School-based Treatment for Anxious Children
School-Based CBT for Anxious African-American Children
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
Anxiety disorders are among the most common childhood disorders. Although anxiety is a normal part of life and growing up, for some children this anxiety becomes chronic, relentless, and progressively worse if left untreated. Physical symptoms typically accompany the intense anxiety caused by the disorder and may include blushing, profuse sweating, trembling, nausea, and difficulty talking. Anxiety disorders among children have become increasingly prevalent, indicating that excessive fear, worry, and anxiety in children are emerging public health issues. Recent studies have shown that CBT is an effective form of treatment for childhood anxiety disorders; however, it often requires the use of expert CBT clinicians. The purpose of this study is to deliver a school-based version of CBT to predominantly low-income, inner-city, African-American children with anxiety disorders. Clinicians within the school will undergo CBT training and adapt the treatment program to fit the needs of the participating children.
All participants in this study will undergo an initial evaluation to assess anxiety symptoms, disorders, and associated impairments. The children will then be randomly assigned to receive 12 weekly sessions of school-based CBT or treatment as usual, which will involve 12 weekly sessions of psychosocial treatment. Three parent sessions will be offered for families in both groups at Weeks 2, 6, and 10. All treatment sessions will occur at school during the day and will be led by school-based clinicians. A follow-up session will be conducted at post-treatment and 1 month after the last session to assess anxiety symptoms and disorders. Parent, teacher, and clinician ratings will also be used to assess the treatment outcomes of each child.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Fase 3
Contatti e Sedi
Luoghi di studio
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Maryland
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Baltimore, Maryland, Stati Uniti, 21287
- Johns Hopkins School of Medicine
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- Meets DSM-IV criteria for primary diagnosis of generalized anxiety disorder (GAD), social anxiety disorder (SAD), specific phobia (SP), or social phobia (SOP)
- Received a score of at least 4 on the ADIS for DSM-IV:C's Clinician's Severity Rating Scale (CSR) for GAD, SAD, SP, and/or SOP
- Received a minimum 1 point difference in ADIS for DSM-IV:C severity scores between the primary disorder and other disorders (e.g., depressive disorders, disruptive behavior disorders, attention deficit hyperactive disorder [ADHD], and other anxiety disorders such as obsessive compulsive disorder [OCD], post-traumatic stress disorder [PTSD], acute stress disorder)
Exclusion Criteria:
- Diagnosed with a pervasive developmental disorder, mental retardation, organic mental disorders, schizophrenia, or other psychotic disorders
- Psychotic or suicidal
- Currently receiving treatment for anxiety
- Requires immediate or alternative treatment
- Previously failed a trial of at least 10 sessions for anxiety within 2 years of study entry
- Absent 50% of school days in the 2 months preceding random assignment to treatment groups
- History of child abuse and requires ongoing Department of Social Services supervision
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Triplicare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Sperimentale: 1
Participants will receive cognitive behavioral therapy for anxiety that includes exposure
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CBT includes 45-minute psychotherapy sessions once a week for a period of approximately 12 weeks.
Altri nomi:
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Comparatore attivo: 2
Participants will receive treatment as usual as delivered by school-based clinicians
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TAU includes 45-minute psychosocial treatment sessions once a week for a period of approximately 12 weeks.
Altri nomi:
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
|---|---|
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Anxiety Disorders Interview Schedule for DSM-IV: Child Version
Lasso di tempo: Measured at pre-treatment, post-treatment, and one month follow-up
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Measured at pre-treatment, post-treatment, and one month follow-up
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Misure di risultato secondarie
Misura del risultato |
Lasso di tempo |
|---|---|
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Screen for Child Anxiety Related Disorders (SCARED) - Child Version
Lasso di tempo: Measured at pre-treatment, post-treatment, and one month follow-up
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Measured at pre-treatment, post-treatment, and one month follow-up
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Collaboratori e investigatori
Sponsor
Collaboratori
Investigatori
- Investigatore principale: Golda Ginsburg, PhD, Johns Hopkins School of Medicine
Pubblicazioni e link utili
Pubblicazioni generali
- Ginsburg, G. S., Becker, K. D., Kingery, J.,and Nichols, T. (2008). Transporting CBT for childhood anxiety disorders into inner city school-based mental health clinics. Cognitive and Behavioral Practice, 15, 148-158.
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- R34MH074552 (Sovvenzione/contratto NIH degli Stati Uniti)
- DSIR 84-CTS (Division of Services and Intervention Research)
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .