Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

Preventing Anxiety Disorders in Urban Youth

This study has been completed.
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Johns Hopkins Bloomberg School of Public Health
ClinicalTrials.gov Identifier:
NCT00073619
First received: December 2, 2003
Last updated: June 22, 2016
Last verified: June 2016

December 2, 2003
June 22, 2016
December 2001
July 2007   (final data collection date for primary outcome measure)
Revised Children's Manifest Anxiety Scale [ Time Frame: Past month ] [ Designated as safety issue: No ]
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.
Not Provided
Complete list of historical versions of study NCT00073619 on ClinicalTrials.gov Archive Site
  • Wechsler Individual Achievement Test-Screener [ Time Frame: Past year ] [ Designated as safety issue: No ]
    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).
  • Multicultural Events Schedule for Adolescents [ Time Frame: Past year ] [ Designated as safety issue: No ]
    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.
  • Children's Report of Exposure to Violence [ Time Frame: Past year and Lifetime ] [ Designated as safety issue: No ]
    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.
Not Provided
Not Provided
Not Provided
 
Preventing Anxiety Disorders in Urban Youth
Community Violence and Youth: Preventing Anxiety Disorders
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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Anxiety Disorders
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.
  • 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.
    Intervention: Behavioral: Cognitive-behavioral group therapy
  • 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
200
July 2011
July 2007   (final data collection date for primary outcome measure)

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
Both
8 Years to 12 Years   (Child)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00073619
R21MH063143, R21MH063143, DSIR CT-P
No
No
There is no plan to make individual participant data available.
Johns Hopkins Bloomberg School of Public Health
Johns Hopkins Bloomberg School of Public Health
National Institute of Mental Health (NIMH)
Principal Investigator: Michele R Cooley, Ph.D. Johns Hopkins Bloomberg School of Public Health
Johns Hopkins Bloomberg School of Public Health
June 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP