Preventing Anxiety Disorders in Urban Youth

• ClinicalTrials.gov Identifier: NCT00073619
• Recruitment Status: Completed
• First Posted: December 3, 2003
• Last Update Posted: June 23, 2016
• Sponsor: Johns Hopkins Bloomberg School of Public Health
• Collaborator: National Institute of Mental Health (NIMH)
• Information provided by (Responsible Party): Johns Hopkins Bloomberg School of Public Health

Study Description

Brief Summary:

This study will determine the effectiveness of a cognitive-behavioral group therapy program in preventing anxiety disorders in at-risk children exposed to community violence.

Condition or disease	Intervention/treatment	Phase
Anxiety Disorders	Behavioral: Cognitive-behavioral group therapy	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 200 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Community Violence and Youth: Preventing Anxiety Disorders
• Study Start Date: December 2001
• Actual Primary Completion Date: July 2007
• Actual Study Completion Date: July 2011

Arms and Interventions

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.	Behavioral: 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.
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.

Outcome Measures

Primary Outcome Measures :

1. 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.

Secondary Outcome Measures :

1. 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).
2. 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.
3. 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.

Eligibility Criteria

• Ages Eligible for Study: 8 Years to 12 Years (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

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

Contacts and Locations

Locations

United States, Maryland

Johns Hopkins Bloomberg School of Public Health

Baltimore, Maryland, United States, 21205

Sponsors and Collaborators

Johns Hopkins Bloomberg School of Public Health

National Institute of Mental Health (NIMH)

Investigators

• Principal Investigator: Michele R Cooley, Ph.D.; Johns Hopkins Bloomberg School of Public Health

More Information

Publications of Results:

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.

Other 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.

• Responsible Party: Johns Hopkins Bloomberg School of Public Health
• ClinicalTrials.gov Identifier: NCT00073619
• Other Study ID Numbers: R21MH063143 ( U.S. NIH Grant/Contract ); R21MH063143 ( U.S. NIH Grant/Contract ); DSIR CT-P ( Other Identifier: NIMH )
• First Posted: December 3, 2003
• Last Update Posted: June 23, 2016
• Last Verified: June 2016

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No
• Plan Description: There is no plan to make individual participant data available.

Keywords provided by Johns Hopkins Bloomberg School of Public Health:

Violence; School based; Urban Youth; Prevention; Community

Additional relevant MeSH terms:

Anxiety Disorders; Mental Disorders