help school children deal with violence-related trauma.
Detailed description
The number of children who have been indirectly or directly exposed to violence has dramatically increased in the last decade. The emotional and behavioral consequences of violence exposure can be particularly devastating to children. Interventions are needed that can reduce symptoms related to traumas already experienced and enhance children's skills for handling extreme stress that might be experienced in the future. The Cognitive-Behavioral Intervention for Trauma in Schools (CBITS) program was developed between 1998 and 2001 to help children in the Los Angeles school district deal with traumatic events. Although promising, the program required a school-based mental health clinician for implementation. This study will evaluate the effectiveness of a program adapted for the Los Angeles CBITS program that can be used by school staff in a middle school setting. The adapted CBITS program will be compared to a wait list to determine which is more effective in reducing trauma-related stress and depression among sixth grade students. Students who have experienced violence-related trauma will be randomly assigned to receive either 10 weekly sessions of group cognitive behavioral therapy or to wait 3 months. Self-report scales and interviews will be used to assess the emotional states of participants at study entry and study completion. No follow-up visits will be required.
Interventions
BEHAVIORALSchool-based cognitive behavioral support group
Sponsors
National Institute of Mental Health (NIMH)
RAND
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
10 Years to 14 Years
Healthy volunteers
No
Inclusion criteria
* Students in 6th and 7th grade in two participating Los Angeles area schools * Exposure to severe violence, as either a victim or witness, within 1 year prior to study entry * Have symptoms of post-traumatic stress disorder at study entry * Able to speak and understand English * Parent or guardian willing to give informed consent
Exclusion criteria
* Post-traumatic stress disorder symptoms that are not related to a traumatic event * Mental retardation * Conduct disorder that would interfere with the participant's ability to engage in group therapy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Post-traumatic Stress Disorder Symptoms | 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. |
| Depressive Symptoms | 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. |
| Parent Report of Behavioral Problems | 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. |
| Teacher Report of Behavior Problems | 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. |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 39 |
| 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. | 37 |
| Total | 76 |
Baseline characteristics
| Characteristic | Wait-list Control Group | School-based Cognitive Behavioral Support Group | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 37 Participants | 39 Participants | 76 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 11.5 years STANDARD_DEVIATION 0.7 | 11.4 years STANDARD_DEVIATION 0.6 | 11.5 years STANDARD_DEVIATION 0.7 |
| Region of Enrollment United States | 37 participants | 39 participants | 76 participants |
| Sex: Female, Male Female | 18 Participants | 21 Participants | 39 Participants |
| Sex: Female, Male Male | 19 Participants | 18 Participants | 37 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 39 | 0 / 37 |
| serious Total, serious adverse events | 0 / 39 | 0 / 37 |
Outcome results
Primary
Depressive Symptoms
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.
Time frame: 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).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| School-based Cognitive Behavioral Support Group | Depressive Symptoms | Baseline | 13.87 units on a scale | Standard Deviation 8.52 |
| School-based Cognitive Behavioral Support Group | Depressive Symptoms | After Intervention for SSET Group | 11.77 units on a scale | Standard Deviation 7.9 |
| School-based Cognitive Behavioral Support Group | Depressive Symptoms | After all receive intervention | 12.21 units on a scale | Standard Deviation 9.79 |
| Wait-list Control Group | Depressive Symptoms | Baseline | 14.32 units on a scale | Standard Deviation 9.2 |
| Wait-list Control Group | Depressive Symptoms | After Intervention for SSET Group | 14.92 units on a scale | Standard Deviation 9.02 |
| Wait-list Control Group | Depressive Symptoms | After all receive intervention | 12.91 units on a scale | Standard Deviation 8.55 |
Primary
Parent Report of Behavioral Problems
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.
Time frame: Problems over the prior month were assessed at baseline, after intervention for the SSET group (10 weeks), and after all receive intervention (20 weeks).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| School-based Cognitive Behavioral Support Group | Parent Report of Behavioral Problems | Baseline | 11.64 units on a scale | Standard Deviation 5.8 |
| School-based Cognitive Behavioral Support Group | Parent Report of Behavioral Problems | After Intervention for SSET Group | 9.72 units on a scale | Standard Deviation 4.94 |
| School-based Cognitive Behavioral Support Group | Parent Report of Behavioral Problems | After all receive intervention | 8.41 units on a scale | Standard Deviation 4.91 |
| Wait-list Control Group | Parent Report of Behavioral Problems | Baseline | 12.46 units on a scale | Standard Deviation 5.9 |
| Wait-list Control Group | Parent Report of Behavioral Problems | After Intervention for SSET Group | 11.30 units on a scale | Standard Deviation 5.84 |
| Wait-list Control Group | Parent Report of Behavioral Problems | After all receive intervention | 8.91 units on a scale | Standard Deviation 6.08 |
Primary
Post-traumatic Stress Disorder Symptoms
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.
Time frame: 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).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| School-based Cognitive Behavioral Support Group | Post-traumatic Stress Disorder Symptoms | Baseline | 17.46 units on a scale | Standard Deviation 10.37 |
| School-based Cognitive Behavioral Support Group | Post-traumatic Stress Disorder Symptoms | After Intervention for SSET Group | 13.72 units on a scale | Standard Deviation 8.43 |
| School-based Cognitive Behavioral Support Group | Post-traumatic Stress Disorder Symptoms | After all receive intervention | 11.97 units on a scale | Standard Deviation 9.07 |
| Wait-list Control Group | Post-traumatic Stress Disorder Symptoms | Baseline | 19.41 units on a scale | Standard Deviation 10 |
| Wait-list Control Group | Post-traumatic Stress Disorder Symptoms | After Intervention for SSET Group | 18.32 units on a scale | Standard Deviation 11.31 |
| Wait-list Control Group | Post-traumatic Stress Disorder Symptoms | After all receive intervention | 15.59 units on a scale | Standard Deviation 9.42 |
Primary
Teacher Report of Behavior Problems
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.
Time frame: Problems over the month were assessed at baseline, after intervention for the SSET group (10 weeks), and after all receive intervention (20 weeks).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| School-based Cognitive Behavioral Support Group | Teacher Report of Behavior Problems | Baseline | 11.33 units on a scale | Standard Deviation 7.87 |
| School-based Cognitive Behavioral Support Group | Teacher Report of Behavior Problems | After Intervention for SSET Group | 10.28 units on a scale | Standard Deviation 6.95 |
| School-based Cognitive Behavioral Support Group | Teacher Report of Behavior Problems | After all receive intervention | 10.47 units on a scale | Standard Deviation 5.75 |
| Wait-list Control Group | Teacher Report of Behavior Problems | Baseline | 8.59 units on a scale | Standard Deviation 7.37 |
| Wait-list Control Group | Teacher Report of Behavior Problems | After Intervention for SSET Group | 9.30 units on a scale | Standard Deviation 7.98 |
| Wait-list Control Group | Teacher Report of Behavior Problems | After all receive intervention | 9.19 units on a scale | Standard Deviation 6.86 |