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Preventing Anxiety Disorders in Urban Youth

22. juni 2016 opdateret af: Johns Hopkins Bloomberg School of Public Health

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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

200

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • Maryland
      • Baltimore, Maryland, Forenede Stater, 21205
        • Johns Hopkins Bloomberg School of Public Health

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

8 år til 12 år (Barn)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Adfærdsmæssigt: 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.
Ingen indgriben: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Revised Children's Manifest Anxiety Scale
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Wechsler Individual Achievement Test-Screener
Tidsramme: 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
Tidsramme: 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.
Past year
Children's Report of Exposure to Violence
Tidsramme: 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.
Past year and Lifetime

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Johns Hopkins Bloomberg School of Public Health

Samarbejdspartnere

National Institute of Mental Health (NIMH)

Efterforskere

  • Ledende efterforsker: Michele R Cooley, Ph.D., Johns Hopkins Bloomberg School of Public Health

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. december 2001

Primær færdiggørelse (Faktiske)

1. juli 2007

Studieafslutning (Faktiske)

1. juli 2011

Datoer for studieregistrering

Først indsendt

2. december 2003

Først indsendt, der opfyldte QC-kriterier

2. december 2003

Først opslået (Skøn)

3. december 2003

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

23. juni 2016

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

22. juni 2016

Sidst verificeret

1. juni 2016

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • R21MH063143 (U.S. NIH-bevilling/kontrakt)
  • DSIR CT-P (Anden identifikator: NIMH)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

There is no plan to make individual participant data available.

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Cognitive-behavioral group therapy

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Sponsorer og samarbejdspartnere

Medicinske tilstande

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CROs in Zimbabwe

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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