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Completed

NCT Number: NCT00073619

Preventing Anxiety Disorders in Urban Youth

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.

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Key information

Age range

8 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Johns Hopkins Bloomberg School of Public Health

Baltimore, Maryland, 21205, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cognitive-behavioral group therapy

Behavioral

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.

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Johns Hopkins Bloomberg School of Public Health

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

Community Violence and Youth: Preventing Anxiety Disorders

Important dates

Study start
2001
Primary completion
2007
Study completion
2011
First posted
Dec 3, 2003
Registry last updated
Jun 23, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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