- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00073619
Preventing Anxiety Disorders in Urban Youth
Community Violence and Youth: Preventing Anxiety Disorders
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Community violence is a major public health problem in low-income, urban communities. The mental health impact of living in a violent community is significant, particularly for children. Community violence exposure is associated with various symptoms of anxiety. Unfortunately, little research on the prevention of community-related anxiety in youth has been conducted. This study involves a school-based prevention and cognitive behavioral therapy program that will involve predominantly African American children who live in urban areas and are at risk for developing anxiety disorders.
Children in this study will be randomly assigned to either an anxiety prevention and early intervention group or a nonintervention group for approximately 3 months. Child, parent, and teacher assessments of anxiety symptoms will be made at the end of the study and at a 6-month follow-up visit.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Maryland
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Baltimore, Maryland, United States, 21205
- Johns Hopkins Bloomberg School of Public Health
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Mild exposure to community violence
- Mild to moderate anxiety symptoms or disorders
- Attending public elementary school in an urban area
- In 3rd to 5th grades
Exclusion Criteria:
- Diagnostic and Statistical Manual-IV disruptive behavior disorder
- Too many or too few anxiety symptoms
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Cognitive-behavioral group therapy
School-based anxiety preventive intervention (cognitive-behavioral group therapy) originally designed for Australian children that was culturally and contextually modified for inner-city children exposed to community violence.
Participants received the weekly intervention and rewards for participating in the assessments.
|
School-based anxiety preventive intervention (cognitive-behavioral group therapy) originally designed for Australian children that was culturally and contextually modified for inner-city children exposed to community violence.
Participants received the weekly intervention and rewards for participating in the assessments.
|
No Intervention: Non-intervention Comparison
Provide no active intervention to the comparison group, although assess the children at the same assessment points as the experimental group.
Participants in the control arm were told they were FRIENDS Program participants.They received rewards for participating in the assessments.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Revised Children's Manifest Anxiety Scale
Time Frame: Past month
|
Revised Children's Manifest Anxiety Scale (RCMAS; Reynolds & Richmond, 1997), a self-report measure of the level and nature of anxiety in children and adolescents.
It is a 37-item questionnaire in which students agree or disagree to statements pertaining to how some people think or feel about themselves, assessing different ways anxiety is manifested.
A higher score indicates more anxiety and distress.
The RCMAS has good internal consistency (alpha = 0.83) and test-retest reliability (r = 0.68).
In the FRIENDS study, Total RCMAS reliability was alpha = 0.83 at baseline and alpha = 0.84 at post-assessment.
|
Past month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Wechsler Individual Achievement Test-Screener
Time Frame: Past year
|
Academic achievement was assessed using the Wechsler Individual Achievement Test-Screener (WIAT-Screener; Psychological Corporation, 1992), which consists of three subtests of the comprehensive WIAT battery (i.e., Basic Reading, Mathematics Reasoning, Spelling).
It assesses basic academic skills; permits the calculation of age- and grade-based standard scores; was standardized using a large representative sample; is widely used; and has demonstrated reliability and validity with little evidence of practice effects (Psychological Corporation, 1992).
|
Past year
|
Multicultural Events Schedule for Adolescents
Time Frame: Past year
|
Adverse life events were assessed using the Multicultural Events Schedule for Adolescents (MESA; Gonzales, Gunnoe, Samaniego, & Jackson, 1995), developed to assess major and minor life events specific to an urban multiethnic population (Gonzales et al., 1995).
It was normed on African American, European American, and English- and Spanish-speaking Mexican Americans.
The MESA includes 84 items in which a student responds yes or no to each life events over the past year.
A Total life events score is based on the number of events endorsed, with a higher score indicating more adverse life events and hassles.
The MESA has adequate concurrent validity and test-retest reliability (Gonzales et al., 1995).
In the FRIENDS project, the MESA Total score alpha = .89
at baseline, and alpha = .95
at the post-assessment.
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Past year
|
Children's Report of Exposure to Violence
Time Frame: Past year and Lifetime
|
Children's Report of Exposure to Violence (CREV; Cooley, Turner, & Beidel, 1995).
The CREV is a widely used self-report questionnaire developed to assess children's lifetime exposure to community violence.
It has good two-week test-retest reliability (r = 0.75), internal consistency (overall alpha = .78),
and construct validity (Cooley et al., 1995).
Twenty-nine scored CREV items are rated on a 5-point Likert scale, ranging from 0-''no, never'' to 4-''everyday,'' to indicate the frequency of exposure to community violence via four modes (i.e., media, hearsay, witness, victimization).
Types of violent situations include being chased or threatened, beaten up, robbed or mugged, shot, stabbed, or killed.
Higher scores indicate more perceived exposure.
A past-year version of the CREV was developed and administered at the post-assessment evaluation.
Cronbach's alpha for the lifetime CREV Total score was .88 at baseline and .90 for the past-year version.
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Past year and Lifetime
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Michele R Cooley, Ph.D., Johns Hopkins Bloomberg School of Public Health
Publications and helpful links
General Publications
- Lambert SF, Cooley MR, Campbell KD, Benoit MZ, Stansbury R. Assessing anxiety sensitivity in inner-city African American children: psychometric properties of the childhood anxiety sensitivity index. J Clin Child Adolesc Psychol. 2004 Jun;33(2):248-59. doi: 10.1207/s15374424jccp3302_5.
- Cooley MR, Boyce CA. An introduction to assessing anxiety in child and adolescent multiethnic populations: challenges and opportunities for enhancing knowledge and practice. J Clin Child Adolesc Psychol. 2004 Jun;33(2):210-5. doi: 10.1207/s15374424jccp3302_1.
- Cooley, M., Boyd, R.C., & Grados, J.J. (2004). Feasibility of an anxiety preventive intervention for community violence exposed children. The Journal of Primary Prevention, 25(1), 105-123.
- Cooley-Strickland MR, Griffin RS, Darney D, Otte K, Ko J. Urban African American youth exposed to community violence: a school-based anxiety preventive intervention efficacy study. J Prev Interv Community. 2011;39(2):149-66. doi: 10.1080/10852352.2011.556573.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- R21MH063143 (U.S. NIH Grant/Contract)
- DSIR CT-P (Other Identifier: NIMH)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
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