NCT00073619

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2001

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2001

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

December 2, 2003

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 3, 2003

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2007

Completed
4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
Last Updated

June 23, 2016

Status Verified

June 1, 2016

Enrollment Period

5.6 years

First QC Date

December 2, 2003

Last Update Submit

June 22, 2016

Conditions

Keywords

ViolenceSchool basedUrban YouthPreventionCommunity

Outcome Measures

Primary Outcomes (1)

  • Revised Children's Manifest Anxiety Scale

    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 Outcomes (3)

  • Wechsler Individual Achievement Test-Screener

    Past year

  • Multicultural Events Schedule for Adolescents

    Past year

  • Children's Report of Exposure to Violence

    Past year and Lifetime

Study Arms (2)

Cognitive-behavioral group therapy

EXPERIMENTAL

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

Non-intervention Comparison

NO INTERVENTION

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.

Interventions

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.

Cognitive-behavioral group therapy

Eligibility Criteria

Age8 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • Diagnostic and Statistical Manual-IV disruptive behavior disorder
  • Too many or too few anxiety symptoms

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Johns Hopkins Bloomberg School of Public Health

Baltimore, Maryland, 21205, United States

Location

Related Publications (4)

  • 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.

    PMID: 15136188BACKGROUND
  • 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.

    PMID: 15136184BACKGROUND
  • 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.

    RESULT
  • 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.

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

  • Michele R Cooley, Ph.D.

    Johns Hopkins Bloomberg School of Public Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 2, 2003

First Posted

December 3, 2003

Study Start

December 1, 2001

Primary Completion

July 1, 2007

Study Completion

July 1, 2011

Last Updated

June 23, 2016

Record last verified: 2016-06

Data Sharing

IPD Sharing
Will not share

There is no plan to make individual participant data available.

Locations